Educating anesthesia residents to obtain and document informed consent for epidural labor analgesia: does simulation play a role?

PubMed

Antoniou, A; Marmai, K; Qasem, F; Cherry, R; Jones, P M; Singh, S

2018-05-01

Informed consent is required before placing an epidural. At our hospital, teaching of residents about this is done informally at the bedside. This study aimed to assess the ability of anesthesia residents to acquire and retain knowledge required when seeking informed consent for epidural labor analgesia. It assessed how well this knowledge was translated to clinical ability, by assessing the verbal consent process during an interaction with a standardized patient. Twenty anesthesia residents were randomized to a 'didactic group' or a 'simulation group'. Each resident was presented with a written scenario and asked to document the informed consent process, as they normally would do (pre-test). The didactic group then had a presentation about informed consent, while the simulation group members interviewed a simulated patient, the scenarios focusing on different aspects of consent. All residents then read a scenario and documented their informed consent process (post-test). Six weeks later all residents interviewed a standardized patient in labor and documented the consent from this interaction (six-week test). There was no significant difference in the baseline performance of the two groups. Both groups showed significant improvement in their written consent documentation at the immediate time point, the improvement in the didactic group being greater. The didactic group performed better at both the immediate time point and the six-week time point. In this small study, a didactic teaching method proved better than simulation-based teaching in helping residents to gain knowledge needed to obtain informed consent for epidural labor analgesia. Copyright © 2017 Elsevier Ltd. All rights reserved.

Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department.

PubMed

Spencer, Sandra P; Stoner, Michael J; Kelleher, Kelly; Cohen, Daniel M

2015-08-01

Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings. The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice. This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation. One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections. Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.

Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

PubMed Central

Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

2016-01-01

Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face-to-face consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials. PMID:26990899

Informed consent for clinical trials: in search of the "best" method.

PubMed

Edwards, S J; Lilford, R J; Thornton, J; Hewison, J

1998-12-01

To review the literature on comparisons between different methods of obtaining informed consent for clinical trials. Eight hundred and twelve articles were traced, in the process of conducting a systematic review of the ethics of clinical trials, by searching a number of sources: bibliographic databases (Medline, Psychlit and BIDS science and social science indices), hand searches, personal contacts, an original collection and a systematic follow-up of reference lists. Fourteen research reports were found which provided comparative data on different methods of obtaining informed consent. Eleven of these used a randomised design. Studies were classified according to three outcome measures (anxiety, consent rate and understanding). The results of the various studies suggest that giving people more information and more time to reflect tends to be associated with a lower consent rate. There seems to be an optimal level of information about side-effects such that patients are not overburdened by detail, while grasping the most important risks. More information in general is associated with greater awareness of the research nature of the trial, voluntariness of participation, right to withdraw and (available) alternative treatments. This result does not, however, extend to explanations of the concept of randomisation on which the literature is contradictory--sometimes more information is associated with increased understanding of the concept and sometimes it is not. Although divulging less information seems to be associated with less anxiety, there is evidence of an interaction with knowledge--high levels of knowledge are significantly associated with less anxiety, irrespective of consent method. The more that patients know before they are invited to participate in a trial, the better equipped they are to cope with the informed consent procedure. There is some evidence to suggest that there is an optimal amount of information which enhances patient understanding and which might, in turn, reduce anxiety. However. the studies were not altogether conclusive. More work needs to be carried out, especially on public understanding of science and on how different ways of explaining scientific concepts affect that understanding.

Informed consent: clinical and legal issues in family practice.

PubMed

Searight, H R; Barbarash, R A

1994-04-01

While patient informed consent is an important clinical and legal dimension of specialty medical care, many important issues arise in primary care. Family physicians are in a unique position to implement informed consent discussions in the ethical spirit in which the doctrine was intended. Because of their long-term relationships with patients and sensitivity to psychosocial issues, family physicians can engage patients in collaborative health care decision making. Primary care physicians are optimally suited to assess patients' understanding of medical information and their competence. Instead of viewing the informed consent process simply as a necessary legal requirement, it should be a method for educating patients and allowing them to participate in their health care decision making.

Measuring the Process and Quality of Informed Consent for Clinical Research: Development and Testing

PubMed Central

Cohn, Elizabeth Gross; Jia, Haomiao; Smith, Winifred Chapman; Erwin, Katherine; Larson, Elaine L.

2013-01-01

Purpose/Objectives To develop and assess the reliability and validity of an observational instrument, the Process and Quality of Informed Consent (P-QIC). Design A pilot study of the psychometrics of a tool designed to measure the quality and process of the informed consent encounter in clinical research. The study used professionally filmed, simulated consent encounters designed to vary in process and quality. Setting A major urban teaching hospital in the northeastern region of the United States. Sample 63 students enrolled in health-related programs participated in psychometric testing, 16 students participated in test-retest reliability, and 5 investigator-participant dyads were observed for the actual consent encounters. Methods For reliability and validity testing, students watched and rated videotaped simulations of four consent encounters intentionally varied in process and content and rated them with the proposed instrument. Test-retest reliability was established by raters watching the videotaped simulations twice. Inter-rater reliability was demonstrated by two simultaneous but independent raters observing an actual consent encounter. Main Research Variables The essential elements of information and communication for informed consent. Findings The initial testing of the P-QIC demonstrated reliable and valid psychometric properties in both the simulated standardized consent encounters and actual consent encounters in the hospital setting. Conclusions The P-QIC is an easy-to-use observational tool that provides a quick assessment of the areas of strength and areas that need improvement in a consent encounter. It can be used in the initial trainings of new investigators or consent administrators and in ongoing programs of improvement for informed consent. Implications for Nursing The development of a validated observational instrument will allow investigators to assess the consent process more accurately and evaluate strategies designed to improve it. PMID:21708532

Informed consent in neurosurgery—translating ethical theory into action

PubMed Central

Schmitz, Dagmar; Reinacher, Peter C

2006-01-01

Objective Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. Methods By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. Results The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. Conclusion To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent. PMID:16943326

Email-Based Informed Consent: Innovative Method for Reaching Large Numbers of Subjects for Data Mining Research

NASA Technical Reports Server (NTRS)

Lee, Lesley R.; Mason, Sara S.; Babiak-Vazquez, Adriana; Ray, Stacie L.; Van Baalen, Mary

2015-01-01

Since the 2010 NASA authorization to make the Life Sciences Data Archive (LSDA) and Lifetime Surveillance of Astronaut Health (LSAH) data archives more accessible by the research and operational communities, demand for data has greatly increased. Correspondingly, both the number and scope of requests have increased, from 142 requests fulfilled in 2011 to 224 in 2014, and with some datasets comprising up to 1 million data points. To meet the demand, the LSAH and LSDA Repositories project was launched, which allows active and retired astronauts to authorize full, partial, or no access to their data for research without individual, study-specific informed consent. A one-on-one personal informed consent briefing is required to fully communicate the implications of the several tiers of consent. Due to the need for personal contact to conduct Repositories consent meetings, the rate of consenting has not kept up with demand for individualized, possibly attributable data. As a result, other methods had to be implemented to allow the release of large datasets, such as release of only de-identified data. However the compilation of large, de-identified data sets places a significant resource burden on LSAH and LSDA and may result in diminished scientific usefulness of the dataset. As a result, LSAH and LSDA worked with the JSC Institutional Review Board Chair, Astronaut Office physicians, and NASA Office of General Counsel personnel to develop a "Remote Consenting" process for retrospective data mining studies. This is particularly useful since the majority of the astronaut cohort is retired from the agency and living outside the Houston area. Originally planned as a method to send informed consent briefing slides and consent forms only by mail, Remote Consenting has evolved into a means to accept crewmember decisions on individual studies via their method of choice: email or paper copy by mail. To date, 100 emails have been sent to request participation in eight HRP-funded studies. The development of the Remote Consent process, the laws allowing transmission of consent via electronic means, total metrics to date, and remaining challenges (e.g., response issues, use of International Partner data, biospecimens/genetic data) for the research use of LSAH/LSDA data will be described.

Use of Multimedia Technology in the Doctor-Patient Relationship for Obtaining Patient Informed Consent.

PubMed

Michalski, Andrzej; Stopa, Marcin; Miśkowiak, Bogdan

2016-10-26

Patient informed consent for surgery or for high-risk methods of treatment or diagnosis means that unlawful breach of the patient's personal interests is avoided and the patient accepts the risk of surgery and takes the brunt of it. Patient awareness - their knowledge of the condition and circumstances of continued therapeutic procedure, including offered and available methods of treatment and their possible complications - constitutes a particular aspect of the informed-consent process. The rapid development of technologies and methods of treatment may cause communication problems between the doctor and the patient regarding the scope and method of patient education prior to surgery. The use of multimedia technology (e.g., videos of surgical procedures, computer animation, and graphics), in addition to media used in preoperative patient education, may be a factor in improving the quality of the informed consent process. Studies conducted in clinical centers show that with use of multimedia technology, patients remember more of the information presented. The use of new technology also makes it possible to reduce the difference in the amount of information assimilated by patients with different levels of education. The use of media is a way to improve the quality of preoperative patient education and, at the same time, a step towards their further empowerment in the healing process.

A randomized trial comparing concise and standard consent forms in the START trial

PubMed Central

Touloumi, Giota; Walker, A. Sarah; Smolskis, Mary; Sharma, Shweta; Babiker, Abdel G.; Pantazis, Nikos; Tavel, Jorge; Florence, Eric; Sanchez, Adriana; Hudson, Fleur; Papadopoulos, Antonios; Emanuel, Ezekiel; Clewett, Megan; Munroe, David; Denning, Eileen

2017-01-01

Background Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed. Methods We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin). Results 77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups. Conclusions An easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient. Trial registration Informed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12 PMID:28445471

Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

PubMed Central

Vučemilo, Luka; Borovečki, Ana

2015-01-01

Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

Informed Consent for Case Reports

PubMed Central

Levine, Stephen B.; Stagno, Susan J.

2001-01-01

A new international standard of editorial policy calls for written informed consent by the subject of every case report. Although this appears to be ethically appealing, the authors posit that in some situations, requesting informed consent may be unethical, can harm patients, and may erode the use of case reports as a valuable teaching method in psychiatry and psychotherapy. The authors discuss concerns regarding this new policy for mental health publication based on issues of transference, countertransference, best interest of the patient, and practicality. PMID:11402083

Enhancing the informed consent process in psychiatric outpatients with a brief computer-based method.

PubMed

Morán-Sánchez, Inés; Luna, Aurelio; Pérez-Cárceles, Maria D

2016-11-30

Informed consent is a key element of ethical clinical research. Those with mental disorders may be at risk for impaired consent capacity. Problems with procedures may also contribute to patient's ´difficulties in understanding consent forms. The present investigation explores if a brief technologically based information presentation of the informed consent process may enhance psychiatric patients understanding and satisfaction. In this longitudinal, within-participants comparison study, patients who initially were judged to lack capacity to make research decisions (n=41) and a control group (n=47) were followed up. Decisional capacity, willingness to participate and cognitive and clinical scores were assessed at baseline and after receiving the computer-assisted enhanced consent. With sufficient cueing, patients with impaired research-related decision-making capacity at baseline were able to display enough understanding of the consent form. Patient satisfaction and willingness to participate also increased at follow up. Implications of these results for clinical practice and medical research involving people with mental disorders are discussed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Multimedia patient education to assist the informed consent process for knee arthroscopy.

PubMed

Cornoiu, Andrei; Beischer, Andrew D; Donnan, Leo; Graves, Stephen; de Steiger, Richard

2011-03-01

In contemporary clinical practice, the ability for orthopaedic surgeons to obtain true 'informed consent' is becoming increasingly difficult. This problem has been driven by factors including increased expectations of surgical outcome by patients and increasing complexity of surgical procedures. Surgical pamphlets and computer presentations have been advocated as ways of improving patient education, but evidence of their efficacy is limited. The aim of this study was to compare the efficacy of a computer-based multimedia (MM) presentation against standardized verbal consent and information pamphlets for patients considering knee arthroscopy surgery. A randomized, controlled prospective trial was conducted, comparing the efficacy of three methods of providing preoperative informed consent information to patients. Sixty-one patients were randomly allocated into MM, verbal consent or pamphlet groups 3-6 weeks prior to knee arthroscopy surgery. Information recall after the initial consent process was assessed by questionnaire. Retention of this information was again assessed by questionnaire at the time of surgery and 6 weeks after surgery. The MM group demonstrated a significantly greater proportion of correct responses, 98%, in the questionnaire at the time of consent, in comparison with 88% for verbal and 76% for pamphlet groups, with no difference in anxiety levels. Information was also better retained by the MM group up to 6 weeks after surgery. Patient satisfaction with information delivery was higher in the MM group. MM is an effective tool for aiding in the provision and retention of information during the informed consent process. © 2010 The Authors. ANZ Journal of Surgery © 2010 Royal Australasian College of Surgeons.

[Schizophrenia and informed consent to research].

PubMed

Fovet, T; Amad, A; Thomas, P; Jardri, R

2015-10-01

Informed consent to research remains a complex issue, while sometimes staying difficult to obtain, even in the general population. This problem may be maximized with patients suffering from schizophrenia. This paper summarizes available data in the literature about informed consent for research involving patients suffering from schizophrenia. Medline and Google Scholar searches were conducted using the following MESH terms: schizophrenia, informed consent and research. Studies using dedicated standardized scales (e.g. MacCAT-CR) revealed a decrease in the capacity to consent of patients with schizophrenia when compared with healthy individuals. Keeping in mind that schizophrenia is an heterogeneous disorder, patients with the lowest insight as well as those with the most severe cognitive symptoms appeared more impaired in their capacity to consent. Such a poor capacity to understand and consent to trials was shown linked with alterations in decision-making. For these specific patients, interventions may be set up to increase their capacity to consent. Various strategies were proposed: enhanced consent forms, extended discussion, test/feedback method or multimedia interventions. Among them, interventions relying on communication and the growing field of information technologies (e.g. web-based tools) seem promising. Finally, associations grouping families and patients (like the French Association UNAFAM) may facilitate the involvement of patients in research programs with safer conditions. Patients suffering from schizophrenia appear able to consent to research programs when suitable interventions are proposed. Further studies are now needed to optimize and individualize such interventions. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

A Randomized Study of a Method for Optimizing Adolescent Assent to Biomedical Research

PubMed Central

Annett, Robert D.; Brody, Janet L.; Scherer, David G.; Turner, Charles W.; Dalen, Jeanne; Raissy, Hengameh

2018-01-01

Purpose Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Methods Families were randomly assigned to remain together or separated during a consent/assent process, the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Results 64 adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. Conclusions The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent’s informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a “diffusion of responsibility” effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits. PMID:28949898

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

PubMed Central

Bleiberg, H.; Decoster, G.; de Gramont, A.; Rougier, P.; Sobrero, A.; Benson, A.; Chibaudel, B.; Douillard, J. Y.; Eng, C.; Fuchs, C.; Fujii, M.; Labianca, R.; Larsen, A. K.; Mitchell, E.; Schmoll, H. J.; Sprumont, D.; Zalcberg, J.

2017-01-01

Background In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results A simplified form of informed consent with the leading part of 1200–1800 words containing all of the key information necessary to meet ethical and regulatory requirements and ‘relevant supportive information appendix’ of 2000–3000 words is provided. Conclusions This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. PMID:28453700

Survey of risks and benefits communication strategies by research nurses.

PubMed

Nusbaum, Lika; Douglas, Brenda; Estrella-Luna, Neenah; Paasche-Orlow, Michael; Damus, Karla

2017-01-01

An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? A survey was developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Ethical considerations: Participants were instructed they need not answer each question and could stop at any time. They consented by clicking "accept" on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process.

Use of Multimedia Technology in the Doctor-Patient Relationship for Obtaining Patient Informed Consent

PubMed Central

Michalski, Andrzej; Stopa, Marcin; Miśkowiak, Bogdan

2016-01-01

Patient informed consent for surgery or for high-risk methods of treatment or diagnosis means that unlawful breach of the patient’s personal interests is avoided and the patient accepts the risk of surgery and takes the brunt of it. Patient awareness – their knowledge of the condition and circumstances of continued therapeutic procedure, including offered and available methods of treatment and their possible complications – constitutes a particular aspect of the informed-consent process. The rapid development of technologies and methods of treatment may cause communication problems between the doctor and the patient regarding the scope and method of patient education prior to surgery. The use of multimedia technology (e.g., videos of surgical procedures, computer animation, and graphics), in addition to media used in preoperative patient education, may be a factor in improving the quality of the informed consent process. Studies conducted in clinical centers show that with use of multimedia technology, patients remember more of the information presented. The use of new technology also makes it possible to reduce the difference in the amount of information assimilated by patients with different levels of education. The use of media is a way to improve the quality of preoperative patient education and, at the same time, a step towards their further empowerment in the healing process. PMID:27780964

Public Preferences Regarding Informed Consent Models for Participation in Population-based Genomic Research

PubMed Central

Platt, Jodyn; Bollinger, Juli; Dvoskin, Rachel; Kardia, Sharon LR; Kaufman, David

2013-01-01

Purpose Some large population biobanks that house biospecimens and health information for research seek broad consent from participants, while others re-consent for specific new studies. Understanding research participants’ attitudes and preferences about broad and narrow consent may improve recruitment, retention, and public support. Methods An online survey was conducted among a representative sample of 4,659 US adults to examine relationships between consent preferences and demographic factors, beliefs about privacy, the value of research, and the perceived trustworthiness of researchers. Results Participants preferred broad consent (52%) over study-by-study consent models (48%). Higher preferences for study-by-study consent observed among Black non-Hispanic respondents, and respondents with lower income and education were explained by differences in the prevalence of one or more beliefs about the study. Respondents with fears about research and those that would feel respected if asked for permission for each research use preferred study-by-study consent. Preference for broad consent was related to the desire not to be bothered with multiple requests and the belief that the study could lead to improved treatments, cures, and lives saved. Conclusion These data suggest that support for broad consent is contingent on sufficient information about data use. Work with research participants and community leaders to understand, respond to, and influence opinions about a given, ongoing study may improve uptake of broad consent. PMID:23660530

Audio-visual presentation of information for informed consent for participation in clinical trials.

PubMed

Synnot, Anneliese; Ryan, Rebecca; Prictor, Megan; Fetherstonhaugh, Deirdre; Parker, Barbara

2014-05-09

Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented, for example, on the Internet or on DVD) are one such method. We updated a 2008 review of the effects of these interventions for informed consent for trial participation. To assess the effects of audio-visual information interventions regarding informed consent compared with standard information or placebo audio-visual interventions regarding informed consent for potential clinical trial participants, in terms of their understanding, satisfaction, willingness to participate, and anxiety or other psychological distress. We searched: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 6, 2012; MEDLINE (OvidSP) (1946 to 13 June 2012); EMBASE (OvidSP) (1947 to 12 June 2012); PsycINFO (OvidSP) (1806 to June week 1 2012); CINAHL (EbscoHOST) (1981 to 27 June 2012); Current Contents (OvidSP) (1993 Week 27 to 2012 Week 26); and ERIC (Proquest) (searched 27 June 2012). We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. We included randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or verbal information), with standard forms of information provision or placebo audio-visual information, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to consider participating in a real or hypothetical clinical study. (In the earlier version of this review we only included studies evaluating informed consent interventions for real studies). Two authors independently assessed studies for inclusion and extracted data. We synthesised the findings using meta-analysis, where possible, and narrative synthesis of results. We assessed the risk of bias of individual studies and considered the impact of the quality of the overall evidence on the strength of the results. We included 16 studies involving data from 1884 participants. Nine studies included participants considering real clinical trials, and eight included participants considering hypothetical clinical trials, with one including both. All studies were conducted in high-income countries.There is still much uncertainty about the effect of audio-visual informed consent interventions on a range of patient outcomes. However, when considered across comparisons, we found low to very low quality evidence that such interventions may slightly improve knowledge or understanding of the parent trial, but may make little or no difference to rate of participation or willingness to participate. Audio-visual presentation of informed consent may improve participant satisfaction with the consent information provided. However its effect on satisfaction with other aspects of the process is not clear. There is insufficient evidence to draw conclusions about anxiety arising from audio-visual informed consent. We found conflicting, very low quality evidence about whether audio-visual interventions took more or less time to administer. No study measured researcher satisfaction with the informed consent process, nor ease of use.The evidence from real clinical trials was rated as low quality for most outcomes, and for hypothetical studies, very low. We note, however, that this was in large part due to poor study reporting, the hypothetical nature of some studies and low participant numbers, rather than inconsistent results between studies or confirmed poor trial quality. We do not believe that any studies were funded by organisations with a vested interest in the results. The value of audio-visual interventions as a tool for helping to enhance the informed consent process for people considering participating in clinical trials remains largely unclear, although trends are emerging with regard to improvements in knowledge and satisfaction. Many relevant outcomes have not been evaluated in randomised trials. Triallists should continue to explore innovative methods of providing information to potential trial participants during the informed consent process, mindful of the range of outcomes that the intervention should be designed to achieve, and balancing the resource implications of intervention development and delivery against the purported benefits of any intervention.More trials, adhering to CONSORT standards, and conducted in settings and populations underserved in this review, i.e. low- and middle-income countries and people with low literacy, would strengthen the results of this review and broaden its applicability. Assessing process measures, such as time taken to administer the intervention and researcher satisfaction, would inform the implementation of audio-visual consent materials.

Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision.

PubMed

Allen, Ashleigh A; Chen, Donna T; Bonnie, Richard J; Ko, Tomohiro M; Suratt, Colleen E; Lee, Joshua D; Friedmann, Peter D; Gordon, Michael; McDonald, Ryan; Murphy, Sean M; Boney, Tamara Y; Nunes, Edward V; O'Brien, Charles P

2017-10-01

Concerns persist that individuals with substance use disorders who are under community criminal justice supervision experience circumstances that might compromise their provision of valid, informed consent for research participation. These concerns include the possibilities that desire to obtain access to treatment might lead individuals to ignore important information about research participation, including information about risks, or that cognitive impairment associated with substance use might interfere with attending to important information. We report results from a consent quiz (CQ) administered in a multisite randomized clinical trial of long-acting naltrexone to prevent relapse to opioid use disorder among adults under community criminal justice supervision-a treatment option difficult to access by this population of individuals. Participants were required to answer all 11 items correctly before randomization. On average, participants answered 9.8 items correctly (89%) at baseline first attempt (n=306). At week 21 (n=212), participants scored 87% (9.5 items correct) without review. Performance was equivalent to, or better than, published results from other populations on a basic consent quiz instrument across multiple content domains. The consent quiz is an efficient method to screen for adequate knowledge of consent information as part of the informed consent process. Clinical researchers who are concerned about these issues should consider using a consent quiz with corrected feedback to enhance the informed consent process. Overall, while primarily useful as an educational tool, employing a CQ as part of the gateway to participation in research may be particularly important as the field continues to advance and tests novel experimental treatments with significant risks and uncertain potential for benefit. Copyright © 2017. Published by Elsevier Inc.

Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India

PubMed Central

Joglekar, Neelam S.; Deshpande, Swapna S.; Sahay, Seema; Ghate, Manisha V.; Bollinger, Robert C.; Mehendale, Sanjay M.

2013-01-01

Background Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India. Methods As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the ‘optimal comprehension group’, whilst those scoring 80–89% were categorised into the ‘lower comprehension group’. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension. Results The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71–11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42–28.55), illiteracy (AOR= 1.65, 95% CI 1.19–2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12–2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01–1.82) were more likely to have lower consent comprehension. Conclusions We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants. PMID:24029848

Effectiveness of Visual Methods in Information Procedures for Stem Cell Recipients and Donors

PubMed Central

Sarıtürk, Çağla; Gereklioğlu, Çiğdem; Korur, Aslı; Asma, Süheyl; Yeral, Mahmut; Solmaz, Soner; Büyükkurt, Nurhilal; Tepebaşı, Songül; Kozanoğlu, İlknur; Boğa, Can; Özdoğu, Hakan

2017-01-01

Objective: Obtaining informed consent from hematopoietic stem cell recipients and donors is a critical step in the transplantation process. Anxiety may affect their understanding of the provided information. However, use of audiovisual methods may facilitate understanding. In this prospective randomized study, we investigated the effectiveness of using an audiovisual method of providing information to patients and donors in combination with the standard model. Materials and Methods: A 10-min informational animation was prepared for this purpose. In total, 82 participants were randomly assigned to two groups: group 1 received the additional audiovisual information and group 2 received standard information. A 20-item questionnaire was administered to participants at the end of the informational session. Results: A reliability test and factor analysis showed that the questionnaire was reliable and valid. For all participants, the mean overall satisfaction score was 184.8±19.8 (maximum possible score of 200). However, for satisfaction with information about written informed consent, group 1 scored significantly higher than group 2 (p=0.039). Satisfaction level was not affected by age, education level, or differences between the physicians conducting the informative session. Conclusion: This study shows that using audiovisual tools may contribute to a better understanding of the informed consent procedure and potential risks of stem cell transplantation. PMID:27476890

Interactive multimedia consent for biobanking: A randomized trial

PubMed Central

Simon, Christian M.; Klein, David W.; Schartz, Helen A.

2015-01-01

Purpose Interactive multimedia’s potential to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence of understanding of informed consent, compared to a standard, face-to-face (F2F) biobank consent process. Methods A 2 (F2F versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the Biobank’s 9-page consent document. Results Interactivity (F(1,196)=7.56, p=0.007, partial η2=0.037) and Media (F(1,196)=4.27, p=0.04, partial η2=0.021) independently improved participants’ understanding of the Biobank consent. Interactivity (F(1,196) = 6.793, p = 0.01, partial η2=0.033), but not Media (F(1,196) = 0.455, n.s.), resulted in increased participant confidence in their understanding of the Biobank’s consent. Patients took more time to complete the multimedia (M=18.2 min.) than the F2F (M=12.6 min.) conditions. Conclusion This study demonstrated that interactivity and multimedia each can be effective at promoting individuals’ understanding and confidence in understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather separate the two constructs when studying electronic consent. PMID:25834945

Alternatives to project-specific consent for access to personal information for health research: Insights from a public dialogue

PubMed Central

Willison, Donald J; Swinton, Marilyn; Schwartz, Lisa; Abelson, Julia; Charles, Cathy; Northrup, David; Cheng, Ji; Thabane, Lehana

2008-01-01

Background The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. Methods We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Results Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Conclusion Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research. PMID:19019239

Active choice but not too active: Public perspectives on biobank consent models

PubMed Central

Simon, Christian M.; L’Heureux, Jamie; Murray, Jeffrey C.; Winokur, Patricia; Weiner, George; Newbury, Elizabeth; Shinkunas, Laura; Zimmerman, Bridget

2013-01-01

Purpose Despite important recent work, US public attitudes toward specific biobank consent models are not well understood. Public opinion data can help shape efforts to develop ethically sound and publicly trusted mechanisms for informing and consenting prospective biobank donors. The purpose of this study was to explore public perspectives toward a range of consent models currently being used or considered for use among comprehensive US biobanks. Methods The study used an exploratory mixed-methods design, using focus groups and telephone surveys. Eligible participants were English-speaking residents in the catchment area of a comprehensive biobank being developed at the University of Iowa. Results Forty-eight participants in seven focus groups and 751 survey participants were recruited. Biobanks were unfamiliar to almost all study participants but were seen as valuable resources. Most focus group (63%) and survey (67%) participants preferred a prospective opt-in over an opt-out consent approach. Broad, research-unspecific consent was preferred over categorical and study-specific consent models for purposes of approving future research use. Conclusion Many individuals may want to make an active and informed choice at the point of being approached for biobank participation but are prepared to consent broadly to future research use and to forego additional choices as a result. PMID:21555942

Challenges of Obtaining Informed Consent in Emergency Ward: A Qualitative Study in One Iranian Hospital

PubMed Central

Davoudi, Nayyereh; Nayeri, Nahid Dehghan; Zokaei, Mohammad Saeed; Fazeli, Nematallah

2017-01-01

Background and Objective: Regarding the fact that emergency ward has unique characteristics, whose uniqueness affects informed consent processes by creating specific challenges. Hence, it seems necessary to identify the process and challenges of informed consent in the emergency ward through a qualitative study to understand actual patients’ and health care providers’ experiences, beliefs, values, and feelings about the informed consent in the emergency ward. Through such studies, new insight can be gained on the process of informed consent and its challenges with the hope that the resulting knowledge will enable the promotion of ethical, legal as well as effective health services to the patients in the emergency ward. Method: In this qualitative study, research field was one of the emergency wards of educational and public hospitals in Iran. Field work and participant observation were carried out for 515 hours from June 2014 to March 2016. Also, conversations and semi-structured interviews based on the observations were conducted. The participants of the study were nurses and physicians working in the emergency ward, as well as patients and their attendants who were involved in the process of obtaining informed consent. Results: Three main categories were extracted from the data: a sense of frustration; reverse protection; and culture of paternalism in consent process. Conclusion: Findings of this study can be utilized in correcting the structures and processes of obtaining informed consent together with promotion of patients' ethical and legal care in emergency ward. In this way, the approaches in consent process will be changed from paternalistic approach to patient-centered care which concomitantly protects patient’s autonomy. PMID:29399235

Communication about the Risks and Benefits of Phase I Pediatric Oncology Trials

PubMed Central

Hazen, Rebecca A.; Zyzanski, Stephen; Baker, Justin; Drotar, Dennis; Kodish, Eric

2015-01-01

Introduction Phase 1 pediatric oncology trials offer only a small chance of direct benefit and may have significant risks and an impact on quality of life. To date, research has not examined discussions of risks and benefits during informed consent conferences for phase 1 pediatric oncology trials. The objective of the current study was to examine clinician and family communication about risks, benefits, and quality of life during informed consent conferences for phase 1 pediatric oncology trials. Methods Participants included clinician investigators, parents, and children recruited from 6 sites conducting phase 1 pediatric oncology trials. Eighty-five informed consent conferences were observed and audiotaped. Trained coders assessed discussions of risks, benefits, and quality of life. Types of risks discussed were coded (e.g., unanticipated risks, digestive system risks, death). Types of benefits were categorized as therapeutic (e.g. discussion of how participation may or may not directly benefit child), psychological, bridge to future trial, and altruism. Results Risks and benefits were discussed in 95% and 88% of informed consent conferences, respectively. Therapeutic benefit was the most frequently discussed benefit. The impact of trial participation on quality of life was discussed in the majority (88%) of informed consent conferences. Conclusion Therapeutic benefit, risks, and quality of life were frequently discussed. The range of information discussed during informed consent conferences suggests the need for considering a staged process of informed consent for phase 1 pediatric oncology trials. PMID:25638751

Informed consent for MRI and fMRI research: Analysis of a sample of Canadian consent documents

PubMed Central

2011-01-01

Background Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards. Methods We examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs). Results We found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites. Conclusion The causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions. PMID:21235768

EFFECTS OF DEPRESSION AND SOCIAL SUPPORT ON COMPREHENSION AND RECALL OF INFORMED CONSENT INFORMATION AMONG PARKINSON DISEASE PATIENTS AND THEIR CAREGIVERS*

PubMed Central

TENG, ELLEN J.; PETERSEN, NANCY J.; HARTMAN, CHRISTINE; MATTHIESEN, ELLEN; KALLEN, MICHAEL; COOK, KARON F.; FORD, MARVELLA E.

2014-01-01

Objective Relatively little attention has focused on the impact of psychiatric conditions on human subjects’ comprehension of consent information. The purpose of this randomized study was to determine whether depression affects comprehension and recall of informed consent information among persons with Parkinson's disease and their caregivers and to evaluate the effects of support on comprehension and recall during the consent process. Method Comprehension and recall of information were assessed using a modified version of the Modified Quality of Informed Consent Questionnaire, taken 1 week and 1 month later, and scored using a consensus-based algorithm. Participants also completed the Center for Epidemiologic Studies Depression Scale. Data analyses were conducted on 129 patients and caregivers (t-tests, Fisher's exact test, and ANCOVAs). Results T-tests showed no significant differences in comprehension and recall between depressed and nondepressed participants at 1 week and 1 month. However, ANCOVA showed patients with a support person present had significantly higher comprehension and recall at 1 week but not at 1 month compared with controls. Caregivers present with a patient had lower comprehension/recall than those without a patient present (p = 0.02). Conclusions Having a support person present during the informed consent process helps depressed PD patients better retain information in the short term, but effects diminish over the long term. Implications for interventions will be discussed. PMID:22641931

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting

PubMed Central

2014-01-01

Background Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. Results In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. Conclusion The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended. PMID:24885049

Consenting options for posthumous organ donation: presumed consent and incentives are not favored

PubMed Central

2012-01-01

Background Posthumous organ procurement is hindered by the consenting process. Several consenting systems have been proposed. There is limited information on public relative attitudes towards various consenting systems, especially in Middle Eastern/Islamic countries. Methods We surveyed 698 Saudi Adults attending outpatient clinics at a tertiary care hospital. Preference and perception of norm regarding consenting options for posthumous organ donation were explored. Participants ranked (1, most agreeable) the following, randomly-presented, options from 1 to 11: no-organ-donation, presumed consent, informed consent by donor-only, informed consent by donor-or-surrogate, and mandatory choice; the last three options ± medical or financial incentive. Results Mean(SD) age was 32(9) year, 27% were males, 50% were patients’ companions, 60% had ≥ college education, and 20% and 32%, respectively, knew an organ donor or recipient. Mandated choice was among the top three choices for preference of 54% of respondents, with an overall median[25%,75%] ranking score of 3[2,6], and was preferred over donor-or-surrogate informed consent (4[2,7], p < 0.001), donor-only informed consent (5[3,7], p < 0.001), and presumed consent (7[3,10], p < 0.001). The addition of a financial or medical incentive, respectively, reduced ranking of mandated choice to 7[4,9], p < 0.001, and 5[3,8], p < 0.001; for donor-or-surrogate informed consent to 7[5,9], p < 0.001, and 5[3,7], p = 0.004; and for donor-only informed consent to 8[6,10], p < 0.001, and 5[3,7], p = 0.56. Distribution of ranking score of perception of norm and preference were similar except for no-organ donation (11[7,11] vs. 11[6,11], respectively, p = 0.002). Compared to females, males more perceived donor-or-surrogate informed consent as the norm (3[1,6] vs. 5[3,7], p < 0.001), more preferred mandated choice with financial incentive option (6[3,8] vs. 8[4,9], p < 0.001), and less preferred mandated choice with medical incentive option (7[4,9] vs. 5[2,7], p < 0.001). There was no association between consenting options ranking scores and age, health status, education level, or knowing an organ donor or recipient. Conclusions We conclude that: 1) most respondents were in favor of posthumous organ donation, 2) mandated choice system was the most preferred and presumed consent system was the least preferred, 3) there was no difference between preference and perception of norm in consenting systems ranking, and 4) financial (especially in females) and medical (especially in males) incentives reduced preference. PMID:23173834

INFORMED CONSENT: THE MEDICAL AND LEGAL CHALLENGE OF OUR TIME

PubMed Central

Séllos Simões, Luiz Carlos

2015-01-01

Objective: To assess the real importance of obtaining informed consent, through an appropriate form, and its role in the outcome from civil liability claims. Methods: The wordings of the current Brazilian law and jurisprudence were compared with rulings from the State Court of the State of Rio de Janeiro, in 269 civil liability claims against healthcare professionals and hospitals. Results: Favorable and unfavorable outcomes (i.e. acquittals and convictions) were compared, and possible variations in the verdicts were discussed in relation to whether informed consent forms had been filled out or not. Conclusions: Obtaining informed consent, by means of appropriate forms, is still not a widespread practice in the Brazilian healthcare or judicial systems. It is recommended that this practice be adopted in the manner described in this paper, since this is prescribed in Brazilian law. PMID:27022541

Real-Time Captioning for Improving Informed Consent: Patient and Physician Benefits.

PubMed

Spehar, Brent; Tye-Murray, Nancy; Myerson, Joel; Murray, David J

2016-01-01

New methods are needed to improve physicians' skill in communicating information and to enhance patients' ability to recall that information. We evaluated a real-time speech-to-text captioning system that simultaneously provided a speech-to-text record for both patient and anesthesiologist. The goals of the study were to assess hearing-impaired patients' recall of an informed consent discussion about regional anesthesia using real-time captioning and to determine whether the physicians found the system useful for monitoring their own performance. We recorded 2 simulated informed consent encounters with hearing-impaired older adults, in which physicians described regional anesthetic procedures. The conversations were conducted with and without real-time captioning. Subsequently, the patient participants, who wore their hearing aids throughout, were tested on the material presented, and video recordings of the encounters were analyzed to determine how effectively physicians communicated with and without the captioning system. The anesthesiology residents provided similar information to the patient participants regardless of whether the real-time captioning system was used. Although the patients retained relatively few details regardless of the informed consent discussion, they could recall significantly more of the key points when provided with real-time captioning. Real-time speech-to-text captioning improved recall in hearing-impaired patients and proved useful for determining the information provided during an informed consent encounter. Real-time speech-to-text captioning could provide a method for assessing physicians' communication that could be used both for self-assessment and as an evaluative approach to training communication skills in practice settings.

Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.

PubMed

Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

2014-07-30

Informed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making. Potential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers. No differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial. To our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research. International Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN60695184 (date of registration: 13 May 2009), ISRCTN80061723 (date of registration: 8 March 2010), ISRCTN69423238 (date of registration: 18 November 2010).

Public preferences on written informed consent for low‐risk pragmatic clinical trials in Spain

PubMed Central

Carcas, Antonio J.; Carné, Xavier; Wendler, David

2017-01-01

Aims Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low‐risk pRCTs. The present study was designed to assess whether this view is specific to the US. Methods The study took the form of a cross‐sectional, probability‐based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low‐risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives. Results A total of 2008 adults sampled from a probability‐based online panel responded to the web‐based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7–37.1%) than the alternative of verbal consent (12.7–14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent. Conclusions The results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low‐risk pRCTs. PMID:28419518

Informed Consent Conversations and Documents: A Quantitative Comparison

PubMed Central

Koyfman, Shlomo A.; Reddy, Chandana A.; Hizlan, Sabahat; Leek, Angela C.; Kodish, Eric

2015-01-01

Background Informed consent for clinical research includes two components: informed consent documents (ICD) and informed consent conversations (ICC). Readability software has been used to help simplify the language of the ICD, but rarely employed to assess the language during the ICC, which may influence the quality of informed consent. This analysis was completed to determine if length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected use of simpler language and comprehensiveness. Methods Prospective study where ICCs were audio-recorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL) and Flesch Reading Ease Score (FRES) of ICCs were compared to corresponding ICDs, including the frequency that investigators addressed 8 pre-specified critical consent elements during the ICC. Results Sixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4,677 vs. 6,364; p=0.0016), had lower FKGL (6 vs. 9.7; p=<0.0001) and higher FRES (77.8 vs. 56.7; p<0.0001) than their respective ICDs, but were more likely to omit critical consent elements, such as voluntariness (55%) and dose limiting toxicities (26%). Years of investigator experience was not correlated with reliably covering critical elements or decreased linguistic complexity. Conclusions Clinicians use more understandable language during ICCs than the corresponding ICD, but less reliably cover elements critical to fully informed consent. Focused efforts at providing communication training for clinician-investigators should be done to optimize the synergy between the ICD and conversation. PMID:26505269

Informed consent and the readability of the written consent form.

PubMed

Sivanadarajah, N; El-Daly, I; Mamarelis, G; Sohail, M Z; Bates, P

2017-11-01

Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Elements of informed consent. 50.25 Section 50.25... OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to...

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project—study protocol for a nationwide prospective cohort study

PubMed Central

Kortram, Kirsten; Spoon, Emerentia Q W; Ismail, Sohal Y; d'Ancona, Frank C H; Christiaans, Maarten H L; van Heurn, L W Ernest; Hofker, H Sijbrand; Hoksbergen, Arjan W J; Homan van der Heide, Jaap J; Idu, Mirza M; Looman, Caspar W N; Nurmohamed, S Azam; Ringers, Jan; Toorop, Raechel J; van de Wetering, Jacqueline; Ijzermans, Jan N M; Dor, Frank J M F

2016-01-01

Introduction Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. Methods and analysis The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. Ethics and dissemination Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. Results Outcome will be published in a scientific journal. Trial registration number NTR5374; Pre-results. PMID:27036141

Development and pilot testing of an informed consent video for patients with limb trauma prior to debridement surgery using a modified Delphi technique.

PubMed

Lin, Yen-Ko; Chen, Chao-Wen; Lee, Wei-Che; Lin, Tsung-Ying; Kuo, Liang-Chi; Lin, Chia-Ju; Shi, Leiyu; Tien, Yin-Chun; Cheng, Yuan-Chia

2017-11-29

Ensuring adequate informed consent for surgery in a trauma setting is challenging. We developed and pilot tested an educational video containing information regarding the informed consent process for surgery in trauma patients and a knowledge measure instrument and evaluated whether the audiovisual presentation improved the patients' knowledge regarding their procedure and aftercare and their satisfaction with the informed consent process. A modified Delphi technique in which a panel of experts participated in successive rounds of shared scoring of items to forecast outcomes was applied to reach a consensus among the experts. The resulting consensus was used to develop the video content and questions for measuring the understanding of the informed consent for debridement surgery in limb trauma patients. The expert panel included experienced patients. The participants in this pilot study were enrolled as a convenience sample of adult trauma patients scheduled to receive surgery. The modified Delphi technique comprised three rounds over a 4-month period. The items given higher scores by the experts in several categories were chosen for the subsequent rounds until consensus was reached. The experts reached a consensus on each item after the three-round process. The final knowledge measure comprising 10 questions was developed and validated. Thirty eligible trauma patients presenting to the Emergency Department (ED) were approached and completed the questionnaires in this pilot study. The participants exhibited significantly higher mean knowledge and satisfaction scores after watching the educational video than before watching the video. Our process is promising for developing procedure-specific informed consent and audiovisual aids in medical and surgical specialties. The educational video was developed using a scientific method that integrated the opinions of different stakeholders, particularly patients. This video is a useful tool for improving the knowledge and satisfaction of trauma patients in the ED. The modified Delphi technique is an effective method for collecting experts' opinions and reaching a consensus on the content of educational materials for informed consent. Institutions should prioritize patient-centered health care and develop a structured informed consent process to improve the quality of care. The ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study

PubMed Central

2013-01-01

Background Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. Methods The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. Results The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001). Conclusions This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery. PMID:24564932

Informed Consent for Interventional Radiology Procedures: A Survey Detailing Current European Practice

DOE Office of Scientific and Technical Information (OSTI.GOV)

O'Dwyer, H.M.; Lyon, S.M.; Fotheringham, T.

Purpose: Official recommendations for obtaining informed consent for interventional radiology procedures are that the patient gives their consent to the operator more than 24 hr prior to the procedure. This has significant implications for interventional radiology practice. The purpose of this study was to identify the proportion of European interventional radiologists who conform to these guidelines. Methods: A questionnaire was designed consisting of 12 questions on current working practice and opinions regarding informed consent. These questions related to where, when and by whom consent was obtained from the patient. Questions also related to the use of formal consent forms andmore » written patient information leaflets. Respondents were asked whether they felt patients received adequate explanation regarding indications for intervention,the procedure, alternative treatment options and complications. The questionnaire was distributed to 786 European interventional radiologists who were members of interventional societies. The anonymous replies were then entered into a database and analyzed. Results: Two hundred and fifty-four (32.3%) questionnaires were returned. Institutions were classified as academic (56.7%),non-academic (40.5%) or private (2.8%). Depending on the procedure,in a significant proportion of patients consent was obtained in the outpatient department (22%), on the ward (65%) and in the radiology day case ward (25%), but in over half (56%) of patients consent or re-consent was obtained in the interventional suite. Fifty percent of respondents indicated that they obtain consent more than 24 hr before some procedures, in 42.9% consent is obtained on the morning of the procedure and 48.8% indicated that in some patients consent is obtained immediately before the procedure. We found that junior medical staff obtained consent in 58% of cases. Eighty-two percent of respondents do not use specific consent forms and 61% have patient information leaflets. The majority of respondents were satisfied with their level of explanation regarding indications for treatment (69.3%) and the procedure (78.7%). Fifty-nine percent felt patients understood alternative treatment options. Only 37.8% of radiologists document possible complications in the patient's chart. Comments from respondents indicated that there is insufficient time for radiologists to obtain consent in all patients. Suggestions to improve current local policies included developing the role of radiology nursing staff and the use of radiology outpatient clinics. Conclusions: More than 50% of respondents are unhappy with their policies for obtaining informed consent. Interventional societies have a role to play in advocating formal consent guidelines.« less

Evaluating the Readibility of Informed Consent Forms Available Before Anaesthesia: A Comparative Study

PubMed Central

Boztaş, Nilay; Özbilgin, Şule; Öçmen, Elvan; Altuntaş, Gözde; Özkardeşler, Sevda; Hancı, Volkan; Günerli, Ali

2014-01-01

Objective Informed consent forms that are used prior to administering anaesthesia inform patients before any proposed surgical procedure or treatment. They should provide patients with sufficient information about the operation and treatment. Readibility refers to whether it is easy or hard for a reader to read and understand an available text, and this is evaluated via various formulas. The aim of this study was to evaluate the readability of different informed consent forms commonly used in the anaesthesiology departments of different hospitals in our country using different readability formulas. Methods After obtaining ethics committee approval, the readability of different consent forms used in the anaesthesiology departments of university hospitals (n=15), Ministry of Health (MOH) education and research hospitals (n=15), and public hospitals (n=15) was analysed. Each consent form was displayed electronically in “Microsoft Word” and the number of words contained was counted automatically. The first 100 words on the first page of the forms were evaluated using the Gunning Fog, Flesch-Kincaid and Ateşman readability formulations. The rate of medical terms detected within these 100 words was determined as a percentage (%). Results Different consent forms obtained from 45 anaesthesia departments were assessed using various readability formulas. According to the Gunning Fog index, the readability of the consent forms obtained from MOH education and research and public hospitals was relatively low. The Flesch-Kincaid index measured very low levels of readability in all institutions. The Ateşman index displayed very low readability levels for the consent forms used in university hospitals, and low levels in other institutions. Conclusion We conclude that the readability of the anaesthesia informed consent forms is low. The level of education in our country should be considered in the preparation of anaesthesia consent forms. We believe that physicians should pay more attention to this medical and legal issue. PMID:27366408

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

PubMed Central

2013-01-01

Background Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Conclusions Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons. PMID:23879694

Architecture of a consent management suite and integration into IHE-based regional health information networks

PubMed Central

2011-01-01

Background The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Methods Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. Results The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are stored in a CDA document to be transferred to the first service. Three workflows have to be considered to integrate the suite into the PEHR: recording the consent, publishing documents and viewing documents. Conclusions Our approach solves the consent issue when using IHE profiles for regional health information networks. It is highly interoperable due to the use of international standards and can hence be used in any other region to leverage consent issues and substantially promote the use of IHE for regional health information networks in general. PMID:21970788

How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study

PubMed Central

Woolfall, Kerry; Frith, Lucy; Gamble, Carrol; Gilbert, Ruth; Mok, Quen; Young, Bridget

2015-01-01

Objective Alternatives to prospective informed consent to enable children with life-threatening conditions to be entered into trials of emergency treatments are needed. Across Europe, a process called deferred consent has been developed as an alternative. Little is known about the views and experiences of those with first-hand experience of this controversial consent process. To inform how consent is sought for future paediatric critical care trials, we explored the views and experiences of parents and practitioners involved in the CATheter infections in CHildren (CATCH) trial, which allowed for deferred consent in certain circumstances. Design Mixed method survey, interview and focus group study. Participants 275 parents completed a questionnaire; 20 families participated in an interview (18 mothers, 5 fathers). 17 CATCH practitioners participated in one of four focus groups (10 nurses, 3 doctors and 4 clinical trial unit staff). Setting 12 UK children's hospitals. Results Some parents were momentarily shocked or angered to discover that their child had or could have been entered into CATCH without their prior consent. Although these feelings resolved after the reasons why consent needed to be deferred were explained and that the CATCH interventions were already used in clinical care. Prior to seeking deferred consent for the first few times, CATCH practitioners were apprehensive, although their feelings abated with experience of talking to parents about CATCH. Parents reported that their decisions about their child's participation in the trial had been voluntary. However, mistiming the deferred consent discussion had caused distress for some. Practitioners and parents supported the use of deferred consent in CATCH and in future trials of interventions already used in clinical care. Conclusions Our study provides evidence to support the use of deferred consent in paediatric emergency medicine; it also indicates the crucial importance of practitioner communication and appropriate timing of deferred consent discussions. PMID:26384724

Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico

PubMed Central

Verástegui, Emma L

2006-01-01

Background A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. Methods To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Results Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade. Conclusion The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients. PMID:17166274

Provision of information about newborn screening antenatally: a sequential exploratory mixed-methods project.

PubMed

Ulph, Fiona; Wright, Stuart; Dharni, Nimarta; Payne, Katherine; Bennett, Rebecca; Roberts, Stephen; Walshe, Kieran; Lavender, Tina

2017-10-01

Participation in the UK Newborn Bloodspot Screening Programme (NBSP) requires parental consent but concerns exist about whether or not this happens in practice and the best methods and timing to obtain consent at reasonable cost. To collate all possible modes of prescreening communication and consent for newborn (neonatal) screening (NBS); examine midwives', screening professionals' and users' views about the feasibility, efficiency and impact on understanding of each; measure midwives' and parents' preferences for information provision; and identify key drivers of cost-effectiveness for alternative modes of information provision. Six study designs were used: (1) realist review - to generate alternative communication and consent models; (2) qualitative interviews with parents and health professionals - to examine the implications of current practice for understanding and views on alternative models; (3) survey and observation of midwives - to establish current costs; (4) stated preference surveys with midwives, parents and potential future parents - to establish preferences for information provision; (5) economic analysis - to identify cost-effectiveness drivers of alternative models; and (6) stakeholder validation focus groups and interviews - to examine the acceptability, views and broader impact of alternative communication and consent models. Providers and users of NBS in England. Study 2: 45 parents and 37 health professionals; study 3: 22 midwives and eight observations; study 4: 705 adults aged 18-45 years and 134 midwives; and study 6: 12 health-care professionals and five parents. The realist review identified low parental knowledge and evidence of coercive consent practices. Interview, focus group and stated preference data suggested a preference for full information, with some valuing this more than choice. Health professionals preferred informed choice models but parents and health professionals queried whether or not current consent was fully informed. Barriers to using leaflets effectively were highlighted. All studies indicated that a 'personalised' approach to NBS communication, allowing parents to select the mode and level of information suited to their learning needs, could have added value. A personalised approach should rely on midwife communication and should occur in the third trimester. Overall awareness was identified as requiring improvement. Starting NBS communication by alerting parents that they have a choice to make and telling them that samples could be stored are both likely to enhance engagement. The methods of information provision and maternal anxiety causing additional visits to health-care professionals were the drivers of relative cost-effectiveness. Lack of data to populate an economic analysis, confirmed by value of information analysis, indicated a need for further research. There are some limitations with regard to the range of participants used in studies 2 and 3 and so caution should be exercised when interpreting some of the results. This project highlighted the importance of focusing on information receipt and identified key communication barriers. Health professionals strongly preferred informed consent, which parents endorsed if they were made aware of sample storage. Uniform models of information provision were perceived as ineffective. A choice of information provision was supported by health professionals and parents, which both enhances cost-effectiveness and improves engagement, understanding and the validity of consent. Remaining uncertainties suggest that more research is needed before new communication modes are introduced into practice. Future research should measure the impact of the suggested practice changes (informing in third trimester, information toolkits, changed role of midwife). Current Controlled Trials ISRCTN70227207. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 55. See the NIHR Journals Library website for further project information.

Is Consent Based on Trust Morally Inferior to Consent Based on Information?

PubMed

Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

2017-07-01

Informed consent is considered by many to be a moral imperative in medical research. However, it is increasingly acknowledged that in many actual instances of consent to participation in medical research, participants do not employ the provided information in their decision to consent, but rather consent based on the trust they hold in the researcher or research enterprise. In this article we explore whether trust-based consent is morally inferior to information-based consent. We analyse the moral values essential to valid consent - autonomy, voluntariness, non-manipulation, and non-exploitation - and assess whether these values are less protected and promoted by consent based on trust than they are by consent based on information. We find that this is not the case, and thus conclude that trust-based consent if not morally inferior to information-based consent. © 2017 John Wiley & Sons Ltd.

A randomized study of a method for optimizing adolescent assent to biomedical research.

PubMed

Annett, Robert D; Brody, Janet L; Scherer, David G; Turner, Charles W; Dalen, Jeanne; Raissy, Hengameh

2017-01-01

Voluntary consent/assent with adolescents invited to participate in research raises challenging problems. No studies to date have attempted to manipulate autonomy in relation to assent/consent processes. This study evaluated the effects of an autonomy-enhanced individualized assent/consent procedure embedded within a randomized pediatric asthma clinical trial. Families were randomly assigned to remain together or separated during a consent/assent process; the latter we characterize as an autonomy-enhanced assent/consent procedure. We hypothesized that separating adolescents from their parents would improve adolescent assent by increasing knowledge and appreciation of the clinical trial and willingness to participate. Sixty-four adolescent-parent dyads completed procedures. The together versus separate randomization made no difference in adolescent or parent willingness to participate. However, significant differences were found in both parent and adolescent knowledge of the asthma clinical trial based on the assent/consent procedure and adolescent age. The separate assent/consent procedure improved knowledge of study risks and benefits for older adolescents and their parents but not for the younger youth or their parents. Regardless of the assent/consent process, younger adolescents had lower comprehension of information associated with the study medication and research risks and benefits, but not study procedures or their research rights and privileges. The use of an autonomy-enhanced assent/consent procedure for adolescents may improve their and their parent's informed assent/consent without impacting research participation decisions. Traditional assent/consent procedures may result in a "diffusion of responsibility" effect between parents and older adolescents, specifically in attending to key information associated with study risks and benefits.

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

PubMed

Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

2016-09-09

Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to continuing participation and follow-up.

THE PARAMETERS OF INFORMED CONSENT

PubMed Central

Raab, Edward L

2004-01-01

ABSTRACT Purpose To describe the components of a proper informed consent; which risks must be disclosed and which need not; additional safeguards for incapacitated persons, minors, and research subjects; and where the law will imply consent that is not otherwise obtained. Methods Summarization of current law obtained from legal treatises, reports of recent cases, and personal experience as a reviewer and expert. Results Lack of informed consent can reinforce a claim of medical malpractice or serve as an alternative point of attack when the case is otherwise weak. Special requirements must be met when patients are the subjects of clinical research. Conclusion Demonstration of a well-conducted process, not merely of a paper, not only protects the physician from exposure to liability, but increases the patient’s autonomy in decisions concerning health and encourages compliance with treatment. PMID:15747761

Obtaining subjects’ consent to publish identifying personal information: current practices and identifying potential issues

PubMed Central

2013-01-01

Background In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Methods Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Results Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects’ right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Conclusion Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study objective, subjects’ right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed. PMID:24267590

Informed consent recall and comprehension in orthodontics: traditional vs improved readability and processability methods.

PubMed

Kang, Edith Y; Fields, Henry W; Kiyak, Asuman; Beck, F Michael; Firestone, Allen R

2009-10-01

Low general and health literacy in the United States means informed consent documents are not well understood by most adults. Methods to improve recall and comprehension of informed consent have not been tested in orthodontics. The purposes of this study were to evaluate (1) recall and comprehension among patients and parents by using the American Association of Orthodontists' (AAO) informed consent form and new forms incorporating improved readability and processability; (2) the association between reading ability, anxiety, and sociodemographic variables and recall and comprehension; and (3) how various domains (treatment, risk, and responsibility) of information are affected by the forms. Three treatment groups (30 patient-parent pairs in each) received an orthodontic case presentation and either the AAO form, an improved readability form (MIC), or an improved readability and processability (pairing audio and visual cues) form (MIC + SS). Structured interviews were transcribed and coded to evaluate recall and comprehension. Significant relationships among patient-related variables and recall and comprehension explained little of the variance. The MIC + SS form significantly improved patient recall and parent recall and comprehension. Recall was better than comprehension, and parents performed better than patients. The MIC + SS form significantly improved patient treatment comprehension and risk recall and parent treatment recall and comprehension. Patients and parents both overestimated their understanding of the materials. Improving the readability of consent materials made little difference, but combining improved readability and processability benefited both patients' recall and parents' recall and comprehension compared with the AAO form.

Parental views on informed consent for expanded newborn screening.

PubMed

Moody, Louise; Choudhry, Kubra

2013-09-01

An increasing array of rare inherited conditions can be detected as part of the universal newborn screening programme. The introduction and evaluation of these service developments require consideration of the ethical issues involved and appropriate mechanisms for informing parents and gaining consent if required. Exploration of parental views is needed to inform the debate and specifically consider whether more flexible protocols are needed to fit with the public perception of new developments in this context. This study has been undertaken to explore perceptions and attitudes of parents and future parents to an expanded newborn screening programme in the United Kingdom and the necessary information provision and consent processes. A mixed methods study involving focus groups (n = 29) and a web-survey (n = 142) undertaken with parents and future parents. Parents want guaranteed information provision with clear decision-making powers and an awareness of the choices available to them. The difference between existing screening provision and expanded screening was not considered to be significant enough by participants to warrant formal written, informed consent for expanded screening. It is argued that the ethical review processes need to be more flexible towards the provision of information and consent processes for service developments in newborn screening. © 2011 John Wiley & Sons Ltd.

Audit of the informed consent process as a part of a clinical research quality assurance program.

PubMed

Lad, Pramod M; Dahl, Rebecca

2014-06-01

Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing

PubMed Central

Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D’Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

2014-01-01

Background International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. Objectives This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. Methods We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants’ comprehension of the study information was measured by using a validated digitised audio questionnaire. Results The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants’ ‘recall’ and ‘understanding’ between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Conclusions Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings. PMID:25133065

Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial.

PubMed

Siu, Jennifer M; Rotenberg, Brian W; Franklin, Jason H; Sowerby, Leigh J

2016-06-01

To determine patient recall of specific risks associated with endoscopic sinus surgery and whether an adjunct multimedia education module is an effective patient tool in enhancing the standard informed consent process. Prospective, randomized, controlled trial. Fifty consecutive adult patients scheduled for endoscopic sinus surgery at a rhinology clinic of a tertiary care hospital were recruited for this study. Informed consent was studied by comparing the number of risks recalled when patients had a verbal discussion in conjunction with a 6-minute interactive module or the verbal discussion alone. Early recall was measured immediately following the informed consent process, and delayed recall was measured 3 to 4 weeks after patient preference details were also collected. Early risk recall in the multimedia group was significantly higher than the control group (P = .0036); however, there was no difference between the groups in delayed risk recall. Seventy-six percent of participants expressed interest in viewing the multimedia module if available online between the preoperative and procedural day. Sixty-eight percent of patients preferred having the multimedia module as an adjunct to the informed consent process as opposed to the multimedia consent process alone. There is an early improvement in overall risk recall in patients who complete an interactive multimedia module, with a clear patient preference for this method. Here we emphasize the well-known challenges of patient education and demonstrate the effectiveness of integrating technology into clinical practice in order to enhance the informed consent process. 1b Laryngoscope, 126:1273-1278, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

PubMed

Gillies, Katie; Entwistle, Vikki; Treweek, Shaun P; Fraser, Cynthia; Williamson, Paula R; Campbell, Marion K

2015-10-27

The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to recognise any potential risks or benefits associated with the research. A number of interventions have been put forward to improve this process. Outcomes reported in trials of interventions to improve the informed consent process for decisions about trial participation tend to focus on the 'understanding' of trial information. However, the operationalization of understanding as a concept, the tools used to measure it and the timing of the measurements are heterogeneous. A lack of clarity exists regarding which outcomes matter (to whom) and why. This inconsistency between studies results in difficulties when making comparisons across studies as evidenced in two recent systematic reviews of informed consent interventions. As such, no optimal method for measuring the impact of these interventions aimed at improving informed consent for RCTs has been identified. The project will adopt and adapt methodology previously developed and used in projects developing core outcome sets for assessment of clinical treatments. Specifically, the work will consist of three stages: 1) A systematic methodology review of existing outcome measures of trial informed consent interventions; 2) Interviews with key stakeholders to explore additional outcomes relevant for trial participation decisions; and 3) A Delphi study to refine the core outcome set for evaluation of trial informed consent interventions. All stages will include the stakeholders involved in the various aspects of RCT consent: users (that is, patients), developers (that is, trialists), deliverers (focusing on research nurses) and authorisers (that is, ethics committees). A final consensus meeting including all stakeholders will be held to review outcomes. The ELICIT study aims to develop a core outcome set for the evaluation of interventions intended to improve informed consent for RCTs for use in future RCTs and reviews, thereby improving the reliability and consistency of research in this area.

[The informed consent in international clinical trials including developing countries].

PubMed

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

Description of a Mobile-based Electronic Informed Consent System Development.

PubMed

Hwang, Min-A; Kwak, In Ja

2015-01-01

Seoul National University Hospital constructed and implemented a computer-based informed consent system in December 2011. As of 2013, 30% of the informed consents were still filled out manually on paper. Patients and medical staff continuously suggested the implementation of a system for electronic informed consent using portable devices. Therefore, a mobile-based system for electronic informed consent was developed in 2013 to prevent the issues that arise with computer-based systems and paper informed consent. The rate of filling out electronic informed consent increased from 69% to 95% following the implementation of the mobile-based electronic informed consent. This construction of a mobile-based electronic informed consent system would be a good reference point for the development of a mobile-based Electronic Medical Record and for various mobile system environments in medical institutions.

Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior

PubMed Central

Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

2016-01-01

Background Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments’ valence on prospective participants’ beliefs and behavior. Objective This study focuses specifically on the influence of annotations’ valence on participants’ perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. Methods In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants’ perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. Results We find that comment valence has a marginally significant main effect on participants’ perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the organization (F2=2.566, P=.08). Participants in the negative condition (mean 3.59, SD 1.14) were marginally less trusting than participants exposed to the positive condition (mean 4.02, SD 0.90, P=.06). Finally, we found that consent rate did not differ across comment valence conditions; however, participants who spent less time studying the consent form were more likely to consent when they were exposed to positive-valence comments. Conclusions This work explores the effects of adding a computer-mediated social dimension, which inherently contains human emotions and opinions, to the consent deliberation process. We proposed that augmenting the consent deliberation process to incorporate multiple voices can enable individuals to capitalize on the knowledge of others, which brings to light questions, problems, and concerns they may not have considered on their own. We found that consent forms containing positive valence annotations are likely to lead participants to feel less informed and simultaneously more trusting of the organization seeking consent. In certain cases where participants spent little time considering the content of the consent form, participants exposed to positive valence annotations were even more likely to consent to the study. We suggest that these findings represent important considerations for the design of future electronic informed consent mechanisms. PMID:27439320

Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture

PubMed Central

2014-01-01

Background Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Discussion Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients. There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Summary Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner. PMID:24495473

Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture.

PubMed

Masaki, Sakiko; Ishimoto, Hiroko; Asai, Atsushi

2014-02-04

Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient's best interest, and doing no harm in decision-making for patients.There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner.

Testing an alternate informed consent process.

PubMed

Yates, Bernice C; Dodendorf, Diane; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

2009-01-01

One of the main problems in conducting clinical trials is low participation rate due to potential participants' misunderstanding of the rationale for the clinical trial or perceptions of loss of control over treatment decisions. The objective of this study was to test an alternate informed consent process in cardiac rehabilitation participants that involved the use of a multimedia flip chart to describe a future randomized clinical trial and then asked, hypothetically, if they would participate in the future trial. An attractive and inviting visual presentation of the study was created in the form of a 23-page flip chart that included 24 color photographs displaying information about the purpose of the study, similarities and differences between the two treatment groups, and the data collection process. We tested the flip chart in 35 cardiac rehabilitation participants. Participants were asked if they would participate in this future study on two occasions: immediately after the description of the flip chart and 24 hours later, after reading through the informed consent document. Participants were also asked their perceptions of the flip chart and consent process. Of the 35 participants surveyed, 19 (54%) indicated that they would participate in the future study. No participant changed his or her decision 24 hours later after reading the full consent form. The participation rate improved 145% over that of an earlier feasibility study where the recruitment rate was 22%. Most participants stated that the flip chart was helpful and informative and that the photographs were effective in communicating the purpose of the study. Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

A mixed-methods study on perceptions towards use of Rapid Ethical Assessment to improve informed consent processes for health research in a low-income setting.

PubMed

Addissie, Adamu; Davey, Gail; Newport, Melanie J; Addissie, Thomas; MacGregor, Hayley; Feleke, Yeweyenhareg; Farsides, Bobbie

2014-05-02

Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among health researchers and regulators including ethics committee members in Ethiopian health research institutions and universities. In their evaluation of the consent process, only 40.2% thought that the consent process and information given were adequately understood by study participants; 84.6% claimed they were not satisfied with the current consent process and 85.5% thought the best interests of study participants were not adequately considered. Commonly mentioned consent-related problems included lack of clarity (48.1%), inadequate information (34%), language barriers (28.2%), cultural differences (27.4%), undue expectations (26.6%) and power imbalances (20.7%). About 95.4% believed that consent should be contextualized to the study setting and 39.4% thought REA would be an appropriate approach to improve the perceived problems. Qualitative findings helped to further explore the gaps identified in the quantitative findings and to map-out concerns related to the current research consent process in Ethiopia. Suggestions included, conducting REA during the pre-test (pilot) phase of studies when applicable. The need for clear guidance for researchers on issues such as when and how to apply the REA tools was stressed. The study findings clearly indicated that there are perceived to be correctable gaps in the consent process of medical research in Ethiopia. REA is considered relevant by researchers and stakeholders to address these gaps. Exploring further the feasibility and applicability of REA is recommended.

Psychiatric Residents' Needs for Education about Informed Consent, Principles of Ethics and Professionalism, and Caring for Vulnerable Populations: Results of a Multisite Survey

ERIC Educational Resources Information Center

Jain, Shaili; Lapid, Maria I.; Dunn, Laura B.; Roberts, Laura Weiss

2011-01-01

Objective: The authors examined psychiatric residents' perceived needs for education in informed consent, principles of ethics and professionalism, and treating vulnerable populations. Method: A written survey was distributed to psychiatric residents (N = 249) at seven U.S. residency programs in 2005. The survey contained 149 questions in 10…

Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level.

PubMed

Kim, Eun Jin; Kim, Su Hyun

2015-06-01

This study evaluated the effect of a simplified informed consent form for clinical trials on the understanding and efficacy of informed consent information across health literacy levels. A total of 150 participants were randomly assigned to one of two groups and provided with either standard or simplified consent forms for a cancer clinical trial. The features of the simplified informed consent form included plain language, short sentences, diagrams, pictures, and bullet points. Levels of objective and subjective understanding were significantly higher in participants provided with simplified informed consent forms relative to those provided with standard informed consent forms. The interaction effects between type of consent form and health literacy level on objective and subjective understanding were nonsignificant. Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy. © The Author(s) 2015.

Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.

PubMed

Denning, E; Sharma, S; Smolskis, M; Touloumi, G; Walker, S; Babiker, A; Clewett, M; Emanuel, E; Florence, E; Papadopoulos, A; Sánchez, A; Tavel, J; Grady, C

2015-04-01

Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants. Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants. A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment. These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world. © 2015 British HIV Association.

Core information sets for informed consent to surgical interventions: baseline information of importance to patients and clinicians.

PubMed

Main, Barry G; McNair, Angus G K; Huxtable, Richard; Donovan, Jenny L; Thomas, Steven J; Kinnersley, Paul; Blazeby, Jane M

2017-04-26

Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient's values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe 'core information sets' which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this 'core information'. We propose that such information addresses the 'reasonable patient' standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice.

Emergency research without consent under Polish law.

PubMed

Rózyńska, Joanna; Czarkowski, Marek

2007-09-01

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.

Seeking consent for research with indigenous communities: a systematic review.

PubMed

Fitzpatrick, Emily F M; Martiniuk, Alexandra L C; D'Antoine, Heather; Oscar, June; Carter, Maureen; Elliott, Elizabeth J

2016-10-22

When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations. A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review. Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and included. Articles were categorised into original research that evaluated the consent process (n = 5) or publications detailing the process of seeking consent (n = 13) and guidelines for ethical research (n = 38). Guidelines were categorised into international (n = 8); national (n = 20) and state/regional/local guidelines (n = 10). In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and "plain language" forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the 'Grey literature' concerns about the consent process are identified but no solutions are offered. Consultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process.

Getting meaningful informed consent from older adults: a structured literature review of empirical research.

PubMed

Sugarman, J; McCrory, D C; Hubal, R C

1998-04-01

To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve understanding and include a variety of novel formats (e.g., simplified, storybook, video) and procedures (e.g., use of health educators, quizzing subjects, multiple disclosure sessions). A systematic review of the published literature on informed consent reveals evidence for impaired understanding of informed consent information in older subjects and those with less formal education. Effective strategies to improve the understanding of informed consent information should be considered when designing materials, forms, policies, and procedures for obtaining informed consent. Other than empirical research that has investigated disclosure and understanding of informed consent information, little systematic research has examined other aspects of the informed consent process. This deficit should be rectified to ensure that the rights and interests of patients and of human subjects who participate in research are adequately protected.

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

PubMed

Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

2017-08-01

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28%) had no identifiable data collected from any research participants. Overall, only three trials (9%) indicated that a waiver of consent had been granted by a research ethics committee. When considering the combined requirement of research ethics review and informed consent (or a waiver), only one in three studies were compliant. Conclusion The ethical conduct and reporting of key ethical protections in stepped wedge trials, namely, research ethics review and informed consent, are inadequate. We recommend that stepped wedge trials be classified as research and reviewed and approved by a research ethics committee. We also recommend that researchers appropriately identify research participants (which may include health professionals), seek informed consent or appeal to an ethics committee for a waiver of consent, and include explicit details of research ethics approval and informed consent in the trial report.

Improving readability of informed consents for research at an academic medical institution.

PubMed

Hadden, Kristie B; Prince, Latrina Y; Moore, Tina D; James, Laura P; Holland, Jennifer R; Trudeau, Christopher R

2017-12-01

The final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention. Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year. The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade. Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.

A multimedia consent tool for research participants in the Gambia: a randomized controlled trial

PubMed Central

McGrath, Nuala; D’Alessandro, Umberto; Kampmann, Beate; Imoukhuede, Egeruan B; Ravinetto, Raffaella M; Alexander, Neal; Larson, Heidi J; Chandramohan, Daniel; Bojang, Kalifa

2015-01-01

Abstract Objective To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Methods Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants’ comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups. Findings On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12–0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13–0.82). There was no significant independent association with educational level. The risk that a participant’s comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16–0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand. Conclusion A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy. PMID:26229203

Written Informed-Consent Statutes and HIV Testing

PubMed Central

Ehrenkranz, Peter D.; Pagán, José A.; Begier, Elizabeth M.; Linas, Benjamin; Madison, Kristin; Armstrong, Katrina

2009-01-01

Background Almost 1 million Americans are infected with HIV, yet it is estimated that as many as 250,000 of them do not know their serostatus. This study examined whether people residing in states with statutes requiring written informed consent prior to HIV testing were less likely to report a recent HIV test. Methods The study is based on survey data from the 2004 Behavioral Risk Factor Surveillance System. Logistic regression was used to assess the association between residence in a state with a pre-test written informed-consent requirement and individual self-report of recent HIV testing. The regression analyses controlled for potential state- and individual-level confounders. Results Almost 17% of respondents reported that they had been tested for HIV in the prior 12 months. Ten states had statutes requiring written informed consent prior to routine HIV testing; nine of those were analyzed in this study. After adjusting for other state- and individual-level factors, people who resided in these nine states were less likely to report a recent history of HIV testing (OR=0.85; 95% CI=0.80, 0.90). The average marginal effect was −0.02 (p<0.001, 95%CI= −0.03, −0.01); thus, written informed-consent statutes are associated with a 12% reduction in HIV testing from the baseline testing level of 17%. The association between a consent requirement and lack of testing was greatest among respondents who denied HIV risk factors, were non-Hispanic whites, or who had higher levels of education. Conclusions This study’s findings suggest that the removal of written informed-consent requirements might promote the non–risk-based routine-testing approach that the CDC advocates in its new testing guidelines. PMID:19423271

Research participation by people with intellectual disability and mental health issues: an examination of the processes of consent.

PubMed

Taua, Chris; Neville, Christine; Hepworth, Julie

2014-12-01

Balancing the demands of research and ethics is always challenging, and even more so when recruiting vulnerable groups. Within the context of current legislation and international human rights declarations, it is strongly advocated that research can and must be undertaken with all recipients of health-care services. Research in the field of intellectual disability presents particular challenges in regards to consenting processes. This paper is a reflective overview and analysis of the complex processes undertaken, and events that occurred in gaining informed consent from people with intellectual disability to participate in a study exploring their experiences of being an inpatient in mental health hospitals within Aotearoa/New Zealand. A framework based on capacity, information, and voluntariness is presented, with excerpts from the field provided to explore consenting processes. The practical implications of the processes utilized are then discussed in order to stimulate debate regarding clearer and enhanced methods of gaining informed consent from people with intellectual disability. © 2014 Australian College of Mental Health Nurses Inc.

Comparison of Informed Consent Preferences for Multiplex Genetic Carrier Screening among a Diverse Population.

PubMed

Reeves, Ashley; Trepanier, Angela

2016-02-01

Multiplex genetic carrier screening is increasingly being integrated into reproductive care. Obtaining informed consent becomes more challenging as the number of screened conditions increases. Implementing a model of generic informed consent may facilitate informed decision-making. Current Wayne State University students and staff were invited to complete a web-based survey by blast email solicitation. Participants were asked to determine which of two generic informed consent scenarios they preferred: a brief versus a detailed consent. They were asked to rank the importance of different informational components in making an informed decision and to provide demographic information. Comparisons between informational preferences, demographic variables and scenario preferences were made. Six hundred ninety three participants completed the survey. When evaluating these generic consents, the majority preferred the more detailed consent (74.5%), and agreed that it provided enough information to make an informed decision (89.5%). Those who thought it would be more important to know the severity of the conditions being screened (p = .002) and range of symptoms (p = .000) were more likely to prefer the more detailed consent. There were no significant associations between scenario preferences and demographic variables. A generic consent was perceived to provide sufficient information for informed decision making regarding multiplex carrier screening with most preferring a more detailed version of the consent. Individual attitudes rather than demographic variables influenced preferences regarding the amount of information that should be included in the generic consent. The findings have implications for how clinicians approach providing tailored informed consent.

Participant comprehension of research for which they volunteer: a systematic review.

PubMed

Montalvo, Wanda; Larson, Elaine

2014-11-01

Evidence indicates that research participants often do not fully understand the studies for which they have volunteered. The aim of this systematic review was to examine the relationship between the process of obtaining informed consent for research and participant comprehension and satisfaction with the research. Systematic review of published research on informed consent and participant comprehension of research for which they volunteer using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement as a guide. PubMed, Cumulative Index for Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trails, and Cochrane Database of Systematic Reviews were used to search the literature for studies meeting the following inclusion criteria: (a) published between January 1, 2006, and December 31, 2013, (b) interventional or descriptive quantitative design, (c) published in a peer-reviewed journal, (d) written in English, and (e) assessed participant comprehension or satisfaction with the research process. Studies were assessed for quality using seven indicators: sampling method, use of controls or comparison groups, response rate, description of intervention, description of outcome, statistical method, and health literacy assessment. Of 176 studies identified, 27 met inclusion criteria: 13 (48%) were randomized interventional designs and 14 (52%) were descriptive. Three categories of studies included projects assessing (a) enhanced consent process or form, (b) multimedia methods, and (c) education to improve participant understanding. Most (78%) used investigator-developed tools to assess participant comprehension, did not assess participant health literacy (74%), or did not assess the readability level of the consent form (89%). Researchers found participants lacked basic understanding of research elements: randomization, placebo, risks, and therapeutic misconception. Findings indicate (a) inconsistent assessment of participant reading or health literacy level, (b) measurement variation associated with use of nonstandardized tools, and (c) continued therapeutic misconception and lack of understanding among research participants of randomization, placebo, benefit, and risk. While the Agency for Healthcare and Quality and National Quality Forum have published informed consent and authorization toolkits, previously published validated tools are underutilized. Informed consent requires the assessment of health literacy, reading level, and comprehension of research participants using validated assessment tools and methods. © 2014 Sigma Theta Tau International.

Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.

PubMed

Addissie, Adamu; Abay, Serebe; Feleke, Yeweyenhareg; Newport, Melanie; Farsides, Bobbie; Davey, Gail

2016-07-12

Maximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process. A cluster randomized trial was conducted among participants of HPV sero-prevalence study in two districts of Northern Ethiopia, in 2013. A total of 300 study participants, 150 in the intervention and 150 in the control group, were included in the study. For the intervention group, the informed consent process was designed with further revisions based on REA findings. Informed consent comprehension levels and quality of the consent process were measured using the Modular Informed Consent Comprehension Assessment (MICCA) and Quality of Informed Consent (QuIC) process assessment tools, respectively. Study recruitment rates were 88.7 % and 80.7 % (p = 0.05), while study retention rates were 85.7 % and 70.3 % (p < 0.005) for the intervention and control groups respectively. Overall, the mean informed consent comprehension scores for the intervention and control groups were 73.1 % and 45.2 %, respectively, with a mean difference in comprehension score of 27.9 % (95 % CI 24.0 % - 33.4 %; p < 0.001,). Mean scores for quality of informed consent for the intervention and control groups were 89.1 % and 78.5 %, respectively, with a mean difference of 10.5 % (95 % CI 6.8 -14.2 %; p < 0.001). Levels of informed consent comprehension, quality of the consent process, study recruitment and retention rates were significantly improved in the intervention group. We recommend REA as a potential modality to improve informed consent comprehension and quality of informed consent process in low resource settings.

Readability of Invasive Procedure Consent Forms

PubMed Central

Eltorai, Adam E. M.; Naqvi, Syed S.; Ghanian, Soha; Eberson, Craig P.; Weiss, Arnold‐Peter C.; Born, Christopher T.

2015-01-01

Abstract Background Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information. Materials and methods To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch–Kincaid Grade Level, Fog Scale, SMOG Index, Coleman–Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level. Results Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001). Conclusion Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions. PMID:26678039

Communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks – a randomized controlled trial

PubMed Central

2013-01-01

Background Informed consent talks are mandatory before invasive interventions. However, the patients’ information recall has been shown to be rather poor. We investigated, whether medical laypersons recalled more information items from a simulated informed consent talk after advanced medical students participated in a communication training aiming to reduce a layperson’s cognitive load. Methods Using a randomized, controlled, prospective cross-over-design, 30 5th and 6th year medical students were randomized into two groups. One group received communication training, followed by a comparison intervention (early intervention group, EI); the other group first received the comparison intervention and then communication training (late intervention group, LI). Before and after the interventions, the 30 medical students performed simulated informed consent talks with 30 blinded medical laypersons using a standardized set of information. We then recorded the number of information items the medical laypersons recalled. Results After the communication training both groups of medical laypersons recalled significantly more information items (EI: 41 ± 9% vs. 23 ± 9%, p < .0001, LI 49 ± 10% vs. 35 ± 6%, p < .0001). After the comparison intervention the improvement was modest and significant only in the LI (EI: 42 ± 9% vs. 40 ± 9%, p = .41, LI 35 ± 6% vs. 29 ± 9%, p = .016). Conclusion Short communication training for advanced medical students improves information recall of medical laypersons in simulated informed consent talks. PMID:23374907

Educational advantage.

PubMed

2013-07-01

This issue of JERHRE examines informed consent requirements as they arise in diverse countries and cultures, and in relation to level of risk of the research and vulnerability of the potential participants. It also examines issues of literacy as they affect informed consent. And it examines whether research participants want to be informed. Adequate informed consent is a statement that is meaningful and understandable by the particular research participant and that allows the participant free choice regarding participation. The way in which an adequate consent procedure is administered must, by definition, depend on the level of literacy of the potential research participants, and the nature and values of the culture of the potential participants. An implication of these requirements is that Western consent procedures are likely to violate ethical standards when employed in non-Western cultures. Educational activities presented below will enable readers to consolidate their knowledge and understanding of these issues. Written informed consent statements are not valid for use with research participants who lack literacy. The level of literacy required depends on the complexity of the research topic. In Clough et al., we find that cultural differences in self-concept, understanding of research methods, level of education, and deference to researchers challenge researchers to modify standard consent procedures to render them valid in some cultural contexts. In Abou Zeina et al., we find an even more complex problem of communicating patients' rights to illiterate patients in an Egyptian public hospital: not only can they not read, but they consider "patients' rights" as the least of their problems. In Iverson et al., we find still different issues concerning the scientific literacy of surrogate decision makers for critically ill patients. And in Ghandour et al., we find in Lebanon, within a very large sample of socioeconomically diverse students, a virtually total lack of interest in being informed before participating in a survey on a highly sensitive topic. For those of us who would unthinkingly impose standard Western consent procedures on everyone, these four articles may have much to teach us.

A Patient-Centered Approach to Informed Consent: Results from a Survey and Randomized Trial.

PubMed

Krishnamurti, Tamar; Argo, Nichole

2016-08-01

Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement. This study aimed to develop and evaluate patient-centered, patient-designed paper and video informed consent formats. Two studies were conducted. In study 1, 118 self-identifying asthma patients recruited from a national, online pool completed survey tasks from their personal computers. Participants in study 1 were randomly assigned to examine sections of a standard informed consent document for an asthma trial and to select information they deemed critical to their decision making. In study 2, a sample of 83 self-identifying asthma patients completed experimental tasks in a university laboratory. Participants in study 2 were randomly assigned to a full informed consent document; a shortened, patient-designed informed consent document created from study 1; or a video with content matched to the shortened paper form. Study 1 yielded a more readable, concise version of a standard informed consent document (5 v. 17 pages). This shortened, patient-designed form closely met normative criteria for good clinical practice. In study 2, participants who viewed either the shortened paper consent or video reported greater engagement than those viewing the standard paper consent, without lowered performance on any other decision-relevant variables (i.e., comprehension, judged risk/benefit, feelings of trust). The video consent format did not cause increased enrollment. Results suggest that providing concise informed consent content, systematically developed from patients' self-reported information needs, may be more effective at engaging and informing clinical trial participants than the traditional consent approach, without detriment to trial comprehension, risk assessment, or enrollment. © The Author(s) 2016.

Dynamic consent: a patient interface for twenty-first century research networks

PubMed Central

Kaye, Jane; Whitley, Edgar A; Lund, David; Morrison, Michael; Teare, Harriet; Melham, Karen

2015-01-01

Biomedical research is being transformed through the application of information technologies that allow ever greater amounts of data to be shared on an unprecedented scale. However, the methods for involving participants have not kept pace with changes in research capability. In an era when information is shared digitally at the global level, mechanisms of informed consent remain static, paper-based and organised around national boundaries and legal frameworks. Dynamic consent (DC) is both a specific project and a wider concept that offers a new approach to consent; one designed to meet the needs of the twenty-first century research landscape. At the heart of DC is a personalised, digital communication interface that connects researchers and participants, placing participants at the heart of decision making. The interface facilitates two-way communication to stimulate a more engaged, informed and scientifically literate participant population where individuals can tailor and manage their own consent preferences. The technical architecture of DC includes components that can securely encrypt sensitive data and allow participant consent preferences to travel with their data and samples when they are shared with third parties. In addition to improving transparency and public trust, this system benefits researchers by streamlining recruitment and enabling more efficient participant recontact. DC has mainly been developed in biobanking contexts, but it also has potential application in other domains for a variety of purposes. PMID:24801761

Informed Consent in Dentistry.

PubMed

Reid, Kevin I

2017-03-01

A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India.

PubMed

Rajaraman, Divya; Jesuraj, Nelson; Geiter, Lawrence; Bennett, Sean; Grewal, Harleen Ms; Vaz, Mario

2011-02-15

A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed. The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation. In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process. In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location. The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.

When is informed consent required in cluster randomized trials in health research?

PubMed Central

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation. PMID:21906277

Consent Processes for Mobile App Mediated Research: Systematic Review

PubMed Central

Tassé, Anne-Marie; Thorogood, Adrian; Winship, Ingrid; Zawati, Ma'n; Doerr, Megan

2017-01-01

Background Since the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women. Objective The aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies. Methods This review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing. Results Consistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted. Conclusions This review advocates the importance of participant informedness in a novel and largely unregulated research setting. PMID:28855147

Obstetrics and gynaecology residents' knowledge of the informed consent process and its practice in their training institutions.

PubMed

Okonta, P I

2015-01-01

The ethical principle of autonomy as expressed in the practice of informed consent is a core tenet of clinical practice and good patient physician relationship. The aim was to identify specific gaps in the knowledge of trainee obstetricians and gynecologists in Nigeria about the informed consent process and its content. It also sought to describe the practice of informed consent in their respective institutions. A survey of Residents in obstetrics and gynecology attending the revision course of the Faculty of obstetrics and gynecology of the national postgraduate medical college was done to determine their knowledge of the informed consent process and its practice in their institutions. None of the residents was able to give responses that contained all five conditions for informed consent to be valid. Furthermore, only 3 (2.22%) Residents mentioned that the name of the surgeon to perform the surgery should be part of the information provided to patients during the informed consent process. Similarly, only 8 (5.93%) mentioned that consequences of not having the surgery should be part of the informed consent process. The concept of the 'emancipated minor' being competent to give consent was known by 38% of the residents. Although Residents in obstetrics and gynecology in Nigeria have some knowledge of the informed consent process, this knowledge is deficient in key areas such as competence to give consent, content and scope of information to be disclosed to patients for surgery. There is a need to teach residents the rudiments of informed consent and bioethics in general.

A Rural Community's Involvement in the Design and Usability Testing of a Computer-Based Informed Consent Process for the Personalized Medicine Research Project

PubMed Central

Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

2014-01-01

Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants’ understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, such as genetic clinical trials consents. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is retained over time. PMID:24273095

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

PubMed

Borello, Alessandro; Ferrarese, Alessia; Passera, Roberto; Surace, Alessandra; Marola, Silvia; Buccelli, Claudio; Niola, Massimo; Di Lorenzo, Pierpaolo; Amato, Maurizio; Di Domenico, Lorenza; Solej, Mario; Martino, Valter

2016-01-01

Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

Engaging research participants to inform the ethical conduct of mobile imaging, pervasive sensing, and location tracking research.

PubMed

Nebeker, Camille; Lagare, Tiffany; Takemoto, Michelle; Lewars, Brittany; Crist, Katie; Bloss, Cinnamon S; Kerr, Jacqueline

2016-12-01

Researchers utilize mobile imaging, pervasive sensing, social media, and location tracking (MISST) technologies to observe and intervene with participants in their natural environment. The use of MISST methods and tools introduces unique ethical issues due to the type and quantity of data, and produces raising new challenges around informed consent, risk assessment, and data management. Since MISST methods are relatively new in behavioral research, there is little documented evidence to guide institutional review board (IRB) risk assessment and inform appropriate risk management strategies. This study was conducted to contribute the participant perspectives when considering ethical and responsible practices. Participants (n = 82) enrolled in an observational study where they wore several MISST devices for 1 week completed an exit survey. Survey items focused on the following: 1-device comfort, 2-informed consent, 3-privacy protections, and 4-bystander engagement. The informed consent process reflected participant actual experience. Device comfort and privacy were raised as concerns to both the participants and bystanders. While the majority of the participants reported a positive experience, it is important to note that the participants were volunteers who were not mandated to wear tracking devices and that persons who are mandated may not have a similar response. Findings support strategies proposed in the Kelly et al. (2013) ethical framework, which emphasizes procedures to improve informed consent, protect privacy, manage data, and respect bystander rights when using a wearable camera.

Informed consent under the European Convention on Biomedicine and the UNESCO Declaration on Bioethics.

PubMed

Salako, Solomon E

2011-03-01

The desirability of obtaining freely given consent is universally accepted. The point, however, is that there is no unanimity on the definition of informed consent or its application in bioethics. Whether informed consent is based on principalism or casuistry or the virtue theory, the problem is how to handle the ethically complex situation created in the interface between informed consent and social justice under international biomedical instruments. This article will proceed by offering detailed historical and critical analyses of informed consent under the European Convention on Human Rights and Biomedicine 1997 and The UNESCO Universal Declaration on Bioethics and Human Rights 2005. Three conceptions of justice will be utilised to show that the doctrine of informed consent has driven the ethos of research on human beings and shaped the physician-patient relationship; and that casuistry and virtue theory are consistent with and not rivals of a principle-based account of informed consent.

Orthodontic informed consent considering information load and serial position effect.

PubMed

Pawlak, Caroline E; Fields, Henry W; Beck, F Michael; Firestone, Allen R

2015-03-01

Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents. The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom "chunks" at the beginning of an informed consent presentation improved the recall and comprehension of the risks, benefits, and alternatives of orthodontic treatment. A second objective was to evaluate the current related data for recommendable practices. Seventy patient-parent pairs were randomly divided into 2 groups. The intervention group (group A) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment. Group B followed the same protocol without viewing the videotape. All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions. Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook. Lastly, the patients and parents were given 2 reading literacy tests, 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires. There were no significant differences between the groups for sociodemographic variables. There were no significant differences between the groups for overall recall and comprehension; recall and comprehension for the domains of treatment, risk, and responsibility; and recall and comprehension for core, general, and custom items. The positional effects were limited in impact. When compared with previous studies, these data further demonstrate the benefit of improved readability and audiovisual supplementation with the addition of "chunking." There is no benefit to adding a short video to the previously established improved readability and audiovisual supplementation. There is a significant benefit of improved readability and audiovisual slide supplementation with the addition of "chunking" over traditional informed consent methods in terms of patient improvement in overall comprehension, treatment recall, and treatment comprehension. The treatment domain is the most affected. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

HIV and the epidemiologist.

PubMed

Gillett, G

1989-11-18

The need for reliable epidemiological data on HIV seropositivity rates in a general population appears to conflict with the ethical requirement that consent be obtained from persons whose blood is screened for HIV antibodies. Gillet contends that informed consent is not necessary for epidemiological screening since there is no reason to link blood samples and test results with identifiable individuals. He argues that it is ethical to test blood drawn from hospital patients who have given a very general and "non-informative sort of consent" that their blood can be used anonymously for research. Even this degree of consent may be unnecessary since it would be impossible to trace an HIV positive anonymous blood sample to its source. Gillet also argues that this method of obtaining samples relieves epidemiologists of the obligation to notify individuals whose blood tests positive for HIV.

Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

PubMed Central

Sumathipala, Athula; Siribaddana, Sisira; Hewege, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin

2008-01-01

Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal. PMID:18267015

[Bias of results in clinical research due to method of informed consent].

PubMed

Appels, C W Y

2007-03-24

Research ethics committees increasingly demand that investigators use an opt-in method (prior informed consent) to recruit their potential participants. Recent research has shown that opt-in systems of recruitment increase the response bias and reduce response rates. People willing to participate seem to find it burdensome to opt in. In contrast to this, public concern about an opt-out approach is minimal and will probably be outweighed by the potential harm caused by biased results from opt-in approaches. Concerns about protecting the rights of the individual should not override the importance of recruiting patients in medical research.

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

... individual has given informed consent only if— (1) The person who obtained consent for the sterilization..., provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized: (i) Advice that the individual is free to withhold or withdraw consent to the...

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... individual has given informed consent only if— (1) The person who obtained consent for the sterilization..., provided a copy of the consent form and provided orally all of the following information or advice to the individual to be sterilized: (i) Advice that the individual is free to withhold or withdraw consent to the...

How do clinical genetics consent forms address the familial approach to confidentiality and incidental findings? A mixed-methods study.

PubMed

Dheensa, Sandi; Crawford, Gillian; Salter, Claire; Parker, Michael; Fenwick, Angela; Lucassen, Anneke

2018-01-01

Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about how they broach this and other issues, including the potential for incidental findings, in consent (forms) for genetic testing. We conducted a content analysis of UK-wide genetic testing consent forms and interviewed 128 clinicians/laboratory scientists. We found that almost all genetic services offered patients multiple, sometimes unworkable, choices on forms, including an option to veto the use of familial genetic information to benefit relatives. Participants worried that documented choices were overriding professional judgement and cautioned against any future forms dictating practice around incidental findings. We conclude that 'tick-box' forms, which do little to enhance autonomy, are masking valid consent processes in clinical practice. As genome-wide testing becomes commonplace, we must re-consider consent processes, so that they protects patients'-and relatives'-interests.

A rural community's involvement in the design and usability testing of a computer-based informed consent process for the Personalized Medicine Research Project.

PubMed

Mahnke, Andrea N; Plasek, Joseph M; Hoffman, David G; Partridge, Nathan S; Foth, Wendy S; Waudby, Carol J; Rasmussen, Luke V; McManus, Valerie D; McCarty, Catherine A

2014-01-01

Many informed consent studies demonstrate that research subjects poorly retain and understand information in written consent documents. Previous research in multimedia consent is mixed in terms of success for improving participants' understanding, satisfaction, and retention. This failure may be due to a lack of a community-centered design approach to building the interventions. The goal of this study was to gather information from the community to determine the best way to undertake the consent process. Community perceptions regarding different computer-based consenting approaches were evaluated, and a computer-based consent was developed and tested. A second goal was to evaluate whether participants make truly informed decisions to participate in research. Simulations of an informed consent process were videotaped to document the process. Focus groups were conducted to determine community attitudes towards a computer-based informed consent process. Hybrid focus groups were conducted to determine the most acceptable hardware device. Usability testing was conducted on a computer-based consent prototype using a touch-screen kiosk. Based on feedback, a computer-based consent was developed. Representative study participants were able to easily complete the consent, and all were able to correctly answer the comprehension check questions. Community involvement in developing a computer-based consent proved valuable for a population-based genetic study. These findings may translate to other types of informed consents, including those for trials involving treatment of genetic disorders. A computer-based consent may serve to better communicate consistent, clear, accurate, and complete information regarding the risks and benefits of study participation. Additional analysis is necessary to measure the level of comprehension of the check-question answers by larger numbers of participants. The next step will involve contacting participants to measure whether understanding of what they consented to is retained over time. © 2013 Wiley Periodicals, Inc.

Population attitudes towards research use of health care registries: a population-based survey in Finland.

PubMed

Eloranta, Katariina; Auvinen, Anssi

2015-07-17

Register-based research can provide important and valuable contributions to public health research, but involves ethical issues concerning the balance of public health benefits and individual autonomy. This study aimed to describe the opinions of the Finnish public about these issues. Mail survey questionnaire sent to a random sample of 1000 Finns. Participation proportion was 42%, with 258 women and 160 men. The majority of the participants (61%) were willing to provide their identifiable health information for research. Almost half of the participants (48%) would, nevertheless, like to be informed when their information is used. A third (30%) indicated no need for informed consent in register-based research, a similar proportion felt it should be obtained for every study, and 40% thought it necessary in some situations, such as studies addressing a sensitive study topic. As for the best policy for obtaining consent, the majority (86%) favoured broader consent methods: one consent covering a certain register or a research topic. Half of the participants (55%) desired a required ethical evaluation from register-based research addressing a sensitive issue. Privacy protection was the most common concern for register-based research. More than half of the participants were either content with the current Finnish laws concerning register-based research or wanted to liberalize them to advance research. The Finnish public is supportive of register-based research, but the requirement for informed consent divides opinions and many would at least like to be informed of the research use of their information.

Paper trails, trailing behind: improving informed consent to IVF through multimedia applications

PubMed Central

Madeira, Jody Lyneé; Andraka-Christou, Barbara

2016-01-01

Though intended to educate patients on the risks, benefits, side effects and alternatives within medical treatment, informed consent documents may have unanticipated consequences for patients. Patients may regard these forms as little more than a ritual to access treatment. Or patients may perceive that these forms exist to protect doctors rather than to contribute to a meaningful, patient-protective educational interaction. To rehabilitate the informed consent project, this essay considers the baggage that informed consent documents have acquired through practical use, explores patients' and providers' lived experience of informed consent, and considers whether a multimedia consent application would be a viable solution to the various difficulties that currently erode perceptions of and confidence in the informed consent process. PMID:27774231

Informed consent needed for sterilization or research.

PubMed

Barnett, B

1998-01-01

Informed choice involves enabling family planning clients to base their decisions about contraceptive use upon adequate information. It is a process in which clients give their permission to undergo a procedure, take a medication, or participate in a study after being fully informed. Informed consent protects an individual's freedom of choice, respects his or her autonomy, is important in both family planning programs and reproductive health research, and should always be available to clients seeking health services. Although written informed consent is not needed for most reproductive health services, it should be obtained from men and women who undergo sterilization, since that involves surgery and is considered permanent. In addition, people who volunteer to participate in contraceptive studies need to be fully informed of the risks and benefits of any new drugs or devices they receive. Volunteers should understand the potential effects of methods upon their physical health and other aspects of their lives. Ethical reviews need to be conducted before research begins.

Informed consent in posthumous sperm procurement.

PubMed

Hostiuc, Sorin; Curca, Cristian George

2010-10-01

Assisted reproductive technologies are increasingly more present in our everyday life: from classical sperm/egg donation or in vitro fertilization to newer, more controversial methods such as surrogate motherhood, male pregnancies or posthumous sperm procurement. Every year, new concepts are emerging in this field and the medical world is not always prepared to deal with them. The greatest problem of using posthumous sperm procurement as an assisted reproductive method resides in analyzing consent related. An extensive research of the scientific literature revealed eight possible situations which we will present and analyze in this article. By analyzing consent related issues we present a decision making algorithm for posthumous sperm procurement.

Informed consent comprehension and recollection in adult dental patients: A systematic review.

PubMed

Moreira, Narjara Conduru Fernandes; Pachêco-Pereira, Camila; Keenan, Louanne; Cummings, Greta; Flores-Mir, Carlos

2016-08-01

Patients' ability to recollect and comprehend treatment information plays a fundamental role in their decision making. The authors considered original studies assessing recollection or comprehension of dental informed consent in adults. The authors searched 6 electronic databases and partial gray literature and hand searched and cross-checked reference lists published through April 2015. The authors assessed the risk of bias in the included studies via different validated tools according to the study design. Nineteen studies were included: 5 randomized clinical trials, 8 cross-sectional studies, 3 qualitative studies, 2 mixed-methods studies, and 1 case series. Conventional informed consent processes yielded comprehension results of 27% to 85% and recollection of 20% to 86%, whereas informed consent processes enhanced by additional media ranged from 44% to 93% for comprehension and from 30% to 94% for recollection. Patient self-reported understanding ranged positively, with most patients feeling that they understood all or almost all the information presented. Results of qualitative data analyses indicated that patients did not always understand explanations, although dentists thought they did. Some patients firmly stated that they did not receive any related information. Only a few patients were able to remember complications related to their treatment options. Results of this systematic review should alert dentists that although patients in general report that they understand information given to them, they may have limited comprehension. Additional media may improve conventional informed consent processes in dentistry in a meaningful way. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

Informed Consent in Genome-Scale Research: What Do Prospective Participants Think?

PubMed Central

Trinidad, Susan Brown; Fullerton, Stephanie M.; Bares, Julie M.; Jarvik, Gail P.; Larson, Eric B.; Burke, Wylie

2012-01-01

Background To promote effective genome-scale research, genomic and clinical data for large population samples must be collected, stored, and shared. Methods We conducted focus groups with 45 members of a Seattle-based integrated healthcare delivery system to learn about their views and expectations for informed consent in genome-scale studies. Results Participants viewed information about study purpose, aims, and how and by whom study data could be used to be at least as important as information about risks and possible harms. They generally supported a tiered consent approach for specific issues, including research purpose, data sharing, and access to individual research results. Participants expressed a continuum of opinions with respect to the acceptability of broad consent, ranging from completely acceptable to completely unacceptable. Older participants were more likely to view the consent process in relational – rather than contractual – terms, compared with younger participants. The majority of participants endorsed seeking study subjects’ permission regarding material changes in study purpose and data sharing. Conclusions Although this study sample was limited in terms of racial and socioeconomic diversity, our results suggest a strong positive interest in genomic research on the part of at least some prospective participants and indicate a need for increased public engagement, as well as strategies for ongoing communication with study participants. PMID:23493836

Recruitment and Consent of Women with Intellectual Disabilities in a Randomised Control Trial of a Health Promotion Intervention

ERIC Educational Resources Information Center

Swaine, J.; Parish, S. L.; Luken, K.; Atkins, L.

2011-01-01

Background: The need for evidence-based health promotion interventions for women with intellectual and developmental disabilities is critical. However, significant barriers impede them from participating in research, including those related to recruitment and obtaining informed consent. Methods: This study describes a procedure for the recruitment…

Informed consent for cardiac procedures: deficiencies in patient comprehension with current methods.

PubMed

Dathatri, Shubha; Gruberg, Luis; Anand, Jatin; Romeiser, Jamie; Sharma, Shephali; Finnin, Eileen; Shroyer, A Laurie W; Rosengart, Todd K

2014-05-01

Patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) often have a poor understanding of their disease and of related therapeutic risks, benefits, and alternatives. This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients' knowledge of standard consent elements. Patients undergoing first-time elective, outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process (group I) or a web-based, audiovisual presentation (group II). Preconsent and postconsent questionnaires were administered to evaluate changes in patients' self-reported understanding of standard consent elements. One hundred and two patients enrolled at a single institution completed the pre- and postconsent surveys (group I=48; group II=54). Changes in patient comprehension rates were similar between groups for risk and benefit consent elements, but group II had significantly greater improvement in the identification of treatment alternatives than group I (p=0.028). Independent of intervention, correct identification of all risks and alternatives increased significantly after consent (p<0.05); 4 of 5 queried risks were correctly identified by greater than 90% of respondents. However, misperceptions of benefits persisted after consent; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by 83% and 46% of respondents, respectively. Although both scripted verbal and audiovisual informed consent improved patient comprehension, important patient misperceptions regarding PCI-related outcomes and alternatives persist, independent of informed consent approach, and considerable challenges still exist in educating patients about contemplated medical procedures. Future research appears warranted to improve patient comprehension. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research.

PubMed

Wilman, E; Megone, C; Oliver, S; Duley, L; Gyte, G; Wright, J M

2015-11-04

Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet approaching parents at this difficult time raises challenges for the obtaining of valid informed consent to such research. This study asked: what light does the empirical literature cast on an ethically defensible approach to the obtaining of informed consent in perinatal clinical trials? A systematic search identified 49 studies. Analysis began by applying philosophical frameworks which were then refined in light of the concepts emerging from empirical studies to present a coherent picture of a broad literature. Between them, studies addressed the attitudes of both parents and clinicians concerning consent in neonatal trials; the validity of the consent process in the neonatal research context; and different possible methods of obtaining consent. Despite a variety of opinions among parents and clinicians there is a strongly and widely held view that it is important that parents do give or decline consent for neonatal participation in trials. However, none of the range of existing consent processes reviewed by the research is satisfactory. A significant gap is evaluation of the widespread practice of emergency 'assent', in which parents assent or refuse their baby's participation as best they can during the emergency and later give full consent to ongoing participation and follow-up. Emergency assent has not been evaluated for its acceptability, how such a process would deal with bad outcomes such as neonatal death between assent and consent, or the extent to which late parental refusal might bias results. This review of a large number of empirical papers, while not making fundamental changes, has refined and developed the conceptual framework from philosophy for examining informed consent in this context.

Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

PubMed

Williams, Barbara F; French, John K; White, Harvey D

2003-03-15

Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

Enhancing informed consent for research and treatment.

PubMed

Dunn, L B; Jeste, D V

2001-06-01

Increased scrutiny of informed consent calls for further research into decision making by patients who may be at risk for impairments. We review interventions designed to improve patient understanding of informed consent. A number of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" of understanding of consent, such as subject characteristics, psychiatric symptoms, and cognitive impairment. Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions. We find that effective interventions include corrected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with levels of understanding. Even among individuals with psychiatric illness or cognitive impairment, deficits in understanding can be remedied with certain educational interventions. A variety of interventions can enhance understanding of informed consent.

Informed consent in colonoscopy: A comparative analysis of 2 methods.

PubMed

Sanguinetti, J M; Lotero Polesel, J C; Iriarte, S M; Ledesma, C; Canseco Fuentes, S E; Caro, L E

2015-01-01

The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent. A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later. The study included a total of 176 subjects (group A [n=55] and group B [n=121]). As regards education level, 69.88% (n=123) of the patients had completed university education, 23.29% (n= 41) secondary level, 5.68% (n=10) primary level, and the remaining subjects (n=2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n=44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P=.0027) and group A had a better recollection of the major complications (P<.0001). Group A had a higher number of affirmative answers (P<.0001). The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure. Copyright © 2014 Asociación Mexicana de Gastroenterología. Published by Masson Doyma México S.A. All rights reserved.

What emergency physicians should know about informed consent: legal scenarios, cases, and caveats.

PubMed

Moore, Gregory P; Moffett, Peter M; Fider, Cyril; Moore, Malia J

2014-08-01

The basic concept of obtaining informed consent is familiar to emergency physicians, and many consider themselves well versed on the topic; however, lack of obtaining proper informed consent is a frequent source of lawsuits. The legal definitions and nuances of informed consent might surprise even the most experienced physician. This article will detail the historical legal evolution of the concept of informed consent. It will also report defining and recent court cases that illustrate the current medical-legal status of informed consent. Special scenarios, caveats, and documentation recommendations are discussed. After reading this article the emergency physician will know how to practice and document the appropriate aspects of informed consent in emergency medicine, as well as understand available legal defenses if a lawsuit should arise. © 2014 by the Society for Academic Emergency Medicine.

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

PubMed Central

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

Informed consent process: A step further towards making it meaningful!

PubMed Central

Kadam, Rashmi Ashish

2017-01-01

Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process. PMID:28828304

The adequacy of informed consent forms in genetic research in Oman: a pilot study.

PubMed

Al-Riyami, Asya; Jaju, Deepali; Jaju, Sanjay; Silverman, Henry J

2011-08-01

Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman. The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. In order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review. Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms. Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms. © 2011 Blackwell Publishing Ltd.

Effect of a multimedia-assisted informed consent procedure on the information gain, satisfaction, and anxiety of cataract surgery patients.

PubMed

Tipotsch-Maca, Saskia M; Varsits, Ralph M; Ginzel, Christian; Vecsei-Marlovits, Pia V

2016-01-01

To assess whether a multimedia-assisted preoperative informed consent procedure has an effect on patients' knowledge concerning cataract surgery, satisfaction with the informed consent process, and reduction in anxiety levels. Hietzing Hospital, Vienna, Austria. Prospective randomized controlled clinical trial. Patients participated in an informed consent procedure for age-related cataract surgery that included the standard approach only (reading the information brochure and having a standardized face-to-face discussion) or supplemented with a computer-animated video. The main outcome was information retention assessed by a questionnaire. Further outcome measures used were the State-Trait Anxiety Inventory, the Visual Function-14 score, and an assessment of satisfaction. The study included 123 patients (64 in standard-only group; 59 in computer-animated video group). Both groups scored well on the questionnaire; however, patients who watched the video performed better (82% retention versus 72%) (P = .002). Scores tended to decrease with increasing age (r = -0.25, P = .005); however, this decrease was smaller in the group that watched the video. Both groups had elevated anxiety levels (means in video group: anxiety concerning the current situation [S-anxiety] = 63.8 ± 9.6 [SD], general tendency toward anxiety [T-anxiety] = 65.5 ± 7.9; means in control group: S-anxiety = 61.9 ± 10.3, T-anxiety = 66.2 ± 7.8). A high level of information retention was achieved using an informed consent procedure consisting of an information brochure and a standardized face-to-face discussion. A further increase in information retention was achieved, even with increasing patient age, by adding a multimedia presentation. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2016 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

42 CFR 50.204 - Informed consent requirement.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Informed consent requirement. 50.204 Section 50.204 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.204 Informed consent requirement. Informed consent...

National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis.

PubMed

Mendelson, Scott J; Courtney, D Mark; Gordon, Elisa J; Thomas, Leena F; Holl, Jane L; Prabhakaran, Shyam

2018-03-01

No standard approach to obtaining informed consent for stroke thrombolysis with tPA (tissue-type plasminogen activator) currently exists. We aimed to assess current nationwide practice patterns of obtaining informed consent for tPA. An online survey was developed and distributed by e-mail to clinicians involved in acute stroke care. Multivariable logistic regression analyses were performed to determine independent factors contributing to always obtaining informed consent for tPA. Among 268 respondents, 36.7% reported always obtaining informed consent and 51.8% reported the informed consent process caused treatment delays. Being an emergency medicine physician (odds ratio, 5.8; 95% confidence interval, 2.9-11.5) and practicing at a nonacademic medical center (odds ratio, 2.1; 95% confidence interval, 1.0-4.3) were independently associated with always requiring informed consent. The most commonly cited cause of delay was waiting for a patient's family to reach consensus about treatment. Most clinicians always or often require informed consent for stroke thrombolysis. Future research should focus on standardizing content and delivery of tPA information to reduce delays. © 2018 American Heart Association, Inc.

Informed consent comprehension in African research settings.

PubMed

Afolabi, Muhammed O; Okebe, Joseph U; McGrath, Nuala; Larson, Heidi J; Bojang, Kalifa; Chandramohan, Daniel

2014-06-01

Previous reviews on participants' comprehension of informed consent information have focused on developed countries. Experience has shown that ethical standards developed on Western values may not be appropriate for African settings where research concepts are unfamiliar. We undertook this review to describe how informed consent comprehension is defined and measured in African research settings. We conducted a comprehensive search involving five electronic databases: Medline, Embase, Global Health, EthxWeb and Bioethics Literature Database (BELIT). We also examined African Index Medicus and Google Scholar for relevant publications on informed consent comprehension in clinical studies conducted in sub-Saharan Africa. 29 studies satisfied the inclusion criteria; meta-analysis was possible in 21 studies. We further conducted a direct comparison of participants' comprehension on domains of informed consent in all eligible studies. Comprehension of key concepts of informed consent varies considerably from country to country and depends on the nature and complexity of the study. Meta-analysis showed that 47% of a total of 1633 participants across four studies demonstrated comprehension about randomisation (95% CI 13.9-80.9%). Similarly, 48% of 3946 participants in six studies had understanding about placebo (95% CI 19.0-77.5%), while only 30% of 753 participants in five studies understood the concept of therapeutic misconception (95% CI 4.6-66.7%). Measurement tools for informed consent comprehension were developed with little or no validation. Assessment of comprehension was carried out at variable times after disclosure of study information. No uniform definition of informed consent comprehension exists to form the basis for development of an appropriate tool to measure comprehension in African participants. Comprehension of key concepts of informed consent is poor among study participants across Africa. There is a vital need to develop a uniform definition for informed consent comprehension in low literacy research settings in Africa. This will be an essential step towards developing appropriate tools that can adequately measure informed consent comprehension. This may consequently suggest adequate measures to improve the informed consent procedure. © 2014 John Wiley & Sons Ltd.

Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.

PubMed

Afolabi, Muhammed Olanrewaju; Bojang, Kalifa; D'Alessandro, Umberto; Imoukhuede, Egeruan Babatunde; Ravinetto, Raffaella M; Larson, Heidi Jane; McGrath, Nuala; Chandramohan, Daniel

2014-04-05

International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants' comprehension of the study information was measured by using a validated digitised audio questionnaire. The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants' 'recall' and 'understanding' between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings.

Making sense of adolescent decision-making: challenge and reality.

PubMed

Unguru, Yoram

2011-08-01

Few topics in pediatric bioethics are as vexing as decision-making. Decision-making in pediatrics presents challenges for children, parents, and physicians alike. The related, yet distinct, concepts of assent and consent are central to pediatric decision-making. Although informed consent is largely regarded as a worthwhile adult principle, assent has been, and continues to be, mired in debate. Controversial subjects include a meaningful definition of assent; how old children should be to assent; who should be included in the assent process; parental permission; how to resolve disputes between children and their parents; the relationship between assent and consent; the quantity and quality of information to disclose to children and their families; how much and what information children desire and need; the necessity and methods for assessing both children's understanding of disclosed information and of the assent process itself; reconciling ethical and legal attitudes toward assent; and finally, an effective, practical, and realistically applicable decision-making model.

Lay concepts in informed consent to biomedical research: the capacity to understand and appreciate risk.

PubMed

Iltis, Ana

2006-08-01

Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk.

Considerations of informed consent and decision-making competence in older adults with cognitive impairment.

PubMed

Mayo, Ann M; Wallhagen, Margaret I

2009-04-01

Including older adults with cognitive impairment in research studies is necessary to ensure that interventions designed to improve care are effective for all older adults. However, issues related to capacity to consent raise many difficult questions that nurse researchers must address. Protecting vulnerable participants while simultaneously maintaining autonomy and moving important research forward can be challenging. Assessing the decision-making abilities of understanding, appreciation, reasoning, and expressing a choice is an important aspect of determining decision-making capacity. Yet although this is the prominent rational method for judging decision-making competence, it does not take into consideration the importance of culture, values, and emotions. This article focuses on the assessment of decision-making capacity to consent, recommendations for obtaining informed consent in older adults with cognitive impairment, the use of surrogate decision makers, strategies to maximize research participation, and directions for future research. Copyright 2009, SLACK Incorporated.

Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

PubMed Central

Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Paasche-Orlow, Michael; Estrella-Luna, Neenah

2017-01-01

Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research. PMID:28975139

Capacity of People with Intellectual Disabilities to Consent to Take Part in a Research Study

ERIC Educational Resources Information Center

Dye, Linda; Hare, Dougal Julian; Hendy, Steve

2007-01-01

Background: Within the context of current legislation relating to mental capacity in adults, the capacity of people with intellectual disabilities to consent to take part in research studies and the impact of different forms of information provision was experimentally investigated. Materials and methods: A questionnaire measure of ability to…

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials.

PubMed

Nishimura, Adam; Carey, Jantey; Erwin, Patricia J; Tilburt, Jon C; Murad, M Hassan; McCormick, Jennifer B

2013-07-23

Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.

Informed consent for genetic research.

PubMed

Hamvas, Aaron; Madden, Katherine K; Nogee, Lawrence M; Trusgnich, Michelle A; Wegner, Daniel J; Heins, Hillary B; Cole, F Sessions

2004-06-01

Rapid technological advances in genetic research and public concern about genetic discrimination have led to anticipatory safeguards in the informed consent process in the absence of legal examples of proven discrimination. Despite federal and state regulations to restrict access to personal health information, including genetic information, institutional review boards have required the addition of language to informed consent documents that warns about the risks of discrimination with participation in genetic research. To determine the reasons that families refused consent for their infant's participation in a study evaluating a genetic cause of respiratory distress syndrome. Survey conducted between February 1, 2002, and March 31, 2003. Academic, tertiary free-standing children's hospital. A convenience sample of 465 families were approached for consent. The 135 families who refused consent were surveyed. Reasons for refusal. Of the nonconsenting families, 79% spontaneously and specifically identified institutionally required language in our consent form concerning the risk of denial of access to health insurance and employment as the primary reason for refusal; 97% indicated that their fears resulted directly from language in our consent form. Only 20% of families who refused consent cited inadequate time to consider the study. The institutionally required description of risk of genetic discrimination due solely to participation in genetic research was the primary reason for refusal to consent in this cohort. Information about federally and institutionally mandated protections for confidentiality of participants in genetic research should be included in the informed consent document to balance the description of hypothetical risks and more accurately inform subjects.

Can Broad Consent be Informed Consent?

PubMed Central

Sheehan, Mark

2011-01-01

In biobanks, a broader model of consent is often used and justified by a range of different strategies that make reference to the potential benefits brought by the research it will facilitate combined with the low level of risk involved (provided adequate measures are in place to protect privacy and confidentiality) or a questioning of the centrality of the notion of informed consent. Against this, it has been suggested that the lack of specific information about particular uses of the samples means that such consent cannot be fully autonomous and so is unethical. My answer to the title question is a definite ‘yes’. Broad consent can be informed consent and is justified by appeal to the principle of respect for autonomy. Indeed, I will suggest that the distinction between the various kinds of consent is not a distinction between kinds of consent but between the kinds of choice a person makes. When an individual makes a choice (of any kind) it is important that they do so according to the standards of informed consent and consistent with the choice that they are making. PMID:22102849

Informed consent in psychiatry clinical research: A conceptual review of issues, challenges, and recommendations

PubMed Central

Gupta, Umesh Chandra; Kharawala, Saifuddin

2012-01-01

Obtaining informed consent in psychiatry clinical research involving subjects with diminished mental abilities and impaired consent capacity has been a challenge for researchers, posing many ethical concerns and procedural hurdles due to participants’ cognitive deficits and impaired ability to judge reality. Regulations seem inadequate and provide limited guidance, not sufficient to address all the ethical issues inherent in different situations related to obtaining consent from decisionally impaired persons. Researchers are struggling to find a balance between risk-benefit ratio, research advancement, and autonomy of study subjects. Inspired to improve the consent process in psychiatry clinical research, many studies have been conducted focusing on various informed consent-related ethical concerns, with the aim of developing appropriate strategies and optimizing the informed consent procedure in psychiatry clinical research, overcoming the ethical concerns. This article critically reviews the various ethical issues and consent challenges, their underlying reasons, and investigates the appropriate strategies and practices needed to be adopted while obtaining informed consent from subjects with impaired consent capacity, participating in psychiatry clinical research. PMID:22347696

Using video-taped examples of standardized patient to teach medical students taking informed consent.

PubMed

Habibi Khorasani, Shirin; Ebrahimi, Sedigheh

2015-04-01

Medical student should be trained in medical ethics and one of the most essential issues in this field is taking informed consents. In this research, we compared the effect of effectiveness of teaching methods on students' ability intaking informed consent from patients. This semi-experimental study was carried out on fifty eight subjects from the 4th-year students  of Shiraz University of Medical Sciences who attended in medical ethics coursebefore their 'clinical clerkship'training.Method of sampling was census and students were randomly allocated into two groups of control group(n=28) was trained in traditional lecture-based class and the case groupnamed as A1(n=22) were taught by video-taped examples of standardized patient.Then A1 group attended in traditional lecture-based classes named as A2. The groups were evaluated in terms the ability of recognition of ethical issuesthrough the scenario based ethical examination before and after each training. Scenarios were related to the topics ofinformed consent. Data were analyzed by SPSS 14 software using descriptive statistics and anovatest.P-Value less than 0.05 was considered as significant. The mean scores results of A2, A1and B groupwere found to be7.21 , 5.91 and 5.73 out of 8,respectively. Comparison between the groups demonstrated that the ability of taking informed consent was significantly higher in A2 group (p<0.001), followed by A1group (p<0.05),while was the leastin the B group (p=0.875). According to this research, lecture-based teaching is still of great value in teaching medical ethics, but when combined with standardized patient, the outcome will be much better.it should be considered that mixed methodsof teaching should be used together for better result.

Development and Pilot Testing of a Video-Assisted Informed Consent Process

PubMed Central

Sonne, Susan C.; Andrews, Jeannette O.; Gentilin, Stephanie M.; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

2013-01-01

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n=61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. PMID:23747986

Development and pilot testing of a video-assisted informed consent process.

PubMed

Sonne, Susan C; Andrews, Jeannette O; Gentilin, Stephanie M; Oppenheimer, Stephanie; Obeid, Jihad; Brady, Kathleen; Wolf, Sharon; Davis, Randal; Magruder, Kathryn

2013-09-01

The informed consent process for research has come under scrutiny, as consent documents are increasingly long and difficult to understand. Innovations are needed to improve comprehension in order to make the consent process truly informed. We report on the development and pilot testing of video clips that could be used during the consent process to better explain research procedures to potential participants. Based on input from researchers and community partners, 15 videos of common research procedures/concepts were produced. The utility of the videos was then tested by embedding them in mock-informed consent documents that were presented via an online electronic consent system designed for delivery via iPad. Three mock consents were developed, each containing five videos. All participants (n = 61) read both a paper version and the video-assisted iPad version of the same mock consent and were randomized to which format they reviewed first. Participants were given a competency quiz that posed specific questions about the information in the consent after reviewing the first consent document to which they were exposed. Most participants (78.7%) preferred the video-assisted format compared to paper (12.9%). Nearly all (96.7%) reported that the videos improved their understanding of the procedures described in the consent document; however, the comprehension of material did not significantly differ by consent format. Results suggest videos may be helpful in providing participants with information about study procedures in a way that is easy to understand. Additional testing of video consents for complex protocols and with subjects of lower literacy is warranted. Copyright © 2013 Elsevier Inc. All rights reserved.

Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals

PubMed Central

Strech, Daniel; Metz, Courtney; Knüppel, Hannes

2014-01-01

Introduction According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal’s instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. Methods and Findings The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author’s instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Conclusions Only every second psychiatry journal adheres to the ICMJE’s recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE’s recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research. PMID:24901366

Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

PubMed Central

Desch, Karl; Li, Jun; Kim, Scott; Laventhal, Naomi; Metzger, Kristen; Siemieniak, David; Ginsburg, David

2012-01-01

Background The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research. Objective To examine the use of online consent documents in a minimal-risk genetic study. Design Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits. Setting University of Michigan Campus, Ann Arbor, Michigan. Participants Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. Measurements Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document. Results The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. Limitation The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once. Conclusion Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. Primary Funding Source National Institutes of Health. PMID:21893624

Ethics, informed consent, and assisted reproduction.

PubMed

Macklin, R

1995-09-01

Informed consent to treatment is an ethical requirement often misunderstood or not fully appreciated by physicians. The purpose of obtaining informed consent is to ensure that patients know what doctors propose to do and freely grant their permission. Although the purpose of informed consent and the standards by which it is to be employed are the same in all areas of medical practice, special problems arise in assisted reproduction. Voluntary, informed consent is an instance of a reproductive right that should be recognized by the international medical community, and not limited to Western and European countries.

Access to special care dentistry, part 3. Consent and capacity.

PubMed

Dougall, A; Fiske, J

2008-07-26

This article considers what is meant by informed consent and the implications of the Mental Capacity Act in obtaining consent from vulnerable adults. It explores a number of conditions which impact on this task, namely dyslexia, literacy problems and learning disability. The focus on encouraging and facilitating autonomy and the use of the appropriate level of language in the consent giving process ensures that consent is valid. The use of appropriate methods to facilitate communication with individuals in order to be able to assess capacity and ensure that any treatment options that are chosen on their behalf are in their best interests are outlined. The use of physical intervention in special care dentistry in order to provide dental care safely for both the patient and the dental team is also considered.

Procedures of recruiting, obtaining informed consent, and compensating research participants in Qatar: findings from a qualitative investigation.

PubMed

Killawi, Amal; Khidir, Amal; Elnashar, Maha; Abdelrahim, Huda; Hammoud, Maya; Elliott, Heather; Thurston, Michelle; Asad, Humna; Al-Khal, Abdul Latif; Fetters, Michael D

2014-02-04

Very few researchers have reported on procedures of recruiting, obtaining informed consent, and compensating participants in health research in the Arabian Gulf Region. Empirical research can inform the debate about whether to adjust these procedures for culturally diverse settings. Our objective was to delineate procedures related to recruiting, obtaining informed consent, and compensating health research participants in the extremely high-density multicultural setting of Qatar. During a multistage mixed methods project, field observations and qualitative interviews were conducted in a general medicine clinic of a major medical center in Qatar. Participants were chosen based on gender, age, literacy, and preferred language, i.e., Arabic, English, Hindi and Urdu. Qualitative analysis identified themes about recruitment, informed consent, compensation, and other research procedures. A total of 153 individuals were approached and 84 enrolled; the latter showed a diverse age range (18 to 75 years); varied language representation: Arabic (n = 24), English (n = 20), Hindi (n = 20), and Urdu (n = 20); and balanced gender distribution: women (n = 43) and men (n = 41). Primary reasons for 30 declinations included concern about interview length and recording. The study achieved a 74% participation rate. Qualitative analytics revealed key themes about hesitation to participate, decisions about participation with family members as well as discussions with them as "incidental research participants", the informed consent process, privacy and gender rules of the interview environment, reactions to member checking and compensation, and motivation for participating. Vulnerability emerged as a recurring issue throughout the process among a minority of participants. This study from Qatar is the first to provide empirical data on recruitment, informed consent, compensation and other research procedures in a general adult population in the Middle East and Arabian Gulf. This investigation illustrates how potential research participants perceive research participation. Fundamentally, Western ethical research principles were applicable, but required flexibility and culturally informed adaptations.

Patient and public attitudes towards informed consent models and levels of awareness of Electronic Health Records in the UK

PubMed Central

Riordan, Fiona; Papoutsi, Chrysanthi; Reed, Julie E.; Marston, Cicely; Bell, Derek; Majeed, Azeem

2015-01-01

Background The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. Objectives To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. Methods A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. Results The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and respondents with degree-level education, respectively. Those who reported being aware of EHRs were less likely to say they expected explicit consent to be sought before use of their de-identified record. Conclusions A large number of patients remain unaware of EHRs, while preference for implicit consent is stronger among those who report previous awareness. Differences in awareness levels and consent expectations between groups with different socio-demographic characteristics suggest that public education and information campaigns should target specific groups to increase public awareness and ensure meaningful informed consent mechanisms. PMID:25649841

Pilot evaluation of parental and professional views regarding consent in neonatal medicine by telephone interviews and questionnaires

PubMed Central

2017-01-01

Objective The objectives of the study were to determine (1) parental and professional views regarding the type of consent required for common neonatal interventions and (2) whether there has been a change in professional understanding regarding the requirements of consent since the last UK survey in 2003. Design Cohort study of (1) parents of babies admitted to a single-centre tertiary neonatal unit and (2) healthcare professionals. Methods The views of 8 parents of former neonatal patients and 69 neonatal professionals were sought using online and telephone survey methodology regarding 20 neonatal interventions and whether implied consent, explicit verbal consent or explicit written consent should be obtained. Results Agreement, defined as both parental and professional consensus on the type of consent required, was present in 12/20 of the interventions. Comparison between professional views in 2003 demonstrated a change regarding type of consent for 50% of interventions with a shift towards obtaining explicit written consent certain treatments. Conclusions The study indicates areas of consensus that exist between parents and professionals regarding consent for common neonatal interventions and a change in professional views regarding consent since the last UK survey in 2003. These data might help inform the development of national guidance for how professionals should obtain consent in neonatology. PMID:29637148

Analysis of the status of informed consent in medical research involving human subjects in public hospitals in Shanghai.

PubMed

Jianping, Wang; Li, Lan; Xue, Di; Tang, Zhongjin; Jia, Xieyang; Wu, Rong; Xi, Yiqun; Wang, Tong; Zhou, Ping

2010-07-01

The objectives of the study are to understand the current practice of informed consent in medical research in public hospitals in Shanghai, and to share our views with other countries, especially developing countries. In the study, 145 consent forms (CFs) of the selected research projects in eight public hospitals with ethics committees in Shanghai were audited, and the principle investigators (PIs) of these research projects and 40 student subjects who had participated in clinical drug tests were surveyed by questionnaires. The CFs of medical researches in public hospitals with ethics committees in Shanghai were generally acceptable. However, there were some defects in the CFs. Although most of the surveyed PIs had correct recognition of informed consent, some processes of informed consent were not in accordance with generally accepted requirements. A large number of the PIs considered the greatest difficulty with informal consent was lack of correct recognition of subjects or legally authorised representatives on medical research. Informed consent in medical research should consider the research ethics, the background of potential subjects, the local resources and culture of medical research. In addition, special protection is needed for student subjects in informed consent as well as efforts for building and restoring the public's trust in biomedical research. The informed consent in Shanghai's public hospitals with ethics committees was generally acceptable and the achievement of adequate informed consent is influenced by many factors.

Scientists' perspectives on consent in the context of biobanking research

PubMed Central

Master, Zubin; Campo-Engelstein, Lisa; Caulfield, Timothy

2015-01-01

Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking. PMID:25074466

Implications of the UK NHS consent policy for nuclear medicine practice.

PubMed

Greaves, Claire D; Tindale, Wendy B

2005-02-01

To comply with government policy on consent, the Sheffield Teaching Hospitals (STH) National Health Service (NHS) Trust introduced a new consent policy in February 2002. Verbal or written consent (depending on the level of risk) must be obtained prior to each study. The patient must be fully informed and given time to reach a decision. Consideration needs to be given to the following: to whom, when and how to provide such information and obtain consent. Each study type and patient circumstance needs to be classified according to risk. Consideration of the risks resulted in a local policy in which written consent is required for the following: therapeutic procedures, studies on pregnant women, studies in which pregnancy needs to be avoided, research procedures, cardiac stress for myocardial perfusion scintigraphy and intrathecal administration. Patient information leaflets have been updated with new information about the study and any risks. Information is now available for both patients and hospital staff. Compliance with the consent policy in a service department provides logistic challenges, but it is possible to fully inform patients in advance about their treatment, allowing them to give informed consent.

A Troubled Past? Reassessing Ethics in the History of Tissue Culture.

PubMed

Wilson, Duncan

2016-09-01

Recent books, articles and plays about the 'immortal' HeLa cell line have prompted renewed interest in the history of tissue culture methods that were first employed in 1907 and became common experimental tools during the twentieth century. Many of these sources claim tissue cultures like HeLa had a "troubled past" because medical researchers did not seek informed consent before using tissues in research, contravening a long held desire for self-determination on the part of patients and the public. In this article, I argue these claims are unfair and misleading. No professional guidelines required informed consent for tissue culture during the early and mid twentieth century, and popular sources expressed no concern at the widespread use of human tissues in research. When calls for informed consent did emerge in the 1970s and 1980s, moreover, they reflected specific political changes and often emanated from medical researchers themselves. I conclude by arguing that more balanced histories of tissue culture can make a decisive contribution to public debates today: by refuting a false dichotomy between science and its publics, and showing how ethical concepts such as informed consent arise from a historically specific engagement between professional and social groups.

Best practice guidelines on informed consent for weight loss surgery patients.

PubMed

Sabin, James; Fanelli, Robert; Flaherty, Helen; Istfan, Nawfal; Mariner, Wendy; Barnes, Janet Nally; Pratt, Janey S A; Rossi, Laura; Samour, Patricia

2005-02-01

To provide evidence-based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients. We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion. This Task Group found that the informed consent process contributes to long-term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding. Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.

Dynamic axes of informed consent in Japan.

PubMed

Specker Sullivan, Laura

2017-02-01

Scholarship in cross-cultural bioethics routinely frames Japanese informed consent in contrast to informed consent in North America. This contrastive analysis foregrounds cancer diagnosis disclosure and physician paternalism as unique aspects of Japanese informed consent that deviate from American practices. Drawing on in-depth interviews with 15 Japanese medical professionals obtained during fieldwork in Japan from 2013 to 15, this article complicates the informed consent discourse beyond East-West comparisons premised on Anglo-American ethical frameworks. It expands professional perspectives to include nurses, medical social workers, clinical psychologists, and ethicists and it addresses informed consent for a broad range of conditions in addition to cancer. The results suggest that division of affective labor is an under-theorized dimension of informed consent that is perceived as at odds with principled demands for universal informed consent. These practical tensions are conceptualized as cultural differences, with Japan identified in terms of omakase as practical and supportive and the United States identified in terms of jiko kettei as principled and self-determining. These results have implications for the methodology of cross-cultural bioethics as well as for theories and practices of informed consent in both Japan and the United States. I conclude that responsible cross-cultural work in bioethics must begin from the ground up, incorporating all relevant stakeholder perspectives, attitudes, and experiences. Copyright © 2016 Elsevier Ltd. All rights reserved.

Clinical records anonymisation and text extraction (CRATE): an open-source software system.

PubMed

Cardinal, Rudolf N

2017-04-26

Electronic medical records contain information of value for research, but contain identifiable and often highly sensitive confidential information. Patient-identifiable information cannot in general be shared outside clinical care teams without explicit consent, but anonymisation/de-identification allows research uses of clinical data without explicit consent. This article presents CRATE (Clinical Records Anonymisation and Text Extraction), an open-source software system with separable functions: (1) it anonymises or de-identifies arbitrary relational databases, with sensitivity and precision similar to previous comparable systems; (2) it uses public secure cryptographic methods to map patient identifiers to research identifiers (pseudonyms); (3) it connects relational databases to external tools for natural language processing; (4) it provides a web front end for research and administrative functions; and (5) it supports a specific model through which patients may consent to be contacted about research. Creation and management of a research database from sensitive clinical records with secure pseudonym generation, full-text indexing, and a consent-to-contact process is possible and practical using entirely free and open-source software.

An evaluation of "informed consent" with volunteer prisoner subjects.

PubMed

Marini, J L; Sheard, M H; Bridges, C I

1976-11-01

"Informed consent" sets a goal for investigators experimenting with human subjects, but little is known about how to achieve or evaluate it in an experiment. In a 3-year, double-blind study with incarcerated men, we attempted to provide a "free and informed consent" and evaluated our efforts with an unannounced questionnaire administered to subjects after they completed the experiment. At that time, approximately two-thirds had sufficient information for an informed consent, but only one-third was well informed about all key aspects of the experiment and one-third was insufficiently informed to give an informed consent. We found that institution- or study-based coercion was minimal in our experiment. From our evaluation of the questionnaire and experience at the study institution, we conclude that an experiment with human subjects should be designed to include an ongoing evaluation of informed consent, and active attempts should be made to avoid or minimize coercive inducements. Experiments with significant risk, which require a long duration and/or large sample size relative to the institution's population, should probably not be performed on prisoner subjects. The experimenter should be independent of the penal institution's power structure. Presenting and explaining a consent form to volunteers on one occasion is probably an in adequate procedure for obtaining and maintaining an informed consent.

From the Patient Perspective, Consent Forms Fall Short of Providing Information to Guide Decision Making

PubMed Central

Manta, Christine J.; Ortiz, Jacqueline; Moulton, Benjamin W.; Sonnad, Seema S.

2016-01-01

Objective This study aimed to gather qualitative feedback on patient perceptions of informed consent forms and elicit recommendations to improve readability and utility for enhanced patient safety and engagement in shared decision making. Methods Sixty in person interviews were conducted consisting of a literacy and numeracy assessment, a comprehension quiz to assess retention of key information and open ended questions to determine reactions, clarity of information and suggestions for improvement. Results While 68% of the participants had education beyond high school, many still missed comprehension questions and found the forms difficult to read. Recurrent suggestions included: specific formatting changes to enhance readability, a need for additional sources of information, mixed attitudes towards inclusion of risk information and the recognized importance of physician-patient conversations. Conclusion This study provides evidence from the patient perspective that consent forms are too complex and fail to achieve comprehension. Future studies should be conducted using patients’ suggestions for form redesign and inclusion of supplemental educational tools in order to optimize communication and safety to achieve more informed health care decision making. PMID:27490160

PATIENT'S RIGHT TO INFORMED CONSENT IN REPUBLIC SRPSKA: LEGAL AND ETHICAL ASPECTS (WITH SPECIAL REFERENCE TO PHYSICAL REHABILITATION).

PubMed

Milinkovic, Igor; Majstorovic, Biljana

2014-12-01

The principle of informed consent, which requires a patient's fully-informed consent prior to the medical treatment, is closely connected with the value of human dignity. The realization and protection of a patient's dignity is not possible without his/her right to choose the character and scope of medical treatment. This goal cannot be adequately achieved within the traditional model of medical paternalism characterized by the physician's authoritative position. The first part of the article deals with the content and ethical significance of the informed consent doctrine. The legal framework of informed consent in Republic Srpska (RS), one of the two Bosnia and Herzegovina (BH)entities, is analyzed. Special reference is made to the relevance of the informed consent principle within the physical rehabilitation process. Although ethical aspects of physical rehabilitation are often overlooked, this medical field possesses a strong ethical dimension (including an appropriate realization of the patient's right to informed consent).

A Pilot Study of Simple Interventions to Improve Informed Consent in Clinical Research: Feasibility, Approach, and Results

PubMed Central

Kass, Nancy; Taylor, Holly; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

2014-01-01

Background Informed consent is intended to ensure that individuals understand the purpose, risks, and benefits of research studies, and then can decide, voluntarily, whether to enroll. However, research suggests that consent procedures do not always lead to adequate participant understanding and may be longer and more complex than necessary. Studies also suggest some consent interventions, including enhanced consent forms and extended discussions with patients, increase understanding, yet methodologic challenges have been raised in studying consent in actual trial settings. This study aimed to examine the feasibility of testing two consent interventions in actual studies and also to measure effectiveness of interventions in improving understanding of trials. Methods Participants enrolling in any of eight ongoing clinical trials (“collaborating studies”) were, for the purposes of this study, sequentially assigned to one of three study arms involving different informed consent procedures (one control and two intervention). Control participants received standard consent form and processes. Participants in the 1st intervention arm received a bulleted fact-sheet providing simple summaries of all study components in addition to the standard consent form. Participants in the 2nd intervention arm received the bulleted fact-sheet and standard consent materials and then also engaged with a member of the collaborating study staff in a feedback Q&A session. Following consent procedures, we administered closed and open ended questions to assess patient understanding and we assessed literacy level. Descriptive statistics, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of patient understanding. Results 144 participants enrolled. Using regression analysis participants receiving the 2nd intervention, which included a standard consent form, bulleted fact sheet and structured question and answer session with a study staff member, had open-ended question scores that were 7.6 percentage points higher (p=.02) than participants who received the control arm (standard consent only), although unadjusted comparisons did not reach statistical significance. Eleven clinical trial investigators agreed to participate and 8 trials provided sufficient data to be included, thereby demonstrating feasibility of consent research in actual settings. Conclusions Our study supports the hypothesis that patients receiving both bulleted fact sheets and a question and answer session have higher understanding compared to patients receiving standard consent form and procedures alone. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples for effectiveness. PMID:25475879

Passive Consent for Clinical Research in the Age of HIPAA

PubMed Central

Littenberg, Benjamin; MacLean, Charles D

2006-01-01

BACKGROUND Federal laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) of 1996, intended primarily to protect individuals, have been described as significant barriers to the use of clinical registries and other population-based tools for health care research. Although these regulations allow for the waiver or alteration of usual consent procedures when the research meets certain specific criteria, waivers and alterations are rarely used in health care research. METHODS The Vermont Diabetes Information System is a multistate randomized trial of a quality improvement intervention that uses a novel alteration of informed consent to help ensure that the study sample is representative of the target population. Patients are notified by mail that they are eligible for the study and that they may opt out of the study, if they desire, by calling a toll-free number. RESULTS Seven thousand five hundred and fifty-eight patients were invited to participate. Two hundred and ten (2.8%) opted out. Three patients (0.04%) filed complaints, all of which were addressed satisfactorily. CONCLUSIONS Health Insurance Portability and Accountability Act and other federal regulations raise challenges to the use of clinical registries in research, but modifications to the consent process, including passive consent methods, are useful tools to overcome these challenges. It is possible to recruit a broad and representative population under current law while maintaining appropriate protections for research subjects. PMID:16637821

Informed Consent for Electroconvulsive Therapy--Finding Balance.

PubMed

Mankad, Mehul

2015-09-01

Informed consent underpins all medical decisions, including the decision to undergo electroconvulsive therapy (ECT). Written informed consent remains the standard before the initiation of ECT and requires the inclusion of several components to be considered valid. Prospective patients must be aware of risks and benefits of ECT as well as risks and benefits of alternate, and potentially less effective, interventions. Patients must also possess adequate decision-making capacity to make an informed choice about treatment. Consent for ECT may present unique issues, such as the interplay between potential cognitive adverse effects and informed consent. Options to address this concern include thorough explanation of this topic before the initiation of ECT, continued reassessment of consent during ECT, or some combination of approaches.

The Effect of New Model PREPARED on Obtaining Informed Consent Skill in Midwifery Students of Shahid Sadoughi University of Medical Sciences

PubMed Central

Farajkhoda, Tahmineh; Bokaie, Mahshid; Abbasi, Mahmoud; NajafiHedeshi, Saeedeh; Alavi, Zahra; Rahimdel, Mahin

2017-01-01

Background: Professional ethics culture should be taught to students appropriately. Studies have shown that midwifery students are not entirely familiar with the skill of obtaining informed consent. Using a new and applicable model to teach this skill to midwifery students is necessary. This study was conducted to determine the effect of a new standard model, PREPARED, on the skill of obtaining informed consent in midwifery students of Shahid Sadoughi University of Medical Sciences. Materials and Methods: This interventional study was conducted on 37 5th semester midwifery students through a census method. After determining psychometric indices, in two phases with a 4-week interval (before and after the training), the PREPARED checklist was completed by the professors of the research team in the presence of students in the delivery room while they were performing midwifery care considering their compliance to the checklist. Descriptive statistics paired t-test were used for data analysis. Results: The lowest mean score before the training belonged to alternative methods (1.00) and treatment expenses (1.00). After the training, treatment plan had the highest mean score (3.54 (0.69)). The mean and standard deviation of scores before and after training the students were 9.12 (2.00) and 30.6824 (5.25), respectively. Based on the results of the paired t-test (P = 0.001), the difference was statistically significant. Conclusion: Results showed that the implementation of the new model of PREPARED would increase the skill of obtaining informed consent in midwifery students and could be applied for educating students of other medical majors in Iran. PMID:28904537

Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

PubMed

Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

2011-11-01

Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

Patient preferences toward an interactive e-consent application for research using electronic health records.

PubMed

Harle, Christopher A; Golembiewski, Elizabeth H; Rahmanian, Kiarash P; Krieger, Janice L; Hagmajer, Dorothy; Mainous, Arch G; Moseley, Ray E

2017-12-19

The purpose of this study was to assess patient perceptions of using an interactive electronic consent (e-consent) application when deciding whether or not to grant broad consent for research use of their identifiable electronic health record (EHR) information. For this qualitative study, we conducted a series of 42 think-aloud interviews with 32 adults. Interview transcripts were coded and analyzed using a modified grounded theory approach. We identified themes related to patient preferences, reservations, and mixed attitudes toward consenting electronically; low- and high-information-seeking behavior; and an emphasis on reassuring information, such as data protections and prohibitions against sharing data with pharmaceutical companies. Participants expressed interest in the types of information contained in their EHRs, safeguards protecting EHR data, and specifics on studies that might use their EHR data. This study supports the potential value of interactive e-consent applications that allow patients to customize their consent experience. This study also highlights that some people have concerns about e-consent platforms and desire more detailed information about administrative processes and safeguards that protect EHR data used in research. This study contributes new insights on how e-consent applications could be designed to ensure that patients' information needs are met when seeking consent for research use of health record information. Also, this study offers a potential electronic approach to meeting the new Common Rule requirement that consent documents contain a "concise and focused" presentation of key information followed by more details. © The Author(s) 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Using informed consent to save trust.

PubMed

Eyal, Nir

2014-07-01

Increasingly, bioethicists defend informed consent as a safeguard for trust in caretakers and medical institutions.This paper discusses an ‘ideal type’ of that move. What I call the trust-promotion argument for informed consent states:1. Social trust, especially trust in caretakers and medical institutions, is necessary so that, for example,people seek medical advice, comply with it, and participate in medical research.2. Therefore, it is usually wrong to jeopardise that trust.3. Coercion, deception, manipulation and other violations of standard informed consent requirements seriously jeopardise that trust.4. Thus, standard informed consent requirements are justified.This article describes the initial promise of this argument, then identifies challenges to it. As I show, the value of trust fails to account for some common sense intuitions about informed consent. We should revise the argument, common sense morality, or both.

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.

PubMed

Allmark, P; Mason, S

2006-08-01

To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test of the effectiveness of continuous consent. Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. Consent validity was found to compare favourably with similar trials examined in the Euricon study. Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process.

Increased Access to Professional Interpreters in the Hospital Improves Informed Consent for Patients with Limited English Proficiency.

PubMed

Lee, Jonathan S; Pérez-Stable, Eliseo J; Gregorich, Steven E; Crawford, Michael H; Green, Adrienne; Livaudais-Toman, Jennifer; Karliner, Leah S

2017-08-01

Language barriers disrupt communication and impede informed consent for patients with limited English proficiency (LEP) undergoing healthcare procedures. Effective interventions for this disparity remain unclear. Assess the impact of a bedside interpreter phone system intervention on informed consent for patients with LEP and compare outcomes to those of English speakers. Prospective, pre-post intervention implementation study using propensity analysis. Hospitalized patients undergoing invasive procedures on the cardiovascular, general surgery or orthopedic surgery floors. Installation of dual-handset interpreter phones at every bedside enabling 24-h immediate access to professional interpreters. Primary predictor: pre- vs. post-implementation group; secondary predictor: post-implementation patients with LEP vs. English speakers. Primary outcomes: three central informed consent elements, patient-reported understanding of the (1) reasons for and (2) risks of the procedure and (3) having had all questions answered. We considered consent adequately informed when all three elements were met. We enrolled 152 Chinese- and Spanish-speaking patients with LEP (84 pre- and 68 post-implementation) and 86 English speakers. Post-implementation (vs. pre-implementation) patients with LEP were more likely to meet criteria for adequately informed consent (54% vs. 29%, p = 0.001) and, after propensity score adjustment, had significantly higher odds of adequately informed consent (AOR 2.56; 95% CI, 1.15-5.72) as well as of each consent element individually. However, compared to post-implementation English speakers, post-implementation patients with LEP had significantly lower adjusted odds of adequately informed consent (AOR, 0.38; 95% CI, 0.16-0.91). A bedside interpreter phone system intervention to increase rapid access to professional interpreters was associated with improvements in patient-reported informed consent and should be considered by hospitals seeking to improve care for patients with LEP; however, these improvements did not eliminate the language-based disparity. Additional clinician educational interventions and more language-concordant care may be necessary for informed consent to equal that for English speakers.

Making a difference: incorporating theories of autonomy into models of informed consent.

PubMed

Delany, C

2008-09-01

Obtaining patients' informed consent is an ethical and legal obligation in healthcare practice. Whilst the law provides prescriptive rules and guidelines, ethical theories of autonomy provide moral foundations. Models of practice of consent, have been developed in the bioethical literature to assist in understanding and integrating the ethical theory of autonomy and legal obligations into the clinical process of obtaining a patient's informed consent to treatment. To review four models of consent and analyse the way each model incorporates the ethical meaning of autonomy and how, as a consequence, they might change the actual communicative process of obtaining informed consent within clinical contexts. An iceberg framework of consent is used to conceptualise how ethical theories of autonomy are positioned and underpin the above surface, and visible clinical communication, including associated legal guidelines and ethical rules. Each model of consent is critically reviewed from the perspective of how it might shape the process of informed consent. All four models would alter the process of obtaining consent. Two models provide structure and guidelines for the content and timing of obtaining patients' consent. The two other models rely on an attitudinal shift in clinicians. They provide ideas for consent by focusing on underlying values, attitudes and meaning associated with the ethical meaning of autonomy. The paper concludes that models of practice that explicitly incorporate the underlying ethical meaning of autonomy as their basis, provide less prescriptive, but more theoretically rich guidance for healthcare communicative practices.

78 FR 27404 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

...; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... submitted a proposed collection of information entitled ``Guidance on Informed Consent for In Vitro...

Ethical issues with informed consent from potential living kidney donors.

PubMed

Petrini, C

2010-05-01

Living organ donation and participation in clinical research trials have several features in common from an ethical perspective. The primary similarity is risk justification: the risk of harm to living organ donors and clinical research participants is justified by a resulting benefit to one or more other individuals. Some authors hold that organ donation and clinical trial participation are full-fledged duties. Such an implicit likening of the two leads to several considerations regarding informed consent in each situation. Informed consent raises ethical concerns in every medical context, and some of those concerns, such as competence, understanding, autonomy, and free or voluntary choice, are uniquely relevant to living organ donation and clinical trial participation. Most countries regulate informed consent procedures for living organ donation in great detail, and although informed consent procedures for clinical trial participation are somewhat less detailed, their rules are subject to review by ethics committees. It would be constructive for research participation informed consent procedures and living organ donation informed consent procedures to learn from one another. Copyright (c) 2009 Elsevier Inc. All rights reserved.

Informed consent in neurosurgery--translating ethical theory into action.

PubMed

Schmitz, Dagmar; Reinacher, Peter C

2006-09-01

Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans. By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed. The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician-patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence. To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent.

Disclosure of Individual Surgeon's Performance Rates During Informed Consent

PubMed Central

Burger, Ingrid; Schill, Kathryn; Goodman, Steven

2007-01-01

Objective: The purpose of the paper is to examine the ethical arguments for and against disclosing surgeon-specific performance rates to patients during informed consent, and to examine the challenges that generating and using performance rates entail. Methods: Ethical, legal, and statistical theory is explored to approach the question of whether, when, and how surgeons should disclosure their personal performance rates to patients. The main ethical question addressed is what type of information surgeons owe their patients during informed consent. This question comprises 3 related, ethically relevant considerations that are explored in detail: 1) Does surgeon-specific performance information enhance patient decision-making? 2) Do patients want this type of information? 3) How do the potential benefits of disclosure balance against the risks? Results: Calculating individual performance measures requires tradeoffs and involves inherent uncertainty. There is a lack of evidence regarding whether patients want this information, whether it facilitates their decision-making for surgery, and how it is best communicated to them. Disclosure of personal performance rates during informed consent has the potential benefits of enhancing patient autonomy, improving patient decision-making, and improving quality of care. The major risks of disclosure include inaccurate and misleading performance rates, avoidance of high-risk cases, unjust damage to surgeon's reputations, and jeopardized patient trust. Conclusion: At this time, we think that, for most conditions, surgical procedures, and outcomes, the accuracy of surgeon- and patient-specific performance rates is illusory, obviating the ethical obligation to communicate them as part of the informed consent process. Nonetheless, the surgical profession has the duty to develop information systems that allow for performance to be evaluated to a high degree of accuracy. In the meantime, patients should be informed of the quantity of procedures their surgeons have performed, providing an idea of the surgeon's experience and qualitative idea of potential risk. PMID:17414595

Pharmaceutical information systems and possible implementations of informed consent -- developing an heuristic.

PubMed

Ploug, Thomas; Holm, Søren

2012-11-16

Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system.The danger of routinisation of consent is identified.The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent.

Opt-Out Parental Consent in Online Surveys: Ethical Considerations.

PubMed

Harris, Jane; Porcellato, Lorna

2018-07-01

This article aims to foster discussion and debate around seeking parental consent from young people recruited online. The growth of social media, particularly for young people, has led to increased interest in young people's online activities as both a research topic and recruitment setting. In a health-related study, which sought to recruit young people aged 13 to 18 years old from YouTuber fan communities to an online survey, the question arose of how parental consent could be sought from young people below 16 when no link existed between researcher and parents/guardians. A practical strategy is proposed which combines novel communication methods for participant information, opt-out online consent and age verification to address this issue. Strengths and limitations of these approaches are discussed.

Improving the Quality of Informed Consent in Clinical Research with Information Technology.

PubMed

Taber, Celia; Warren, Jim; Day, Karen

2016-01-01

The clinical research industry has yet to fully embrace information technology (IT) for informed consent purposes, even though it is used indispensably in our everyday lives and in other areas of clinical research and healthcare. This paper presents findings of a meta-narrative literature review to discuss the potential for IT to improve the quality of clinical research informed consent. The review reveals three main rationales for including IT in research consent. First, in the current context consent documents frequently fail to be effective decision aids for patients, and the lack of patient centricity in the process. Second, social media provides opportunities for patients to consult with a broader community during research consent to seek broader support, and potential to participate in creating a more patient centric process. Third, multimedia tools provide opportunities for improved patient education, engagement and decision making during research consent. IT offers opportunities to achieve more meaningful research consent, but more research is needed to create an evidence base, policies and economic analyses on the return on investment of using IT in the process.

Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh

PubMed Central

2014-01-01

Background Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects’ understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. Methods In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Results Of 16 participants, the vast majority (81%) were illiterate. All subjects had a ‘therapeutic misconception’ i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients’ perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants’ satisfaction with treatment and nursing care. Conclusion There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings. PMID:24893933

Simulated Patient Studies: An Ethical Analysis

PubMed Central

Rhodes, Karin V; Miller, Franklin G

2012-01-01

Context In connection with health care reform, the U.S. Department of Health and Human Services commissioned a “mystery shopper,” or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over “government spying” on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. Methods We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. Findings Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy-relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. Conclusions As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy-relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge. PMID:23216428

The legal and ethical implications of consent to nursing procedures.

PubMed

Power, K J

Nurses are increasingly expanding their practice to include many more invasive procedures. Consequently, there is a need to re-examine nurses' responsibilities in relation to obtaining consent for nursing as opposed to medical procedures. Fully informed consent is not a legal requirement in England, for either medical or nursing procedures. However, this article argues that to comply with the standard set by the Code of Professional Conduct nurses should obtain informed consent for any proposed procedure they undertake. The concept of informed consent is examined and applied to practice. Ultimately, nurses are charged with four key tasks in relation to securing consent for nursing procedures: educating themselves about the risks and benefits of the procedures they propose to undertake; conveying this information to patients; assessing their understanding of the information given; and endeavouring to support the patient in his/her decision.

Nudging, informed consent and bullshit.

PubMed

Simkulet, William

2017-11-18

Some philosophers have argued that during the process of obtaining informed consent, physicians should try to nudge their patients towards consenting to the option the physician believes best, where a nudge is any influence that is expected to predictably alter a person's behaviour without (substantively) restricting her options. Some proponents of nudging even argue that it is a necessary and unavoidable part of securing informed consent. Here I argue that nudging is incompatible with obtaining informed consent. I assume informed consent requires that a physician tells her patient the truth about her options and argue that nudging is incompatible with truth-telling. Instead, nudging satisfies Harry Frankfurt's account of bullshit. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

78 FR 56183 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; Imperium, LLC...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

... Proposed Parental Consent Method; Imperium, LLC Application for Approval of Parental Consent Method AGENCY... Trade Commission requests public comment concerning the proposed parental consent method submitted by... Parental Consent Method, Project No. P-135419'' on your comment, and file your comment online at https...

A computer-based education intervention to enhance surrogates' informed consent for genomics research.

PubMed

Shelton, Ann K; Freeman, Bradley D; Fish, Anne F; Bachman, Jean A; Richardson, Lloyd I

2015-03-01

Many research studies conducted today in critical care have a genomics component. Patients' surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patient's participation in the research. To examine the effectiveness of a new, computer-based education module on surrogates' understanding of the process of informed consent for genomics research. A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent. Understanding the process of informed consent was greater (P = .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P = .02), definition of surrogate consenter (P= .001), withdrawal from the study (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P = .001), definition of substituted judgment (P = .03), compensation for harm (P = .001), and alternative treatments (P = .004). Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients' family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care. ©2015 American Association of Critical-Care Nurses.

Interventions to improve patient comprehension in informed consent for medical and surgical procedures: a systematic review.

PubMed

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2011-01-01

Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. . To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources. A systematic literature search of English-language articles in MEDLINE (1949-2008) and EMBASE (1974-2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection. Randomized controlled trials and controlled trials with nonrandom allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction. Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis. Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations. Many studies failed to include adequate description of the study population, and outcome measures varied widely. . A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations.

Do surgeons and patients discuss what they document on consent forms?

PubMed

Hall, Daniel E; Hanusa, Barbara H; Fine, Michael J; Arnold, Robert M

2015-07-01

Previous studies of surgeon behavior report that surgeons rarely meet basic standards of informed consent, raising concerns that current practice requires urgent remediation. We wondered if the Veterans Affairs Healthcare System's recent implementation of standardized, procedure-specific consent forms might produce a better practice of informed consent than has been reported previously. Our goal was to determine how the discussions shared between surgeons and patients correspond to the VA's standardized consent forms. We enrolled a prospective cohort of patients presenting for possible cholecystectomy or inguinal herniorrhaphy and the surgical providers for those patients. Audio recordings captured the clinical encounter(s) culminating in a decision to have surgery. Each patient's informed consent was documented using a standardized, computer-generated form. We abstracted and compared the information documented with the information discussed. Of 75 consecutively enrolled patients, 37 eventually decided to have surgery and signed the standardized consent form. Patients and providers discussed 37% (95% confidence interval, 0.07-0.67) and 33% (95% confidence interval, 0.21-0.43) of the information found on the cholecystectomy and herniorrhaphy consent forms, respectively. However, the patient-provider discussions frequently included relevant details nowhere documented on the standardized forms, culminating in discussions that included a median 27.5 information items for cholecystectomy and 20 items for herniorrhaphy. Fully, 80% of cholecystectomy discussions and 76% of herniorrhaphy discussions mentioned at least one risk, benefit or alternative, indication for, and description of the procedure. The patients and providers observed here collaborated in a detailed process of informed consent that challenges the initial reports suggesting the need to remediate surgeon's practice of informed consent. However, because the discrepancy between the information documented and discussed exposes legal and ethical liability, there is an opportunity to improve the iMed system so that it better reflects what surgeons discuss and more frequently includes all the information patients need. Published by Elsevier Inc.

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: A Systematic Review

PubMed Central

Schenker, Yael; Fernandez, Alicia; Sudore, Rebecca; Schillinger, Dean

2017-01-01

Background Patient understanding in clinical informed consent is often poor. Little is known about the effectiveness of interventions to improve comprehension or the extent to which such interventions address different elements of understanding in informed consent. Purpose To systematically review communication interventions to improve patient comprehension in informed consent for medical and surgical procedures. Data Sources A systematic literature search of English-language articles in MEDLINE (1949–2008) and EMBASE (1974–2008) was performed. In addition, a published bibliography of empirical research on informed consent and the reference lists of all eligible studies were reviewed. Study Selection Randomized controlled trials and controlled trials with non-random allocation were included if they compared comprehension in informed consent for a medical or surgical procedure. Only studies that used a quantitative, objective measure of understanding were included. All studies addressed informed consent for a needed or recommended procedure in actual patients. Data Extraction Reviewers independently extracted data using a standardized form. All results were compared, and disagreements were resolved by consensus. Data Synthesis Forty-four studies were eligible. Intervention categories included written information, audiovisual/multimedia, extended discussions, and test/feedback techniques. The majority of studies assessed patient understanding of procedural risks; other elements included benefits, alternatives, and general knowledge about the procedure. Only 6 of 44 studies assessed all 4 elements of understanding. Interventions were generally effective in improving patient comprehension, especially regarding risks and general knowledge. Limitations Many studies failed to include adequate description of the study population, and outcome measures varied widely. Conclusions A wide range of communication interventions improve comprehension in clinical informed consent. Decisions to enhance informed consent should consider the importance of different elements of understanding, beyond procedural risks, as well as feasibility and acceptability of the intervention to clinicians and patients. Conceptual clarity regarding the key elements of informed consent knowledge will help to focus improvements and standardize evaluations. PMID:20357225

Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study.

PubMed

Wood, Fiona; Martin, Sean Michael; Carson-Stevens, Andrew; Elwyn, Glyn; Precious, Elizabeth; Kinnersley, Paul

2016-06-01

The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. To explore doctors' perspectives of gaining informed consent for routine surgical procedures. Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. Twenty doctors in two teaching hospitals in the UK. Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients' reluctance to be involved. Current consent processes do not appear to be ideal for many doctors. In particular, junior doctors are often not confident taking consent for surgical procedures and require more support to undertake this task. This might include written information for junior staff, observation by senior colleagues when undertaking the task and ward-based communication skills teaching on consent taking. © 2014 John Wiley & Sons Ltd.

Current practices and medico-legal aspects of pre-operative consent.

PubMed

Osime, O C; Okojie, O; Osadolor, F; Mohammed, S

2004-07-01

Written informed consent is a pre requisite for surgical intervention as it provides the forum for the patient to appreciate implications of the procedure and the doctor to explain details and effects of the surgery. To evaluate the practice of obtaining informed consent pre-operatively by surgeons in Benin City and proffer solutions that would enhance its practice. Cross-sectional study involving surgical patients or their relations or gurdian (in cases involving minors and unconscious patients) who were interviewed with structured ended questionnaires. Study was carried out at the University of Benin Teaching Hospital, Benin City, between 5th July and 6th September 2002. One hundred and thirty-three respondents; 53(39.2%) males and 80(60.2%) females were interviewed. Documentations regarding consent were noted in 118(88.7%) cases. Of these, 74.6% felt they had enough time to reflect on the consent obtained while 48(36.1%) respondents were meeting the individual who obtained their consent for the first time. The content of information offered patients prior to obtaining consent was found to be significantly related to the levels of education (X2= 31.44; P<0.001). Over a hundred respondents were not informed of risk of procedure. Nonetheless over 50% of respondents felt satisfied with information supplied. The quality of consent obtained from the average patient fell below expected standard. There is need for greater awareness amongst administrators of consent on the essence of improving quality of information given and mode of obtaining consent from patients.

The use of multimedia as an adjunct to the informed consent process for ankle ligament reconstruction surgery.

PubMed

Batuyong, Eldridge; Birks, Christopher; Beischer, Andrew D

2012-06-01

Obtaining "informed consent" is an integral aspect of surgery that can be fraught with difficulty. This study assessed the efficacy of a multimedia education tool in improving patients' understanding when used as an adjunct to the traditional verbal consent process regarding ankle lateral ligament reconstruction surgery. A total of 56 patients (28 males and 28 females) were recruited with a mean age of 36 years. A standardized verbal discussion regarding surgical treatment was provided to each patient. Understanding was then assessed using a knowledge questionnaire. Subsequently, each patient observed a multimedia educational program following which the knowledge questionnaire was repeated. Additional supplementary questions were then given regarding the ease of understanding and satisfaction with the 2 methods of education delivery. The patients answered 75% of the questions correctly before the multimedia module compared with 88% after it (P < .001). Patients rated the ease of understanding and the amount of information provided by the module highly (9.5 cm and 9.0 cm on a 10-cm Visual Analogue Scale scale, respectively), and 61% of patients considered that the multimedia tool performed as well as the treating surgeon. Multimedia tools used in sequence after a verbal consent resulted in improved patient understanding of pertinent information regarding ankle lateral ligament reconstruction surgery. Therapeutic Level II.

Practical Communication Guidance to Improve Phase I Informed Consent Conversations and Decision-Making in Pediatric Oncology

PubMed Central

Johnson, Liza-Marie; Leek, Angela C.; Drotar, Dennis; Noll, Robert B.; Rheingold, Susan R.; Kodish, Eric D.; Baker, Justin N.

2015-01-01

Background It can be difficult to explain pediatric Phase I oncology trials to families of children with refractory cancer. Parents may misunderstand the information presented to them, and physicians may assume that certain topics are covered in the informed consent document and need not be discussed. Communication models can help to ensure effective discussions. Methods Suggestions for improving the informed consent process were first solicited from Phase I study clinicians via questionnaire. Eight parents who had enrolled their child on a Phase I pediatric oncology trial were recruited for an advisory group designed to assess the clinicians’ suggestions and make additional recommendations for improving informed consent for pediatric Phase I trials. Results A Phase I Communication Model was designed to incorporate the suggestions of clinicians and families. It focuses on education of parents/families about Phase I trials at specific time points during a child’s illness, but specifically at the point of relapse. We also present an informative Phase I fact sheet that can be distributed to families. Conclusions Families who will be offered information about a Phase I clinical trial can first receive a standardized fact sheet explaining the general purpose of these early-phase clinical trials. Parental understanding may be further enhanced when oncologists address key themes, beginning at diagnosis and continuing through important decision points during the child’s illness. This model should be prospectively evaluated. PMID:25873253

Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.

PubMed

Vickers, Andrew J; Young-Afat, Danny A; Ehdaie, Behfar; Kim, Scott Yh

2018-02-01

Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.

[The doctrine of free and informed consent: its ethical and legal foundations and its applications in research and practice of psychiatry].

PubMed

Grunberg, F

1990-06-01

This article briefly examines the ethical and legal foundations for the doctrine of informed consent in medical research and practice. The doctrine is based upon the importance of respecting the individual's autonomy and his right to self-determination. The article also reviews the development of the doctrine of informed consent based on its recent application. The authors cite the Nuremburg Code and the Helsinki Declarations and particularly the media denunication of several scandals in the United States during the late 1960s, when Henri Beecher's name figured prominently. The effects of informed consent in psychiatry are examined specifically, as well as the consequences for psychiatric research, on subjects who are able to give their consent, as well as those who are unable to do so. As for its effects on clinical practice, the paper discusses the right of the hospitalized patient to refuse treatment, and informed consent and the risks for patients treated with neuroleptics of developing tardive dyskinesia. The authors conclude that in psychotherapy the concept of informed consent cannot be taken for granted.

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Informed consent. 441.257 Section 441.257 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations § 441.257 Informed consent. (a) Informing...

US Public Cord Blood Banking Practices: Recruitment, Donation, and the Timing of Consent

PubMed Central

Broder, Sherri; Ponsaran, Roselle; Goldenberg, Aaron

2012-01-01

BACKGROUND Cord blood has moved rapidly from an experimental stem cell source to an accepted and important source of hematopoietic stem cells. There has been no comprehensive assessment of US public cord blood banking practices since the Institute of Medicine study in 2005. STUDY DESIGN AND METHODS Of 34 US public cord blood banks identified, 16 participated in our qualitative survey of public cord blood banking practices. Participants took part in in-depth telephone interviews in which they were asked structured and open-ended questions regarding recruitment, donation, and the informed consent process at these banks. RESULTS 13 of 16 participants reported a variably high percentage of women who consented to public cord blood donation. 15 banks offered donor registration at the time of hospital admission for labor and delivery. 7 obtained full informed consent and medical history during early labor and 8 conducted some form of phased consent and/or phased medical screening and history. 9 participants identified initial selection of the collection site location as the chief mode by which they recruited minority donors. CONCLUSION Since 2005, more public banks offer cord blood donor registration at the time of admission for labor and delivery. That, and the targeted location of cord blood collection sites, are the main methods used to increase access to donation and HLA diversity of banked units. Currently, the ability to collect and process donations, rather than donor willingness, is the major barrier to public cord blood banking. PMID:22803637

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond

PubMed Central

Yoshizawa, Go; Sasongko, Teguh H.; Ho, Chih-Hsing; Kato, Kazuto

2017-01-01

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases. PMID:28775738

Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond.

PubMed

Yoshizawa, Go; Sasongko, Teguh H; Ho, Chih-Hsing; Kato, Kazuto

2017-01-01

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia - the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases.

Enhancing the informed consent process for critical care research: strategies from a thromboprophylaxis trial.

PubMed

Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Fleury, Suzie; Krause, Katie; McArdle, Tracey; Skrobik, Yoanna; Cook, Deborah J

2013-12-01

Critically ill patients lack capacity for decisions about research participation. Consent to enrol these patients in studies is typically obtained from substitute decision-makers. To present strategies that may optimise the process of obtaining informed consent from substitute decision-makers for participation of critically ill patients in trials. We use examples from a randomised trial of heparin thromboprophylaxis in the intensive care unit (PROTECT, clinicaltrials.gov NCT00182143). 3764 patients were randomised, with an informed consent rate of 82%; 90% of consents were obtained from substitute decision-makers. North American PROTECT research coordinators attended three meetings to discuss enrolment: (1) Trial start-up (January 2006); (2) Near trial closure (January 2010); and (3) Post-publication (April 2011). Data were derived from slide presentations, field notes from break-out groups and plenary discussions, then analysed inductively. We derived three phases for the informed consent process: (1) Preparation for the Consent Encounter; (2) The Consent Encounter; and (3) Follow-up to the Consent Encounter. Specific strategies emerged for each phase: Phase 1 (four strategies); Phase 2 (six strategies); and Phase 3 (three strategies). We identified 13 strategies that may improve the process of obtaining informed consent from substitute decision-makers and be generalisable to other settings and studies. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Individual rights over public good? The future of anthropometric monitoring of school children in the fight against obesity.

PubMed

Stubbs, Joanne M; Achat, Helen M

2009-02-02

Available evidence indicates that rates of childhood overweight and obesity have been increasing over the past two decades, but inconsistencies between study methods moderate the strength of this evidence. Concomitant health problems and associated costs make it imperative that primary prevention initiatives are introduced to combat the obesity epidemic. Fundamental to informed action is anthropometric monitoring, which if properly implemented will identify changes over time in specific populations to inform policies, practices and services aimed at prevention and treatment. Sample representativeness is essential for valid trend and prevalence data, but efforts to obtain population-based anthropometric data from school children with the required written parental consent have been thwarted by low participation rates. Notable improvements in participation rates when utilising opt-out consent, in which participation is assumed unless otherwise indicated, are evident from local as well as international studies. Opt-out consent can facilitate anthropometric monitoring, delivering a more informed, best-value-for-money response to the obesity epidemic. Health and education ethics committees need to acknowledge the benefits of opt-out consent for "low-risk" anthropometric measurement, which ultimately upholds the individual's rights.

Health information technology and the idea of informed consent.

PubMed

Goldstein, Melissa M

2010-01-01

During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent's proper role in a health care environment in which electronic information sharing holds primary importance. This article discusses current implementation of the doctrine within health information exchange networks; the relationship between informed consent and privacy; the variety of ways that the concept is referenced in discussions of information sharing; and challenges that surround incorporation of the doctrine into the evolving HIT environment. The article concludes by reviewing the purpose behind the traditional obligation to obtain informed consent and the possibility of maintaining its relevance in the new environment.

78 FR 77026 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; iVeriFly, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

... Proposed Parental Consent Method; iVeriFly, Inc., Application for Approval of Parental Consent Method... Federal Trade Commission requests public comment concerning the proposed parental consent method submitted... Application for Parental Consent Method, Project No. P-135420'' on your comment, and file your comment online...

Informed consent in paediatric critical care research--a South African perspective.

PubMed

Morrow, Brenda M; Argent, Andrew C; Kling, Sharon

2015-09-09

Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of research risk. This document could provide a basis for debate on consent options in paediatric critical care research and contribute to efforts to advocate for South African law reform.

The ethics of research using biobanks: reason to question the importance attributed to informed consent.

PubMed

Hoeyer, Klaus; Olofsson, Bert-Ove; Mjörndal, Tom; Lynöe, Niels

2005-01-10

During the past decade, the use of stored tissue has become an object of increased ethical query. A Swedish biobank and a biotech company have been praised for solving the ethical problems with explicit informed consent procedures, and we decided to investigate donors' perceptions of the system. A questionnaire was sent to a randomized sample of 1200 donors who had donated blood and signed informed consent forms. The response rate was 80.9%. Of the respondents, 64.5% were aware that they had consented to donate a blood sample, 55.4% thought that they had consented to donate phenotypic information, and 31.6% believed that they could withdraw their consent. Among respondents, 3.9% considered informing donors about the research objective as the most important ethical issue in relation to biobanks, and 5.6% were unsatisfied with the information they had been given. There was 85.9% acceptance of surrogate decision making by regional research ethics committees. Considering that the donors in this study were not always aware of their donation but generally were not unsatisfied with the information they had received, and that they did not rate being informed about the research objective as an important issue, informed consent seems to be an inadequate measure of public acceptance of biobank-based research.

A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions

PubMed Central

Keulers, Bram J.; Scheltinga, Marc R. M.; Spauwen, Paul H. M.; van der Wilt, Gert-Jan

2010-01-01

Background Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process. Methods Relevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed. Results The body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose. Conclusions IC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process. PMID:20372902

Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.

PubMed

Abay, Serebe; Addissie, Adamu; Davey, Gail; Farsides, Bobbie; Addissie, Thomas

2016-01-01

Informed consent is a key component of bio-medical research involving human participants. However, obtaining informed consent is challenging in low literacy and resource limited settings. Rapid Ethical Assessment (REA) can be used to contextualize and simplify consent information within a given study community. The current study aimed to explore the effects of social, cultural, and religious factors during informed consent process on a proposed HPV-serotype prevalence study. A qualitative community-based REA was conducted in Adigudom and Mynebri Kebeles, Northern Ethiopia, from July to August 2013. Data were collected by a multi-disciplinary team using open ended questions concerning informed consent components in relation to the parent study. The team conducted one-to-one In-Depth Interviews (IDI) and Focus Group Discussions (FGDs) with key informants and community members to collect data based on the themes of the study. Tape recorded data were transcribed in Tigrigna and then translated into English. Data were categorized and thematically analyzed using open coding and content analysis based on pre-defined themes. The REA study revealed a number of socio-cultural issues relevant to the proposed study. Low community awareness about health research, participant rights and cervical cancer were documented. Giving a vaginal sample for testing was considered to be highly embarrassing, whereas giving a blood sample made participants worry that they might be given a result without the possibility of treatment. Verbal consent was preferred to written consent for the proposed study. This rapid ethical assessment disclosed important socio-cultural issues which might act as barriers to informed decision making. The findings were important for contextual modification of the Information Sheet, and to guide the best consent process for the proposed study. Both are likely to have enabled participants to understand the informed consent better and consequently to comply with the study.

How to achieve informed consent for research from Spanish-speaking individuals with low literacy: a qualitative report.

PubMed

Cortés, Dharma E; Drainoni, Mari-Lynn; Henault, Lori E; Paasche-Orlow, Michael K

2010-01-01

Investigators have the responsibility to ensure that prospective participants are fully informed about a research protocol prior to consenting to participate, yet many researchers face challenges when obtaining consent, since the majority of the general population has limited or no familiarity with research studies. These challenges are further magnified when obtaining consent from individuals with low literacy levels and who speak languages other than English. In this article we present findings from a qualitative study conducted with Spanish-speaking individuals with low-literacy designed to refine the Agency for Healthcare Research and Quality's Informed Consent and Authorization Toolkit for Minimal Risk Research. Findings from this study indicate that familiarity with providing informed consent and authorization for research or the experience of being a research participant appear to play key roles in an individual's ability to understand the consent and authorization process. While the text of the consent and authorization documents can be simplified using plain language principles, comprehension of several fundamental ideas such as risk and privacy need to be safeguarded with a consent process that confirms comprehension. Recommendations are provided to address the informational needs of individuals with low literacy levels and limited or no experience with research participation.

The efficacy of mobile application use on recall of surgical risks in nasal bone fracture reduction surgery

PubMed Central

Kim, Choong Hyeon; Cheon, Ji Seon; Choi, Woo Young; Son, Kyung Min

2018-01-01

Background The number of surgical risks recalled by a patient after surgery can be used as a parameter for assessing how well the patient has understood the informed consent process. No study has investigated the usefulness of a self-developed mobile application in the traditional informed consent process in patients with a nasal bone fracture. This study aimed to investigate whether delivery of information, such as surgical risks, through a mobile application is more effective than delivery of information through only verbal means and a paper. Methods This prospective, randomized study included 60 patients with a nasal bone fracture. The experimental group (n=30) received preoperative explanation with the traditional informed consent process in addition to a mobile application, while the control group (n=30) received preoperative explanation with only the traditional informed consent process. Four weeks after surgery, the number of recalled surgical risks was compared for analysis. The following six surgical risks were explained: pain, bleeding, nasal deformity, numbness, nasal obstruction, and nasal cartilage necrosis. Results The mean number of recalled surgical risks among all patients was 1.58±0.56. The most frequently recalled surgical risk was nasal deformity in both groups. The mean number of recalled surgical risks was 1.72±0.52 in the experimental group and 1.49±0.57 in the control group. There was a significant association between mobile application use and the mean number of recalled surgical risks (p=0.047). Age, sex, and the level of education were not significantly associated with the mean number of recalled surgical risks. Conclusion This study found that a mobile application could contribute to the efficient delivery of information during the informed consent process. With further improvement, it could be used in other plastic surgeries and other surgeries, and such an application can potentially be used for explaining risks as well as delivering other types of information. PMID:29609431

The extent of surgical patients' understanding.

PubMed

Pugliese, Omar Talhouk; Solari, Juan Lombardi; Ferreres, Alberto R

2014-07-01

The notion that consent to surgery must be informed implies not only that information should be provided by the surgeon but also that the information should be understood by the patient in order to give a foundation to his or her decision to accept or refuse treatment and thus, achieve autonomy for the patient. Nonetheless, this seems to be an idyllic situation, since most patients do not fully understand the facts offered and thus the process of surgical informed consent, as well as the patient's autonomy, may be jeopardized. Informed consent does not always mean rational consent.

A survey on informed consent process for epidural analgesia in labor pain in Korea

PubMed Central

Lee, Nan-Ju; Sim, Jiyeon; Lee, Mi Soon; Han, Sun Sook; Lee, Hwa Mi

2010-01-01

Background There is a legal obligation to explain the procedure and use of epidural analgesia in labor primarily due to the possibility of potential risks and associated complications. The present study details on the survey carried out to ascertain the current status of obtaining informed consent (IC) for explaining the epidural analgesia in labor. Methods The present study is based on a survey through a telephone questionnaire that covered all the hospitals in Korea where the anesthesiologists' belonged to and are registered with Korean Society of Anesthesiologists. The questionnaire included questions pertaining to administration of epidural analgesia to a parturient, information on different steps of obtaining an IC, whether patient status was evaluated, when the consent was obtained, and the reasons behind, if the consent had not being given. Results A total of 1,434 respondents took part in the survey, with a response rate of 97% (1,434/1,467). One hundred seventy-four hospitals had conducted epidural analgesia on the parturient. The overall rate of obtaining IC for epidural analgesia during labor was 85%, of which only 13% was conducted by anesthesiologists. The rate of evaluating preoperative patient status was 74%, of which 45% was conducted by anesthesiologists. Almost all of the consent was obtained prior to the procedure. Conclusions The rate of obtaining IC for epidural analgesia in labor is relatively high (85%) in Korea. However, it is necessary to discuss the content of the consent and the procedure followed for obtaining IC during the rapid progress of labor. PMID:20651996

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

28 CFR 549.52 - Informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Informed consent. 549.52 Section 549.52 Judicial Administration BUREAU OF PRISONS, DEPARTMENT OF JUSTICE INSTITUTIONAL MANAGEMENT MEDICAL SERVICES Plastic Surgery § 549.52 Informed consent. Approved plastic surgery procedures may not be performed...

Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.

PubMed

Grauberger, Jennifer; Kerezoudis, Panagiotis; Choudhry, Asad J; Alvi, Mohammed Ali; Nassr, Ahmad; Currier, Bradford; Bydon, Mohamad

2017-06-21

Predictive factors associated with increased risk of medical malpractice litigation have been identified, including severity of injury, physician sex, and error in diagnosis. However, there is a paucity of literature investigating informed consent in spinal surgery malpractice. To investigate the failure to obtain informed consent as an allegation in medical malpractice claims for patients undergoing a spinal procedure. In this retrospective cohort study, a national medicolegal database was searched for malpractice claim cases related to spinal surgery for all years available (ie, January 1, 1980, through December 31, 2015). Failure to obtain informed consent and associated medical malpractice case verdict. A total of 233 patients (117 [50.4%] male and 116 [49.8%] female; 80 with no informed consent allegation and 153 who cited lack of informed consent) who underwent spinal surgery and filed a malpractice claim were studied (mean [SD] age, 47.1 [13.1] years in the total group, 45.8 [12.9] years in the control group, and 47.9 [13.3] years in the informed consent group). Median interval between year of surgery and year of verdict was 5.4 years (interquartile range, 4-7 years). The most common informed consent allegations were failure to explain risks and adverse effects of surgery (52 [30.4%]) and failure to explain alternative treatment options (17 [9.9%]). In bivariate analysis, patients in the control group were more likely to require additional surgery (45 [56.3%] vs 53 [34.6%], P = .002) and have more permanent injuries compared with the informed consent group (46 [57.5%] vs 63 [42.0%], P = .03). On multivariable regression analysis, permanent injuries were more often associated with indemnity payment after a plaintiff verdict (odds ratio [OR], 3.12; 95% CI, 1.46-6.65; P = .003) or a settlement (OR, 6.26; 95% CI, 1.06-36.70; P = .04). Informed consent allegations were significantly associated with less severe (temporary or emotional) injury (OR, 0.52; 95% CI, 0.28-0.97; P = .04). In addition, allegations of informed consent were found to be predictive of a defense verdict vs a plaintiff ruling (OR, 0.41; 95% CI, 0.17-0.98; P = .046) or settlement (OR, 0.01; 95% CI, 0.001-0.15; P < .001). Lack of informed consent is an important cause of medical malpractice litigation. Although associated with a lower rate of indemnity payments, malpractice lawsuits, including informed consent allegations, still present a time, money, and reputation toll for physicians. The findings of this study can therefore help to improve preoperative discussions to protect spinal surgeons from malpractice claims and ensure that patients are better informed.

Pharmaceutical information systems and possible implementations of informed consent - developing an heuristic

PubMed Central

2012-01-01

Background Denmark has implemented a comprehensive, nationwide pharmaceutical information system, and this system has been evaluated by the Danish Council of Ethics. The system can be seen as an exemplar of a comprehensive health information system for clinical use. Analysis The paper analyses 1) how informed consent can be implemented in the system and how different implementations create different impacts on autonomy and control of information, and 2) arguments directed towards justifying not seeking informed consent in this context. Results and Conclusion Based on the analysis a heuristic is provided which enables a ranking and estimation of the impact on autonomy and control of information of different options for consent to entry of data into the system and use of data from the system. The danger of routinisation of consent is identified. The Danish pharmaceutical information system raises issues in relation to autonomy and control of information, issues that will also occur in relation to other similar comprehensive health information systems. Some of these issues are well understood and their impact can be judged using the heuristic which is provided. More research is, however needed in relation to routinisation of consent. PMID:23157854

The therapeutic misconception and our models of competency and informed consent.

PubMed

Lidz, Charles W

2006-01-01

The doctrine of informed consent rests on empirical claims. This is true particularly of what commentators have characterized as the "strong" model of informed consent. This model assumes that if adequate information is given to a competent individual, understanding will result and, permitted to make a voluntary decision, the individual will make a rational decision. However, the "therapeutic misconception" posits that individuals may confuse the goals of research with those of treatment and may make decisions that do not rest on adequate understanding. This article reviews research suggesting that this may in fact be true, and concludes that, as a result, traditional notions of informed consent may not yield results consistent with the assumptions on which the doctrine of informed consent rests. Copyright (c) 2006 John Wiley & Sons, Ltd.

[Ethics committees bear a responsibility for patient information. Informed consent implies that the patient understands what he has consented to].

PubMed

Werkö, Lars

2002-03-19

A cornerstone in health care is the duty to inform patients not only of their right to partake in decisions about their care but also of the various options for treatment. This applies particularly in clinical research, for which the Helsinki Declaration has defined patients' rights. Informed consent is of great importance both in routine care and in clinical research. Directives defining informed consent in relation to clinical trials have been issued by The EU Commission. The Department of Health and Social Security in England has also published several documents governing patient consent. Even if information is given to the patient it is not always comprehended. In one study of cancer treatment about one third of the patients had misunderstood the information in certain respects.

Balancing the quality of consent.

PubMed Central

Hansson, M O

1998-01-01

The rule that one must obtain informed consent is well established in medical ethics and an intrinsic part of clinical practice and of research in biomedicine. However, there is a tendency that the rule today is being applied too rigidly and with too little sensitivity to the values that are at stake in connection with different kinds of research protocols. It is here argued that the quality of consent needs to be balanced against variables such as degree of confidentiality and importance of values at stake, in order to be ethically acceptable. Appropriate information and consent procedures should be adjusted accordingly. Three levels are suggested, ranging from extensively informed consent with both written and oral information, through informed refusal with only a limited amount of information given to, at the other end of the scale, just making relevant information available. PMID:9650113

75 FR 7278 - Agency Information Collection Activities; Proposed Collection; Comment Request; Exception From...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-18

... the general requirements for informed consent to permit the use of investigational in vitro diagnostic... general requirements for informed consent, to permit the use of investigational in vitro diagnostic... exception to the general rule that informed consent is required for the use of an investigational in vitro...

Development of a tiered and binned genetic counseling model for informed consent in the era of multiplex testing for cancer susceptibility.

PubMed

Bradbury, Angela R; Patrick-Miller, Linda; Long, Jessica; Powers, Jacquelyn; Stopfer, Jill; Forman, Andrea; Rybak, Christina; Mattie, Kristin; Brandt, Amanda; Chambers, Rachelle; Chung, Wendy K; Churpek, Jane; Daly, Mary B; Digiovanni, Laura; Farengo-Clark, Dana; Fetzer, Dominique; Ganschow, Pamela; Grana, Generosa; Gulden, Cassandra; Hall, Michael; Kohler, Lynne; Maxwell, Kara; Merrill, Shana; Montgomery, Susan; Mueller, Rebecca; Nielsen, Sarah; Olopade, Olufunmilayo; Rainey, Kimberly; Seelaus, Christina; Nathanson, Katherine L; Domchek, Susan M

2015-06-01

Multiplex genetic testing, including both moderate- and high-penetrance genes for cancer susceptibility, is associated with greater uncertainty than traditional testing, presenting challenges to informed consent and genetic counseling. We sought to develop a new model for informed consent and genetic counseling for four ongoing studies. Drawing from professional guidelines, literature, conceptual frameworks, and clinical experience, a multidisciplinary group developed a tiered-binned genetic counseling approach proposed to facilitate informed consent and improve outcomes of cancer susceptibility multiplex testing. In this model, tier 1 "indispensable" information is presented to all patients. More specific tier 2 information is provided to support variable informational needs among diverse patient populations. Clinically relevant information is "binned" into groups to minimize information overload, support informed decision making, and facilitate adaptive responses to testing. Seven essential elements of informed consent are provided to address the unique limitations, risks, and uncertainties of multiplex testing. A tiered-binned model for informed consent and genetic counseling has the potential to address the challenges of multiplex testing for cancer susceptibility and to support informed decision making and adaptive responses to testing. Future prospective studies including patient-reported outcomes are needed to inform how to best incorporate multiplex testing for cancer susceptibility into clinical practice.Genet Med 17 6, 485-492.

A Randomized Controlled Trial of an Electronic Informed Consent Process

PubMed Central

Rothwell, Erin; Wong, Bob; Rose, Nancy C.; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A.; Botkin, Jeffrey R.

2018-01-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. PMID:25747685

Informed Consent to Research in Long-Term Care Settings

PubMed Central

Jablonski, Rita A.; Bourbonniere, Meg; Kolanowski, Ann

2010-01-01

Informed consent to nursing home research is a two-tiered process that begins with obtaining the consent of a long-term care community at the institutional level and progresses to the engagement of individuals in the consent process. Drawing on a review of the literature and the authors’ research experiences and institutional review board service, this paper describes the practical implications of nurse investigators’ obligation to ensure informed consent among participants in long-term care research. Recommendations focus on applying a community consent model to long-term care research, promoting an evidence-based approach to the protection of residents with decisional impairment, and increasing investigators’ attention to ethical issues involving long-term care staff. PMID:20078005

User-Centered Design, Experience, and Usability of an Electronic Consent User Interface to Facilitate Informed Decision-Making in an HIV Clinic.

PubMed

Ramos, S Raquel

2017-11-01

Health information exchange is the electronic accessibility and transferability of patient medical records across various healthcare settings and providers. In some states, patients have to formally give consent to allow their medical records to be electronically shared. The purpose of this study was to apply a novel user-centered, multistep, multiframework approach to design and test an electronic consent user interface, so patients with HIV can make more informed decisions about electronically sharing their health information. This study consisted of two steps. Step 1 was a cross-sectional, descriptive, qualitative study that used user-centric design interviews to create the user interface. This informed Step 2. Step 2 consisted of a one group posttest to examine perceptions of usefulness, ease of use, preference, and comprehension of a health information exchange electronic consent user interface. More than half of the study population had college experience, but challenges remained with overall comprehension regarding consent. The user interface was not independently successful, suggesting that in addition to an electronic consent user interface, human interaction may also be necessary to address the complexities associated with consenting to electronically share health information. Comprehension is key factor in the ability to make informed decisions.

Informed consent to opioid agonist maintenance treatment: recommended ethical guidelines.

PubMed

Carter, Adrian; Hall, Wayne

2008-02-01

Some bioethicists have questioned whether opioid addicted individuals are able to provide free and informed consent to opioid agonist maintenance treatment. Conflicting motives for providing such treatment (e.g. improving the personal health of addicts and protecting public health and order) can also influence what individuals are required to consent to, and how that consent is obtained. We discuss both issues and attempt to specify the conditions for obtaining informed consent to agonist maintenance treatment for opioid addiction. We briefly review the neuroscientific literature on the effects of addiction on the autonomy and decision-making capacity of opioid dependent individuals, and ascertain how informed consent to the treatment of opioid addiction should be obtained. We also provide an ethical analysis of the competing social and medical forces that influence the consent process and make some recommendations on how to ensure that individuals enter maintenance treatment that is provided in an effective and ethical way. Our analysis shows that whilst the autonomy of opioid dependent individuals is impaired by their addiction, they do retain the ability to consent to treatment provided they are not in acute withdrawal or intoxication. These symptoms should have abated, either by supervised withdrawal or stabilisation on agonist maintenance, before they are asked to consent to a detailed treatment contract. Once stabilised, individuals should be provided with detailed information about the risks and benefits of all treatments, and restrictions and regulations under which they are provided. Informed consent is an important part of the treatment process that should be obtained in ways that increase the autonomy and decision-making capacity in opioid addicts.

Achieving new levels of recall in consent to research by combining remedial and motivational techniques.

PubMed

Festinger, David S; Dugosh, Karen L; Marlowe, Douglas B; Clements, Nicolle T

2014-04-01

Research supports the efficacy of both a remedial consent procedure (corrected feedback (CF)) and a motivational consent procedure (incentives) for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivised consent and CF procedure that simplifies the cognitive task and increases motivation to learn consent information. We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual (CAU) condition (n=52) or an incentivised CF (ICF) condition (n=52). All participants were told they would be quizzed on their consent recall following their baseline assessment and at 4 monthly follow-ups. ICF participants were also informed that they would earn $5 for each correct answer and receive CF as needed. Quiz scores in the two conditions did not differ at the first administration (p=0.39, d=0.2); however, ICF scores were significantly higher at each subsequent administration (second: p=0.003, Cohen's d=0.6; third: p<0.0001, d=1.4; fourth: p<0.0001, d=1.6; fifth: p<0.0001, d=1.8). The ICF procedure increased consent recall from 72% to 83%, compared with the CAU condition in which recall decreased from 69% to 59%. This supports the statistical and clinical utility of a combined remedial and motivational consent procedure for enhancing recall of study information and human research protections.

Enhancing clinician provision of informed consent and counseling: some pedagogical strategies.

PubMed

Wear, S

1999-02-01

Although long touted as an ethical and legal requirement, some clinicians still seem to offer less than fully adequate informed consent processes; similarly the counseling of patients and families, particularly about post-intervention scenarios, is often perfunctory at best. Keyed to a narrative of a patient's experience with surgery for a deviated septum, this article reflects on why such less than adequate clinician behaviors tend to occur and what might be done about them. Certain legal misconceptions about informed consent are highlighted in this reflection, as well as why certain clinicians seem to take such a narrow view of their responsibilities to patients. Further reference in this regard is also made to a recently constructed module on informed consent for medical residents. In it, though legal requirements for informed consent are reviewed, the basic perspective taken regards informed consent as a clinical intervention that pursues certain basic goods and values, only one of which lies in determining when legal closure for such processes has occurred.

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2013 CFR

2013-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2012 CFR

2012-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2014 CFR

2014-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2011 CFR

2011-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

10 CFR 727.5 - What acknowledgment and consent is required for access to information on DOE computers?

Code of Federal Regulations, 2010 CFR

2010-01-01

... information on DOE computers? 727.5 Section 727.5 Energy DEPARTMENT OF ENERGY CONSENT FOR ACCESS TO INFORMATION ON DEPARTMENT OF ENERGY COMPUTERS § 727.5 What acknowledgment and consent is required for access to information on DOE computers? An individual may not be granted access to information on a DOE...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

45 CFR 672.11 - Informal settlement; consent agreement and order.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SCIENCE FOUNDATION ENFORCEMENT AND HEARING PROCEDURES § 672.11 Informal settlement; consent agreement and...; (2) admits the facts stipulated in the consent agreement or neither admits nor denies specific...

34 CFR 303.401 - Definitions of consent, native language, and personally identifiable information.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 2 2011-07-01 2010-07-01 true Definitions of consent, native language, and personally... Definitions of consent, native language, and personally identifiable information. As used in this subpart— (a... which consent is sought, in the parent's native language or other mode of communication; (2) The parent...

Long term understanding of study information in research participants with Parkinson's disease.

PubMed

Ravina, Bernard; Swearingen, Christopher; Elm, Jordan; Kamp, Cornelia; Kieburtz, Karl; Kim, Scott Y H

2010-01-01

Little is known about research participants' understanding of consent information over the course of a clinical study and the relationship of this information with participant behavior. We conducted a cross sectional patient completed questionnaire of comprehension and satisfaction administered at the end of a Parkinson's disease clinical trial. Scores on 9 comprehension items in a 30 item questionnaire covering the key elements of informed consent. 78% of eligible trial participants completed this substudy. Greater than 90% of respondents showed good comprehension of the study purpose, method of treatment assignment, experimental nature of drugs, voluntary participation, and expected effect of the trial on their PD. However, 42.3% of subjects incorrectly endorsed that participating in the study was part of the "usual treatment" for their PD. We found no relationship between comprehension, compliance, and satisfaction with whether or not one's own neurologist was also the study doctor. Years of education and cognitive function at baseline were correlated with comprehension of study information. Overall comprehension of key study information presented in the consent was high after 12 months of trial participation, although there were inconsistencies in responses that need further study.

Use of a modified informed consent process among vulnerable patients: a descriptive study.

PubMed

Sudore, Rebecca L; Landefeld, C Seth; Williams, Brie A; Barnes, Deborah E; Lindquist, Karla; Schillinger, Dean

2006-08-01

Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding. To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information. Descriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal). Two hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives. Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36). Participants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension. Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.

Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean.

PubMed

Rampersad, Kavi; Chen, Deryk; Hariharan, Seetharaman

2016-01-01

This study aimed to determine whether a separate written consent form improved the efficacy of the informed consent process for anesthesia in adult patients undergoing elective surgery at a tertiary care teaching hospital. We randomized patients into two groups prospectively. The first group (Group A) signed the hospital's standard Consent for Operation form only while the second group (Group B) signed a separate Consent for Anesthesia form additionally. Patients were interviewed postoperatively with an eight-item questionnaire with responses in a 5-point Likert scale. A composite adequacy of consent index was generated from the responses and analyzed. Two hundred patients (100 in each group) were studied. All patients indicated that the anesthesiologist(s) had their permission to proceed with their anesthesia care. The mean adequacy of consent index score in Group B was higher than that of Group A (30.6 ± 4.6 [standard deviation (SD)] vs. 27.9 ± 5.2 [SD]) (P < 0.001). The separate written consent had a positive impact on the patients' understanding of the nature and purpose of the intended anesthesia procedures (P = 0.04), satisfaction with the adequacy of information provided about common side effects (P < 0.001) and rare but serious complications (P = 0.008). A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications.

Pattern of informed consent acquisition in patients undergoing emergent endovascular treatment for acute ischemic stroke

PubMed Central

Qureshi, Adnan I; Gilani, Sarwat; Adil, Malik M; Majidi, Shahram; Hassan, Ameer E; Miley, Jefferson T; Rodriguez, Gustavo J

2014-01-01

Background Telephone consent and two physician consents based on medical necessity are alternate strategies for time sensitive medical decisions but are not uniformly accepted for clinical practice or recruitment into clinical trials. We determined the rate of and associated outcomes with alternate consenting strategies in consecutive acute ischemic stroke patients receiving emergent endovascular treatment. Methods We divided patients into those treated based on in-person consent and those based on alternate strategies. We identified clinical and procedural differences and differences in hospital outcomes: symptomatic ICH and favorable outcome (defined by modified Rankin Scale of 0–2 at discharge) based on consenting methodology. Results Of a total of 159 patients treated, 119 were treated based on in-person consent (by the patient in 27 and legally authorized representative in 92 procedures). Another 40 patients were treated using alternate strategies (20 telephone consents and 20 two physician consents based on medical necessity). There was no difference in the mean ages and proportion of men among the two groups based on consenting methodology. There was a significantly greater time interval incurred between CT scan and initiation of endovascular procedure in those in whom in-person consent was obtained (117 ± 65 min versus 101 ± 45 min, p = 0.01). There was no significant difference in rates of ICH (9% versus 8%, p = 0.9), or favorable outcome at discharge (28% versus 30%, p = 0.8). Conclusions Consent through alternate strategies does not adversely affect procedural characteristics or outcome of patients and may be more time efficient than in-person consenting process. PMID:25132906

32 CFR 219.117 - Documentation of informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 2 2014-07-01 2014-07-01 false Documentation of informed consent. 219.117 Section 219.117 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS PROTECTION OF HUMAN SUBJECTS § 219.117 Documentation of informed consent. (a...

Facebook study: a little bit unethical but worth it?

PubMed

Kleinsman, John; Buckley, Sue

2015-06-01

Human research involving the use social media raises many of the same issues as medical research. The publication of a paper in June 2014 investigating "emotional contagion" received extensive publicity recently because of the methods used. The approach involved manipulating the "News Feeds" of Facebook users, but the participants were not informed of their involvement in the research and had no opportunity to consent or opt out. Some commentators have argued that although it would have been preferable to obtain informed consent, it was not strictly required because the research was unlikely to cause significant harm and was important. This paper argues that the research was unethical because (i) it should have been overseen by an independent ethics committee or review board and (ii) informed consent could and should have been obtained. Regardless of the importance of any research and irrespective of its likelihood to cause harm, the ethical principles that have evolved since the 1940s should be followed in all instances when experimental research is being carried out on human participants.

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study

PubMed Central

de Laat, Sonya; Schwartz, Lisa

2016-01-01

Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Children's Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE trial and support development of evidence-based ethics guidelines. PMID:27625066

Patients’ perceived purpose of clinical informed consent: Mill’s individual autonomy model is preferred

PubMed Central

2014-01-01

Background Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes. Methods We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: “meaningless routine”, “courtesy gesture” “litigation protection”, “take away compensation rights”, “inform patient’, “make sure patient understand”, “document patient’s decision”, “discover patient’s preferences”, “have shared decision”, and “help patient decide”. Results Respondents’ mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was “meaningless routine” (ranked 1–3 by 2.6% of respondents) and the most reflective statements were “help patient decide”, “make sure patient understand”, and “inform patient” (ranked 1–3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked “help patient decide” better, whereas females and post-procedure respondents ranked “inform patient” better (p = 0.007 to p < 0.001). Age was associated with better ranking of “help patient decide” and “make sure patient understand” statements (p < 0.001 and p = 0.002, respectively), which were ranked 1–3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both). Conclusions 1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients’ self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill’s individual autonomy model may be suitable for most patients. PMID:24406020

Obtaining consent to oral and maxillofacial surgery.

PubMed

Poswillo, D

1989-09-01

The question of whether or not a patient has consented to treatment has recently become significant to all who practise oral and maxillofacial surgery. It is often linked to professional negligence when the outcome differs from the patient's perception or expectation of the operation. Consent may be oral or written, applies to referred patients and all those with physical and mental handicap and religious restrictions. Examples of procedure in discussing consent assist the surgeon to inform without creating fear. Knowledge of the benefits of informed consent and current legal opinion assist the oral and maxillofacial surgeon to avoid the pitfalls of failure to inform.

Customising informed consent procedures for people with schizophrenia in India.

PubMed

Chatterjee, Sudipto; Kieselbach, Berit; Naik, Smita; Kumar, Shuba; John, Sujit; Balaji, Madhumitha; Koschorke, Mirja; Dabholkar, Hamid; Varghese, Mathew; Patel, Vikram; Thornicroft, Graham; Thara, Rangaswamy

2015-10-01

There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

Towards a standardized informed consent procedure for live donor nephrectomy: What do surgeons tell their donors?

PubMed

Kortram, Kirsten; Ijzermans, Jan N M; Dor, Frank J M F

2016-08-01

Living kidney donors comprise a unique group of "patients", undergoing an operation for the benefit of others. The informed consent process is therefore valued differently. Although this is a team effort, the surgeon is responsible for performing the donor nephrectomy, and often the one held accountable, should adverse events occur. Although there is some consensus on how the informed consent procedure should be arranged, practices vary. The aim of this study was to evaluate the surgical informed consent procedure for live donor nephrectomy, with special regards to disclosure of complications. A web-based survey was sent to all kidney transplant surgeons (n = 50) in eight transplant centers with questions regarding the local procedure and disclosure of specific details. Response rate was 98% (n = 49), of which 32 (65%) were involved in living donor education; overall, transplant- (50%), vascular- (31%), and abdominal surgeons (13%), and urologists (6%) performed donor nephrectomies in the eight centers. Informed consent procedures varied, ranging from assumed to signed consent. Bleeding was the only complication every surgeon mentioned. Risk of death was always mentioned by 16 surgeons (50%), sometimes by 13 (41%), three surgeons (9%) never disclosed this disastrous complication. Reported mortality rates ranged from 0.003% to 0.1%. Mentioning frequencies for all other complications varied. Important complications are not always disclosed during the surgical informed consent process for live donor nephrectomy. Informed consent procedures vary. To optimally prepare living kidney donors for the procedure, a standardized informed consent procedure for live donor nephrectomy is highly recommended. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

The role of effective communication in achieving informed consent for clinical trials.

PubMed

Pick, Andrew; Gilbert, Kayleigh; McCaul, James

2014-11-11

Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.

Culturally Competent Informed-Consent Process to Evaluate a Social Policy for Older Persons With Low Literacy: The Mexican Case

PubMed Central

Aguila, Emma; Weidmer, Beverly A.; Illingworth, Alfonso Rivera; Martinez, Homero

2017-01-01

The informed-consent process seeks to provide complete information to participants about a research project and to protect personal information they may disclose. In this article, we present an informed-consent process that we piloted and improved to obtain consent from older adults in Yucatan, Mexico. Respondents had limited fluency in Spanish, spoke the local Mayan language, and had some physical limitations due to their age. We describe how we adapted the informed-consent process to comply with U.S. and Mexican regulations, while simplifying the forms and providing them in Spanish and Mayan. We present the challenges and lessons learned when dealing with low-literacy older populations, some with diminished autonomy, in a bilingual context and a binational approach to the legal framework. PMID:28824826

[Dentistry and healthcare legislation 3: informed consent].

PubMed

Brands, W G; van der Ven, J M; Eijkman, M A J

2013-06-01

The relationship between a dentist and his patient is based on trust. The principle of informed consent contributes to the quality of that relationship of trust. According to the professional standards for such a relationship, it is up to the dentist to make sure that the patient is well informed. Reliable information is necessary if the patient is to be in a position to give his or her consent for treatment. The Dutch Law of Agreement to Medical Treatment (WGBO) provides aframework for informed consent. Disciplinary judges establish the scope and if necessary the limits. It is clear that, among other things, not defining the risks beforehand can be the basis for a (disciplinary) complaint. Determining the requirements of informed consent calls for familiarity with the law and communication skills. Programmes in dental education ought to devote more attention to this issue.

Applying a sociolinguistic model to the analysis of informed consent documents.

PubMed

Granero-Molina, José; Fernández-Sola, Cayetano; Aguilera-Manrique, Gabriel

2009-11-01

Information on the risks and benefits related to surgical procedures is essential for patients in order to obtain their informed consent. Some disciplines, such as sociolinguistics, offer insights that are helpful for patient-professional communication in both written and oral consent. Communication difficulties become more acute when patients make decisions through an informed consent document because they may sign this with a lack of understanding and information, and consequently feel deprived of their freedom to make their choice about different treatments or surgery. This article discusses findings from documentary analysis using the sociolinguistic SPEAKING model, which was applied to the general and specific informed consent documents required for laparoscopic surgery of the bile duct at Torrecárdenas Hospital, Almería, Spain. The objective of this procedure was to identify flaws when information was provided, together with its readability, its voluntary basis, and patients' consent. The results suggest potential linguistic communication difficulties, different languages being used, cultural clashes, asymmetry of communication between professionals and patients, assignment of rights on the part of patients, and overprotection of professionals and institutions.

On the Ottoman consent documents for medical interventions and the modern concept of informed consent.

PubMed

Kara, Mahmut A; Aksoy, Sahin

2006-09-01

Information for patients prior to medical intervention is one of the principles of modern medical practice. In this study, we looked at an earlier practice of this principle. Ottoman judges had record books called sicil. One of the categories in sicils was the consent documents called riza senedi, which was a patient-physician contract approved by the courts. These contracts were especially for the protection of physicians from punishment if the patient dies. It is not clear whether patients were informed properly or not. Consent for minors was obtained from parents. However, a situation where an adult does not have the capacity to consent, was not clear in these documents. Any sign of free withdrawal of consent was not found in these records. Due to the legal system of Ottoman State, these contracts were related to Islamic law rather than modern civil law. We aim, in this paper, to present a legal practice, which is possible to consider as an early example of the informed consent practice.

Refusal of Emergency Medical Treatment: Case Studies and Ethical Foundations.

PubMed

Marco, Catherine A; Brenner, Jay M; Kraus, Chadd K; McGrath, Norine A; Derse, Arthur R

2017-11-01

Informed consent is an important component of emergency medical treatment. Most emergency department patients can provide informed consent for treatment upon arrival. Informed consent should also be obtained for emergency medical interventions that may entail significant risk. A related concept to informed consent is informed refusal of treatment. Patients may refuse emergency medical treatment during their evaluation and treatment. This article addresses important considerations for patients who refuse treatment, including case studies and discussion of definitions, epidemiology, assessment of decisional capacity, information delivery, medicolegal considerations, and alternative care plans. Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

A survey on surgeons' perceived quality of the informed consent process in a Swiss paediatric surgery unit.

PubMed

Guinand, Julie; Gapany, Christophe; Simon, Jeanne-Pascale; Wasserfallen, Jean-Blaise; Joseph, Jean-Marc

2015-01-01

To evaluate the levels of satisfaction and opinions on the usefulness of the informed consent form currently in use in our Paediatric Surgery Department. Qualitative study carried out via interviews of senior paediatric surgeons, based on a questionnaire built up from reference criteria in the literature and public health law. Physicians with between 2 and 35 years experience of paediatric surgery, with a participation rate of 92 %, agreed on the definition of an informed consent form, were satisfied with the form in use and did not wish to modify its structure. The study revealed that signing the form was viewed as mandatory, but meant different things to different participants, who diverged over whom that signature protected. Finally, all respondents were in agreement over what information was necessary for parents of children requiring surgery. Paediatric surgeons seemed to be satisfied with the informed consent form in use. Most of them did not identify that the first aim of the informed consent form is to give the patient adequate information to allow him to base his consent, which is a legal obligation, the protection of physicians by the formalisation and proof of the informed consent being secondary. Few surgeons brought up the fact that the foremost stakeholder in paediatric surgery are the children themselves and that their opinions are not always sought. In the future, moving from informed consent process to shared decision-making, a more active bidirectional exchange may be strongly considered. Involving children in such vital decisions should become the norm while keeping in mind their level of maturity.

The influence of process and patient factors on the recall of consent information in mentally competent patients undergoing surgery for neck of femur fractures.

PubMed

Khan, S K; Karuppaiah, K; Bajwa, A S

2012-07-01

Informed consent is an ethical and legal prerequisite for major surgical procedures. Recent literature has identified 'poor consent' as a major cause of litigation in trauma cases. We aimed to investigate the patient and process factors that influence consent information recall in mentally competent patients (abbreviated mental test score [AMTS] ≥6) presenting with neck of femur (NOF) fractures. A prospective study was conducted at a tertiary unit. Fifty NOF patients (cases) and fifty total hip replacement (THR) patients (controls) were assessed for process factors (adequacy and validity of consent) as well as patient factors (comprehension and retention) using consent forms and structured interview proformas. The two groups were matched for ASA (American Society of Anesthesiologists) grade and AMTS. The consent forms were adequate in both groups but scored poorly for validity in the NOF group. Only 26% of NOF patients remembered correctly what surgery they had while only 48% recalled the risks and benefits of the procedure. These results were significantly poorer than in THR patients (p = 0.0001). This study confirms that NOF patients are poor at remembering the information conveyed to them at the time of consent when compared with THR patients despite being intellectually and physiologically matched. We suggest using preprinted consent forms (process factors), information sheets and visual aids (patient factors) to improve retention and recall.

Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India.

PubMed

Joglekar, Neelam S; Deshpande, Swapna S; Sahay, Seema; Ghate, Manisha V; Bollinger, Robert C; Mehendale, Sanjay M

2013-03-01

Optimum comprehension of informed consent by research participants is essential yet challenging. This study explored correlates of lower comprehension of informed consent among 1334 participants of a cohort study aimed at estimating HIV incidence in Pune, India. As part of the informed consent process, a structured comprehension tool was administered to study participants. Participants scoring ≥90% were categorised into the 'optimal comprehension group', whilst those scoring 80-89% were categorised into the 'lower comprehension group'. Data were analysed to identify sociodemographic and behavioural correlates of lower consent comprehension. The mean ± SD comprehension score was 94.4 ± 5.00%. Information pertaining to study-related risks was not comprehended by 61.7% of participants. HIV-negative men (adjusted OR [AOR] = 4.36, 95% CI 1.71-11.05) or HIV-negative women (AOR = 13.54, 95% CI 6.42-28.55), illiteracy (AOR= 1.65, 95% CI 1.19-2.30), those with a history of multiple partners (AOR = 1.73, 95% CI 1.12-2.66) and those never using condoms (AOR = 1.35, 95% CI 1.01-1.82) were more likely to have lower consent comprehension. We recommend exploration of domains of lower consent comprehension using a validated consent comprehension tool. Improved education in these specific domains would optimise consent comprehension among research participants.

14 CFR § 1230.116 - General requirements for informed consent.

Code of Federal Regulations, 2014 CFR

2014-01-01

... will not adversely affect the rights and welfare of the subjects; (3) The research could not... research covered by this policy unless the investigator has obtained the legally effective informed consent..., the institution or its agents from liability for negligence. (a) Basic elements of informed consent...

Readability of Informed Consent Documents at University Counseling Centers

ERIC Educational Resources Information Center

Lustgarten, Samuel D.; Elchert, Daniel M.; Cederberg, Charles; Garrison, Yunkyoung L.; Ho, Y. C. S.

2017-01-01

The extent to which clients understand the nature and anticipated course of therapy is referred to as informed consent. Counseling psychologists often provide informed consent documents to enhance the education of services and for liability purposes. Professionals in numerous health care settings have evaluated the readability of their informed…

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if...

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.25 Elements of informed consent. (a) Basic... pertinent questions about the research and research subjects' rights, and whom to contact in the event of a...

21 CFR 640.61 - Informed consent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

21 CFR 640.61 - Informed consent.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

21 CFR 640.61 - Informed consent.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

21 CFR 640.61 - Informed consent.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

21 CFR 640.61 - Informed consent.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Informed consent. 640.61 Section 640.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.61 Informed consent. The written...

Informed consent in a multicultural cancer patient population: implications for nursing practice.

PubMed

Barnes, D M; Davis, A J; Moran, T; Portillo, C J; Koenig, B A

1998-09-01

Obtaining informed consent, an ethical obligation of nurses and other health care providers, occurs routinely when patients make health care decisions. The values underlying informed consent (promotion of patients' well-being and respect for their self-determination) are embedded in the dominant American culture. Nurses who apply the USA's cultural values of informed consent when caring for patients who come from other cultures encounter some ethical dilemmas. This descriptive study, conducted with Latino, Chinese and Anglo-American cancer patients in a large, public, west-coast clinic, describes constraints on the informed consent process in a multicultural setting, including language barriers, the clinical environment, control in decision making, and conflicting desired health outcomes for health care providers and patients, and suggests some implications for nursing practice.

Relational autonomy in informed consent (RAIC) as an ethics of care approach to the concept of informed consent.

PubMed

Osuji, Peter I

2018-03-01

The perspectives of the dominant Western ethical theories, have dominated the concepts of autonomy and informed consent for many years. Recently this dominant understanding has been challenged by ethics of care which, although, also emanates from the West presents a more nuanced concept: relational autonomy, which is more faithful to our human experience. By paying particular attention to relational autonomy, particularity and Process approach to ethical deliberations in ethics of care, this paper seeks to construct a concept of informed consent from the perspective of ethics of care which is here called relational autonomy-in-informed consent (RAIC). Thus, providing a broader theoretical basis for informed consent beyond the usual theoretical perspectives that are particularly Western. Care ethics provides such a broader basis because it appeals to a global perspective that encompasses lessons from other cultures, and this will help to enrich the current ideas of bioethics principles of autonomy and informed consent. This objective will be achieved by exploring the ethics of care emphasis on relationships based on a universal experience of caring; and by contrasting its concept of autonomy as relational with the understanding of autonomy in the approaches of the dominant moral theories that reflect rational, individualistic, and rights-oriented autonomy of the American liberalism.

The risks and benefits of disclosing psychotherapy records to the legal system: What psychologists and patients need to know for informed consent.

PubMed

Borkosky, Bruce; Smith, Deirdre M

2015-01-01

When psychologists release patient records to the legal system, the typical practice is to obtain the patient's signature on a consent form, but rarely is a formal informed-consent obtained from the patient. Although psychologists are legally and ethically required to obtain informed consent for all services (including disclosure of records), there are a number of barriers to obtaining truly informed consent. Furthermore, compared to disclosures to nonlegal third parties, there are significantly greater risks when records are disclosed to the legal system. For these reasons, true informed consent should be obtained from the patient when records are disclosed to the legal system. A model for informed consent is proposed. This procedure should include a description of risks and benefits of disclosing or refusing to disclose by the psychotherapist, an opportunity to ask questions, and indication by the patient of a freely made choice. Both psychotherapist and patient share decision making responsibilities in our suggested model. The patient should be informed about potential harm to the therapeutic relationship, if applicable. Several recommendations for practice are described, including appropriate communications with attorneys and the legal system. A sample form, for use by psychotherapists, is included. Copyright © 2015 Elsevier Ltd. All rights reserved.

A randomized controlled trial of an electronic informed consent process.

PubMed

Rothwell, Erin; Wong, Bob; Rose, Nancy C; Anderson, Rebecca; Fedor, Beth; Stark, Louisa A; Botkin, Jeffrey R

2014-12-01

A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and who to contact if they had questions or concerns about the study. However, participants in the paper-based control group reported higher mean scores on some survey items. This research suggests that an electronic informed consent presentation may improve participant understanding for some aspects of a research study. © The Author(s) 2014.

Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims

PubMed Central

Grauberger, Jennifer; Kerezoudis, Panagiotis; Choudhry, Asad J.; Alvi, Mohammed Ali; Nassr, Ahmad; Currier, Bradford

2017-01-01

Importance Predictive factors associated with increased risk of medical malpractice litigation have been identified, including severity of injury, physician sex, and error in diagnosis. However, there is a paucity of literature investigating informed consent in spinal surgery malpractice. Objective To investigate the failure to obtain informed consent as an allegation in medical malpractice claims for patients undergoing a spinal procedure. Design, Setting, and Participants In this retrospective cohort study, a national medicolegal database was searched for malpractice claim cases related to spinal surgery for all years available (ie, January 1, 1980, through December 31, 2015). Main Outcomes and Measures Failure to obtain informed consent and associated medical malpractice case verdict. Results A total of 233 patients (117 [50.4%] male and 116 [49.8%] female; 80 with no informed consent allegation and 153 who cited lack of informed consent) who underwent spinal surgery and filed a malpractice claim were studied (mean [SD] age, 47.1 [13.1] years in the total group, 45.8 [12.9] years in the control group, and 47.9 [13.3] years in the informed consent group). Median interval between year of surgery and year of verdict was 5.4 years (interquartile range, 4-7 years). The most common informed consent allegations were failure to explain risks and adverse effects of surgery (52 [30.4%]) and failure to explain alternative treatment options (17 [9.9%]). In bivariate analysis, patients in the control group were more likely to require additional surgery (45 [56.3%] vs 53 [34.6%], P = .002) and have more permanent injuries compared with the informed consent group (46 [57.5%] vs 63 [42.0%], P = .03). On multivariable regression analysis, permanent injuries were more often associated with indemnity payment after a plaintiff verdict (odds ratio [OR], 3.12; 95% CI, 1.46-6.65; P = .003) or a settlement (OR, 6.26; 95% CI, 1.06-36.70; P = .04). Informed consent allegations were significantly associated with less severe (temporary or emotional) injury (OR, 0.52; 95% CI, 0.28-0.97; P = .04). In addition, allegations of informed consent were found to be predictive of a defense verdict vs a plaintiff ruling (OR, 0.41; 95% CI, 0.17-0.98; P = .046) or settlement (OR, 0.01; 95% CI, 0.001-0.15; P < .001). Conclusions and Relevance Lack of informed consent is an important cause of medical malpractice litigation. Although associated with a lower rate of indemnity payments, malpractice lawsuits, including informed consent allegations, still present a time, money, and reputation toll for physicians. The findings of this study can therefore help to improve preoperative discussions to protect spinal surgeons from malpractice claims and ensure that patients are better informed. PMID:28445561

A randomised study of three different informational AIDS prior to coronary angiography, measuring patient recall, satisfaction and anxiety.

PubMed

Astley, Carolyn M; Chew, Derek P; Aylward, Philip E; Molloy, Danielle A; De Pasquale, Carmine G

2008-02-01

Informed consent is a basic standard of care for all patients undergoing medical procedures, but recall of information has been shown to be poor. We sought to compare verbal, written and animated audiovisual information delivery, during consent for coronary angiography, by measuring improvement in recall. A sample population of 99 cardiac patients at Flinders Medical Centre was randomised (1:1:1) to receive one of three information delivery methods. The information content was standardised by a risk proforma, which explained the procedure and defined 12 specific risks. Recall, satisfaction and anxiety were assessed by a questionnaire administered at three different time points: post-consent, post-procedure and at 30 days. Effect of delivery method on satisfaction and anxiety was rated on a self-reported scale from 1-5, with 5 representing very satisfied or very anxious. Groups were compared by non-parametric testing and a p-value of <0.05 was considered statistically significant. Patients were a median age of 64 (i.q.r. 56, 72) years. Information delivery method had no effect on recall of risks at any time-point (p=0.2, 0.7, 0.5, respectively) and the average recall score across the population was 3-4 out of 12. There was no significant effect on median satisfaction scores: verbal; 5 (i.q.r.4, 5) versus written/audiovisual; 4 (i.q.r.4, 5) (p=ns), or on median anxiety scores: verbal; 3 (i.q.r.2, 4) versus written/audiovisual; 3 (i.q.r.2, 4) (p=ns). Despite careful design of an innovative audiovisual delivery technique aimed at optimising comprehension and aiding memory, recall of information was poor and informational aids showed no improvement. Modes of information delivery are not the key to patient assimilation of complex medical information.

A randomized study of the effect of anonymity, quasi-anonymity, and Certificates of Confidentiality on postpartum women's disclosure of sensitive information.

PubMed

Beatty, Jessica R; Chase, Sara K; Ondersma, Steven J

2014-01-01

Under-reporting of substance use and other sensitive information is a substantial threat to internal study validity, particularly during the perinatal period. Anonymous approaches are associated with greater disclosure but are incompatible with longitudinal follow-up. Alternative approaches include use of a U.S. Federal Certificate of Confidentiality (CoC) and quasi-anonymous methods, in which there is no link between name and data. However, the relative effect of these procedures on disclosure is unknown. This randomized study was designed to evaluate the effects of consent condition (anonymous, quasi-anonymous, CoC, and traditional confidentiality) on disclosure of sensitive information among postpartum women. Participants were 200 postpartum, primarily African-American women who were randomly assigned to one of the four consent conditions and completed a brief computer-delivered assessment of alcohol and drug use, sexual risk, intimate partner violence, and emotional distress. Participants in the anonymous and quasi-anonymous conditions disclosed significantly more sensitive information than those in the traditional consent condition. In contrast, no advantage in overall disclosure was observed for the CoC condition. This result was largely consistent across specific content areas with the exception of emotional distress, disclosure of which was unrelated to consent condition. Although use of a CoC has limited impact on disclosure, the quasi-anonymous method may increase disclosure to a similar extent as full anonymity. Quasi-anonymous approaches should be considered when under-reporting is likely, a context in which the disadvantages of this approach must be balanced against its advantages. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Assessing the content, presentation, and readability of dental informed consents.

PubMed

Glick, Aaron; Taylor, David; Valenza, John A; Walji, Muhammad F

2010-08-01

Informed consents are important aids in helping patients make optimal decisions. Little knowledge exists about the quality of dental informed consents. Fifty-two informed consents used throughout the University of Texas Health Science Center at Houston Dental Branch were evaluated based on the quality of their content, readability, and presentation. Content quality was judged on four basic elements: description of procedure, risk, benefits, and alternatives. Of the clinical consents, 26 percent of forms contained all four of the basic content elements, 48 percent contained three of four elements, 16 percent contained two of four elements, and 10 percent contained one of four elements. Presentation quality was judged on twelve criteria items. The average clinical consent included seven out of twelve presentation items, and the average nonclinical consent included eight out of twelve items. Readability was judged using three standard instruments for rating readability: Flesch Reading Ease, Flesch-Kincaid Grade-Level, and Simple Measure of Gobbledygook (SMOG) grading. Average Flesch-Kincaid Grade-Level was 12.7 (range, 7.4 to 19.1), significantly higher than the recommended ninth grade level (p<.001). The results suggest that many existing dental informed consents may be improved by 1) increasing the comprehensiveness of the content, 2) improving the design and layout, and 3) reducing the readability levels for patient comprehension.

Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

PubMed

Lawrence, Dana J

2011-11-01

To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Voluntary participation and comprehension of informed consent in a genetic epidemiological study of breast cancer in Nigeria

PubMed Central

2014-01-01

Background Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups. Methods Surveys were administered in face-to-face interviews with 215 participants following their enrollment in the genetic study (106 patients, 109 controls). Audio-taped in-depth interviews were conducted with a sub-sample of 17 (8%) women who completed the survey. Results The majority of all participants reported being told that participation in the genetic study was voluntary (97%), that they did not feel pressured to participate in the study (99%), and that they could withdraw from the study (81%). The majority of the breast cancer patients (83%) compared to 58% of women in the control group reported that the study purpose was to learn about the genetic inheritance of breast cancer (OR 3.44; 95% CI =1.66, 7.14, p value = 0.001). Most participants reported being told about study procedures (95%) and study benefits (98%). Sixty-eight percent of the patients, compared to 47% of the control group reported being told about study risks (p-value <0.001). Of the 165 married women, 19% reported asking permission from their husbands to enroll in the breast cancer study; no one sought permission from local elders. In-depth interviews highlight the use of persuasion and negotiation between a wife and her husband regarding study participation. Conclusions The global expansion of genetic and genomic research highlights our need to understand informed consent practices for studies in ethnically diverse cultural environments such as Africa. Quantitative and qualitative empirical investigations of the informed consent process for genetic and genomic research will further our knowledge of complex issues associated with communication of information, comprehension, decisional authority and voluntary participation. In the future, the development and testing of innovative strategies to promote voluntary participation and comprehension of the goals of genomic research will contribute to our understanding of strategies that enhance the consent process. PMID:24885380

Informed consent in high-risk renal transplant recipients.

PubMed

Cocchiara, G; Lo Monte, A I; Romano, G; Romano, M; Buscemi, G

2009-06-01

Before performing a clinical, diagnostic, and/or therapeutic action, the doctor is required to provide the patient with a bulk of information defined as informed consent. This expression was used for the first time in 1957 during a court case in California and the two words--informed and consent--are used together to underline the fact that the patient cannot give his or her true consent without first receiving correct information concerning the medical act in question. With regard to the medicolegal aspects governing organ transplants, despite the bulk of detailed work performed by health service workers involved in this surgical field with the aim of preparing adequate informed consent models, this has not yet been accompanied by the necessary legislative development. The informed consent model to be presented to the kidney transplant candidate should include a detailed description of the recipient's comorbidity and should aim at reducing the number of medicolegal actions, which have become more and more frequent in the last few years due to the ever increasing number of patients considered as suitable for transplantation. Informed consent, therefore, should not be a mere bureaucratic formality to be obtained casually, but should be carefully stipulated together with the patient by the transplant surgeon. It is, in fact, an indispensable condition for transforming a potentially illegal action, that is, the violation of an individual's psychophysical integrity, into a legal one.

Modified informed consent in a viral seroprevalence study in the Caribbean.

PubMed

Cox, Cheryl; Macpherson, CNL

1996-07-01

An unlinked seroprevalence study of HIV and other viruses was conducted on pregnant women on the Caribbean island of Grenada in 1994. Investigators were from both the developed world and the Grenadian Ministry of Health (MOH). There was then no board on Grenada to protect research subjects or review ethical aspects of studies. Nurses from the MOH were asked to verbally inform their patients about the study, and request that patients become subjects of the study and give blood for screening. If consent was given nurses took blood and administered a survey about each subjects' knowledge of HIV transmission routes. Nurses shared a spoken dialect and cultural heritage with prospective subjects and were probably more effective than foreign researchers at informing subjects. Informed consent was obtained with a simplified consent form supplemented with conversation with each prospective research subject. Facilitating discussion between people with common cultural backgrounds helps apply the Western approach to informed consent to communites in the developing world. Researchers must disclose all information to nurses or other mediators, and ensure that nurses disclose as much information as possible to prospective subjects. So modified, informed consent maintains respect for persons and becomes applicable and relevant to various cultures.

Informed Consent and Genomic Incidental Findings: IRB Chair Perspectives

PubMed Central

Simon, Christian M.; Williams, Janet K.; Shinkunas, Laura; Brandt, Debra; Daack-Hirsch, Sandra; Driessnack, Martha

2013-01-01

It is unclear how genomic incidental finding (GIF) prospects should be addressed in informed consent processes. An exploratory study on this topic was conducted with 34 purposively sampled Chairs of institutional review boards (IRBs) at centers conducting genome-wide association studies. Most Chairs (96%) reported no knowledge of local IRB requirements regarding GIFs and informed consent. Chairs suggested consent processes should address the prospect of, and study disclosure policy on, GIFs; GIF management and follow-up; potential clinical significance of GIFs; potential risks of GIF disclosure; an opportunity for participants to opt out of GIF disclosure; and duration of the researcher's duty to disclose GIFs. Chairs were concerned about participant disclosure preferences changing over time; inherent limitations in determining the scope and accuracy of claims about GIFs; and making consent processes longer and more complex. IRB Chair and other stakeholder perspectives can help advance informed consent efforts to accommodate GIF prospects. PMID:22228060

Informed consent and genomic incidental findings: IRB chair perspectives.

PubMed

Simon, Christian M; Williams, Janet K; Shinkunas, Laura; Brandt, Debra; Daack-Hirsch, Sandra; Driessnack, Martha

2011-12-01

It is unclear how genomic incidental finding (GIF) prospects should be addressed in informed consent processes. An exploratory study on this topic was conducted with 34 purposively sampled Chairs of institutional review boards (IRBs) at centers conducting genome-wide association studies. Most Chairs (96%) reported no knowledge of local IRB requirements regarding GIFs and informed consent. Chairs suggested consent processes should address the prospect of, and study disclosure policy on, GIFs; GIF management and follow-up; potential clinical significance of GIFs; potential risks of GIF disclosure; an opportunity for participants to opt out of GIF disclosure; and duration of the researcher's duty to disclose GIFs. Chairs were concerned about participant disclosure preferences changing over time; inherent limitations in determining the scope and accuracy of claims about GIFs; and making consent processes longer and more complex. IRB Chair and other stakeholder perspectives can help advance informed consent efforts to accommodate GIF prospects.

Undergraduate Consent Form Reading in Relation to Conscientiousness, Procrastination, and the Point-of-Time Effect.

PubMed

Theiss, Justin D; Hobbs, William B; Giordano, Peter J; Brunson, Olivia M

2014-07-01

Informed consent is central to conducting ethical research with human participants. The present study investigated differences in consent form reading in relation to conscientiousness, procrastination, and the point-of-time (PT) effect among undergraduate participants at a U.S. university. As hypothesized, conscientious participants and those who signed up to participate in a research study more days in advance and for earlier sessions (PT effect) read the consent form more thoroughly. However, procrastination was not related to consent form reading. Most importantly, consent form reading in general was poor, with 80% of participants demonstrating that they had not read the consent form. Conscientious participants were more likely to self-report reading the consent form, irrespective of their measured consent form reading. The article closes with suggestions to improve the process of obtaining informed consent with undergraduate participants. © The Author(s) 2014.

The Picture Talk Project: Starting a Conversation with Community Leaders on Research with Remote Aboriginal Communities of Australia.

PubMed

Fitzpatrick, E F M; Macdonald, G; Martiniuk, A L C; D'Antoine, H; Oscar, J; Carter, M; Lawford, T; Elliott, E J

2017-05-11

Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this consent process. Few studies evaluate the preference or understanding of the consent process for research with Indigenous populations. Lack of informed consent can impact on research findings. The Picture Talk Project was initiated with senior Aboriginal leaders of the Fitzroy Valley community situated in the far north of Western Australia. Aboriginal people were interviewed about their understanding and experiences of research and consent processes. Transcripts were analysed using NVivo10 software with an integrated method of inductive and deductive coding and based in grounded theory. Local Aboriginal interpreters validated coding. Major themes were defined and supporting quotes sourced. Interviews with Aboriginal leaders (n = 20) were facilitated by a local Aboriginal Community Navigator who could interpret if necessary and provide cultural guidance. Participants were from all four major local language groups of the Fitzroy Valley; aged 31 years and above; and half were male. Themes emerging from these discussions included Research-finding knowledge; Being respectful of Aboriginal people, Working on country, and Being flexible with time; Working together with good communication; Reciprocity-two-way learning; and Reaching consent. The project revealed how much more there is to be learned about how research with remote Aboriginal communities should be conducted such that it is both culturally respectful and, importantly, meaningful for participants. We identify important elements in community consultation about research and seeking consent.

Social Annotation Valence: The Impact on Online Informed Consent Beliefs and Behavior.

PubMed

Balestra, Martina; Shaer, Orit; Okerlund, Johanna; Westendorf, Lauren; Ball, Madeleine; Nov, Oded

2016-07-20

Social media, mobile and wearable technology, and connected devices have significantly expanded the opportunities for conducting biomedical research online. Electronic consent to collecting such data, however, poses new challenges when contrasted to traditional consent processes. It reduces the participant-researcher dialogue but provides an opportunity for the consent deliberation process to move from solitary to social settings. In this research, we propose that social annotations, embedded in the consent form, can help prospective participants deliberate on the research and the organization behind it in ways that traditional consent forms cannot. Furthermore, we examine the role of the comments' valence on prospective participants' beliefs and behavior. This study focuses specifically on the influence of annotations' valence on participants' perceptions and behaviors surrounding online consent for biomedical research. We hope to shed light on how social annotation can be incorporated into digitally mediated consent forms responsibly and effectively. In this controlled between-subjects experiment, participants were presented with an online consent form for a personal genomics study that contained social annotations embedded in its margins. Individuals were randomly assigned to view the consent form with positive-, negative-, or mixed-valence comments beside the text of the consent form. We compared participants' perceptions of being informed and having understood the material, their trust in the organization seeking the consent, and their actual consent across conditions. We find that comment valence has a marginally significant main effect on participants' perception of being informed (F2=2.40, P=.07); specifically, participants in the positive condition (mean 4.17, SD 0.94) felt less informed than those in the mixed condition (mean 4.50, SD 0.69, P=.09). Comment valence also had a marginal main effect on the extent to which participants reported trusting the organization (F2=2.566, P=.08). Participants in the negative condition (mean 3.59, SD 1.14) were marginally less trusting than participants exposed to the positive condition (mean 4.02, SD 0.90, P=.06). Finally, we found that consent rate did not differ across comment valence conditions; however, participants who spent less time studying the consent form were more likely to consent when they were exposed to positive-valence comments. This work explores the effects of adding a computer-mediated social dimension, which inherently contains human emotions and opinions, to the consent deliberation process. We proposed that augmenting the consent deliberation process to incorporate multiple voices can enable individuals to capitalize on the knowledge of others, which brings to light questions, problems, and concerns they may not have considered on their own. We found that consent forms containing positive valence annotations are likely to lead participants to feel less informed and simultaneously more trusting of the organization seeking consent. In certain cases where participants spent little time considering the content of the consent form, participants exposed to positive valence annotations were even more likely to consent to the study. We suggest that these findings represent important considerations for the design of future electronic informed consent mechanisms.

Informed Consent as a Litigation Strategy in the Field of Aesthetic Surgery: An Analysis Based on Court Precedents.

PubMed

Park, Bo Young; Kwon, Jungwoo; Kang, So Ra; Hong, Seung Eun

2016-09-01

In an increasing number of lawsuits doctors lose, despite providing preoperative patient education, because of failure to prove informed consent. We analyzed judicial precedents associated with insufficient informed consent to identify judicial factors and trends related to aesthetic surgery medical litigation. We collected data from civil trials between 1995 and 2015 that were related to aesthetic surgery and resulted in findings of insufficient informed consent. Based on these data, we analyzed the lawsuits, including the distribution of surgeries, dissatisfactions, litigation expenses, and relationship to informed consent. Cases were found involving the following types of surgery: facial rejuvenation (38 cases), facial contouring surgery (27 cases), mammoplasty (16 cases), blepharoplasty (29 cases), rhinoplasty (21 cases), body-contouring surgery (15 cases), and breast reconstruction (2 cases). Common reasons for postoperative dissatisfaction were deformities (22%), scars (17%), asymmetry (14%), and infections (6%). Most of the malpractice lawsuits occurred in Seoul (population 10 million people; 54% of total plastic surgeons) and in primary-level local clinics (113 cases, 82.5%). In cases in which only invalid informed consent was recognized, the average amount of consolation money was KRW 9,107,143 (USD 8438). In cases in which both violation of non-malfeasance and invalid informed consent were recognized, the average amount of consolation money was KRW 12,741,857 (USD 11,806), corresponding to 38.6% of the amount of the judgment. Surgeons should pay special attention to obtaining informed consent, because it is a double-edged sword; it has clinical purposes for doctors and patients but may also be a litigation strategy for lawyers.

Voluntary Informed Consent in Paediatric Oncology Research.

PubMed

Dekking, Sara A S; Van Der Graaf, Rieke; Van Delden, Johannes J M

2016-07-01

In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context. © 2015 John Wiley & Sons Ltd.

Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: an empirical study.

PubMed

Chima, Sylvester C

2013-01-01

Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001). This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery.

Open consent, biobanking and data protection law: can open consent be 'informed' under the forthcoming data protection regulation?

PubMed

Hallinan, Dara; Friedewald, Michael

2015-01-01

This article focuses on whether a certain form of consent used by biobanks--open consent--is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent--in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context--exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of 'data'. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

A memory and organizational aid improves Alzheimer disease research consent capacity: results of a randomized, controlled trial.

PubMed

Rubright, Jonathan; Sankar, Pamela; Casarett, David J; Gur, Ruben; Xie, Sharon X; Karlawish, Jason

2010-12-01

Early and progressive cognitive impairments of patients with Alzheimer disease (AD) hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, the authors tested whether a memory and organizational aid improves the performance of patients with AD on measures of capacity and competency to give informed consent. Patients with AD randomly assigned to standard consent or standard plus a memory and organizational aid. Memory and organizational aid summarized the content of information mandated under the informed consent disclosure requirements of the Common Rule at a sixth grade reading level. Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of the three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison with cognitively normal older adult norms. AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on the measures of appreciation or reasoning. A consent process that addresses the deficits in memory and attention of a patient with AD can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale. ClinicalTrials.Gov#NCT00105612, http://clinicaltrials.gov/show/NCT00105612.

A memory and organizational aid improves AD research consent capacity: Results of a randomized, controlled trial

PubMed Central

Rubright, Jonathan; Sankar, Pamela; Casarett, David J; Gur, Ruben; Xie, Sharon X; Karlawish, Jason

2010-01-01

Objectives AD patients' early and progressive cognitive impairments hinder their capacity to provide informed consent. Unfortunately, the limited research on techniques to improve capacity has shown mixed results. Therefore, we tested whether a memory and organizational aid improves AD patient performance on measures of capacity and competency to give informed consent. Design, Setting, and Participants AD patients randomly assigned to standard consent, or standard plus a memory and organizational aid. Intervention Memory and organizational aid summarized at a 6th grade reading level the content of information mandated under the Common Rule's informed consent disclosure requirements. Measurements Three psychiatrists without access to patient data independently reviewed MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) interview transcripts to judge whether the patient was capable of providing informed consent. The agreement of at least two of three experts defined a participant as capable of providing informed consent. Secondary outcomes are MacCAT-CR measures of understanding, appreciation and reasoning, and comparison to cognitively normal older adult norms. Results AD intervention and control groups were similar in terms of age, education, and cognitive status. The intervention group was more likely to be judged competent than control group and had higher scores on MacCAT-CR measure of understanding. The intervention had no effect on measures of appreciation or reasoning. Conclusions A consent process that addresses an AD patients' deficits in memory and attention can improve capacity to give informed consent for early phase AD research. The results also validate the MacCAT-CR as an instrument to measure capacity, especially the understanding subscale. PMID:20808101

The importance of purpose: moving beyond consent in the societal use of personal health information.

PubMed

Grande, David; Mitra, Nandita; Shah, Anand; Wan, Fei; Asch, David A

2014-12-16

Adoption of electronic health record systems has increased the availability of patient-level electronic health information. To examine public support for secondary uses of electronic health information under different consent arrangements. National experimental survey to examine perceptions of uses of electronic health information according to patient consent (obtained vs. not obtained), use (research vs. marketing), and framing of the findings (abstract description without results vs. specific results). Nationally representative survey. 3064 African American, Hispanic, and non-Hispanic white persons (response rate, 65%). Appropriateness of health information use described in vignettes on a scale of 1 (not at all appropriate) to 10 (very appropriate). Mean ratings ranged from a low of 3.81 for a marketing use when consent was not obtained and specific results were presented to a high of 7.06 for a research use when consent was obtained and specific results were presented. Participants rated scenarios in which consent was obtained as more appropriate than when consent was not obtained (difference, 1.01 [95% CI, 0.69 to 1.34]; P<0.001). Participants rated scenarios in which the use was marketing as less appropriate than when the use was research (difference, -2.03 [CI, -2.27 to -1.78]; P<0.001). Unconsented research uses were rated as more appropriate than consented marketing uses (5.65 vs. 4.52; difference, 1.13 [CI, 0.87 to 1.39]). Participants rated hypothetical scenarios. Results could be vulnerable to nonresponse bias despite the high response rate. Although approaches to health information sharing emphasize consent, public opinion also emphasizes purpose, which suggests a need to focus more attention on the social value of information use. National Human Genome Research Institute.

[Evaluation and improvement of the management of informed consent in the emergency department].

PubMed

del Pozo, P; García, J A; Escribano, M; Soria, V; Campillo-Soto, A; Aguayo-Albasini, J L

2009-01-01

To assess the preoperative management in our emergency surgical service and to improve the quality of the care provided to patients. In order to find the causes of non-compliance, the Ishikawa Fishbone diagram was used and eight assessment criteria were chosen. The first assessment includes 120 patients operated on from January to April 2007. Corrective measures were implemented, which consisted of meetings and conferences with doctors and nurses, insisting on the importance of the informed consent as a legal document which must be signed by patients, and the obligation of giving a copy to patients or relatives. The second assessment includes the period from July to October 2007 (n=120). We observed a high non-compliance of C1 signing of surgical consent (CRITERION 1: all patients or relatives have to sign the surgical informed consent for the operation to be performed [27.5%]) and C2 giving a copy of the surgical consent (CRITERION 2: all patients or relatives must have received a copy of the surgical informed consent for the Surgery to be performed [72.5%]) and C4 anaesthetic consent copy (CRITERION 4: all patients or relatives must have received a copy of the Anaesthesia informed consent corresponding to the operation performed [90%]). After implementing corrective measures a significant improvement was observed in the compliance of C2 and C4. In C1 there was an improvement without statistical significance. The carrying out of an improvement cycle enabled the main objective of this paper to be achieved: to improve the management of informed consent and the quality of the care and information provided to our patients.

Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda.

PubMed

Ssali, Agnes; Poland, Fiona; Seeley, Janet

2015-12-03

Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team. Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis. Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects. Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers' perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.

21 CFR 50.24 - Exception from informed consent requirements for emergency research.

Code of Federal Regulations, 2010 CFR

2010-04-01

... emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.24 Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review...

Random Assignment and Informed Consent: A Case Study of Multiple Perspectives

ERIC Educational Resources Information Center

Walker, Robert; Hoggart, Lesley; Hamilton, Gayle

2008-01-01

Although random assignment is generally the preferred methodology in impact evaluations, it raises numerous ethical concerns, some of which are addressed by securing participants' informed consent. However, there has been little investigation of how consent is obtained in social experiments and the amount of information that can be conveyed--and…

Informed Consent in Research on Second Language Acquisition

ERIC Educational Resources Information Center

Thomas, Margaret; Pettitt, Nicole

2017-01-01

The practice of securing informed consent from research participants has a relatively low profile in second language (L2) acquisition research, despite its prominence in the biomedical and social sciences. This review article analyses the role that informed consent now typically plays in L2 research; discusses an example of an L2 study where…

Obtaining subjects' consent to publish identifying personal information: current practices and identifying potential issues.

PubMed

Yoshida, Akiko; Dowa, Yuri; Murakami, Hiromi; Kosugi, Shinji

2013-11-25

In studies publishing identifying personal information, obtaining consent is regarded as necessary, as it is impossible to ensure complete anonymity. However, current journal practices around specific points to consider when obtaining consent, the contents of consent forms and how consent forms are managed have not yet been fully examined. This study was conducted to identify potential issues surrounding consent to publish identifying personal information. Content analysis was carried out on instructions for authors and consent forms developed by academic journals in four fields (as classified by Journal Citation Reports): medicine general and internal, genetics and heredity, pediatrics, and psychiatry. An online questionnaire survey of editors working for journals that require the submission of consent forms was also conducted. Instructions for authors were reviewed for 491 academic journals (132 for medicine general and internal, 147 for genetics and heredity, 100 for pediatrics, and 112 for psychiatry). Approximately 40% (203: 74 for medicine general and internal, 31 for genetics and heredity, 58 for pediatrics, and 40 for psychiatry) stated that subject consent was necessary. The submission of consent forms was required by 30% (154) of the journals studied, and 10% (50) provided their own consent forms for authors to use. Two journals mentioned that the possible effects of publication on subjects should be considered. Many journal consent forms mentioned the difficulties in ensuring complete anonymity of subjects, but few addressed the study objective, the subjects' right to refuse consent and the withdrawal of consent. The main reason for requiring the submission of consent forms was to confirm that consent had been obtained. Approximately 40% of journals required subject consent to be obtained. However, differences were observed depending on the fields. Specific considerations were not always documented. There is a need to address issues around the study objective, subjects' right to refuse consent and the withdrawal of consent. Whether responsibility for ensuring that the consent form has been signed lies with publishers also needs to be discussed.

Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context?

PubMed

Mendyk, Anne-Marie; Labreuche, Julien; Henon, Hilde; Girot, Marie; Cordonnier, Charlotte; Duhamel, Alain; Leys, Didier; Bordet, Régis

2015-04-24

The provision of informed consent is a prerequisite for inclusion of a patient in a clinical research project. In some countries, the legislation on clinical research authorizes a third person to provide informed consent if the patient is unable to do so directly (i.e. surrogate consent). This is the case during acute stroke, when the symptoms may prevent the patient from providing informed consent and thus require a third party to be approached. Identification of factors associated with the medical team's decision to resort to surrogate consent may (i) help the care team during the inclusion process and (ii) enable the patient's family circle to be better informed (and thus feel less guilty) about providing surrogate consent. Patients included in the BIOSTROKE cohort (initially dedicated to the analysis of factors influencing stroke severity) were divided into two groups: those having provided informed consent directly and those for whom a third party (such as a family member) had provided surrogate consent. We compared the groups in terms of the initial clinical characteristics (age, gender, type of stroke, severity on the National Institutes of Health Stroke Scale (NIHSS), pre-stroke cognitive status according to the Informant Questionnaire on Cognitive Decline in the Elderly, and the stroke's aetiology) and the functional and cognitive impairments (according to the NIHSS, the modified Rankin score (mRS) and the Mini Mental State Examination) on post-stroke days 8 and 90. Three hundred and ninety five patients were included (mean ± SD age: 67 ± 15 years; 53% males). Surrogate consent had been obtained in 228 cases, and 167 patients had provided consent themselves. The patients included with surrogate consent were likely to be older and more aphasic, with a pre-existing cognitive disorder and more severe stroke (relative to the patients having provided consent). In terms of recovery, the patients included with surrogate consent had a worse functional prognosis (day 90 mRS ≥3: 57.6%, compared with 16.8% in patients having provided consent themselves; p < 0.0001) and a worse cognitive prognosis (day 90 MMS < 24: 15.4% and 4.8%, respectively; p < 0.002). The mortality rate was significantly higher in the surrogate consent group. We found that in addition to age, aphasia and stroke severity, pre-stroke cognitive status is a factor that should prompt the care team to consider requesting surrogate consent for participation in a clinical study. Given that the unfavourable outcome in patients with surrogate consent is often due to their initial clinical state (rather than inclusion in a trial per se), the issue of the family's feelings of guilt (and how to avoid these feelings) should be further addressed.

A videotape intervention to enhance the informed consent process for medical and psychiatric treatment research.

PubMed

Wirshing, Donna A; Sergi, Mark J; Mintz, Jim

2005-01-01

This study evaluated a brief educational video designed to enhance the informed consent process for people with serious mental and medical illnesses who are considering participating in treatment research. Individuals with schizophrenia who were being recruited for ongoing clinical trials, medical patients without self-reported psychiatric comorbidity, and university undergraduates were randomly assigned to view either a highly structured instructional videotape about the consent process in treatment research or a control videotape that presented only general information about bioethical issues in human research. Knowledge about informed consent was measured before and after viewing. Viewing the experimental videotape resulted in larger gains in knowledge about informed consent. Standardized effect sizes were large in all groups. The videotape was thus an effective teaching tool across diverse populations, ranging from individuals with severe chronic mental illness to university undergraduates.

Forced to be free? Increasing patient autonomy by constraining it

PubMed Central

2014-01-01

It is universally accepted in bioethics that doctors and other medical professionals have an obligation to procure the informed consent of their patients. Informed consent is required because patients have the moral right to autonomy in furthering the pursuit of their most important goals. In the present work, it is argued that evidence from psychology shows that human beings are subject to a number of biases and limitations as reasoners, which can be expected to lower the quality of their decisions and which therefore make it more difficult for them to pursue their most important goals by giving informed consent. It is further argued that patient autonomy is best promoted by constraining the informed consent procedure. By limiting the degree of freedom patients have to choose, the good that informed consent is supposed to protect can be promoted. PMID:22318413

Forced to be free? Increasing patient autonomy by constraining it.

PubMed

Levy, Neil

2014-05-01

It is universally accepted in bioethics that doctors and other medical professionals have an obligation to procure the informed consent of their patients. Informed consent is required because patients have the moral right to autonomy in furthering the pursuit of their most important goals. In the present work, it is argued that evidence from psychology shows that human beings are subject to a number of biases and limitations as reasoners, which can be expected to lower the quality of their decisions and which therefore make it more difficult for them to pursue their most important goals by giving informed consent. It is further argued that patient autonomy is best promoted by constraining the informed consent procedure. By limiting the degree of freedom patients have to choose, the good that informed consent is supposed to protect can be promoted.

Informed Consent to Treatment in Psychiatry

PubMed Central

Neilson, Grainne; Chaimowitz, Gary

2015-01-01

Summary Patients have a right to be informed and actively involved in their health care. Fundamental to a person’s dignity and autonomy is the right to make decisions about their psychiatric treatment, including their right to refuse unwanted treatments, providing that the refusal is a capable one. It is important that psychiatrists have an awareness of the ethical underpinnings of consent and the legislated requirements related to consent, including precedent cases. Consent may change over time and for different conditions and circumstances. Consent must be an ongoing process.

75 FR 28327 - Proposed Collection; Comment Request for Revenue Procedure 2001-24

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-20

... consent to change its method of accounting for cash advances on commissions paid to its agents must agree... information unless the collection of information displays a valid OMB control number. Books or records... for the proper performance of the functions of the agency, including whether the information shall...

Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent.

PubMed

Bunnik, Eline M; Janssens, A Cecile J W; Schermer, Maartje H N

2014-09-01

Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than informed consent procedures. However, to protect consumers from the potential physical, psychological and social harms associated with personal genome testing and to promote autonomous decision-making with regard to the testing offer, we argue that current practices of information provision are insufficient and that there is a place--and a need--for informed consent in personal genome testing, also when it is offered commercially. The increasing quantity, complexity and diversity of most testing offers, however, pose challenges for information provision and informed consent. Both specific and generic models for informed consent fail to meet its moral aims when applied to personal genome testing. Consumers should be enabled to know the limitations, risks and implications of personal genome testing and should be given control over the genetic information they do or do not wish to obtain. We present the outline of a new model for informed consent which can meet both the norm of providing sufficient information and the norm of providing understandable information. The model can be used for personal genome testing, but will also be applicable to other, future forms of broad genetic testing or screening in commercial and clinical settings. © 2012 John Wiley & Sons Ltd.

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.

PubMed

Bleiberg, H; Decoster, G; de Gramont, A; Rougier, P; Sobrero, A; Benson, A; Chibaudel, B; Douillard, J Y; Eng, C; Fuchs, C; Fujii, M; Labianca, R; Larsen, A K; Mitchell, E; Schmoll, H J; Sprumont, D; Zalcberg, J

2017-05-01

In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Routinisation of informed consent in online health care systems.

PubMed

Ploug, Thomas; Holm, Søren

2015-04-01

To investigate (1) the extent to which informed consent is routinised, i.e., given habitually and without reflection, in relation to the use of web-portals containing personal health information, and (2) the reasons given by users for routinised and non-routinised consent behaviour. Anonymous web-questionnaire among users of the official Danish health information web-portal, Sundhed.dk. Sundhed.dk allows Danish residents access to their electronic patient records and other personal health information and allows them to update some of this information. Use of the portal requires explicit consent to the terms and conditions of use and the data protection policies of the site. Degree to which information materials are read before use of the portal. Reasons given for reading or not reading materials. Seventy-nine percent of respondents read half or less of the information materials before using the portal. The main reasons given for not reading (all) of the materials relate to the length of the materials, the frequency of having to read such things, and the perception that use of the portal is 'low risk'. The reasons given for reading and not reading indicate that the consent process is routinised. Most users of Sundhed.dk do not provide informed consent before using the portal, since most do not read the information fully. The reasons given for not reading strongly supports the idea that consent has become a routinised behaviour in this context. This finding is important because web-portals offering access to personal health information held by the health care system are becoming ever more frequent. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Rates and determinants of informed consent: a case study of an international thromboprophylaxis trial.

PubMed

Smith, Orla M; McDonald, Ellen; Zytaruk, Nicole; Foster, Denise; Matte, Andrea; Clarke, France; Meade, Laurie; O'Callaghan, Nicole; Vallance, Shirley; Galt, Pauline; Rajbhandari, Dorrilyn; Rocha, Marcelo; Mehta, Sangeeta; Ferguson, Niall D; Hall, Richard; Fowler, Robert; Burns, Karen; Qushmaq, Ismael; Ostermann, Marlies; Heels-Ansdell, Diane; Cook, Deborah

2013-02-01

Successful completion of randomized trials depends upon efficiently and ethically screening patients and obtaining informed consent. Awareness of modifiable barriers to obtaining consent may inform ongoing and future trials. The objective of this study is to describe and examine determinants of consent rates in an international heparin thromboprophylaxis trial (Prophylaxis for ThromboEmbolism in Critical Care Trial, clinicaltrials.gov NCT00182143). Throughout the 4-year trial, research personnel approached eligible critically ill patients or their substitute decision makers for informed consent. Whether consent was obtained or declined was documented daily. The trial was conducted in 67 centers in 6 countries. A total of 3764 patients were randomized. The overall consent rate was 82.2% (range, 50%-100%) across participating centers. Consent was obtained from substitute decision makers and patients in 90.1% and 9.9% of cases, respectively. Five factors were independently associated with consent rates. Research coordinators with more experience achieved higher consent rates (odds ratio [OR], 3.43; 95% confidence interval, 2.42-4.86; P < .001 for those with >10 years of experience). Consent rates were higher in smaller intensive care units with less than 15 beds compared with intensive care units with 15 to 20 beds, 21 to 25 beds, and greater than 25 beds (all ORs, <0.5; P < .001) and were higher in centers with more than 1 full-time research staff (OR, 1.95; 95% confidence interval, 1.28-2.99; P < .001). Consent rates were lower in centers affiliated with the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group compared with other centers (OR, 0.57; 95% confidence interval, 0.42-0.77; P < .001). Finally, consent rates were highest during the pilot trial, lowest during the initiation of the full trial, and increased over years of recruitment (P < .001). Characteristics of study centers, research infrastructure, and experience were important factors associated with successfully procuring informed consent to participate in this thromboprophylaxis trial. Copyright © 2013 Elsevier Inc. All rights reserved.

Architecture of a consent management suite and integration into IHE-based Regional Health Information Networks.

PubMed

Heinze, Oliver; Birkle, Markus; Köster, Lennart; Bergh, Björn

2011-10-04

The University Hospital Heidelberg is implementing a Regional Health Information Network (RHIN) in the Rhine-Neckar-Region in order to establish a shared-care environment, which is based on established Health IT standards and in particular Integrating the Healthcare Enterprise (IHE). Similar to all other Electronic Health Record (EHR) and Personal Health Record (PHR) approaches the chosen Personal Electronic Health Record (PEHR) architecture relies on the patient's consent in order to share documents and medical data with other care delivery organizations, with the additional requirement that the German legislation explicitly demands a patients' opt-in and does not allow opt-out solutions. This creates two issues: firstly the current IHE consent profile does not address this approach properly and secondly none of the employed intra- and inter-institutional information systems, like almost all systems on the market, offers consent management solutions at all. Hence, the objective of our work is to develop and introduce an extensible architecture for creating, managing and querying patient consents in an IHE-based environment. Based on the features offered by the IHE profile Basic Patient Privacy Consent (BPPC) and literature, the functionalities and components to meet the requirements of a centralized opt-in consent management solution compliant with German legislation have been analyzed. Two services have been developed and integrated into the Heidelberg PEHR. The standard-based Consent Management Suite consists of two services. The Consent Management Service is able to receive and store consent documents. It can receive queries concerning a dedicated patient consent, process it and return an answer. It represents a centralized policy enforcement point. The Consent Creator Service allows patients to create their consents electronically. Interfaces to a Master Patient Index (MPI) and a provider index allow to dynamically generate XACML-based policies which are stored in a CDA document to be transferred to the first service. Three workflows have to be considered to integrate the suite into the PEHR: recording the consent, publishing documents and viewing documents. Our approach solves the consent issue when using IHE profiles for regional health information networks. It is highly interoperable due to the use of international standards and can hence be used in any other region to leverage consent issues and substantially promote the use of IHE for regional health information networks in general.

Evaluating Active Parental Consent Procedures for School Programming: Addressing the Sensitive Topic of Suicide Prevention.

PubMed

Totura, Christine M Wienke; Kutash, Krista; Labouliere, Christa D; Karver, Marc S

2017-02-01

Suicide is the second leading cause of death for adolescents. Whereas school-based prevention programs are effective, obtaining active consent for youth participation in public health programming concerning sensitive topics is challenging. We explored several active consent procedures for improving participation rates. Five active consent methods (in-person, students taking forms home, mailing, mailing preceded by primers, mailing followed by reminder calls) were compared against passive consent procedures to evaluate recruitment success, as determined by participation (proportion who responded yes) and response (proportion who returned any response) rates. Participation acceptance rates ranged from 38 to 100% depending on consent method implemented. Compared with passive consent, active consent procedures were more variable in response and participation rates. In-person methods provided higher rates than less interpersonal methods, such as mailing or students taking consents home. Mailed primers before or reminder calls after consent forms were mailed increased response but not participation rates. Students taking consents home resulted in the lowest rates. Although passive consent produces the highest student participation, these methods are not always appropriate for programs addressing sensitive topics in schools. In-person active consent procedures may be the best option when prioritizing balance between parental awareness and successful student recruitment. © 2017, American School Health Association.

Race, religion, and informed consent--lessons from social science.

PubMed

Matthew, Dayna Bowen

2008-01-01

That minority patients have not figured at all in the literature about informed consent is an egregious omission which this article begins to repair. Moreover, the article demonstrates that by addressing identifiable harms which informed consent law now causes to racial, religious, and ethnic minority patients, the law may also better address many of the concerns legal commentators have been discussing for years with only majority patients in mind. Ironically, the solution to the discrimination felt by the excluded members of society may turn out to provide the remedy for the informed consent doctrine as a whole.

Audio-visual presentation of information for informed consent for participation in clinical trials.

PubMed

Ryan, R E; Prictor, M J; McLaughlin, K J; Hill, S J

2008-01-23

Informed consent is a critical component of clinical research. Different methods of presenting information to potential participants of clinical trials may improve the informed consent process. Audio-visual interventions (presented for example on the Internet, DVD, or video cassette) are one such method. To assess the effects of providing audio-visual information alone, or in conjunction with standard forms of information provision, to potential clinical trial participants in the informed consent process, in terms of their satisfaction, understanding and recall of information about the study, level of anxiety and their decision whether or not to participate. We searched: the Cochrane Consumers and Communication Review Group Specialised Register (searched 20 June 2006); the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, issue 2, 2006; MEDLINE (Ovid) (1966 to June week 1 2006); EMBASE (Ovid) (1988 to 2006 week 24); and other databases. We also searched reference lists of included studies and relevant review articles, and contacted study authors and experts. There were no language restrictions. Randomised and quasi-randomised controlled trials comparing audio-visual information alone, or in conjunction with standard forms of information provision (such as written or oral information as usually employed in the particular service setting), with standard forms of information provision alone, in the informed consent process for clinical trials. Trials involved individuals or their guardians asked to participate in a real (not hypothetical) clinical study. Two authors independently assessed studies for inclusion and extracted data. Due to heterogeneity no meta-analysis was possible; we present the findings in a narrative review. We included 4 trials involving data from 511 people. Studies were set in the USA and Canada. Three were randomised controlled trials (RCTs) and the fourth a quasi-randomised trial. Their quality was mixed and results should be interpreted with caution. Considerable uncertainty remains about the effects of audio-visual interventions, compared with standard forms of information provision (such as written or oral information normally used in the particular setting), for use in the process of obtaining informed consent for clinical trials. Audio-visual interventions did not consistently increase participants' levels of knowledge/understanding (assessed in four studies), although one study showed better retention of knowledge amongst intervention recipients. An audio-visual intervention may transiently increase people's willingness to participate in trials (one study), but this was not sustained at two to four weeks post-intervention. Perceived worth of the trial did not appear to be influenced by an audio-visual intervention (one study), but another study suggested that the quality of information disclosed may be enhanced by an audio-visual intervention. Many relevant outcomes including harms were not measured. The heterogeneity in results may reflect the differences in intervention design, content and delivery, the populations studied and the diverse methods of outcome assessment in included studies. The value of audio-visual interventions for people considering participating in clinical trials remains unclear. Evidence is mixed as to whether audio-visual interventions enhance people's knowledge of the trial they are considering entering, and/or the health condition the trial is designed to address; one study showed improved retention of knowledge amongst intervention recipients. The intervention may also have small positive effects on the quality of information disclosed, and may increase willingness to participate in the short-term; however the evidence is weak. There were no data for several primary outcomes, including harms. In the absence of clear results, triallists should continue to explore innovative methods of providing information to potential trial participants. Further research should take the form of high-quality randomised controlled trials, with clear reporting of methods. Studies should conduct content assessment of audio-visual and other innovative interventions for people of differing levels of understanding and education; also for different age and cultural groups. Researchers should assess systematically the effects of different intervention components and delivery characteristics, and should involve consumers in intervention development. Studies should assess additional outcomes relevant to individuals' decisional capacity, using validated tools, including satisfaction; anxiety; and adherence to the subsequent trial protocol.

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

PubMed

Kortram, Kirsten; Spoon, Emerentia Q W; Ismail, Sohal Y; d'Ancona, Frank C H; Christiaans, Maarten H L; van Heurn, L W Ernest; Hofker, H Sijbrand; Hoksbergen, Arjan W J; Homan van der Heide, Jaap J; Idu, Mirza M; Looman, Caspar W N; Nurmohamed, S Azam; Ringers, Jan; Toorop, Raechel J; van de Wetering, Jacqueline; Ijzermans, Jan N M; Dor, Frank J M F

2016-04-01

Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. Outcome will be published in a scientific journal. NTR5374; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Contents and readability of currently used surgical/procedure informed consent forms in Nigerian tertiary health institutions.

PubMed

Ezeome, E R; Chuke, P I; Ezeome, I V

2011-01-01

Surgical informed consent forms should have evidence that their use will enhance a shared decision-making which is the fundamental objective of informed consent in clinical practice. In the absence of any guideline in Nigeria on the content and language of informed consent forms, we sort to examine the surgical and procedure consent forms used by Federal tertiary health institutions in Nigeria, to know whether they fulfill the basic elements of informed consent. The surgical and procedure informed consent forms of 33 tertiary health institutions in Nigeria were assessed for their readability and contents. Adequacy of their content was evaluated based on provision for 28 content items identified as necessary information to be provided in a good consent form. The potential of the forms to be comprehended were assessed with Flesch readability formula. The contents of majority of the forms were scant. None of the forms made provision for documentation of the patient's permission for blood transfusion, tissue disposal, awareness of the risks of not undergoing the prescribed treatment, and the risk of anesthesia. Risk disclosures were only mentioned in specific terms in 11.4% of the forms. Less than 10% of the forms made provisions for an interpreter, signature of anesthetists, alternative to the procedure to be mentioned, and answering of the patient's questions. The Flesch reading ease scores of the forms ranged from 34.1 (Difficult) to 67.5 (Standard), with a mean score of 55.2 (Fairly difficult level). Field evaluation of the forms show that they shall be partly understood by 13- to 15-year-old patients with basic education but are best understood by literate adult patients. The content of majority of the informed consent forms used in Nigerian tertiary health institutions are poor and their readability scores are not better than those used in developed parts of the world. Health Institutions in Nigeria should revise their informed consent forms to improve their contents and do a usability trial on the sample forms before deployment in order to ensure that they are comprehensible for their patient population.

[Quality of information in the process of informed consent for anesthesia].

PubMed

Guillén-Perales, José; Luna-Maldonado, Aurelio; Fernández-Prada, María; Guillén-Solvas, José Francisco; Bueno-Cavanillas, Aurora

2013-11-01

To assess the quality of the information that patients receive in the informed consent document signed prior to surgery. Cross-sectional study of a sample of cancer patients admitted for surgery at the University Hospital San Cecilio of Granada in 2011. After checking the inclusion criteria and obtaining their consent, demographic data were collected and procedure data, and a questionnaire «ad hoc» to assess the quality and comprehensiveness of the information provided in the informed consent. 150 patients were studied. The majority (109 over 150) said they had received sufficient information, in appropriate language, and had the opportunity to ask questions, but only 44.7% correctly answered three or more issues related to anesthesia. University education level, knowledge of the intervention, information about the anesthesia problems and appropriate language were associated. Although systematic informed consent was performed, half of the patients did not comprehend the anesthesia risks. Variables primarily related to the information received were associated with the quality of the response, but not with patient characteristics. Copyright © 2013 AEC. Published by Elsevier Espana. All rights reserved.

Cardiac imaging modalities with ionizing radiation: the role of informed consent.

PubMed

Paterick, Timothy E; Jan, M Fuad; Paterick, Zachary R; Tajik, A Jamil; Gerber, Thomas C

2012-06-01

Informed consent ideally results in patient autonomy and rational health care decisions. Frequently, patients face complex medical decisions that require a delicate balancing of anticipated benefits and potential risks, which is the concept of informed consent. This balancing process requires an understanding of available medical evidence and alternative medical options, and input from experienced physicians. The informed consent doctrine places a positive obligation on physicians to partner with patients as they try to make the best decision for their specific medical situation. The high prevalence and mortality related to heart disease in our society has led to increased cardiac imaging with modalities that use ionizing radiation. This paper reviews how physicians can meet the ideals of informed consent when considering cardiac imaging with ionizing radiation, given the limited evidence for risks and benefits. The goal is an informed patient making rational choices based on available medical information. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Does informed consent given by healthy individuals when enrolling in clinical research feel less voluntary than for ill individuals?

PubMed

Roberts, Laura; Kim, Jane Paik

2018-04-30

Clinical research is predicated ethically on the authentic voluntarism of individuals who choose to enroll in human studies. Existing literature has focused on aspects of informed consent for clinical research other than voluntarism. The objective of this study was to compare the perspectives of clinical research participants who are in good health and who are ill regarding voluntarism-related aspects of informed consent and to assess situational influences that enable voluntarism in the process of obtaining clinical research consent. A 23-item written survey, the Informed Consent Questionnaire (ICQ), was administered in a "piggyback" semi-structured interview study of ill and healthy volunteers enrolled in IRB-approved clinical research studies. A total of 150 (60 mentally ill, 43 physically ill, and 47 healthy) clinical research participants participated. Respondents expressed positive views of their experiences with the informed consent processes for their respective clinical research protocols and respondents strongly endorsed items related to voluntarism irrespective of their illness type (range of means = [3.9, 4.8]). Ill participants more highly endorsed items relating to informed consent conditions (mentally ill vs healthy: 0.54 on a 5-point scale, P value = 0.01) (physically ill vs. healthy: 0.47 on a 5-point scale, P value = 0.01). The favorable views of clinical research participants regarding their experience of giving informed consent to enroll in a study were not surprising. Contrary to our a priori hypothesis, healthy individuals did not feel as positively as their ill counterparts. Copyright © 2018 Elsevier Ltd. All rights reserved.

Voices of people who have received ECT.

PubMed

Rajkumar, A P; Saravanan, B; Jacob, K S

2007-01-01

Electroconvulsive therapy (ECT) is controversial but widely practised in India. We elicited perspectives, using qualitative interviews, from patients who received ECT and their relatives. Ethical issues related to personal autonomy, right to information, competence, informed consent and consent by proxy are discussed. We suggest strategies to ensure a basic minimum standard for obtaining informed consent for ECT in India.

Black Boxing Restraints: The Need for Full Disclosure and Consent

ERIC Educational Resources Information Center

Mohr, Wanda K.; Nunno, Michael A.

2011-01-01

In this article we discuss the necessity of fully informing patients and their families of what constitutes physical interventions and their attendant risks under the established principles and obligations of informed consent. After a brief review of the elements of informed consent and the nature of the duty to advise patients and their families…

34 CFR 99.30 - Under what conditions is prior consent required to disclose information?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false Under what conditions is prior consent required to disclose information? 99.30 Section 99.30 Education Office of the Secretary, Department of Education FAMILY... Information From Education Records? § 99.30 Under what conditions is prior consent required to disclose...

Interactive multimedia consent for biobanking: a randomized trial.

PubMed

Simon, Christian M; Klein, David W; Schartz, Helen A

2016-01-01

The potential of interactive multimedia to improve biobank informed consent has yet to be investigated. The aim of this study was to test the separate effectiveness of interactivity and multimedia at improving participant understanding and confidence in understanding of informed consent compared with a standard, face-to-face (F2F) biobank consent process. A 2 (face-to-face versus multimedia) × 2 (standard versus enhanced interactivity) experimental design was used with 200 patients randomly assigned to receive informed consent. All patients received the same information provided in the biobank's nine-page consent document. Interactivity (F(1,196) = 7.56, P = 0.007, partial η(2) = 0.037) and media (F(1,196) = 4.27, P = 0.04, partial η(2) = 0.021) independently improved participants' understanding of the biobank consent. Interactivity (F(1,196) = 6.793, P = 0.01, partial η(2) = 0.033), but not media (F(1,196) = 0.455, not significant), resulted in increased participant confidence in their understanding of the biobank's consent materials. Patients took more time to complete the multimedia condition (mean = 18.2 min) than the face-to-face condition (mean = 12.6 min). This study demonstrated that interactivity and multimedia each can be effective at promoting an individual's understanding and confidence in their understanding of a biobank consent, albeit with additional time investment. Researchers should not assume that multimedia is inherently interactive, but rather should separate the two constructs when studying electronic consent.

78 FR 51677 - Children's Online Privacy Protection Rule Proposed Parental Consent Method; AssertID, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

...-AB20 Children's Online Privacy Protection Rule Proposed Parental Consent Method; AssertID, Inc. Application for Approval of Parental Consent Method AGENCY: Federal Trade Commission (FTC or Commission... concerning the proposed parental consent method submitted by AssertID, Inc. (``AssertID'') under the...

Satisfying the needs of Japanese cancer patients: a comparative study of detailed and standard informed consent documents.

PubMed

Sato, Keiko; Watanabe, Toru; Katsumata, Noriyuki; Sato, Tosiya; Ohashi, Yasuo

2014-02-01

Simplified informed consent forms have been successful in improving patient satisfaction and decreasing patient anxiety. However, unsolved problems remain about whether these documents improve comprehension and satisfaction of patients with standard literacy skills. s To investigate whether a detailed consent form explaining the key elements of informed consent, in comparison to a standard consent form, would increase the comprehension and satisfaction of adult cancer patients. Patients who were eligible for the National Surgical Adjuvant Study of Breast Cancer (protocol 01(N-SAS/BC-01)) were randomly selected to receive one of the following four versions: detailed document with graphics, detailed document without graphics, standard document with graphics, and standard document without graphics. The forms were written in plain language from the patients' point of view. A total of 85 patients were administered questionnaires via interview to assess levels of comprehension, satisfaction, and anxiety. Patients demonstrated a strong understanding of information regarding treatment and research. Patient comprehension did not differ significantly between the detailed document arms and the standard document arms. Patient satisfaction level increased according to the amount of information presented in the consent form; most patients preferred the detailed document with graphics. Anxiety and accrual rates in the parent study were not affected by informed consent procedures. Findings were limited to adults who had standard literacy skills and may not be generalizable to a population with lower literacy. Informed consent can be a significant experience for a population with standard literacy skills, as long as the document is easily comprehensible. Such information should be provided in a format that corresponds with patient needs, education levels, and preferences.

Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial.

PubMed

Fraval, Andrew; Chandrananth, Janan; Chong, Yew M; Coventry, Lillian S; Tran, Phong

2015-02-07

Obtaining informed consent is an essential step in the surgical pathway. Providing adequate patient education to enable informed decision making is a continued challenge of contemporary surgical practice. This study investigates whether the use of a patient information website, to augment patient education and informed consent for elective orthopaedic procedures is an effective measure. A randomised controlled trial was conducted comparing the quality of informed consent provided by a standard discussion with the treating surgeon compared to augmentation of this discussion with an online education resource (www.orthoanswer.org). Participants were recruited from orthopaedic outpatient clinics. Patients undergoing five common orthopaedic procedures were eligible to participate in the trial. The primary outcome measure was knowledge about their operation. Satisfaction with their informed consent and anxiety relating to their operation were the secondary outcome measures. There was a statistically significant increase in patient knowledge for the intervention arm as compared to the control arm (p < 0.01). Patients in the intervention arm, had an average score of 69.25% (SD 14.91) correct answers as compared to 47.38% (SD 17.77) in the control arm. Satisfaction was also improved in the intervention arm (p = 0.043). There was no statistically significant difference between the control and intervention arm relating to their anxiety scores (p = 0.195). The use of a patient education website as an augment to informed consent improves patient knowledge about their planned operation as well as satisfaction with the consent process whilst not increasing their anxiety levels. We recommend that all patients be directed to web based education tools to augment their consent. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614001058662 .

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China

PubMed Central

Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

2016-01-01

Purpose To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. Methods The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Results Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02–4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05). Conclusion The ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China. PMID:27701471

Informed Consent: Does Anyone Really Understand What Is Contained In The Medical Record?

PubMed

Fenton, S H; Manion, F; Hsieh, K; Harris, M

2015-01-01

Despite efforts to provide standard definitions of terms such as "medical record", "computer-based patient record", "electronic medical record" and "electronic health record", the terms are still used interchangeably. Initiatives like data and information governance, research biorepositories, and learning health systems require availability and reuse of data, as well as common understandings of the scope for specific purposes. Lacking widely shared definitions, utilization of the afore-mentioned terms in research informed consent documents calls to question whether all participants in the research process - patients, information technology and regulatory staff, and the investigative team - fully understand what data and information they are asking to obtain and agreeing to share. This descriptive study explored the terminology used in research informed consent documents when describing patient data and information, asking the question "Does the use of the term "medical record" in the context of a research informed consent document accurately represent the scope of the data involved?" Informed consent document templates found on 17 Institutional Review Board (IRB) websites with Clinical and Translational Science Awards (CTSA) were searched for terms that appeared to be describing the data resources to be accessed. The National Library of Medicine's (NLM) Terminology Services was searched for definitions provided by key standards groups that deposit terminologies with the NLM. The results suggest research consent documents are using outdated terms to describe patient information, health care terminology systems need to consider the context of research for use cases, and that there is significant work to be done to assure the HIPAA Omnibus Rule is applied to contemporary activities such as biorepositories and learning health systems. "Medical record", a term used extensively in research informed consent documents, is ambiguous and does not serve us well in the context of contemporary information management and governance.

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.

PubMed

Sanchini, Virginia; Reni, Michele; Calori, Giliola; Riva, Elisabetta; Reichlin, Massimo

2014-04-01

We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices

NASA Astrophysics Data System (ADS)

Klein, Eran; Ojemann, Jeffrey

2016-08-01

Objective. Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. Approach. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Main results. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Significance. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.

Informed Consent at Gunpoint: When Psychiatry Affects Gun Ownership.

PubMed

Candilis, Philip J; Khurana, Gagandeep; Leong, Gregory B; Weinstock, Robert

2015-06-01

As states take more steps to connect patients' gun ownership to their mental health, psychiatrists are being asked to provide mental health information after clinical interviews as well as after confiscation. This move into the patient-physician relationship raises new questions about how psychiatrists should obtain informed consent when interviews may result in reports to legal authorities. Consent warnings are already practiced more in the breach than in the observance and informed consent is imperfect at its best. In communities torn by controversies surrounding gun control, vehement political views will further influence these established themes to result in unprecedented pressures on patient confidentiality. This analysis draws on new movements in ethical theory and behavioral medicine that go beyond balancing principles to question the use of psychiatry in firearm reporting, and support a vigorous practice of informed consent to protect both individuals and the communities they live in. Copyright © 2015 John Wiley & Sons, Ltd.

Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices.

PubMed

Klein, Eran; Ojemann, Jeffrey

2016-08-01

Implantable brain-computer interface (BCI) research promises improvements in human health and enhancements in quality of life. Informed consent of subjects is a central tenet of this research. Rapid advances in neuroscience, and the intimate connection between functioning of the brain and conceptions of the self, make informed consent particularly challenging in BCI research. Identification of safety and research-related risks associated with BCI devices is an important step in ensuring meaningful informed consent. This paper highlights a number of BCI research risks, including safety concerns, cognitive and communicative impairments, inappropriate subject expectations, group vulnerabilities, privacy and security, and disruptions of identity. Based on identified BCI research risks, best practices are needed for understanding and incorporating BCI-related risks into informed consent protocols. Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.

An analysis of the readability of patient information and consent forms used in research studies in anaesthesia in Australia and New Zealand.

PubMed

Taylor, H E; Bramley, D E P

2012-11-01

The provision of written information is a component of the informed consent process for research participants. We conducted a readability analysis to test the hypothesis that the language used in patient information and consent forms in anaesthesia research in Australia and New Zealand does not meet the readability standards or expectations of the Good Clinical Practice Guidelines, the National Health and Medical Research Council in Australia and the Health Research Council of New Zealand. We calculated readability scores for 40 patient information and consent forms using the Simple Measure of Gobbledygook and Flesch-Kincaid formulas. The mean grade level of patient information and consent forms when using the Simple Measure of Gobbledygook and Flesch-Kincaid readability formulas was 12.9 (standard deviation of 0.8, 95% confidence interval 12.6 to 13.1) and 11.9 (standard deviation 1.1, 95% confidence interval 11.6 to 12.3), respectively. This exceeds the average literacy and comprehension of the general population in Australia and New Zealand. Complex language decreases readability and negatively impacts on the informed consent process. Care should be exercised when providing written information to research participants to ensure language and readability is appropriate for the audience.

Informed consent in otolaryngologic surgery: case scenario from a nigerian specialist hospital.

PubMed

Afolabi, O A; Fadare, J O; Ajiboye, O T

2014-01-01

Informed consent is a foundational concept necessary for ethical conduct of clinical research and practice. It is a technical tool that shifts the autonomy to decide whether a medical procedure should be performed-from the doctor to the patient. However there is an ongoing discussion in bioethical circles on the level of comprehension of the informed consent process by the patients and research participants. We present this case vignette and the discussion afterwards to explore the question of to what extent a patient comprehends the information given to him/her before a surgical procedure is carried out. In other words, the question being asked here is how informed is informed consent in the context of oto-laryngological practice.

Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial

PubMed Central

2012-01-01

Background Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. Findings In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. Conclusion The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers. PMID:22818109

Ethical and legal constraints to children's participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial.

PubMed

Bwakura-Dangarembizi, Mutsa; Musesengwa, Rosemary; Nathoo, Kusum J; Takaidza, Patrick; Mhute, Tawanda; Vhembo, Tichaona

2012-07-20

Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation. In Zimbabwe the parental informed consent document for children participating in clinical research is modeled after Western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians. The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.

The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

PubMed

Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

2015-10-01

The aim of this systematic review is to establish the best available evidence of the effectiveness of health literacy interventions on the informed consent process for health care users. The specific review question is:What is the effectiveness of health literacy interventions on health care users' informed consent to health procedures processes? Informed consent is a fundamental principal in the health care context which nowadays includes the patient's capacity to judge and to be involved in the decision making concerning their care that ensures that the care received reflects their goals, preferences and values. The importance of obtaining a valid consent before any medical procedure is well-established. In a US court case in 1914, it was stated that it is the right of any adult with the capability of making decisions concerning his own body, and that any surgical operation without the patient's consent could be considered as an assault. In another US court case, the court stated that it is a doctor's duty to make a reasonable disclosure to his patient of the nature, probable consequences and dangers of the proposed treatment to the patient. The application of the doctrine of informed consent as a legal procedure may slightly differ from country to country or from state to state, and may have different forms even within the same country. For example in the UK, consent can be written, verbal or non-verbal/implied, and a written consent form is not the actual consent itself but merely serves as evidence that consent has been given. If the elements of voluntariness, appropriate information and capacity have not been satisfied, a signed informed consent form will not make the consent valid. Nowadays it is widely accepted that prior to the application of any medical procedure, its benefits, risks and alternatives must have been explained to the patient, and the competent patient should have voluntarily and understandingly consented. Hence, the informed consent refers both to the health professional's obligation of information disclosure to the patient and to the quality of the patient's understanding and decision making. In other words, it does not refer to the single moment of the agreement, but to the whole complex process of gaining information, deciding and consenting. Several factors may restrict informed consent, including the patient's competence, provision of limited information, ineffective communication between patients and professionals, the hospital environment itself and privacy problems.According to the World Health Organization (WHO), people are increasingly urged to make choices for themselves or for their family members in regards to health care use. However, at the same time, inadequate or problematic health literacy skills have been reported in approximately half of the adult population in eight European countries. "Health literacy is linked to literacy and entails people's knowledge, motivation and competences to access, understand, appraise and apply health information in order to make judgments and take decisions in everyday life concerning health care, disease prevention and health promotion to maintain or improve quality of life during the life course". There are many instruments measuring either health literacy in general or some dimensions of health literacy (e.g. numeracy), health literacy related to specific issues (e.g. nutrition, diabetes) or health literacy of specific populations (e.g. adolescents). The diversity of existing instruments, which includes diversity in terms of scoring and ranges, makes the comparison of the results of different studies difficult. Index thresholds and ranges for different levels of health literacy for most tools were set based either on that of other well established health literacy instruments used in the same study, or on experts' assessments of the required health literacy scores. Adequate health literacy could be considered as the capacity of successfully completing most tasks required to function in the health care setting.Low or inadequate health literacy has been found to have several adverse effects on health and health care use: reduced ability to take medications properly and to interpret labels and health messages, poorer overall health status and higher risk of mortality in seniors, increased emergency department and hospital use, and decreased use of preventive interventions.Most studies examining the relationship between health literacy and informed consent conclude that patients with low health literacy are less likely to participate in decision making concerning their health care. According to a recent literature review, health care users' literacy, together with other factors, were found to be important determinants of a patient's capacity to provide fully informed consent. According to this review, 21 to 86% of the patients were able to recall the potential risks and complications of their medical procedure. This percentage may be even lower because most of the included studies referred to self-reported recall, which may be a flawed measure. According to the literature, much of the written material related to the informed consent is too difficult for health care users to understand. In addition, in their study, McCarthy et al. observed that during consultations, physicians spoke and used significantly more complex language than their patients, which may result in inappropriate communication for the patients, mainly for those with limited literacy. The situations described above may raise a number of critical legal and ethical problems. Health professionals, who shape the conditions of interactions with the patient, are responsible for adapting appropriate interventions, such as communication approaches that take into account patients' health literacy. These interventions could have a major contribution to the improvement of the informed consent process.Sheridan et al. conducted a systematic review on interventions designed to reduce the effects of limited health literacy in general. Some of the outcomes of the included studies were comprehension and behavioral intent, outcomes which could be strongly related to the informed consent process. Without making any distinction of the studies referring to the informed consent process, they conclude that several health literacy interventions, for example, adding video to narrative, could improve an individual's comprehension. Schenker et al. conducted a systematic review on the interventions to improve patient comprehension of medical and surgical procedures, including articles published until 2008. One of their conclusions was that, in most studies, while particular attention is needed for interventions provided to patients with limited literacy, the literacy of the patients was not addressed or assessed.Since then, many articles on health literacy and informed consent have been published. According to a recent review on best practices and new models of health literacy for informed consent, which includes papers published from 2004 to 2014, over half of the collected articles were published since 2010. This review, which is limited to literature within the US and its territories, and does not focus on the evaluation of the recommended practices in the literature, concludes that different tactics for simplifying written documents and clarifying verbal exchanges, and the use of multimedia formats and computerized exchanges might ameliorate constraints to health literate communications required for informed consent.Studies have evaluated the effectiveness of health literacy interventions which aim to improve the informed consent process. Improvement of the informed consent process may refer not only to the patients' comprehension but also, for example, to the recall of the information provided, to their intention to ask for clarifications, or to their satisfaction with the procedure. Interventions described and tested in the literature focus on the improvement of the print material, the process (e.g. the communication of the appropriate information) or both. Davis et al. conducted a randomized controlled trial to compare two polio vaccine pamphlets written at a sixth grade level - an international standardized pamphlet and an easy-to-read pamphlet - for the comprehension and preference among parents. Although the parents in the intervention group (N=304) achieved significantly higher comprehension than the control group (N=306) (65% vs 60%, p<0.005), the authors concluded that simplifying written material increases appeal but not the comprehension to an adequate level without use of instructional graphics. Similarly, Lorenzen et al. found that a reader friendly informed consent document to surgical procedures was more commonly read by the health care users as compared to the original consent document; however, no difference was found in terms of the participants' capacity to describe the procedure in their own words. Kang et al. evaluated recall and comprehension of orthodontic informed consent among pairs of children and their parents (N=90) applying three different informed consent procedures. According to this study, a combination of improving the readability of consent materials and the informed consent process (audio and visual cues) led to better recall for the patients and better recall and comprehension for their parents compared to an improved readability form or the usual informed consent form. Smith et al. used a randomized controlled trial to compare a decision aid (booklet and DVD) specifically designed for adults with low literacy skills (N=357) with a standard information booklet (N=173) on screening for bowel cancer. They found that the proportion of participants making an informed choice was 22% higher in the intervention group than in the control group (34% vs 12%, P<0.001). Matsuyama et al. (ABSTRACT TRUNCATED)

Informed consent and nudging.

PubMed

Simkulet, William

2018-06-19

In order to avoid patient abuse, under normal situations before performing a medical intervention on a patient, a physician must obtain informed consent from that patient, where to give genuine informed consent a patient must be competent, understand her condition, her options and their expected risks and benefits, and must expressly consent to one of those options. However, many patients refrain from the option that their physician believes to be best, and many physicians worry that their patients make irrational healthcare decisions, hindering their ability to provide efficient healthcare for their patients. Some philosophers have proposed a solution to this problem: they advocate that physicians nudge their patients to steer them towards their physician's preferred option. A nudge is any influence designed to predictably alter a person's behavior without limiting their options or giving them reasons to act. Proponents of nudging contend that nudges are consistent with obtaining informed consent. Here I argue that nudging is incompatible with genuine informed consent, as it violates a physician's obligation to tell their patients the truth, the whole truth, and nothing but the truth during adequate disclosure. © 2018 John Wiley & Sons Ltd.

No Understanding, No Consent: The Case Against Alternative Medicine.

PubMed

Shahvisi, Arianne

2016-02-01

The demand for informed consent in clinical medicine is usually justified on the basis that it promotes patient autonomy. In this article I argue that the most effective way to promote autonomy is to improve patient understanding in order to reduce the epistemic disparity between patient and medical professional. Informed consent therefore derives its moral value from its capacity to reduce inequalities of power as they derive from epistemic inequalities. So in order for a patient to have given informed consent, she must understand the treatment. I take this to mean that she has sufficient knowledge of its causal mechanisms and has accepted the explanations in which the treatment is implicated. If this interpretation of informed consent is correct, it is unethical for medical professionals to offer or endorse 'alternative medicine' treatments, for which there is no known causal mechanism, for if they do, they may end up widening the epistemic disparity. In this way, informed consent may be understood as an effective way of ruling out particular treatments in order to improve patient autonomy and maintain trust in the medical profession. © 2016 John Wiley & Sons Ltd.

Informed consent: Part II.

PubMed

Murphy, E K

1988-05-01

Although the legal responsibility to inform and obtain the patient's consent lies with the surgeon, the agency may have a duty to ensure that the patient's consent has been obtained. Agency liability is limited to those cases in which the agency knew (or should have known) that informed consent was not obtained. It is still unclear whether agencies have an affirmative duty to ensure that consent has been obtained. If this duty does exist, it appears that a policy requiring documentation in the medical record of the patient's consent meets this requirement. It is clear that whatever the extent of the agency's duty, it does not include the duty to give the patient information or assess his or her level of understanding. Court opinions discourage anyone but the physician from doing so. A nurse's legal responsibility is limited to following agency policy. Courts have not recognized any independent nurse duty beyond that which accrues to them as employees of the agency. Perioperative nurses often provide the final checkpoint that consent has been obtained and documented before the procedure begins. This unique position raises additional legal concerns if the agency's policy is not followed or if the premedicated patient arrives without proper consent documentation in the record. Perioperative nursing concerns will be discussed next month in Part III.

Can informed consent to research be adapted to risk?

PubMed

Bromwich, Danielle; Rid, Annette

2015-07-01

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the concern that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorisation. In this paper, we show how the standard view of informed consent--consent as autonomous authorisation--can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

From informed consent to dissemination: Using participatory visual methods with young people with long-term conditions at different stages of research.

PubMed

Vindrola-Padros, Cecilia; Martins, Ana; Coyne, Imelda; Bryan, Gemma; Gibson, Faith

2016-01-01

Research with young people suffering from a long-term illness has more recently incorporated the use of visual methods to foster engagement of research participants from a wide age range, capture the longitudinal and complex factors involved in young people's experiences of care, and allow young people to express their views in multiple ways. Despite its contributions, these methods are not always easy to implement and there is a possibility that they might not generate the results or engagement initially anticipated by researchers. We hope to expand on the emerging discussion on the use of participatory visual methods by presenting the practical issues we have faced while using this methodology during different stages of research: informed assent/consent, data collection, and the dissemination of findings. We propose a combination of techniques to make sure that the research design is flexible enough to allow research participants to shape the research process according to their needs and interests.

Gaining informed consent for blood transfusion.

PubMed

Whitmore, Emma; Gerrard, Rebecca; Coffey, Kairen

Transfusion of blood and blood products is a common procedure that has significant benefits but is also associated with serious risks. Patients needing blood transfusion require full information on these benefits and risks in order to make informed consent. This article, the first in a five-part series, discusses the process of gaining consent and resources available to support patients and health professionals in this.

Meaningful Informed Consent with Young Children: Looking Forward through an Interactive Narrative Approach

ERIC Educational Resources Information Center

Mayne, Fiona; Howitt, Christine; Rennie, Léonie

2016-01-01

Ideas about ethical research with young children are evolving at a rapid rate. Not only can young children participate in the informed consent process, but researchers now also recognize that the process must be meaningful for them. As part of a larger study, this article reviews children's rights and informed consent literature as the foundation…

Sub-orbital commercial human spaceflight and informed consent.

PubMed

Carminati, Maria-Vittoria; Griffith, Doug; Campbell, Mark R

2011-02-01

Commercial spaceflight is expected to rapidly develop in the near future. This will begin with sub-orbital missions and then progress to orbital flights. Technical informed consent of spaceflight participants is required by the commercial spaceflight operator for regulatory purposes. Additionally, though not required by regulation, the aerospace medicine professional involved in the medical screening of both spaceflight participants and crewmembers will be asked to assist operators in obtaining medical informed consent for liability purposes. The various federal and state regulations regarding informed consent for sub-orbital commercial spaceflight are evolving and are unfamiliar to most aerospace medical professionals and are reviewed and discussed.

Should the chiropractic profession embrace the doctrine of informed consent?

PubMed Central

Lehman, James J.; Conwell, Timothy D.; Sherman, Paul R.

2008-01-01

Abstract This commentary provides a narrative review of the literature focusing on the use of a health care informed consent process in the United States. This article reviews the current positions of the World Medical Association, American Medical Association, American Chiropractic Association, Wisconsin and New Jersey State Courts, US Federal Government Office of Health Policy and Clinical Outcomes, and 1 college of chiropractic regarding the doctrine of informed consent. The authors recommend that the chiropractic profession embrace the doctrine of informed consent and promulgate it as a standard of care. The implementation of this doctrine by chiropractic physicians promotes and improves the safety of chiropractic interventions. PMID:19646372

Surgeons' Silence: A History of Informed Consent in Orthopaedics

PubMed Central

Jones, Kevin B

2007-01-01

The moment of decision to proceed with surgical intervention is charged with some of the deepest uncertainties in medicine, but has long been cloaked under the confidence asserted by the traditionally custodial surgeon. This paper reviews the history and ethical basis for informed surgical consent. Beginning with theoretical foundations and the changing ethics of medical decision making since the ancient Greeks, it then reviews how the stage was set for informed consent by technological breakthroughs that made surgical interventions tolerable and acceptably safe. Finally, the legal generation of the doctrine of informed consent is reviewed and the current state of disclosure, shared decision-making, and uncertainty explored. PMID:17907443

Local Media Influence on Opting-Out from an Exception from Informed Consent Trial

PubMed Central

Nelson, Maria J; DeIorio, Nicole M; MD, Terri Schmidt; Griffiths, Denise; Daya, Mohamud; Haywood, Liana; Zive, Dana; Newgard, Craig D

2010-01-01

Objectives News media are used for community education and notification in exception from informed consent clinical trials, yet their effectiveness as an added safeguard in such research remains unknown. We assessed the number of callers requesting opt-out bracelets following each local media report and described the errors and content within each media report. Methods We undertook a descriptive analysis of local media trial coverage (newspaper, television, radio, and weblog) and opt-out requests over a 41-month period at a single site participating in an exception from informed consent out-of-hospital trial. Two non-trial investigators independently assessed forty-one content-based media variables (including background, trial information, graphics, errors, publication information, assessment) using a standardized, semi-qualitative data collection tool. Major errors were considered serious misrepresentation of the trial purpose or protocol, whereas minor errors included misinformation unlikely to mislead the lay reader about the trial. We plotted the temporal relationship between opt-out bracelet requests and media reports. Descriptive information about the news sources and the trial coverage are presented. Results We collected 39 trial-related media reports (33 newspaper, 1 television, 1 radio, and 4 blogs). There were thirteen errors in 9 (23%) publications, 7 of which were major and 6 minor. Of 384 requests for 710 bracelets, 310 requests (80%) occurred within 4 days after trial media coverage. Graphical timeline representation of the data suggested a close association between media reports about the trial and requests for opt-out bracelets. Conclusions Based on results from a single site, local media coverage for an exception from informed consent clinical trial had a substantial portion of errors and appeared closely associated with opt-out requests. PMID:19682770

Informed consent: it is more than just a document.

PubMed

Wilhite, C Leigh

2010-01-01

With litigation in the forefront of the minds of most healthcare professionals today, obtaining valid, fully informed consent from patients means that no recovery should be allowed in a court of law against that provider for treating, examining, or operating on a patient without his or her informed consent when (1) the action of the provider in obtaining the consent of the patient, or person authorized to give consent, was in accordance with an accepted standard of practice and/or (2) a reasonable individual with information provided by the practitioner, under the circumstances, would have a general understanding of the procedure, the medically acceptable alternative procedures or treatments, and the substantial risks and hazards inherent in the proposed treatment or procedures, which are recognized among providers, in the same or similar community, who perform similar treatments. Most courts do not permit recovery against a provider if the patient would reasonably, under all the surrounding circumstances, have undergone such treatment or procedure as he or she had been advised by the provider. A consent that is evidenced in writing and meets requirements, if validly signed by the patient or another authorized person, raises a rebuttable presumption of a valid consent. A valid signature is the one that is given by a person who under all the surrounding circumstances is mentally and physically competent to give consent. Armed with this knowledge, the plastic surgical nurse will understand that informed consent is far more than just a document signed by the patient that becomes part of his or her medical record.

"I didn't have anything to decide, I wanted to help my kids" - An interview-based study of consent procedures for sampling human biological material for genetic research in rural Pakistan.

PubMed

Kongsholm, Nana Cecilie Halmsted; Lassen, Jesper; Sandøe, Peter

2018-05-03

Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values underlying informed consent. Over a two-week period in April 2014 we conducted semi-structured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute's requirements for consent, and the researchers' strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors' accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. We argue that while building and maintaining trusting relationships in research is important - not least in developing countries - strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out.

Efficacy of a Procedure-Specific Education Module on Informed Consent in Plastic Surgery.

PubMed

Brandel, Michael G; Reid, Christopher M; Parmeshwar, Nisha; Dobke, Marek K; Gosman, Amanda A

2017-05-01

Truly informed consent is an elusive goal, seldom attained in medical or surgical practice. Patients often do not fully understand procedures and therapies they undergo or the associated sequelae. Historically, informed consent and patient education have been limited to physician discussions, sometimes with the addition of simple visual aids. More recently, there is a growing body of decision aids available, including interactive multimedia patient educational modules that review preoperative through postoperative care, risks, benefits, alternatives, different surgical options, as well as commonly asked questions. We hypothesized that the addition of a Web-based educational tool would positively impact attainment of informed consent and satisfaction in plastic surgery patients. We performed a prospective randomized controlled study comparing patients who presented in consultation for breast reconstruction, breast reduction, and abdominoplasty. Patients received standard patient education along with a procedure-specific (study) or general patient safety (control) Web-based educational module. Informed consent was measured using a surgical-focused, modified version of the Shared Decision-making 25 index tool. Patient demographic information as well as surrogate markers of familiarity with technology were recorded preoperatively and postoperatively. Comparisons were made between study and control groups, procedure subgroups, and preoperative and postoperative time points. Demographic factors and consent variables were compared among experimental and procedure groups. Data were collected from 65 patients preoperatively and 48 patients postoperatively. Thirty patients competed both surveys. Overall, no differences in patient characteristics or familiarity with technology were observed between experimental groups. Demographic characteristics were also similar between groups. No meaningful differences were identified in comparisons between experimental groups on either cross-sectional or longitudinal analyses. Nearly all patient responses were consistent with being well informed and satisfied with the educational process. Overall, patients undergoing plastic surgery procedures are adequately informed and have a high degree of satisfaction regarding their patient education. The addition of a Web-based informed consent tool did not make a demonstrable difference in informed consent.

Reading Level and Comprehension of Research Consent Forms: An Integrative Review.

PubMed

Foe, Gabriella; Larson, Elaine L

2016-02-01

Consent forms continue to be at a higher reading level than the recommended sixth to eighth grade, making it difficult for participants to comprehend information before enrolling in research. To assess and address the extent of the problem regarding the level of literacy of consent forms and update previously published reports, we conducted an integrative literature review of English language research published between January 1, 2000, and December 31, 2013; 35 descriptive and eight intervention studies met inclusion criteria. Results confirmed that developing forms at eighth-grade level was attainable though not practiced. It was found that risks of participation was the section most poorly understood. There was also a lack of consensus regarding the most effective method to increase comprehension. Further research using standardized tools is needed to determine the best approach for improving consent forms and processes. © The Author(s) 2016.

Informed consent in the context of pharmacogenomic research: ethical considerations.

PubMed

Howard, H C; Joly, Y; Avard, D; Laplante, N; Phillips, M; Tardif, J C

2011-06-01

Although the scientific research surrounding pharmacogenomics (PGx) has been relatively plentiful, the ethical research concerning this discipline has developed rather conservatively. Following investigation of the ethical, legal and social issues (ELSI) of PGx research, as well as consulting with key stakeholders, we identified six outstanding ethical issues raised by the informed consent process in PGx research: (1) scope of consent; (2) consent to 'add-on' studies; (3) protection of personal information; (4) commercialization; (5) data sharing; and (6) potential risks stemming from population-based research. In discussing these six areas as well as offering specific considerations, this article offers a solid base from which future practical guidelines for informed consent in PGx research can be constructed. As such, this effort works toward filling the ELSI gap and provides ethical support to the numerous PGx projects undertaken by researchers every year.

Legal protection of informed consent of minors.

PubMed

Osuna, Eduardo

2010-06-01

One of the pillars of healthcare provision is respect for the autonomy of the patient's wishes, which is given substance by the process of obtaining informed consent. Minors deserve special protection, entitled to basic rights and increasingly autonomous as they develop. In certain situations, minors are deemed matures and able to consent to treatment without the involvement of a parent or guardian. The assessment of competence would be based on the child's functional ability, not on age or outcome of the decision. This manuscript includes a brief analysis of legal perspectives on informed consent of minors, and minors' capacities to make medical decisions. Remaining questions of how to evaluate capacity and balance parental and minor autonomy are explored. Considerations on informed consent in different situations as refusing treatment and termination of pregnancy by female children are analyzed.

Effects of depression and social support on comprehension and recall of informed consent information among Parkinson disease patients and their caregivers.

PubMed

Teng, Ellen J; Petersen, Nancy J; Hartman, Christine; Matthiesen, Ellen; Kallen, Michael; Cook, Karon F; Ford, Marvella E

2012-01-01

Relatively little attention has focused on the impact of psychiatric conditions on human subjects' comprehension of consent information. The purpose of this randomized study was to determine whether depression affects comprehension and recall of informed consent information among persons with Parkinson's disease and their caregivers and to evaluate the effects of support on comprehension and recall during the consent process. Comprehension and recall of information were assessed using a modified version of the Modified Quality of Informed Consent Questionnaire, taken 1 week and 1 month later, and scored using a consensus-based algorithm. Participants also completed the Center for Epidemiologic Studies Depression Scale. Data analyses were conducted on 129 patients and caregivers (t-tests, Fisher's exact tests, and ANCOVAs). T-tests showed no significant differences in comprehension and recall between depressed and nondepressed participants at 1 week and 1 month. However, ANCOVA showed patients with a support person present had significantly higher comprehension and recall at 1 week but not at 1 month compared with controls. Caregivers present with a patient had lower comprehension/recall than those without a patient present (p = 0.02). Having a support person present during the informed consent process helps depressed PD patients better retain information in the short-term, but effects diminish over the long-term. Implications for interventions will be discussed.

Building the Partners HealthCare Biobank at Partners Personalized Medicine: Informed Consent, Return of Research Results, Recruitment Lessons and Operational Considerations

PubMed Central

Karlson, Elizabeth W.; Boutin, Natalie T.; Hoffnagle, Alison G.; Allen, Nicole L.

2016-01-01

The Partners HealthCare Biobank is a Partners HealthCare enterprise-wide initiative whose goal is to provide a foundation for the next generation of translational research studies of genotype, environment, gene-environment interaction, biomarker and family history associations with disease phenotypes. The Biobank has leveraged in-person and electronic recruitment methods to enroll >30,000 subjects as of October 2015 at two academic medical centers in Partners HealthCare since launching in 2010. Through a close collaboration with the Partners Human Research Committee, the Biobank has developed a comprehensive informed consent process that addresses key patient concerns, including privacy and the return of research results. Lessons learned include the need for careful consideration of ethical issues, attention to the educational content of electronic media, the importance of patient authentication in electronic informed consent, the need for highly secure IT infrastructure and management of communications and the importance of flexible recruitment modalities and processes dependent on the clinical setting for recruitment. PMID:26784234

CTEPP STANDARD OPERATING PROCEDURE FOR OBTAINING INFORMED CONSENT (SOP-1.13)

EPA Science Inventory

The CTEPP informed consent procedures are described in the SOP. After an eligible subject provides verbal consent, staff schedule a visit to meet with the subject in person to explain study activities and answer questions about the study. During the visit, staff demonstrate how...

75 FR 33892 - Proposed Collection; Comment Request For Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-15

... request the consent of the Commissioner to change their methods of accounting for the capitalization of... number. Books or records relating to a collection of information must be retained as long as their... information is necessary for the proper performance of the functions of the agency, including whether the...

78 FR 40549 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-05

... request the consent of the Commissioner to change their methods of accounting for the capitalization of... number. Books or records relating to a collection of information must be retained as long as their... information is necessary for the proper performance of the functions of the agency, including whether the...

National Comparative Audit of Blood Transfusion: report on the 2014 audit of patient information and consent.

PubMed

Booth, C; Grant-Casey, J; Lowe, D; Court, E L; Allard, S

2017-11-28

The aim of this study was to assess current practices around obtaining consent for blood transfusion and provision of patient information in hospitals across the UK and identify areas for improvement. Recommendations from the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) (2011) state that valid consent should be obtained for blood transfusion and documented in clinical records. A standardised source of information should be available to patients. Practices in relation to this have historically been inconsistent. The consent process was studied in hospitals across the UK over a 3-month period in 2014 by means of an audit of case notes and simultaneous surveys of patients and staff. In total, 2784 transfusion episodes were reviewed across 164 hospital sites. 85% of sites had a policy on consent for transfusion. Consent was documented in 43% of case notes. 68% of patients recalled being given information on benefits of transfusion, 38% on risks and 8% on alternatives and 28% reported receiving an information leaflet. In total, 85% of staff stated they had explained the reason for transfusion, but only 65% had documented this. 41% of staff had received training specifically on transfusion consent in the last 2 years. There is a need to improve clinical practice in obtaining valid consent for transfusion in line with existing national guidelines and local Trust policies, with emphasis on documentation within clinical records. Provision of patient information is an area particularly highlighted for action, and transfusion training for clinicians should be strengthened. © 2017 British Blood Transfusion Society.

Informed consent in psychotherapy.

PubMed

Beahrs, J O; Gutheil, T G

2001-01-01

The authors sought a rational approach to implementing informed consent within the practice of psychotherapy. The history of informed consent in psychotherapy was reviewed to define a common synthesis that maximizes the potential benefits and minimizes the potential hazards. The benefits of informed consent in psychotherapy include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgments. The hazards include the unpredictability of interactional outcomes and the possibilities of replacing positive expectancy with negative suggestion, replacing a therapeutic alliance with a legalistic stance, and misimplying that patients are passive recipients. Practical implementation of informed consent in psychotherapy must balance such tensions in service of optimal treatment. As a guiding principle, the authors recommend that psychotherapists convey to a prospective patient information that is material to the particular patient's decision. The level of detail needed in informed consent discussions varies directly with the cost and risks of the proposed treatment, the presence of viable alternatives and their relative grounding in scientific data and professional acceptance, and the presence of significant controversy. Unresolved is the question of how to address problematic or controversial psychotherapeutic trends that temporarily enjoy wide professional support.

Disclosure of information and informed consent: ethical and practical considerations.

PubMed

Steinberg, Avraham

2009-12-01

Disclosure of information and informed consent are relatively new concepts in the patient-physician relationship. They are based primarily on the principle of autonomy and they have many favorable practical advantages. However, the practical implementation of these requirements is fraught with difficulties, some of which can cause harm to the patient or be obstacles in fulfilling the moral obligation of beneficence. This is particularly true when disclosure of information and informed consent are done by physicians in a defensive way for fear of malpractice suits. The most ethically defensible approach is to tailor and navigate the information according to the needs and desires of each individual patient in a sensitive and empathic manner. The informed consent should be a process of mutually shared responsibility by the patient and the physician, ensuring adequate and relevant information that is well comprehended by the individual patient, and is used correctly for his or her decision making.

Seeking consent to genetic and genomic research in a rural Ghanaian setting: A qualitative study of the MalariaGEN experience

PubMed Central

2012-01-01

Background Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study. Methods The study used a rapid assessment incorporating multiple qualitative methods including in depth interviews, focus group discussions and observations of consent processes. Differences between verbal information provided during community engagement processes, and consent processes during the enrolment of cases and controls were identified, as well as the factors influencing the tailoring of such information. Results MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria. Some genetic aspects of the study were also well understood. Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research. Moreover, trust in and previous experience with the Navrongo Health Research Centre which was conducting the research influenced beliefs about the benefits of participating in the MalariaGEN study and subsequent decision-making about research participation. Conclusions It is important to recognise that some aspects of complex genomic research may be of less interest to and less well understood by research participants and that such gaps in understanding may not be entirely addressed by best practice in the design and conduct of consent processes. In such circumstances consideration needs to be given to additional protections for participants that may need to be implemented in such research, and how best to provide such protections. Capacity building for research ethics committees with limited familiarity with genetic and genomic research, and appropriate engagement with communities to elicit opinions of the ethical issues arising and acceptability of downstream uses of genome wide association data are likely to be important. PMID:22747883

Ethical review and informed consent in cardiovascular research reports in Argentina.

PubMed

Borracci, Raúl A; Calderón, Gustavo; Seoane, Martín R; Perez, Analía C; Doval, Hernán C

2008-05-01

Requirements for Institutional Review Board approval and informed consent for research involving human subjects have existed for more than 2 decades. However, evidence of fulfillment of these requirements is sometimes lacking in cardiovascular research reports in Argentina. Since ethical standards vary between committees, there may be some confusion among researchers regarding the need for an ethical review when conducting low risk research. To examine the frequency of obtaining an ethical review and informed consent in cardiovascular research in Argentina. Through a questionnaire, we contacted authors of 100 reports submitted to our annual scientific meeting during 2006. Thirty six per cent of questionnaires were resubmitted with confirmation of ethical review, 34% responded that ethical review was not obtained, 23% reported as being exempt and 7% were never resubmitted. Most articles obtaining ethical review were pharmacological trials or research involving assessment of new devices. On the other hand, most articles reporting lack of or exemption from ethical review come from epidemiological research or studies evaluating non-invasive methods. Sixty percent of phase IV pharmacological trials, research on cellular implantation or assessment of new devices met federal regulations requirements. The rate of ethical review and use of informed consent in cardiovascular reports in Argentina vary among articles. Most research involving prospective observational studies and nearly 50% of protocols including intervention or invasive procedures do not report ethical review. This high proportion of articles lacking ethical review suggests the presence of legal and ethical flaws which should be discussed and overcome.

The Importance of Purpose: Moving beyond Consent in the Societal Use of Personal Health Information

PubMed Central

Grande, David; Mitra, Nandita; Shah, Anand; Wan, Fei; Asch, David A.

2015-01-01

Background Adoption of electronic health record systems has increased the availability of patient-level electronic health information. Objective Examine public support for secondary uses of electronic health information under different consent arrangements. Design National experimental survey to examine perceptions of uses of electronic health information when varying along three dimensions: patient consent (obtained vs. not obtained), use (research vs. marketing), and framing of the findings (abstract description without results vs. specific results). Setting Nationally representative survey. Participants 3,064 African American, Hispanic, and non-Hispanic White individuals representing a response rate of 65%. Measurements Appropriateness of health information use described in vignettes on a 1-10 scale (1=not at all appropriate; 10=very appropriate). Results Mean ratings ranged from a low of 3.81 for a marketing use when consent was not obtained and specific results were presented to a high of 7.06 for a research use when consent was obtained and specific results were presented. Participants rated scenarios where consent was obtained as more appropriate compared to when consent was not obtained (+1.01; 95% CI 0.69, 1.34, P<0.001). Participants rated scenarios where the use was marketing as less appropriate compared to when the use was research (−2.03; 95% CI −2.27, −1.78, P<0.001). Unconsented research uses were seen as more appropriate than consented marketing uses (5.65 vs. 4.52; difference = 1.13; 95% CI 0.87, 1.39).. Limitations Participants rated hypothetical scenarios and results could be vulnerable to non-response bias despite the high response rate. Conclusions Although approaches to health information sharing emphasize consent, public opinion also emphasizes purpose suggesting a need to focus more attention on the social value of information use. Primary Funding Source National Human Genome Research Institute PMID:25506854

Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico.

PubMed

Verástegui, Emma L

2006-12-13

A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. To gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8th grade. The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients.

"Negotiorum Gestio" in Family Medicine, Informed Consent Obtainment, and Disciplinary Responsibility.

PubMed

Birkeland, Søren

2016-01-01

Introduction. Negotiorum gestio (NG) denotes an action where a person well intendedly acts on behalf of another without obtaining the latter's prior consent. In broad terms, NG-like actions have played a considerable role in health care provision. In some settings, health care delivery with only little or presumed patients' consent has been the rule rather than the exception. However, bioethical principles regarding patient autonomy and obtainment of the patient's informed consent (IC) before intervention are now increasingly materialized in the law of many countries. Aim. To study legal consequences of NG in family medicine and IC handling options. Methods. Case law examination. Results. A disciplinary board case is described concerning a family doctor conducting unlawful NG by not coming up to legal IC requirements. Discussion and Conclusion. The practical and legal implications of IC and possible role of novel Shared Decision-Making approaches in coming up to regulation and bioethical demands are discussed. It is concluded that a doctor may run an unnecessary legal risk when conducting NG in decision-competent patients and furthermore it is suggested that novel Shared Decision-Making approaches could help in obtaining a rightful and practicable IC.

Informed consent in surgical trials.

PubMed

Etchells, E

1999-12-01

All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

The myth of informed consent: in daily practice and in clinical trials.

PubMed

Silverman, W A

1989-03-01

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests.

The effect of informed consent on stress levels associated with extraction of impacted mandibular third molars.

PubMed

Casap, Nardy; Alterman, Michael; Sharon, Guy; Samuni, Yuval

2008-05-01

To evaluate the effect of informed consent on stress levels associated with removal of impacted mandibular third molars. A total of 60 patients scheduled for extraction of impacted mandibular third molars participated in this study. The patients were unaware of the study's objectives. Data from 20 patients established the baseline levels of electrodermal activity (EDA). The remaining 40 patients were randomly assigned into 2 equal groups receiving either a detailed document of informed consent, disclosing the possible risks involved with the surgery, or a simplified version. Pulse, blood pressure, and EDA were monitored before, during, and after completion of the consent document. Changes in EDA, but not in blood pressure, were measured on completion of either version of the consent document. A greater increase in EDA was associated with the detailed version of the consent document (P = .004). A similar concomitant increase (although nonsignificant) in pulse values was monitored on completion of both versions. Completion of overdisclosed document of informed consent is associated with changes in physiological parameters. The results suggest that overdetailed listing and disclosure before extraction of impacted mandibular third molars can increase patient stress.

Ethical issues in bipolar disorders pedigree research: privacy concerns, informed consent, and grounds for waiver.

PubMed

Parker, Lisa S

2002-02-01

Focusing on bipolar disorders research, this article considers ethical issues of informed consent and privacy arising in genetic pedigree research at two stages: the construction of tentative pedigrees to determine family eligibility for study and, subsequently, the enrollment of subjects in and conduct of the family study. Increasing concern to protect the privacy of family members of primary subjects or probands, following ethical controversy over a survey study at Virginia Commonwealth University, has led some researchers and Institutional Review Boards (IRBs) to apply informed consent requirements to those represented on a tentative pedigree at the initial stage of research. This article analyzes the possible benefits, risks, and burdens to prospective subjects of seeking prospective consent for pedigree construction at this initial stage. It argues that the likely risk-benefit ratio favors granting a waiver of consent requirements for this stage of pedigree research and presents grounds for IRBs to grant such a waiver. The article closes by considering particular ethical concerns that should be addressed in the informed consent discussion when enrolling subjects in pedigree studies of bipolar disorder, including concerns about subjects' competence to consent, management of interim and incidental findings, and issues particular to psychiatric research.

[Knowledge and willingness to participate in research: a descriptive study of volunteers in a clinical trial].

PubMed

Lobato, Lucas; Gazzinelli, Maria Flávia; Gazzinelli, Andréa; Soares, Amanda Nathale

2014-06-01

The aim of this study was to evaluate volunteers' knowledge of the information on the free informed consent form and their willingness to participate in a clinical trial. This was a quantitative, descriptive, cross-sectional study conducted in November 2011 with subjects from a clinical trial in Americaninhas, northeast Minas Gerais State, Brazil. A convenience sample included 143 adults of both sexes, 18 to 45 years of age. A structured questionnaire was applied one week after signing the free informed consent form. Most participants signed the free informed consent without sufficient knowledge of the research information and were influenced in their decision to participate in the trial. The authors conclude that signing the free informed consent form fails to express all participants' autonomy in clinical trials.

Ethical Issues Regarding Informed Consent for Minors for Space Tourism

NASA Astrophysics Data System (ADS)

Marsh, Melvin S.

2010-01-01

This paper describes the difficulty with informed consent and debates whether or not whether adults should be able to ethically, morally, and legally consent for their children during the high-risk activity of space tourism. The experimental nature of space vehicles combined with the high likelihood of medical complications and the destination places space tourism legally in the category of "adventure activities," which include adventure travel to exotic locations as well as adventure sports, such as mountain climbing, rafting, etc. which carry a high risk of danger (http://rescommunis.wordpress.com/2008/02/14/interview-tracey-l-knutson-adventure-sports-defense-attorney-on-space-tourism-risk-and-informed-consente/). However, unlike other adventure sports, adults currently cannot consent for their minor children. Other topics also receive attention, such as a "mature minors" clause, radiation exposure of potential future children, and other difficulties preventing adults from legally consenting to space travel.

Surgeons' opinions and practice of informed consent in Nigeria.

PubMed

Ogundiran, Temidayo O; Adebamowo, Clement A

2010-12-01

Informed consent is perhaps more relevant to surgical specialties than to other clinical disciplines. Fundamental to this concept is the provision of relevant information for the patient to make an informed choice about a surgical intervention. The opinions of surgeons in Nigeria about informed consent in their practice were surveyed. A cross-sectional survey of surgeons in Nigeria was undertaken in 2004/5 using self-administered semistructured questionnaires. There were 102 respondents, 85.3% of whom were men and 58.8% were aged 31-40 years. 43.1% were consultants and 54.0% were surgical trainees. 27.4% were in surgical subspecialties, 26.5% in general surgery and 21.6% were obstetricians and gynaecologists. 54.9% agreed that sufficient information is not provided to patients while obtaining their consent for surgical procedures. They listed medicolegal reasons (70.6%), informing patients about benefits, risks and alternatives (64.7%) and hospital policy (50.0%) as some reasons for obtaining consent for surgical procedures. When patients decline to give consent for surgery, 84.3% of them thought that poor communication between surgeons and patients may be contributory. They identified taking a course in bioethics during surgical training and compulsory communication skills course as some ways to improve communication between surgeons and patients. Most Nigerian surgeons seemed to have a good knowledge of the informed consent requirements and process but fall short in practice. There is a need to improve the surgeon-patient relationship in line with modern exigencies to provide interactive environments for fruitful patient communication and involvement.

Research subject privacy protection in otolaryngology.

PubMed

Noone, Michael C; Walters, K Christian; Gillespie, M Boyd

2004-03-01

Health Insurance Portability and Accountability Act regulations, which took effect on April 14, 2003, placed new constraints on the use of protected health information for research purposes. To review practices of research subject privacy protection in otolaryngology in order to determine steps necessary to achieve compliance with Health Insurance Portability and Accountability Act regulations. Literature review. Articles appearing in 2001 in 3 widely circulated otolaryngology journals were classified according to study design. The "Methods" section of each article was reviewed to determine whether the informed consent and institutional review board processes were clearly documented. Descriptive studies involving case reports and case series were more common than observational studies that include a control group (66% vs 11%). Few case series documented the consent process (18%) and institutional review board process (19%). Observational designs demonstrated better documentation of the consent process (P<.001) and the institutional review board exemption and approval process (P<.001). Methods used to protect subject privacy are not commonly documented in case series in otolaryngology. More attention needs to be given to research subject privacy concerns in the otolaryngology literature in order to comply with Health Insurance Portability and Accountability Act regulations.

Informed Consent for Research in a Nursing Home: Processes and Issues.

ERIC Educational Resources Information Center

Cohen-Mansfield, Jiska; And Others

1988-01-01

Examined difficulty of obtaining valid informed consent from participants in research with older persons. Of 470 nursing home residents asked to participate in nonrisk study, 406 agreed. High consent rate was attributed to perception of research significance, presentation format, and absence of risk or pain. (Author/NB)

Informed consent: not just for procedures anymore.

PubMed

Feld, Andrew D

2004-06-01

The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.

Attitude towards informed consent practice in a developing country: a community-based assessment of the role of educational status.

PubMed

Agu, Kenneth Amaechi; Obi, Emmanuel Ikechukwu; Eze, Boniface Ikenna; Okenwa, Wilfred Okwudili

2014-10-22

It has been reported by some studies that the desire to be involved in decisions concerning one's healthcare especially with regard to obtaining informed consent is related to educational status. The purpose of this study, therefore, is to assess the influence of educational status on attitude towards informed consent practice in three south-eastern Nigerian communities. Responses from consenting adult participants from three randomly selected communities in Enugu State, southeast Nigeria were obtained using self-/interviewer-administered questionnaire. There were 2545 respondents (1508 males and 1037 females) with an age range of 18 to 65 years. More than 70% were aged 40 years and below and 28.4% were married. More than 70% of the respondents irrespective of educational status will not leave all decisions about their healthcare to the doctor. A lower proportion of those with no formal education (18.5%) will leave this entire decision-making process in the hands of the doctor compared to those with tertiary education (21.9%). On being informed of all that could go wrong with a procedure, 61.5% of those with no formal education would consider the doctor unsafe and incompetent while 64.2% of those with tertiary education would feel confident about the doctor. More than 85% of those with tertiary education would prefer consent to be obtained by the doctor who will carry out the procedure as against 33.8% of those with no formal education. Approximately 70% of those who had tertiary education indicated that informed consent was necessary for procedures on children, while the greater number of those with primary (64.4%) and no formal education (76.4%) indicated that informed consent was not necessary for procedures on children. Inability to understand the information was the most frequent specific response among those without formal education on why they would leave all the decisions to the doctor. The study showed that knowledge of the informed consent practice increased with level of educational attainment but most of the participants irrespective of educational status would want to be involved in decisions about their healthcare. This knowledge will be helpful to healthcare providers in obtaining informed consent.

Surgical Planning and Informed Consent

ClinicalTrials.gov

2018-04-11

Communication; Feedback, Psychological; Health Knowledge, Attitudes, Practice; Humans; Informed Consent; Neurosurgery; Patient Compliance; Patient-Centered Care; Physician-Patient Relations; User-Computer Interface

Adult Spinal Deformity Patients Recall Fewer Than 50% of the Risks Discussed in the Informed Consent Process Preoperatively and the Recall Rate Worsens Significantly in the Postoperative Period.

PubMed

Saigal, Rajiv; Clark, Aaron J; Scheer, Justin K; Smith, Justin S; Bess, Shay; Mummaneni, Praveen V; McCarthy, Ian M; Hart, Robert A; Kebaish, Khaled M; Klineberg, Eric O; Deviren, Vedat; Schwab, Frank; Shaffrey, Christopher I; Ames, Christopher P

2015-07-15

Recall of the informed consent process in patients undergoing adult spinal deformity surgery and their family members was investigated prospectively. To quantify the percentage recall of the most common complications discussed during the informed consent process in adult spinal deformity surgery, assess for differences between patients and family members, and correlate with mental status. Given high rates of complications in adult spinal deformity surgery, it is critical to shared decision making that patients are adequately informed about risks and are able to recall preoperative discussion of possible complications to mitigate medical legal risk. Patients undergoing adult spinal deformity surgery underwent an augmented informed consent process involving both verbal and video explanations. Recall of the 11 most common complications was scored. Mental status was assessed with the mini-mental status examination-brief version. Patients subjectively scored the informed consent process and video. After surgery, the recall test and mini-mental status examination-brief version were readministered at 5 additional time points: hospital discharge, 6 to 8 weeks, 3 months, 6 months, and 1 year postoperatively. Family members were assessed at the first 3 time points for comparison. Fifty-six patients enrolled. Despite ranking the consent process as important (median overall score: 10/10; video score: 9/10), median patient recall was only 45% immediately after discussion and video re-enforcement and subsequently declined to 18% at 6 to 8 weeks and 1 year postoperatively. Median family recall trended higher at 55% immediately and 36% at 6 to 8 weeks postoperatively. The perception of the severity of complications significantly differs between patient and surgeon. Mental status scores showed a transient, significant decrease from preoperation to discharge but were significantly higher at 1 year. Despite being well-informed in an optimized informed consent process, patients cannot recall most surgical risks discussed and recall declines over time. Significant progress remains to improve informed consent retention. 3.

Ethical and practical challenges in implementing informed consent in HIV/AIDS clinical trials in developing or resource-limited countries.

PubMed

Mystakidou, Kyriaki; Panagiotou, Irene; Katsaragakis, Stelios; Tsilika, Eleni; Parpa, Efi

2009-09-01

Ethical issues regarding HIV/AIDS human research in the developing world remain under continuous evaluation; a critical area of concern includes informed consent. This paper reviews several of the most important ethical and practical aspects of informed consent in HIV research in developing countries. Enhancement of overall understanding of such key issues might promote higher ethical standards of future research. The major objective was to address informed consent in human research in non-Western societies, and specifically in HIV clinical trials of affected adults. Secondary end-points included the consent complexities in HIV research involving vulnerable patient populations in resource-limited nations, such as children, adolescents and women. A systematic review of the published literature using MEDLINE and EMBASE from 1998 until December 2008 was performed, using the search terms 'HIV/AIDS', 'informed consent', 'clinical trials', 'developing world'. Ethical complexities such as participants' diminished autonomy, coercion or monetary inducement, language difficulties, illiteracy or lack of true understanding of the entire study, cultural barriers mainly due to communitarianism and social diversities were identified in the 44 studies reviewed. Informed consent of vulnerable patient populations must be tailored to their sex and developmental age, while counselling is fundamental. Children and adolescents' assent must be ensured. Local language is to be used, while trusted community leaders and local cultural representatives may convey information. Despite the heterogeneity of studies, similarities were identified. Providing adequate and comprehensive information and assessing the true understanding of the research represent fundamental prerequisites. Potential solutions to the critical areas of concern include peer counselling and meetings with local community leaders or local cultural representatives. International investigators of HIV human research should bear in mind these ethical issues and their potential solutions, when trying to ensure ethical research conduct, based on a truly informed and culturally relevant consent.

Informed consent and decision-making about adult-to-adult living donor liver transplantation: a systematic review of empirical research.

PubMed

Gordon, Elisa J; Daud, Amna; Caicedo, Juan Carlos; Cameron, Kenzie A; Jay, Colleen; Fryer, Jonathan; Beauvais, Nicole; Skaro, Anton; Baker, Talia

2011-12-27

Adult-to-adult living donor liver transplantation (LDLT) is a complex procedure that poses serious health risks to and provides no direct health benefit for the donor. Because of this uneven risk-benefit ratio, ensuring donor autonomy through informed consent is critical. To assess the current knowledge pertaining to informed consent for LDLT, we conducted a systematic review of the empirical literature on donors' decision-making process, comprehension about risks and outcomes, and information needs for LDLT. Of the 1423 identified articles, 24 met final review criteria, representing the perspective of approximately 2789 potential and actual donors. As donors' decisions to donate often occur before evaluation, they often make uninformed decisions. The review found that 88% to 95% of donors reported understanding information clinicians disclosed about risks and benefits. However, donors reported unmet information needs, knowledge gaps regarding risks, and unanticipated complications. Few donors reported feeling pressure to donate. Most studies were limited by cultural differences, small sample sizes, inconsistent measures, and poor methodological approaches. This systematic review suggests that informed consent for LDLT is sub-optimal as donors do not adequately appreciate disclosed information during the informed consent process, despite United Network for Organ Sharing/CMS regulations requiring formal psychological evaluation of donor candidates. Interventions are needed to improve donor-clinician communication during the LDLT informed consent process such as through the use of comprehension assessment tools and e-health educational tools that leverage adult learning theory to effectively convey LDLT outcome data.

Pragmatic Randomized Trials Without Standard Informed Consent?: A National Survey.

PubMed

Nayak, Rahul K; Wendler, David; Miller, Franklin G; Kim, Scott Y H

2015-09-01

Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. Web-based survey conducted in December 2014. 2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.

Use of Mobile Devices and the Internet for Multimedia Informed Consent Delivery and Data Entry in a Pediatric Asthma Trial: Study Design and Rationale

PubMed Central

Blake, Kathryn; Holbrook, Janet T.; Antal, Holly; Shade, David; Bunnell, H. Timothy; McCahan, Suzanne M.; Wise, Robert A.; Pennington, Chris; Garfinkel, Paul; Wysocki, Tim

2015-01-01

Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial. Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Results Participants have been enrolled in the streamlined and traditional trials and recuitment is ongoing. Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases. PMID:25847579

A novel metadata management model to capture consent for record linkage in longitudinal research studies.

PubMed

McMahon, Christiana; Denaxas, Spiros

2017-11-06

Informed consent is an important feature of longitudinal research studies as it enables the linking of the baseline participant information with administrative data. The lack of standardized models to capture consent elements can lead to substantial challenges. A structured approach to capturing consent-related metadata can address these. a) Explore the state-of-the-art for recording consent; b) Identify key elements of consent required for record linkage; and c) Create and evaluate a novel metadata management model to capture consent-related metadata. The main methodological components of our work were: a) a systematic literature review and qualitative analysis of consent forms; b) the development and evaluation of a novel metadata model. We qualitatively analyzed 61 manuscripts and 30 consent forms. We extracted data elements related to obtaining consent for linkage. We created a novel metadata management model for consent and evaluated it by comparison with the existing standards and by iteratively applying it to case studies. The developed model can facilitate the standardized recording of consent for linkage in longitudinal research studies and enable the linkage of external participant data. Furthermore, it can provide a structured way of recording consent-related metadata and facilitate the harmonization and streamlining of processes.

Informed consent in blood transfusion: knowledge and administrative issues in Uganda hospitals.

PubMed

Kajja, Isaac; Bimenya, Gabriel S; Smit Sibinga, Cees Th

2011-02-01

Blood as a transplant is not free of risks. Clinicians and patients ought to know the parameters of a transfusion informed consent. A mixed methodology to explore patients' and clinicians' knowledge and opinions of administration and strategies to improve the transfusion informed consent process was conducted. The clinicians' level of knowledge was limited to provision of information about and the right to consent to a transfusion. They disagreed on administrative issues but had acceptable opinions on improving the process. Patients perceived this process as a way of assurance of blood safety. This process is important and should not be omitted. Copyright © 2010 Elsevier Ltd. All rights reserved.

"Sign here": nursing value and the process of informed consent.

PubMed

Cook, Wesley E

2014-01-01

Protecting patient autonomy is a key nursing role. The Code of Ethics (American Nurses Association, 2010), contextualizes the nurse's call to advocacy within the doctrine of informed consent. This article offers a primer on the legal, ethical, and practical aspects of procedural informed consent and examines the value of nursing's role within the process. The theory of nursing's value is sound, but the literature lacks data. Higher levels of evidence are necessary to make sound decisions about best practice for the process of informed consent. As such, this article concludes that adding nursing research to the current discourse should prove most valuable to patients, providers, and the nursing profession as a whole.

A Model Designed to Enhance Informed Consent: Experiences From the HIV Prevention Trials Network

PubMed Central

Woodsong, Cynthia; Karim, Quarraisha Abdool

2005-01-01

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment. PMID:15727968

EMS Providers and Exception From Informed Consent Research: Benefits, Ethics, and Community Consultation

PubMed Central

Ripley, Elizabeth; Ramsey, Cornelia; Prorock-Ernest, Amy; Foco, Rebecca; Luckett, Solomon; Ornato, Joseph P.

2013-01-01

As attention to, and motivation for, EMS-related research continues to grow, particularly exception from informed consent (EFIC) research, it is important to understand the thoughts, beliefs, and experiences of EMS providers who are actively engaged in the research. Study Objective We explored the attitudes, beliefs, and experiences of EMS providers regarding their involvement in prehospital emergency research, particularly EFIC research. Method Using a qualitative design, 24 participants were interviewed including Nationally Registered Paramedics and Virginia certified Emergency Medical Technicians employed at Richmond Ambulance Authority, the participating EMS agency. At the time of our interviews, the EMS agency was involved in an exception from informed consent trial. Transcribed interview data were coded and analyzed for themes. Findings were presented back to the EMS agency for validation. Results Overall, there appeared to be support for prehospital emergency research. Participants viewed research as necessary for the advancement of the field of EMS. Improvement in patient care was identified as one of the most important benefits. A number of ethical considerations were identified: individual risk versus public good and consent. EMS providers in our study were open to working with EMS researchers throughout the community consultation and public disclosure process. Conclusions EMS providers in our study value research and are willing to participate in studies. Support for research was balanced with concerns and challenges regarding the role of providers in the research process. PMID:22823963

Informed consent procedures: responsibilities of researchers in developing countries.

PubMed

Sanchez, S; Salazar, G; Tijero, M; Diaz, S

2001-10-01

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision-making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with partners or relatives; and perceived benefits such as quality of care, non-cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk-benefit balance was strongly influenced by women's needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision-making process enhances women's ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process.

Informed consent and the law--an English legal perspective.

PubMed

Hassan, Majid

2008-01-01

'Informed consent' is a widely used term, but its application in a legal perspective can be varied. American and Commonwealth jurisdictions have developed a 'patient-based' true informed consent approach, whereas in the English legal system a 'doctor-based' approach has traditionally been applied in relation to disclosure of risk. This article will seek to compare these approaches and give a brief overview of some of the key legal rulings which have shaped the requirement of consent. The decision in the English case of Chester vs. Afshar is considered as showing the significance the court attached to the principle of autonomy and using ethical and policy considerations to depart from established principles of English law relating to consent to treatment and disclosure of risk. This review is intended as general information and not as legal advice which should be sought from defence organisation and specialist health care lawyers. Copyright 2008 S. Karger AG, Basel.

‘The Words Will Pass with the Blowing Wind’: Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

PubMed Central

Molyneux, Sassy; Njue, Maureen; Boga, Mwanamvua; Akello, Lilian; Olupot-Olupot, Peter; Engoru, Charles; Kiguli, Sarah; Maitland, Kathryn

2013-01-01

Objective To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future. Methods A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya. Findings Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal. Conclusion While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach. PMID:23408950

Consent process for US-based family reference DNA samples.

PubMed

Katsanis, Sara H; Snyder, Lindsey; Arnholt, Kelly; Mundorff, Amy Z

2018-01-01

DNA collection from family members of the missing is a tenet for missing persons' and mass fatality investigations. Procedures for consenting family members are disparate, depending on the context supporting the reason for sample collection. While guidelines and best practices have been developed for handling mass fatalities and for identification of the missing, these guidelines do not address standard consent practices for living family members of potential victims. We examined the relevant U.S. laws, international guidelines and best practices, sampled consent forms currently used for DNA collection of family members, and drafted model language for a consent form to communicate the required and recommended information. We modeled the consent form on biobank consenting practices and tested the consent language among students and the general population for constructive feedback and readability. We also asked respondents to consider the options for DNA collection and either hypothetically agree or disagree. The model language presented here highlights information important to relay in consent processes and can serve as a foundation for future consent practices in mass fatalities and missing persons' investigations. Copyright © 2017 Elsevier B.V. All rights reserved.

Informed consent in physiotherapy practice: it is not what is said but how it is said.

PubMed

Copnell, G

2018-03-01

This paper discusses the concept of informed consent in the context of contemporary biomedical ethics. A change in UK law regarding what information should be provided to patients has brought to the fore the role of physiotherapists in the process of gaining informed consent. It is important that physiotherapists are aware of how this change in the law will affect their practice. For an individual to consent, they need to have both the capacity and freedom to exercise rational thought. These concepts are challenged in contemporary biomedical ethics. An individual's ability to make rational decisions has been increasingly questioned by empirical evidence from behavioural psychology. In addition, the concept of freedom in contemporary neoliberal societies has also been critically examined. Liberal paternalism has been advocated by some as a means of helping patients to make better decisions about their care. Actualised as a 'nudge', liberal paternalism has been influential in a number of health policies, and has recently been discussed as a means of gaining consent from patients for assessments and treatments. Physiotherapists engage directly with patients and, through this engagement, construct a therapeutic environment that aims to build mutual trust. This paper questions the legitimacy of informed consent, and presents the argument that, through communicative actions, physiotherapists nudge patients into consenting to assessments and treatments. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Informed consent for blood tests in people with a learning disability.

PubMed

Goldsmith, Lesley; Woodward, Val; Jackson, Leigh; Skirton, Heather

2013-09-01

This article is a report of a study of informed consent in people with a learning disability. The aims of the study were to explore the information needs of people with mild-to-moderate learning disabilities with respect to consent for blood tests and to identify ways of facilitating informed consent. The recent political agenda for social change in the UK has emphasized the right of people with a learning disability to have more autonomy and make their own decisions. As in other countries, there has also been a shift towards shared decision-making in healthcare practice. Qualitative study using an ethnographic approach. An ethnographic approach was used for this qualitative study. Phase 1 involved observation of six participants with a learning disability having a routine blood test in general practice, followed by semi-structured interviews with 14 participants with a learning disability in Phase 2. Data were collected between February 2009-February 2010. The data showed that consent procedures were often inadequate and provision of information to patients prior to a blood test was variable. People with a learning disability expressed clearly their information requirements when having a routine blood test; this included not wanting any information in some cases. Healthcare practitioners and people with a learning disability need to be familiar with current consent law in their own country to facilitate valid consent in the healthcare context. This study demonstrated the value of qualitative research in exploring the knowledge and attitudes of people with learning disability. © 2012 Blackwell Publishing Ltd.

A Structured Implicit Abstraction Method to Evaluate whether Content of Counseling before Prostate Cancer Screening is Consistent with Recommendations by Experts

PubMed Central

Farrell, Michael H.; Chan, Evelyn C.Y.; Ladouceur, Lynnea K.; Stein, Jeffrey M.

2009-01-01

Objective To assess the content of counseling about prostate-specific antigen (PSA) screening. Guidelines recommend informed consent before screening because of concerns about benefits versus risks. As part of the professional practice standard for informed consent, clinicians should include content customarily provided by experts. Methods 40 transcripts of conversations between medicine residents and standardized patients were abstracted using an instrument derived from an expert Delphi panel that ranked 10 “facts that experts believe men ought to know.” Results Transcripts contained definite criteria for an average of 1.7 facts, and either definite or partial criteria for 5.1 facts. Second- and third-year residents presented more facts than interns (p=0.01). The most common facts were “false positive PSA tests can occur” and “use of the PSA test as a screening test is controversial.” There was an r=0.88 correlation between inclusion by residents and the experts’ ranking. Conclusion Counseling varied but most transcripts included some expert-recommended facts. The absence of other facts could be a quality deficit or an effort to prioritize messages and lessen cognitive demands on the patient. Practice implications Clinicians should adapt counseling for each patient, but our abstraction approach may help to assess the quality of informed consent over larger populations. PMID:19837527

Good eggs? Evaluating consent forms for egg donation.

PubMed

Cattapan, Alana Rose

2016-07-01

Beyond gaps in the provision of information, the informed consent process for egg donation is complicated by conflicts of interest, payment and a lack of longitudinal data about physiological and psychological risks. Recent scholarship has suggested that egg donation programmes could improve the informed consent process by revising consent documents. At a minimum, these documents should include information about eight key criteria: the nature and objectives of treatment; the benefits, risks and inconveniences of egg donation; the privacy of donors and their anonymity (where applicable); disclosure that participation is voluntary (withdrawal); the availability of counselling; financial considerations; the possibility of an unsuccessful cycle and potential uses of the eggs retrieved. This study evaluates the incorporation of these minimum criteria in consent forms for egg donation, obtained through requests to Canadian fertility clinics. Even when clinics were considered to have met criteria simply by mentioning them, among the eight consent forms assessed, none met the minimum standards. Only half of clinics addressed privacy/anonymity concerns, financial issues and the possibility of a future cycle. Improving the quality of consent documentation to meet the minimum standards established by this study may not be an onerous task. For some, this will include re-evaluating how they include one or two elements of disclosure, and for others, this will require a substantial overhaul. Using the criteria provided by this study as the minimum standard for consent could ensure that donors have the basic information they need to make informed decisions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

PubMed

Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

2011-01-04

The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study.

PubMed

Campbell, Megan M; Susser, Ezra; Mall, Sumaya; Mqulwana, Sibonile G; Mndini, Michael M; Ntola, Odwa A; Nagdee, Mohamed; Zingela, Zukiswa; Van Wyk, Stephanus; Stein, Dan J

2017-01-01

Obtaining informed consent is a great challenge in global health research. There is a need for tools that can screen for and improve potential research participants' understanding of the research study at the time of recruitment. Limited empirical research has been conducted in low and middle income countries, evaluating informed consent processes in genomics research. We sought to investigate the quality of informed consent obtained in a South African psychiatric genomics study. A Xhosa language version of the University of California, San Diego Brief Assessment of Capacity to Consent Questionnaire (UBACC) was used to screen for capacity to consent and improve understanding through iterative learning in a sample of 528 Xhosa people with schizophrenia and 528 controls. We address two questions: firstly, whether research participants' understanding of the research study improved through iterative learning; and secondly, what were predictors for better understanding of the research study at the initial screening? During screening 290 (55%) cases and 172 (33%) controls scored below the 14.5 cut-off for acceptable understanding of the research study elements, however after iterative learning only 38 (7%) cases and 13 (2.5%) controls continued to score below this cut-off. Significant variables associated with increased understanding of the consent included the psychiatric nurse recruiter conducting the consent screening, higher participant level of education, and being a control. The UBACC proved an effective tool to improve understanding of research study elements during consent, for both cases and controls. The tool holds utility for complex studies such as those involving genomics, where iterative learning can be used to make significant improvements in understanding of research study elements. The UBACC may be particularly important in groups with severe mental illness and lower education levels. Study recruiters play a significant role in managing the quality of the informed consent process.

Are there limits to respect for autonomy in bioethics?

PubMed

de Roubaix, Malcolm

2008-06-01

I discuss the significance of respect for personal autonomy in bioethics with reference to its practical expression: rational informed patient choice. The question is whether, given the apparent practical limitations to this notion, bioethical autonomy should be seen as an absolute. After a historical review of informed consent and its development, I discuss the requirements for informed consent. Some inherent tensions are evaluated, as is the applicability of the notion that in order to be legitimate, autonomy should do some ethical work. Limits to the notion of informed consent are explored with reference to six examples: the right of women to reproductive autonomy; the autonomy of legally minor Jehovah's Witnesses; autonomy in cosmetic surgery; inappropriate treatment; autonomy and human medical research, and euthanasia and other end-of-life options. The discussion is within a South African framework with reference to other jurisdictions and decisions where appropriate. I conclude that whilst some unusual instances of limitation of bioethical informed consent might be ethically justifiable, the arguments presented point to the opposite: the unfounded limitation of informed consent.

Managed care, medical privacy, and the paradigm of consent.

PubMed

Bloche, M Gregg

1997-12-01

The market success of managed health plans in the 1990s is bringing to medicine the easy availability of electronically stored information that is characteristic of the securities and consumer credit industries. Protection for medical confidentiality, however, has not kept pace with this information revolution. Employers, the managed care industry, and legal and ethics commentators frequently look to the concept of informed consent to justify particular uses of health information, but the elastic use of informed consent as a way of responding to managed care health plans' disclosure of information to third parties fails to address underlying questions involving substantive value choices.

Young people's views about consenting to data linkage: findings from the PEARL qualitative study.

PubMed

Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

2016-03-21

Electronic administrative data exist in several domains which, if linked, are potentially useful for research. However, benefits from data linkage should be considered alongside risks such as the threat to privacy. Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study. The Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. Qualitative research was incorporated in the PEARL study to examine participants' views about data linkage and inform approaches to information sharing. This paper focusses on issues of consent. Digitally recorded interviews were conducted with 55 participants aged 17-19 years. Terms and processes relating to consent, anonymization and data linkage were explained to interviewees. Scenarios were used to prompt consideration of linking different sources of data, and whether consent should be requested. Interview recordings were fully transcribed. Thematic analysis was undertaken using the Framework approach. Participant views on data linkage appeared to be most influenced by: considerations around the social sensitivity of the research question, and; the possibility of tangible health benefits in the public interest. Some participants appeared unsure about the effectiveness of anonymization, or did not always view effective anonymization as making consent unnecessary. This was related to notions of ownership of personal information and etiquette around asking permission for secondary use. Despite different consent procedures being explained, participants tended to equate consent with 'opt-in' consent through which participants are 'asked' if their data can be used for a specific study. Participants raising similar concerns came to differing conclusions about whether consent was needed. Views changed when presented with different scenarios, and were sometimes inconsistent. Findings from this study question the validity of 'informed consent' as a cornerstone of good governance, and the extent to which potential research participants understand different types of consent and what they are consenting, or not consenting, to. Pragmatic, imaginative and flexible approaches are needed if research using data linkage is to successfully realise its potential for public good without undermining public trust in the research process.

Assessing capacity to consent to treatment with cholinesterase inhibitors in dementia using a specific and standardized version of the MacArthur Competence Assessment Tool (MacCAT-T).

PubMed

Mueller, Tanja; Haberstroh, Julia; Knebel, Maren; Oswald, Frank; Kaspar, Roman; Kemper, Christoph J; Halder-Sinn, Petra; Schroeder, Johannes; Pantel, Johannes

2017-02-01

The use of assessment tools has been shown to improve the inter-rater reliability of capacity assessments. However, instrument-based capacity assessments of people with dementia face challenges. In dementia research, measuring capacity with instruments like the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) mostly employ hypothetical treatment vignettes that can overwhelm the abstraction capabilities of people with dementia and are thus not always suitable for this target group. The primary aim of this study was to provide a standardized real informed consent paradigm that enables the dementia-specific properties of capacity to consent to treatment in people with dementia to be identified in a real informed consent process that is both externally valid and ethically justifiable. The sample consisted of 53 people with mild to moderate dementia and a group of 133 people without cognitive impairment. Rather than using a hypothetical treatment vignette, we used a standardized version of the MacCAT-T to assess capacity to consent to treatment with cholinesterase inhibitors in people with dementia. Inter-rater reliability, item statistics, and psychometric properties were also investigated. Intraclass correlations (ICCs) (0.951-0.990) indicated high inter-rater reliability of the standardized real informed consent paradigm. In the dementia group, performance on different items of the MacCAT-T varied. Most people with dementia were able to express a treatment choice, and were aware of the need to take a tablet. Further information on the course of the disorder and the benefits and risks of the treatment were less understood, as was comparative reasoning regarding treatment alternatives. The standardized real informed consent paradigm enabled us to detect dementia-specific characteristics of patients' capacity to consent to treatment with cholinesterase inhibitors. In order to determine suitable enhanced consent procedures for this treatment, we recommend the consideration of MacCAT-T results on an item level. People with dementia seem to understand only basic information. Our data indicate that one useful strategy to enhance capacity to consent is to reduce attention and memory demands as far as possible.

Consent for donation after cardiac death: a survey of organ procurement organizations.

PubMed

Kalkbrenner, Kathy J; Hardart, George E

2012-01-01

Despite the increasing number of policies governing organ donation after cardiac death (DCD), nothing is presently known about the informed consent process for DCD. Without guidelines, organ procurement organizations (OPOs) are likely to structure the consent process similarly to that for organ donation after brain death (DBD), despite important ethical differences between the 2 modes of organ recovery. To describe informed consent practices used by OPOs for DCD. Cross-sectional, internet-based survey of the 58 OPOs in the United States. OPO policies and reported levels of physician participation in the consent process for DCD. Seventeen OPOs completed the survey (29%). Responders and nonresponders did not differ by DCD volume over the last year or last 5 years. None of the OPO's policies require physician involvement in obtaining written informed consent; 94% of policies require only the OPO representative to obtain written consent for DCD and 6% state that either the OPO representative or the treating physician may obtain consent; 71% of OPOs reported that discussions with family regarding DCD occur with the treating physician present less than 51% of the time and 82% indicated that the OPO representative is solely involved in obtaining consent for DCD in the majority of cases. A total of 24% of OPOs require physicians to participate in obtaining consent for procedures performed prior to death exclusively for organ preservation. No differences were found between the OPO consent practices for DCD and DBD. None of the OPOs responding to this survey have a policy requirement for physician involvement in obtaining consent for DCD. These findings raise questions about the role of physicians in DCD and how best to maintain a patient- and family-centered focus on care for patients at the end of life while supporting organ recovery efforts.

Sub-orbital commercial Human space flight and informed consent in the United States

NASA Astrophysics Data System (ADS)

Carminati, Maria-Vittoria « Giugi »; Griffith, Doug; Campbell, Mark R.

2013-12-01

Commercial space flight is expected to rapidly develop in the near future. This will begin with sub-orbital missions and then progress to orbital flights. In the United States, technical informed consent of space flight participants is required by the commercial space flight operator for regulatory purposes. Additionally, though not required by U.S. regulation, the aerospace medicine professional involved in the medical screening of both space flight participants and crewmembers will be asked to assist operators in obtaining medical informed consent for liability purposes. The various US federal and state regulations regarding informed consent for sub-orbital commercial space flight are evolving and are unfamiliar to most aerospace medical professionals and are reviewed and discussed.

Personality, sex of participant, and face-to-face interaction affect reading of informed consent forms.

PubMed

Knepp, Michael M

2014-02-01

Students (N = 183) participated in a study designed to determine if each student read the informed consent form. Approximately 12% of students in the online condition followed the procedure compared with 38% in the laboratory phase. Participants with higher trait worry and those with lower emotion reappraisal were more likely to follow the procedure, while women were more likely to read the form than men. Across conditions, most students do not read informed consent documents, particularly in online formats. These findings of this research support the idea that women tend to be more information-seeking than men in health and research settings and those with higher trait worry tend to read the consent forms to alleviate uncertainty and trust concerns.

Postal consent for upper gastrointestinal endoscopy.

PubMed

Shepherd, H A; Bowman, D; Hancock, B; Anglin, J; Hewett, D

2000-01-01

Standards for good practice in clinical risk management issued by the Clinical Negligence Scheme for Trusts indicate that "appropriate information is provided to patients on the risks and benefits of proposed treatment, and of the alternatives available before a signature on a consent form is sought". To investigate the practicability and patient acceptability of a postal information and consent booklet for patients undergoing outpatient gastroscopy. Information about gastroscopy procedure, personalised appointment details, and a carbonised consent form were compiled into a single booklet. This was mailed to patients well in advance of their endoscopic procedure. Patient satisfaction for this new process was assessed by questionnaire. 275 patients received a patient information booklet. Of these, 150 (54.5%) returned the consent form by post when they confirmed their attendance; 141 (94%) had signed the form, and the other nine requested further information. Of the remaining 125 booklets sent out, 115 (92%) forms were brought back on the day of the investigation having been previously signed. The remaining 10 (8%) required further information before signing the form. An audit of 168 patients was used to test reaction to the booklet and the idea of filling in the form before coming to hospital; 155 patients (92. 2%) reported the information given in the booklet to be "very useful", and all reported it to be "clear and understandable". A specifically designed patient information booklet with integral consent form is accepted by patients, and improves the level of understanding prior to the investigation being carried out.

Assessing capacity to consent for research in cognitively impaired older patients

PubMed Central

Gilbert, Thomas; Bosquet, Antoine; Thomas-Antérion, Catherine; Bonnefoy, Marc; Le Saux, Olivia

2017-01-01

Background The number of clinical trials including older patients, and particularly patients with cognitive impairment, is increasing. While statutory provisions exist to make sure that the capacity to consent is assessed systematically for each patient, many gray areas remain with regard to how this assessment is made or should be made in the routine practice of clinical research. Objectives The aim of this review was to draw up an inventory of assessment tools evaluating older patients’ capacity to consent specifically applicable to clinical research, which could be used in routine practice. Methods Two authors independently searched PubMed, Cochrane, and Google Scholar data-bases between November 2015 and January 2016. The search was actualized in April 2017. We used keywords (MeSH terms and text words) referring to informed consent, capacity to consent, consent for research, research ethics, cognitive impairment, vulnerable older patients, and assessment tools. Existing reviews were also considered. Results Among the numerous existing tools for assessing capacity to consent, 14 seemed potentially suited for clinical research and six were evaluated in older patients. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was the most frequently cited. Conclusion The MacCAT-CR is currently the most used and the best validated questionnaire. However, it appears difficult to use and time-consuming. A more recent tool, the University of California Brief Assessment of Capacity to Consent (UBACC), seems interesting for routine practice because of its simplicity, relevance, and applicability in older patients. PMID:29026293

Mental Capacity to Consent to Research? Experiences of Consenting Adults with Intellectual Disabilities and/or Autism to Research

ERIC Educational Resources Information Center

Hamilton, Jahnese; Ingham, Barry; McKinnon, Iain; Parr, Jeremy R.; Tam, Louise Yuen-Chong; Le Couteur, Ann

2017-01-01

Background: Adults with intellectual disabilities and/or autism are often excluded from participating in health and healthcare research. Understanding study information, which is an important aspect of demonstrating capacity to give informed consent, can be a particular challenge. This study surveyed clinical researchers to discover: (i) their…

The Effects of Enhanced Informed Consent in a Pro-Life Pregnancy Counseling Center.

ERIC Educational Resources Information Center

Mardirosian, Kathryn; And Others

1990-01-01

Investigated effects of enhanced informed consent condition on attitudes of female clients (n=60) toward a counselor, counseling situation, and decision making in a pro-life pregnancy center. Results suggest enhanced consent did not lead to increased or decreased decisions to abort nor to differential attitudes toward counselor or setting.…

Informed consent in Malaysia: an overview.

PubMed

Che Ngah, Anisah

2005-01-01

The right of a person to control his body is a concept that has long been recognized in Malaysia under the law of torts. The purpose of requiring informed consent is to preserve that right in medical decision-making. Informed Consent is a relatively new concept in medical litigation cases. However in the late 1990's, it has become one of the important claims under negligence made against the doctor for failure to disclose relevant information to patients in respect of the treatment proposed. Whether Malaysia has begun to recognize patient's right to decision-making is yet to be seen. Furthermore the social-cultural relationship between doctors and patients had to be considered. In this respect, the researcher had conducted interviews with doctors and patients to gauge their reaction towards a shared process of decision-making, which is the central issue in the doctrine of informed consent. Findings suggest that in society where primary health care is the main thrust to achieve health for all, the possibility of recognition of the rights of patients to receive information before making decisions about treatment appears remote. The findings also underscore the importance of incorporating aspects of informed consent as part of providing quality service to patients.

Hypothetical contractarianism and the disclosure requirement problem in informed consent.

PubMed

Cust, Kenneth F T

1991-01-01

Two of the more deeply problematic issues surrounding the doctrine of informed consent are providing a justification for the practice of informed consent and providing an account of the nature and amount of information that must be disclosed in order for informed consent to take place. This paper is concerned with the latter problem, the problem of disclosure requirements, but it deals with this problem in a novel way; it approaches the problem by asking what fully informed and fully rational agents would agree to under certain hypothetical conditions. In general terms I juxtapose the hypothetical contractarianism found in Rawls' A Theory of Justice with that found in Gauthier's Morals By Agreement and ask what their respective hypothetical contractors would agree to with respect to choosing a particular standard of disclosure to govern the practice of informed consent. In more specific terms a contrast is made between what a Rawlsian agent behind a veil of ignorance would choose as compared to what, in Gauthier's terms, an ideal actor making an Archimedean choice would choose. The idea of an Archimedean point, and the subsequent choice made from that point, although technically identified by Rawls, originated with Archimedes of Syracuse.

I had no other option: Women, electroconvulsive therapy, and informed consent.

PubMed

Clarke, Karen-Ann; Barnes, Margaret; Ross, Dyann

2018-06-01

Electroconvulsive therapy (ECT) is a controversial procedure used in the management of depression. Whilst it may be administered under mental health legislation, it is usually given to people who voluntarily consent. At the practice level, the consent process for ECT requires a detailed explanation of the procedure. The person consenting must have capacity to make this decision, and consent must be given freely and without coercion. Research using a feminist narrative approach unexpectedly highlighted the issue of potential coercion in the context of explaining the procedure. In-depth interviews were used to understand seven women's accounts of deciding to receive ECT. A thematic analysis of their narratives uncovered a shared concern with how they consented to the treatment. Four subthemes were identified that related to the way in which they provided their consent: (i) 'Not enough information'; (ii) 'I had no other choice'; (iii) 'Just go along with it'; and (iv) 'Lacking capacity'. A consent process that includes elements of passive coercion and a lack of timely and appropriate information influences the way some women make decisions. These factors can disempower women at the point of decision-making. A practice shift is needed where women are enabled to have control over decisions. Further, there is a need to adhere more rigorously to noncoercive practice when obtaining consent. © 2017 Australian College of Mental Health Nurses Inc.

Patient representatives' views on patient information in clinical cancer trials.

PubMed

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-02-01

Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

Research ethics committee decision-making in relation to an efficient neonatal trial.

PubMed

Gale, C; Hyde, M J; Modi, N

2017-07-01

Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. RECs in the UK. Number of REC granting favourable opinions. The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon

PubMed Central

2012-01-01

Background Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist’s potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. Method Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. Results Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77%) and informed consent in 77 (47.83%). Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01%) and was not reported in any Bachelors’ degree dissertation. Informed consent was also highly reported in MD theses (64.58%) followed by undergraduate theses (31.58%). Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. Conclusions Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE) be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance. PMID:22686445

Non-completion and informed consent.

PubMed

Wertheimer, Alan

2014-02-01

There is a good deal of biomedical research that does not produce scientifically useful data because it fails to recruit a sufficient number of subjects. This fact is typically not disclosed to prospective subjects. In general, the guidance about consent concerns the information required to make intelligent self-interested decisions and ignores some of the information required for intelligent altruistic decisions. Bioethics has worried about the 'therapeutic misconception', but has ignored the 'completion misconception'. This article argues that, other things being equal, prospective subjects should be informed about the possibility of non-completion as part of the standard consent process if (1) it is or should be anticipatable that there is a non-trivial possibility of non-completion and (2) that information is likely to be relevant to a prospective subject's decision to consent. The article then considers several objections to the argument, including the objection that disclosing non-completion information would make recruitment even more difficult.

Informed consent in emergency research: what every emergency nurse should know.

PubMed

Watts, D D

1997-02-01

Although they are not totally without controversy, proxy consent and prospective consent are generally condoned as being legally and ethically acceptable alternatives to traditional informed consent by the majority of IRBs and researchers. Deferred consent, on the other hand, continues to fuel a heated debate in the emergency research community. Detractors believe that deferred consent is nothing more than unauthorized experimentation on a vulnerable population. They argue that since the subject has no means to prevent the action that it can in no way be construed as consent. Advocates assert that deferred consent allows subjects who are unable to speak for themselves access to potentially lifesaving treatments that they otherwise would be denied if they were forced to wait for proxy consent. In addition, they believe that as long as the study is carefully screened by an IRB, that the rights of the individual have been adequately protected, research that may offer benefits beyond the individual patient to society as a whole is allowed to continue. Because of this controversy, in recent years it had become almost impossible to obtain IRB approval for emergency research because of conflicting and restrictive federal regulations. However, a recent rule change by the Department of Health and Human Services has brought diverse regulations into accord and made deferred consent once more a more viable alternative to researchers. Yet acquiring IRB approval for a waiver of informed consent is by no means a simple process. The requirements are listed in Table 2, and they represent a compromise between the two views. Although researchers are allowed to use deferred consent, it is only in the most life-threatening situations in which current treatments are unsatisfactory or unproven and when the research intervention may offer direct benefit to the patient. The new regulations place a very strong emphasis on protection of the rights of the human subject. In addition, they mandate community consultation by the researcher and advance public disclosure of the nature of the study to the community in which it is to be conducted. In this way it is hoped that both the public good and the individual rights will be equally respected. Informed consent to research in the emergency setting is a difficult issue, and its complexities continue to be debated. Nurses in emergency settings, whether researchers or associates, must understand the informed consent process to ensure that adequate steps have been taken to safeguard the patient and his or her rights. Yet they must also appreciate the precautions that have been taken, and the difficult decisions that have been made, by an IRB before an emergency research study is approved. By understanding the consent process, emergency nurses can become more fully informed research participants, ensuring that the rights of the patients have been protected, while working to advance medical science through legally sound, ethically proper, clinical investigation.

Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

PubMed

Mellado, J M

2016-01-01

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

PubMed

Mellado, J M

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

[Proposal of informed consent by representation for treatment with clozapine].

PubMed

Mercurio, Ezequiel; Rodante, Demián

2017-09-01

Clozapine-induced agranulocytosis, a potentially serious adverse effect, is a limiting factor for its therapeutic use, leading to the suspension of the drug. Its annual incidence in Argentina is 0.05%. In 2000, under provision number 935, the ANMAT approved the Monitoring Program for Ambulatory and Inpatient Patients Treated with Clozapine. In this provision arises the obligation to sign the informed consent where the patient is informed of the risks and benefts of the treatment. In psychiatric care practice patients may not possess, because of their altered psychic state, the level of competence necessary to sign informed consent for their treatment with clozapine. The objective of the present work is to analyze the doctrine of Informed Consent by Representation for the users of clozapine, as well as to propose a decision algorithm for its application in clinical practice.

Community sensitization and decision-making for trial participation: a mixed-methods study from The Gambia.

PubMed

Dierickx, Susan; O'Neill, Sarah; Gryseels, Charlotte; Immaculate Anyango, Edna; Bannister-Tyrrell, Melanie; Okebe, Joseph; Mwesigwa, Julia; Jaiteh, Fatou; Gerrets, René; Ravinetto, Raffaella; D'Alessandro, Umberto; Peeters Grietens, Koen

2017-08-16

Ensuring individual free and informed decision-making for research participation is challenging. It is thought that preliminarily informing communities through 'community sensitization' procedures may improve individual decision-making. This study set out to assess the relevance of community sensitization for individual decision-making in research participation in rural Gambia. This anthropological mixed-methods study triangulated qualitative methods and quantitative survey methods in the context of an observational study and a clinical trial on malaria carried out by the Medical Research Council Unit Gambia. Although 38.7% of the respondents were present during sensitization sessions, 91.1% of the respondents were inclined to participate in the trial when surveyed after the sensitization and prior to the informed consent process. This difference can be explained by the informal transmission of information within the community after the community sensitization, expectations such as the benefits of participation based on previous research experiences, and the positive reputation of the research institute. Commonly mentioned barriers to participation were blood sampling and the potential disapproval of the household head. Community sensitization is effective in providing first-hand, reliable information to communities as the information is cascaded to those who could not attend the sessions. However, further research is needed to assess how the informal spread of information further shapes people's expectations, how the process engages with existing social relations and hierarchies (e.g. local political power structures; permissions of heads of households) and how this influences or changes individual consent. © 2017 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.

The ethical use of existing samples for genome research.

PubMed

Bathe, Oliver F; McGuire, Amy L

2009-10-01

Modern biobanking efforts consist of prospective collections of tissues linked to clinical data for patients who have given informed consent for the research use of their specimens and data, including their DNA. In such efforts, patient autonomy and privacy are well respected because of the prospective nature of the informed consent process. However, one of the richest sources of tissue for research continues to be the millions of archived samples collected by pathology departments during normal clinical care or for research purposes without specific consent for future research or genetic analysis. Because specific consent was not obtained a priori, issues related to individual privacy and autonomy are much more complicated. A framework for accessing these existing samples and related clinical data for research is presented. Archival tissues may be accessed only when there is a reasonable likelihood of generating beneficial and scientifically valid information. To minimize risks, databases containing information related to the tissue and to clinical data should be coded, no personally identifying phenotypic information should be included, and access should be restricted to bona fide researchers for legitimate research purposes. These precautions, if implemented appropriately, should ensure that the research use of archival tissue and data are no more than minimal risk. A waiver of the requirement for informed consent would then be justified if reconsent is shown to be impracticable. A waiver of consent should not be granted, however, if there is a significant risk to privacy, if the proposed research use is inconsistent with the original consent (where there is one), or if the potential harm from a privacy breach is considerable.

A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.

PubMed

Afolabi, Muhammed Olanrewaju; McGrath, Nuala; D'Alessandro, Umberto; Kampmann, Beate; Imoukhuede, Egeruan B; Ravinetto, Raffaella M; Alexander, Neal; Larson, Heidi J; Chandramohan, Daniel; Bojang, Kalifa

2015-05-01

To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups. On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand. A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy.

Local attitudes, moral obligation, customary obedience and other cultural practices: their influence on the process of gaining informed consent for surgery in a tertiary institution in a developing country.

PubMed

Irabor, David O; Omonzejele, Peter

2009-04-01

The process of obtaining informed consent in a teaching hospital in a developing country (e.g. Nigeria) is shaped by factors which, to the Western world, may be seen to be anti-autonomous: autonomy being one of the pillars of an ideal informed consent. However, the mix of cultural bioethics and local moral obligation in the face of communal tradition ensures a mutually acceptable informed consent process. Paternalism is indeed encouraged by the patients who prefer to see the doctor as all-powerful and all-knowing, and this is buttressed by the cultural practice of customary obedience to those 'above you': either in age or social rank. The local moral obligation reassures the patients that those in authority will always look after others placed in their care without recourse to lengthy discussions or signed documentation, while the communal traditions ensure that the designated head of a family unit has the honor and sole responsibility of assenting and consenting to an operation to be carried out on a younger, or female, member of the family. Indeed it is to only a few educated patients that the informed consent process is deemed a shield against litigation by the doctors. This paper later addresses the need for physicians to update their knowledge on the process of informed consent through the attendance of biomedical ethics courses, which should highlight socio-cultural practices that may make this process different from the Western concept, but perfectly acceptable in this setting.

Awareness, knowledge and attitude toward informed consent among doctors in two different cultures in Asia: a cross-sectional comparative study in Malaysia and Kashmir, India.

PubMed

Yousuf, R M; Fauzi, A R M; How, S H; Rasool, A G; Rehana, K

2007-06-01

Informed consent is now accepted as the cornerstone of medical practice, with reasonable patient standards typically considered to be appropriate in the developed countries; however it is still challenged in many developing countries. The objective of this descriptive study was to evaluate the perceptions and practices among attending medical professionals in matters relating to informed consent in selected hospitals. A questionnaire-based cross sectional survey among doctors in the two tertiary care hospitals, one in Malaysia and the other in Kashmir, was performed. Awareness on informed consent was universal with "reasonable physician standard" as the most popular choice. As compared to doctors in Malaysia, doctors from Kashmir showed a tendency to reservedly disclose medical information (p-value equals 0.051) and withhold it, if it was deemed potentially harmful (p-value is less than 0.001) or requested so by relatives (p-value is less than 0.023). They also withheld some information from female patients (p-value is less than 0.001). When consent was refused despite needing lifesaving intervention, the majority of both respondents (73 percent versus 80 percent) considered intervention without consent to be justified. Respondents from Malaysia felt that parents could refuse treatment on their children's behalf on the basis of their beliefs (p-value is less than 0.001). Despite a very high awareness of informed consent, the model chosen reflected age-old medical paternalism. Doctors' opinions are accorded a larger role in clinical decision-making in Kashmir. The results emphasise the need for doctors to change their attitude and acknowledge the patient's autonomy, which is the basis of modern medical ethics, and yet still be aware of the cultural and religious views of the local population.

Time to Improve Informed Consent for Dialysis: An International Perspective.

PubMed

Brennan, Frank; Stewart, Cameron; Burgess, Hannah; Davison, Sara N; Moss, Alvin H; Murtagh, Fliss E M; Germain, Michael; Tranter, Shelley; Brown, Mark

2017-06-07

The literature reveals that current nephrology practice in obtaining informed consent for dialysis falls short of ethical and legal requirements. Meeting these requirements represents a significant challenge, especially because the benefits and risks of dialysis have shifted significantly with the growing number of older, comorbid patients. The importance of informed consent for dialysis is heightened by several concerns, including: ( 1 ) the proportion of predialysis patients and patients on dialysis who lack capacity in decision making and ( 2 ) whether older, comorbid, and frail patients understand their poor prognosis and the full implications to their independence and functional status of being on dialysis. This article outlines the ethical and legal requirements for a valid informed consent to dialysis: ( 1 ) the patient was competent, ( 2 ) the consent was made voluntarily, and ( 3 ) the patient was given sufficient information in an understandable manner to make the decision. It then considers the application of these requirements to practice across different countries. In the process of informed consent, the law requires a discussion by the physician of the material risks associated with dialysis and alternative options. We argue that, legally and ethically, this discussion should include both the anticipated trajectory of the illness and the effect on the life of the patient with particular regard to the outcomes most important to the individual. In addition, a discussion should occur about the option of a conservative, nondialysis pathway. These requirements ensure that the ethical principle of respect for patient autonomy is honored in the context of dialysis. Nephrologists need to be open to, comfortable with, and skillful in communicating this information. From these clear, open, ethically, and legally valid consent discussions, a significant dividend will hopefully flow for patients, families, and nephrologists alike. Copyright © 2017 by the American Society of Nephrology.

Autonomy and informed consent: a mistaken association?

PubMed

Kristinsson, Sigurdur

2007-09-01

For decades, the greater part of efforts to improve regulatory frameworks for research ethics has focused on informed consent procedures; their design, codification and regulation. Why is informed consent thought to be so important? Since the publication of the Belmont Report in 1979, the standard response has been that obtaining informed consent is a way of treating individuals as autonomous agents. Despite its political success, the philosophical validity of this Belmont view cannot be taken for granted. If the Belmont view is to be based on a conception of autonomy that generates moral justification, it will either have to be reinterpreted along Kantian lines or coupled with a something like Mill's conception of individuality. The Kantian interpretation would be a radical reinterpretation of the Belmont view, while the Millian justification is incompatible with the liberal requirement that justification for public policy should be neutral between controversial conceptions of the good. This consequence might be avoided by replacing Mill's conception of individuality with a procedural conception of autonomy, but I argue that the resulting view would in fact fail to support a non-Kantian, autonomy-based justification of informed consent. These difficulties suggest that insofar as informed consent is justified by respect for persons and considerations of autonomy, as the Belmont report maintained, the justification should be along the lines of Kantian autonomy and not individual autonomy.

US public cord blood banking practices: recruitment, donation, and the timing of consent.

PubMed

Broder, Sherri M; Ponsaran, Roselle S; Goldenberg, Aaron J

2013-03-01

Cord blood has moved rapidly from an experimental stem cell source to an accepted and important source of hematopoietic stem cells. There has been no comprehensive assessment of US public cord blood banking practices since the Institute of Medicine study in 2005. Of 34 US public cord blood banks identified, 16 participated in our qualitative survey of public cord blood banking practices. Participants took part in in-depth telephone interviews in which they were asked structured and open-ended questions regarding recruitment, donation, and the informed consent process at these banks. Thirteen of 16 participants reported a variably high percentage of women who consented to public cord blood donation. Fifteen banks offered donor registration at the time of hospital admission for labor and delivery. Seven obtained full informed consent and medical history during early labor and eight conducted some form of phased consent and/or phased medical screening and history. Nine participants identified initial selection of the collection site location as the chief mode by which they recruited minority donors. Since 2005, more public banks offer cord blood donor registration at the time of admission for labor and delivery. That and the targeted location of cord blood collection sites are the main methods used to increase access to donation and HLA diversity of banked units. Currently, the ability to collect and process donations, rather than donor willingness, is the major barrier to public cord blood banking. © 2012 American Association of Blood Banks.

Effect of social support on informed consent in older adults with Parkinson disease and their caregivers.

PubMed

Ford, M E; Kallen, M; Richardson, P; Matthiesen, E; Cox, V; Teng, E J; Cook, K F; Petersen, N J

2008-01-01

To evaluate the effects of social support on comprehension and recall of consent form information in a study of Parkinson disease patients and their caregivers. Comparison of comprehension and recall outcomes among participants who read and signed the consent form accompanied by a family member/friend versus those of participants who read and signed the consent form unaccompanied. Comprehension and recall of consent form information were measured at one week and one month respectively, using Part A of the Quality of Informed Consent Questionnaire (QuIC). The mean age of the sample of 143 participants was 71 years (SD = 8.6 years). Analysis of covariance was used to compare QuIC scores between the intervention group (n = 70) and control group (n = 73). In the 1-week model, no statistically significant intervention effect was found (p = 0.860). However, the intervention status by patient status interaction was statistically significant (p = 0.012). In the 1-month model, no statistically significant intervention effect was found (p = 0.480). Again, however, the intervention status by patient status interaction was statistically significant (p = 0.040). At both time periods, intervention group patients scored higher (better) on the QuIC than did intervention group caregivers, and control group patients scored lower (worse) on the QuIC than did control group caregivers. Social support played a significant role in enhancing comprehension and recall of consent form information among patients.

Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning.

PubMed

Klein, Eran

2016-10-01

Implantable brain-computer interface (BCI) technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified-short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains-risks pertaining to identity, agency, and stigma-are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants.

Research Participants’ Understanding of and Reactions to Certificates of Confidentiality

PubMed Central

Check, Devon K.; Ammarell, Natalie

2013-01-01

Background Certificates of Confidentiality are intended to facilitate participation in critical public health research by protecting against forced disclosure of identifying data in legal proceedings, but little is known about the effect of Certificate descriptions in consent forms. Methods To gain preliminary insights, we conducted qualitative interviews with 50 HIV-positive individuals in Durham, North Carolina to explore their subjective understanding of Certificate descriptions and whether their reactions differed based on receiving a standard versus simplified description. Results Most interviewees were neither reassured nor alarmed by Certificate information, and most said it would not influence their willingness to participate or provide truthful information. However, compared with those receiving the simplified description, more who read the standard description said it raised new concerns, that their likelihood of participating would be lower, and that they might be less forthcoming. Most interviewees said they found the Certificate description clear, but standard-group participants often found particular words and phrases confusing, while simplified-group participants more often questioned the information’s substance. Conclusions Valid informed consent requires comprehension and voluntariness. Our findings highlight the importance of developing consent descriptions of Certificates and other confidentiality protections that are simple and accurate. These qualitative results provide rich detail to inform a larger, quantitative study that would permit further rigorous comparisons. PMID:24563806

Informed consent: what does it mean?

PubMed Central

Kirby, M D

1983-01-01

The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number of specially vulnerable groups are then identified, the most important, and vexed, being children. How can informed consent be secured in the case of young patients? Finally, a few problems are mentioned in an attempt to get this subject back to reality. The appeal to the principle primum non nocere may be medical paternalism in disguise. Informed consent is the competing principle that reminds us of the primacy of human autonomy. A pointer is given to the future: even the use of sound recordings to explain medical procedures and to activate informed consent so that it may become a reality and not just a lawyer's myth, should be considered. PMID:6876100

WASP (Write a Scientific Paper): Informed consent in research.

PubMed

Mallia, Pierre

2018-05-03

The autonomy of patients participating in research means that a proper informed consent process must take place. This means that information must be given according to a reasonable person standard implying what legally and ethical a reasonable person participating in the research would want to know. The research must assure that the patient has understood all the information given and that a voluntary choice has been made. This means that no form of coercion must take place and that information must not be manipulated in such a way as to influence the participant. No undue pressure or persuasion must either occur. Particular attention must be paid to vulnerable groups and participants must be competent and have the capacity to consent. Where necessary the use of a proxy to act on behalf of a patient who does not have legal capacity must be used and the best interests of the patient must be asserted. In research consent must always include a signed consent form which again is duly explained and authorized by the research ethics committee. Copyright © 2018. Published by Elsevier B.V.

Reflecting on Earlier Experiences with Unsolicited Findings: Points to Consider for Next-Generation Sequencing and Informed Consent in Diagnostics

PubMed Central

Rigter, Tessel; Henneman, Lidewij; Kristoffersson, Ulf; Hall, Alison; Yntema, Helger G; Borry, Pascal; Tönnies, Holger; Waisfisz, Quinten; Elting, Mariet W; Dondorp, Wybo J; Cornel, Martina C

2013-01-01

High-throughput nucleotide sequencing (often referred to as next-generation sequencing; NGS) is increasingly being chosen as a diagnostic tool for cases of expected but unresolved genetic origin. When exploring a higher number of genetic variants, there is a higher chance of detecting unsolicited findings. The consequential increased need for decisions on disclosure of these unsolicited findings poses a challenge for the informed consent procedure. This article discusses the ethical and practical dilemmas encountered when contemplating informed consent for NGS in diagnostics from a multidisciplinary point of view. By exploring recent similar experiences with unsolicited findings in other settings, an attempt is made to describe what can be learned so far for implementing NGS in standard genetic diagnostics. The article concludes with a set of points to consider in order to guide decision-making on the extent of return of results in relation to the mode of informed consent. We hereby aim to provide a sound basis for developing guidelines for optimizing the informed consent procedure. PMID:23784691

A Framework for Analysis of Research Risks and Benefits to Participants in Standard of Care Pragmatic Clinical Trials

PubMed Central

Chen, Stephanie C; Kim, Scott Y H

2016-01-01

Background/Aims Standard of care pragmatic clinical trials (SCPCTs) that compare treatments already in use could improve care and reduce cost but there is considerable debate about the research risks of SCPCTs and how to apply informed consent regulations to such trials. We sought to develop a framework integrating the insights from opposing sides of the debate. Methods We developed a formal risk-benefit analysis framework for SCPCTs and then applied it to key provisions of the U.S. federal regulations. Results Our formal framework for SCPCT risk-benefit analysis takes into account three key considerations: the ex ante estimates of risks and benefits of the treatments to be compared in a SCPCT, the allocation ratios of treatments inside and outside a SCPCT, and the significance of some participants receiving a different treatment inside a SCPCT than outside the trial. The framework provides practical guidance on how the research ethics regulations on informed consent should be applied to SCPCTs. Conclusions Our proposed formal model makes explicit the relationship between the concepts used by opposing sides of the debate about the research risks of SCPCTs and can be used to clarify the implications for informed consent. PMID:27365010

Informed Consent for Radiation in Interventional Radiology Procedures.

PubMed

Zener, Rebecca; Johnson, Peter; Wiseman, Daniele; Pandey, Sachin; Mujoomdar, Amol

2018-02-01

To explore the patient perception on radiation-related cancer risk from interventional radiology (IR) procedures and whether informed radiation consent is warranted. A multiple-choice survey was prospectively administered to 68 adults undergoing a body or neuro-IR procedure with ionizing radiation exposure. Subgroup analysis with chi-square or Fisher exact test was performed based on patient past IR history (P < .05). A total of 81% of patients wanted to be informed if there was a radiation-related 3% increased cancer risk over 5 years. Although 55% considered 3% a small risk, 28% wanted to further discuss the risks and alternate options, and 15% would have only proceeded if it were a life-saving procedure: 89%, 80%, and 67% of patients wanted to be informed with exposure risks of 1 in 100, 1 in 1000, and 1 in 10,000, respectively. Only 53% were aware they were going to be exposed to radiation, irrespective of past IR history (P = .15). Most patients believed radiation consent should include radiation-related cancer risks (85%). No past IR history was significantly associated with wanting consent to include cancer-related risk (100% vs 76%; P = .01) and deterministic risks (70% vs 41%; P = .04). A majority (69%) believed both the referring physician and the interventional radiologist were responsible for obtaining radiation consent, and 65% of patients wanted verbal consent followed by signed written consent, regardless of past IR history. Many patients want to discuss cancer-related radiation risks with both radiologists and physicians. Informed radiation consent should be considered for procedures with high anticipated radiation doses. Copyright © 2017. Published by Elsevier Inc.

78 FR 36815 - 30-Day Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

...: Statement of Consent: Issuance of a U.S. Passport to a Minor Under Age 16 ACTION: Notice of request for... Information Collection: Statement of Consent: Issuance of a U.S. Passport to a Minor under Age 16. OMB Control...: Bureau of Consular Affairs, Passport Services, Office of Program Management and Operational Support...

77 FR 74044 - 60-Day Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-12

...: Statement of Consent: Issuance of a U.S. Passport to a Minor Under Age 16 ACTION: Notice of request for... Information Collection: Statement of Consent: Issuance of a U.S. Passport to a Minor under Age 16. OMB Control...: Bureau of Consular Affairs, Passport Services, Office of Program Management and Operational Support...

A written consent form dating back to 1524 in Bursa Ser'iye (Sharia Court) records and a proposal of a new start date for consent forms.

PubMed

Sayligil, Omur; Ozden, Hilmi

2014-01-01

Qadi registers are important documents for Ottoman medical history re.search. "Sharia Court Records (Ser'iyye Sicilleri)" are notebooks that include the records that qadis kept with regard to their decisions and deeds. These registers are the only authentic sources from which to acquire information on rural life, away from the center of the town, and to understand the daily practices of the Ottoman society. The objective of this study is to provide evidence for the fact that the concept of informed consent on medical interventions, and hence the written consent documents arranged between patients and physicians, dates back to older times in our history when compared to the Western world. A large number of Ser'iyye (Sharia Court) record originals have been surveyed. The consent form registered as A-40. 221a in Ser'iyye (Sharia Court) Records found in Bursa has been presented here as the earliest consent document found by the authors. Transcription of the original document has been performed and analyzed. The aforementioned consent form dates back to 26/Dhu al-Qi'dah/933 (August 24, 1524). The original version of the referenced consent document is the earliest consent document presented so far to the best of the authors' knowledge; it was found in Bursa Ser'iyye Records and evaluated accordingly. Based on the document, it is argued that the history of consent forms dates back about 500 years. Obtaining consent in scientific research from human beings was considered to have originated from the Nuremberg Code (1949). However, with this study, it has been shown that the concept of informed consent was already present in the Ottoman Period, during the 16th century, and that the original consent document dates back to 1524, pertaining to a surgical intervention.

Consent for third molar tooth extractions in Australia and New Zealand: a review of current practice.

PubMed

Badenoch-Jones, E K; Lynham, A J; Loessner, D

2016-06-01

Informed consent is the legal requirement to educate a patient about a proposed medical treatment or procedure so that he or she can make informed decisions. The purpose of the study was to examine the current practice for obtaining informed consent for third molar tooth extractions (wisdom teeth) by oral and maxillofacial surgeons in Australia and New Zealand. An online survey was sent to 180 consultant oral and maxillofacial surgeons in Australia and New Zealand. Surgeons were asked to answer (yes/no) whether they routinely warned of a specific risk of third molar tooth extraction in their written consent. Seventy-one replies were received (39%). The only risks that surgeons agreed should be routinely included in written consent were a general warning of infection (not alveolar osteitis), inferior alveolar nerve damage (temporary and permanent) and lingual nerve damage (temporary and permanent). There is significant variability among Australian and New Zealand oral and maxillofacial surgeons regarding risk disclosure for third molar tooth extractions. We aim to improve consistency in consent for third molar extractions by developing an evidence-based consent form. © 2016 Australian Dental Association.

Development of a Video Tape Teaching Module To Facilitate the Patient's Understanding of Chemotherapy.

ERIC Educational Resources Information Center

Vernot, Gertrude W.

A practicum project was conducted to develop a method to enhance the knowledge base of targeted adult cancer patients entering into a treatment plan that included chemotherapy. The educational component necessary for informed consent by the patient had not been consistent; therefore, a videotape was developed containing general information common…

Patients' views of the consent process for adult cardiac surgery: questionnaire survey.

PubMed

Howlader, Mohammad H; Dhanji, Al-Rehan; Uppal, Rakesh; Magee, Patrick; Wood, Alan J; Anyanwu, Ani C

2004-12-01

Consent for surgical procedures has assumed increasing importance in surgical practice in recent days especially following the public inquiry into paediatric cardiac surgery deaths at Bristol in the UK. This study examines patient perceptions and recollections following surgical consent as currently practised in a UK cardiac unit. One hundred consecutive patients who underwent cardiac surgery in a London teaching hospital from January to February 2003 were studied. Patients completed questionnaires a day before their discharge from the hospital. The majority of patients (89/100) responded that the information given at consent had been adequate or more than adequate. The time spent on the consent process was thought to be adequate by 91 patients. Eleven patients felt the consent had been insensitive. Several patients (38/100) felt use of booklets in preference to verbal explanations would be less intimidating. For most patients (94/100) the operation and postoperative course met their expectations; although 12 patients experienced untold complications, only five felt that they should have been informed of the possibility of the complication. Although most patients were informed of the risk of death during consent, at time of discharge 43 had forgotten the figure that had been quoted. Regarding the influence of media and publicity, 19 patients said that media had influenced their expectations of the consent process, 59 would have liked to see hospital league tables while 26 would have liked to know the mortality figures for their surgeon prior to giving consent. Our study shows that patients undergoing cardiac surgery are largely satisfied with our improved consent procedures in the post-Bristol era. Use of booklets may be a useful adjunct to verbal consent as currently practised.

A survey of study participants' understanding of informed consent to participate in a randomised controlled trial of acupuncture.

PubMed

Smith, Caroline A; Fogarty, Sarah

2016-01-12

It is important that potential study participants are appropriately informed and understand what is involved with their research participation. A few studies have examined study participants' understanding of the informed consent process and the adequacy of the information they received when agreeing to participate in a randomised controlled trial. Deficiencies in the consent process have been found. This topic remains an under researched area of acupuncture research. The aim of this study was to examine participants' understanding of their informed consent and the adequacy of the information presented when agreeing to participate in a randomised controlled trial of acupuncture. All women who participated in a randomised controlled trial over an 11 month period were invited to participate in a survey. An anonymous self-completion questionnaire was designed and covered participants' understanding of informed consent in the clinical trial, their views of the information provided, the opportunity to ask questions, the use of sham acupuncture, their recall of study visits and processes for withdrawal, and their reason for participating in the trial. A response rate of 59% was obtained. Over 90% of subjects indicated there was plenty of opportunity to discuss the study prior to giving consent, and 89% indicated that questions asked were answered to their satisfaction. The majority of women indicated the amount of information describing acupuncture was about right, however 24% would have liked more. Information describing sham acupuncture was not considered adequate by 48% of women, and 35% would have liked more information, 30% could not recall why, or were uncertain why a sham group was used. Participants indicated less understanding of the information relating to payment if they became ill due to study participation, risks and discomforts from the study interventions, which of the procedures were experimental and for how long they would be involved in the study. Trial participants' understanding of informed consent was overall satisfactory but highlighted some areas of deficiency. Future studies could consider use of supplementary material such as Q and A fact sheets.

[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].

PubMed

Giménez, Nuria; Pedrazas, David; Redondo, Susana; Quintana, Salvador

2016-10-01

Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. GPs, researchers and patients involved in clinical trials. Included, 504 GPs, 108 researchers, and 71 patients. Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Consent for participating in clinical trials - Is it really informed?

PubMed

Alexa-Stratulat, Teodora; Neagu, Marius; Neagu, Anca-Iulia; Alexa, Ioana Dana; Ioan, Beatrice Gabriela

2018-06-22

The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north-eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants' decision-making is meaningful and that their interests are protected. © 2018 John Wiley & Sons Ltd.

Informed consent in medical decision-making in commercial gestational surrogacy: a mixed methods study in New Delhi, India.

PubMed

Tanderup, Malene; Reddy, Sunita; Patel, Tulsi; Nielsen, Birgitte Bruun

2015-05-01

To investigate ethical issues in informed consent for decisions regarding embryo transfer and fetal reduction in commercial gestational surrogacy. Mixed methods study employing observations, an interview-guide and semi-structured interviews. Fertility clinics and agencies in Delhi, India, between December 2011 and December 2012. Doctors providing conceptive technologies to commissioning couples and carrying out surrogacy procedures; surrogate mothers; agents functioning as links for surrogacy. Interviews using semi-structured interview guides were carried out among 20 doctors in 18 fertility clinics, five agents from four agencies and 14 surrogate mothers. Surrogate mothers were interviewed both individually and in the presence of doctors and agents. Data on socio-economic context and experiences among and between various actors in the surrogacy process were coded to identify categories of ethical concern. Numerical and grounded theory-oriented analyses were used. Informed consent, number of embryos transferred, fetal reduction, conflict of interest among the involved parties. None of the 14 surrogate mothers were able to explain the risks involved in embryo transfer and fetal reduction. The majority of the doctors took unilateral decisions about embryo transfer and fetal reduction. The commissioning parents were usually only indirectly involved. In the qualitative analysis, difficulties in explaining procedures, autonomy, self-payment of fertility treatment and conflicts of interest were the main themes. Clinical procedural decisions were primarily made by the doctors. Surrogate mothers were not adequately informed. There is a need for regulation on decision-making procedures to safeguard the interests of surrogate mothers. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

Informed consent document improvement does not increase patients' comprehension in biomedical research

PubMed Central

Paris, Adeline; Brandt, Christian; Cornu, Catherine; Maison, Patrick; Thalamas, Claire; Cracowski, Jean-Luc

2010-01-01

AIMS International guidelines on ethics in biomedical research require that the informed consent of all enrolled participants is obtained. A written document describing the research, the informed consent (IC) document, must be given to all participants by the investigator. Most IC documents are long, containing much information. The aim of the present study was to determine whether the modification of the IC document by a working group or systematic improvement in its lexicosyntactic readability can improve comprehension of the written information given to patients participating in biomedical research. METHODS One hundred and fifty-nine patients were randomized to read one of the three versions of the IC document: unchanged document, document modified using systematic improvement of lexicosyntactic readability and document modified by a working group. RESULTS Neither the improvement in the lexicosyntactic readability, nor the intervention of the working group significantly improved the score of objective comprehension for the subjects included in this study: it was 66.6 (95% confidence interval 64.0, 69.2) for the control group, 68.8 (66.2, 71.4) for the group with the document improved for lexicosyntactic readability and 69.2 (66.0, 72.4) for the group who read the document improved by the working group (P= 0.38). CONCLUSIONS We failed to show that improving IC document comprehension through a lexicosyntactic approach or by a working group leads to better comprehension. PMID:20233193

A Development of Automatic Audit System for Written Informed Consent using Machine Learning.

PubMed

Yamada, Hitomi; Takemura, Tadamasa; Asai, Takahiro; Okamoto, Kazuya; Kuroda, Tomohiro; Kuwata, Shigeki

2015-01-01

In Japan, most of all the university and advanced hospitals have implemented both electronic order entry systems and electronic charting. In addition, all medical records are subjected to inspector audit for quality assurance. The record of informed consent (IC) is very important as this provides evidence of consent from the patient or patient's family and health care provider. Therefore, we developed an automatic audit system for a hospital information system (HIS) that is able to evaluate IC automatically using machine learning.

Doctors, Patients, and Nudging in the Clinical Context--Four Views on Nudging and Informed Consent.

PubMed

Ploug, Thomas; Holm, Søren

2015-01-01

In an analysis of recent work on nudging we distinguish three positions on the relationship between nudging founded in libertarian paternalism and the protection of personal autonomy through informed consent. We argue that all three positions fail to provide adequate protection of personal autonomy in the clinical context. Acknowledging that nudging may be beneficial, we suggest a fourth position according to which nudging and informed consent are valuable in different domains of interaction.

Chemically dependent physicians and informed consent disclosure.

PubMed

Ackerman, T F

1996-01-01

Developments in law, professional guidelines, and public attitudes support informed consent disclosure by physicians who have been treated for chemical dependency. This view is built on the apparent materiality of the risk of relapse to informed treatment decisions by patients. Several considerations undercut this position. The probability is remote that a patient will be injured by a recovering physician who suffers an undetected relapse while being properly monitored. Monitoring by impaired physicians programs provides a more sensitive and specific mechanism for detecting relapsed physicians. Moreover, compromise of the privacy and employment rights of recovering physicians by consent disclosure is not justified if programs provide rigorous monitoring that protects the welfare of patients. Finally, required consent disclosure will reduce referrals of chemically dependent physicians to impaired physicians programs, thereby increasing the danger to patients. Limiting demands for required consent disclosure necessitates effective operation of impaired physicians programs.

75 FR 25268 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-07

...; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are... on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are...-796-5156, email: [email protected] . SUPPLEMENTARY INFORMATION: In the Federal Register of...

Informed consent from cognitively impaired persons participating in research trials: comparative law observations.

PubMed

Petrini, Carlo

2011-01-01

This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

Consent and refusal in dementia research: conceptual and practical considerations.

PubMed

Cohen-Mansfield, J

2003-01-01

This article discusses types of consent refusals, rates of refusal, factors that affect consent, and methods to increase rates of consent in elderly research participants and in those with dementia in particular. Refusals can be categorized according to several types: complete refusal, refusal that is time-contingent, partial refusal, and contingent agreement. Rates of consent vary greatly across studies of persons with dementia. This variation can also be affected by different methodologies of calculating rates, in addition to differences in content of studies, populations, and procedures. To warrant consent, a study must first be scientifically sound, with a high likelihood of advancing knowledge, and must provide maximal protection to participants. Consent rates are affected by the following factors: levels of anticipated risks and benefits of the study, relationships among the different caregivers involved in the care of the potential subject, the ability of the researcher to properly identify and locate the person who needs to provide consent, characteristics and attitudes of the person providing consent, and the method of obtaining consent, including timing, location, method of presentation, and type of consent requested. An understanding of these issues can assist the researcher in tailoring research procedures so as to maximize rates of consent. It also raises ethical issues that warrant further discussion concerning the process of obtaining consent from and for persons with dementia.

Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries.

PubMed

Kabakama, Severin; Gallagher, Katherine E; Howard, Natasha; Mounier-Jack, Sandra; Burchett, Helen E D; Griffiths, Ulla K; Feletto, Marta; LaMontagne, D Scott; Watson-Jones, Deborah

2016-08-19

Social mobilisation during new vaccine introductions encourages acceptance, uptake and adherence to multi-dose schedules. Effective communication is considered especially important for human papillomavirus (HPV) vaccine, which targets girls of an often-novel age group. This study synthesised experiences and lessons learnt around social mobilisation, consent, and acceptability during 55 HPV vaccine demonstration projects and 8 national programmes in 37 low and middle-income countries (LMICs) between January 2007 and January 2015. A qualitative study design included: (i) a systematic review, in which 1,301 abstracts from five databases were screened and 41 publications included; (ii) soliciting 124 unpublished documents from governments and partner institutions; and (iii) conducting 27 key informant interviews. Data were extracted and analysed thematically. Additionally, first-dose coverage rates were categorised as above 90 %, 90-70 %, and below 70 %, and cross-tabulated with mobilisation timing, message content, materials and methods of delivery, and consent procedures. All but one delivery experience achieved over 70 % first-dose coverage; 60 % achieved over 90 %. Key informants emphasized the benefits of starting social mobilisation early and actively addressing rumours as they emerged. Interactive communication with parents appeared to achieve higher first-dose coverage than non-interactive messaging. Written parental consent (i.e., opt-in), though frequently used, resulted in lower reported coverage than implied consent (i.e., opt-out). Protection against cervical cancer was the primary reason for vaccine acceptability, whereas fear of adverse effects, exposure to rumours, lack of project/programme awareness, and schoolgirl absenteeism were major reasons for non-vaccination. Despite some challenges in obtaining parental consent and addressing rumours, experiences indicated effective social mobilisation and high HPV vaccine acceptability in LMICs. Social mobilisation, consent, and acceptability lessons were consistent across world regions and HPV vaccination projects/programmes. These can be used to guide HPV vaccination communication strategies without additional formative research.

Attitudes of the Japanese public and doctors towards use of archived information and samples without informed consent: preliminary findings based on focus group interviews.

PubMed

Asai, Atsushi; Ohnishi, Motoki; Nishigaki, Etsuyo; Sekimoto, Miho; Fukuhara, Shunichi; Fukui, Tsuguya

2002-01-09

The purpose of this study is to explore laypersons' attitudes toward the use of archived (existing) materials such as medical records and biological samples and to compare them with the attitudes of physicians who are involved in medical research. Three focus group interviews were conducted, in which seven Japanese male members of the general public, seven female members of the general public and seven physicians participated. It was revealed that the lay public expressed diverse attitudes towards the use of archived information and samples without informed consent. Protecting a subject's privacy, maintaining confidentiality, and communicating the outcomes of studies to research subjects were regarded as essential preconditions if researchers were to have access to archived information and samples used for research without the specific informed consent of the subjects who provided the material. Although participating physicians thought that some kind of prior permission from subjects was desirable, they pointed out the difficulties involved in obtaining individual informed consent in each case. The present preliminary study indicates that the lay public and medical professionals may have different attitudes towards the use of archived information and samples without specific informed consent. This hypothesis, however, is derived from our focus groups interviews, and requires validation through research using a larger sample.

Impact of individual clinical outcomes on trial participants' perspectives on enrollment in emergency research without consent.

PubMed

Whitesides, Louisa W; Baren, Jill M; Biros, Michelle H; Fleischman, Ross J; Govindarajan, Prasanthi R; Jones, Elizabeth B; Pancioli, Arthur M; Pentz, Rebecca D; Scicluna, Victoria M; Wright, David W; Dickert, Neal W

2017-04-01

Evidence suggests that patients are generally accepting of their enrollment in trials for emergency care conducted under exception from informed consent. It is unknown whether individuals with more severe initial injuries or worse clinical outcomes have different perspectives. Determining whether these differences exist may help to structure post-enrollment interactions. Primary clinical data from the Progesterone for the Treatment of Traumatic Brain Injury trial were matched to interview data from the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study. Answers to three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study were analyzed in the context of enrolled patients' initial injury severity (initial Glasgow Coma Scale and Injury Severity Score) and principal clinical outcomes (Extended Glasgow Outcome Scale and Extended Glasgow Outcome Scale relative to initial injury severity). The three key questions from Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study addressed participants' general attitude toward inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial (general trial inclusion), their specific attitude toward being included in Progesterone for the Treatment of Traumatic Brain Injury trial under the exception from informed consent (personal exception from informed consent enrollment), and their attitude toward the use of exception from informed consent in the Progesterone for the Treatment of Traumatic Brain Injury trial in general (general exception from informed consent enrollment). Qualitative analysis of interview transcripts was performed to provide contextualization and to determine the extent to which respondents framed their attitudes in terms of clinical experience. Clinical data from Progesterone for the Treatment of Traumatic Brain Injury trial were available for all 74 patients represented in the Patients' Experiences in Emergency Research-Progesterone for the Treatment of Traumatic Brain Injury study (including 46 patients for whom the surrogate was interviewed due to the patient's cognitive status or death). No significant difference was observed regarding acceptance of general trial inclusion or acceptance of general exception from informed consent enrollment between participants with favorable neurological outcomes and those with unfavorable outcomes relative to initial injury. Agreement with personal enrollment in Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent, however, was significantly higher among participants with favorable outcomes compared to those with unfavorable outcomes (89% vs 59%, p = 0.003). There was also a statistically significant relationship between more severe initial injury and increased acceptance of personal exception from informed consent enrollment ( p = 0.040) or general exception from informed consent use ( p = 0.034) in Progesterone for the Treatment of Traumatic Brain Injury trial. Many individuals referenced personal experience as a basis for their attitudes, but these references were not used to support negative views. Patients and surrogates of patients with unfavorable clinical outcomes were somewhat less accepting of their own inclusion in the Progesterone for the Treatment of Traumatic Brain Injury trial under exception from informed consent than were patients or surrogates of patients with favorable clinical outcomes. These findings suggest a need to identify optimal strategies for communicating with patients and their surrogates regarding exception from informed consent enrollment when clinical outcomes are poor.

46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 9 2010-10-01 2010-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S [§ 502.304(e)] of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND.... 502, Subpt. S, Exh. 2 Exhibit No. 2 to Subpart S [§ 502.304(e)] of Part 502—Respondent's Consent Form...

Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial.

PubMed

Andrews, Joseph E; Moore, J Brian; Weinberg, Richard B; Sissine, Mysha; Gesell, Sabina; Halladay, Jacquie; Rosamond, Wayne; Bushnell, Cheryl; Jones, Sara; Means, Paula; King, Nancy M P; Omoyeni, Diana; Duncan, Pamela W

2018-05-02

Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

42 CFR 441.258 - Consent form requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Consent form requirements. 441.258 Section 441.258... informed consent as set forth on the consent form; and (iii) To the best of his or her knowledge and belief...) To the best of his or her knowledge and belief, the individual appeared mentally competent and...

Organ Donation in Switzerland - An Analysis of Factors Associated with Consent Rate

PubMed Central

Keel, Isabelle; Immer, Franz F.; Jüni, Peter

2014-01-01

Background and Aim Switzerland has a low post mortem organ donation rate. Here we examine variables that are associated with the consent of the deceased’s next of kin (NOK) for organ donation, which is a prerequisite for donation in Switzerland. Methods and Analysis During one year, we registered information from NOK of all deceased patients in Swiss intensive care units, who were approached for consent to organ donation. We collected data on patient demographics, characteristics of NOK, factors related to the request process and to the clinical setting. We analyzed the association of collected predictors with consent rate using univariable logistic regression models; predictors with p-values <0.2 were selected for a multivariable logistic regression. Results Of 266 NOK approached for consent, consent was given in 137 (51.5%) cases. In multivariable analysis, we found associations of consent rates with Swiss nationality (OR 3.09, 95% CI: 1.46–6.54) and German language area (OR 0.31, 95% CI: 0.14–0.73). Consent rates tended to be higher if a parent was present during the request (OR 1.76, 95% CI: 0.93–3.33) and if the request was done before brain death was formally declared (OR 1.87, 95% CI: 0.90–3.87). Conclusion Establishing an atmosphere of trust between the medical staff putting forward a request and the NOK, allowing sufficient time for the NOK to consider donation, and respecting personal values and cultural differences, could be of importance for increasing donation rates. Additional measures are needed to address the pronounced differences in consent rates between language regions. PMID:25208215

Electronic processing of informed consents in a global pharmaceutical company environment.

PubMed

Vishnyakova, Dina; Gobeill, Julien; Oezdemir-Zaech, Fatma; Kreim, Olivier; Vachon, Therese; Clade, Thierry; Haenning, Xavier; Mikhailov, Dmitri; Ruch, Patrick

2014-01-01

We present an electronic capture tool to process informed consents, which are mandatory recorded when running a clinical trial. This tool aims at the extraction of information expressing the duration of the consent given by the patient to authorize the exploitation of biomarker-related information collected during clinical trials. The system integrates a language detection module (LDM) to route a document into the appropriate information extraction module (IEM). The IEM is based on language-specific sets of linguistic rules for the identification of relevant textual facts. The achieved accuracy of both the LDM and IEM is 99%. The architecture of the system is described in detail.

Informed Decision Making in Maternity Care

PubMed Central

Goldberg, Holly

2009-01-01

In the United States, federal acts and regulations, as well as professional guidelines, clearly dictate that every pregnant woman has the right to base her maternity care decisions on accurate, up-to-date, comprehensible information. Despite these efforts, evidence suggests that informed consent within current health-care practice is restricted and inconsistently implemented. Patient access to evidence-based research is imperative under the scope of informed consent and is particularly important during a time when perinatal mortality and morbidity rates, interventions, and disparities are on the rise in the United States. This article describes the Coalition for Improving Maternity Services’ investigation of the breakdown of informed consent in maternity care. PMID:19436598

Implementation of Electronic Consent at a Biobank: An Opportunity for Precision Medicine Research

PubMed Central

Boutin, Natalie T.; Mathieu, Kathleen; Hoffnagle, Alison G.; Allen, Nicole L.; Castro, Victor M.; Morash, Megan; O’Rourke, P. Pearl; Hohmann, Elizabeth L.; Herring, Neil; Bry, Lynn; Slaugenhaupt, Susan A.; Karlson, Elizabeth W.; Weiss, Scott T.; Smoller, Jordan W.

2016-01-01

The purpose of this study is to characterize the potential benefits and challenges of electronic informed consent (eIC) as a strategy for rapidly expanding the reach of large biobanks while reducing costs and potentially enhancing participant engagement. The Partners HealthCare Biobank (Partners Biobank) implemented eIC tools and processes to complement traditional recruitment strategies in June 2014. Since then, the Partners Biobank has rigorously collected and tracked a variety of metrics relating to this novel recruitment method. From June 2014 through January 2016, the Partners Biobank sent email invitations to 184,387 patients at Massachusetts General Hospital and Brigham and Women’s Hospital. During the same time period, 7078 patients provided their consent via eIC. The rate of consent of emailed patients was 3.5%, and the rate of consent of patients who log into the eIC website at Partners Biobank was 30%. Banking of biospecimens linked to electronic health records has become a critical element of genomic research and a foundation for the NIH’s Precision Medicine Initiative (PMI). eIC is a feasible and potentially game-changing strategy for these large research studies that depend on patient recruitment. PMID:27294961

Success of University Student Volunteers in Obtaining Consent for Reviewing Private Health Information for Emergency Research.

PubMed

Kramer, Adam I; Stephenson, Elizabeth; Betel, Adam; Crudden, Johanna; Boutis, Kathy

2017-01-01

This study aimed to determine the success of university student volunteers in obtaining consent from parents to allow review of their child's personal health information (PHI) for emergency research screening. This study also aimed to examine the variables associated with successful consent. This was a prospective cross-sectional study conducted at a pediatric emergency department (ED). University students, who functioned as delegates of the health information custodian, approached parents for consent. Of 2,506 parents, 1,852 (73.9%) provided consent to allow review of their child's PHI for research screening. Variables associated with successful consent were high (≥12 months) versus low (<12 months) volunteer experience (OR = 2.0), research related (vs. unrelated) to the child's chief complaint (OR = 2.0), child treated regularly by specialists at the study institution (OR = 1.7), and ED presentation mid-week vs. weekend (OR = 1.7) and morning vs. evening presentation (OR = 1.4). When approached by a university student volunteer, about 25% of parents declined to have their child's PHI reviewed for research screening. This model of obtaining consent may put some emergency research at risk for selection bias. Variables that increase the odds of successful consent can be considered in program design to improve the effectiveness of this model.

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

Understanding the Public's Reservations about Broad Consent and Study-By-Study Consent for Donations to a Biobank: Results of a National Survey.

PubMed

De Vries, Raymond Gene; Tomlinson, Tom; Kim, Hyungjin Myra; Krenz, Chris; Haggerty, Diana; Ryan, Kerry A; Kim, Scott Y H

2016-01-01

Researchers and policymakers do not agree about the most appropriate way to get consent for the use of donations to a biobank. The most commonly used method is blanket-or broad-consent where donors allow their donation to be used for any future research approved by the biobank. This approach does not account for the fact that some donors may have moral concerns about the uses of their biospecimens. This problem can be avoided using "real-time"-or study-by-study-consent, but this policy places a significant burden on biobanks. In order to better understand the public's preferences regarding biobank consent policy, we surveyed a sample that was representative of the population of the United States. Respondents were presented with 5 biobank consent policies and were asked to indicate which policies were acceptable/unacceptable and to identify the best/worst policies. They were also given 7 research scenarios that could create moral concern (e.g. research intending to make abortions safer and more effective) and asked how likely they would be to provide broad consent knowing that their donation might be used in that research. Substantial minorities found both broad and study-by-study consent to be unacceptable and identified those two options as the worst policies. Furthermore, while the type of moral concern (e.g., regarding abortion, the commercial use of donations, or stem cell research) had no effect on policy preferences, an increase in the number of research scenarios generating moral concerns was related to an increased likelihood of finding broad consent to be the worst policy. The rejection of these ethically problematic and costly extremes is good news for biobanks. The challenge now is to design a policy that combines consent with access to information in a way that assures potential donors that their interests and moral concerns are being respected.

Familial Consent for Deceased Organ Donation Among Immigrants and Long-term Residents in Ontario, Canada: A Population-Based Retrospective Cohort Study

PubMed Central

Li, Alvin Ho-ting; Al-Jaishi, Ahmed A.; Weir, Matthew; Lam, Ngan N.; Maclean, Janet; Dhanani, Sonny; Kim, S. Joseph; Knoll, Greg; Garg, Amit X.

2017-01-01

Background: Many families choose not to consent to organ donation at the time of their loved one’s death. In Ontario, Canada, whether these decisions vary by ethnicity remains unclear. Objective: To compare the proportion of families of immigrants who consented for deceased organ donation with families of long-term residents. Design: Population-based retrospective cohort study. Setting: Potential donors in Ontario, Canada, between November 2008 and March 2013. Methods: We used linked administrative databases to study the proportion of families who consented for deceased organ donation. Results: Overall, of the 2873 families of potential donors approached, 1912 (67%) provided consent for deceased organ donation. Families of immigrants were less likely to provide consent compared with families of long-term residents (46% [135 of 291] vs 69% [1777 of 2582]; adjusted rate ratio (RR): 0.72; 95% confidence interval [CI]: 0.63-0.81). When examined by the country of birth, families of immigrants from the following regions were less likely to consent to organ donation compared with long-term residents: South Asia (RR: 0.71; 95% CI: 0.55-0.91), East Asia and Pacific (RR: 0.68; 95% CI: 0.53-0.88) and Middle East, North Africa, and sub-Saharan Africa (RR: 0.58; 95% CI: 0.37-0.91). Limitations: We could not determine why consent was not obtained. We had a small sample of immigrants. We only had access to the potential donors’ information and not the family member who was approached for consent. Many characteristics that we examined were nonmodifiable (eg, age, sex). Conclusions: In Ontario, families of immigrants are less likely to consent to deceased organ donation. There is an opportunity to better understand the reasons for lower consent among certain immigrant groups. PMID:29093824

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

40 CFR 26.1116 - General requirements for informed consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION OF HUMAN SUBJECTS Basic Ethical Requirements for Third-Party Human Research for Pesticides... informed consent. No investigator may involve a human being as a subject in research covered by this...

Return of results in translational iPS cell research: considerations for donor informed consent

PubMed Central

2013-01-01

Efforts have emerged internationally to recruit donors with specific disease indications and to derive induced pluripotent cell lines. These disease-specific induced pluripotent stem cell lines have the potential to accelerate translational goals such as drug discovery and testing. One consideration for donor recruitment and informed consent is the possibility that research will result in findings that are clinically relevant to the cell donor. Management protocols for such findings should be developed a priori and disclosed during the informed consent process. The California Institute for Regenerative Medicine has developed recommendations for informing donors in sponsored research. These recommendations include obtaining consent to recontact tissue donors for a range of scientific, medical and ethical considerations. This article reviews the basis for these recommendations and suggests conditions that may be appropriate when reporting findings to donors. PMID:23336317

Survey of the information given to patients about blood transfusion and the need for consent before transfusion.

PubMed

Murphy, M F; Docherty, S; Greenfield, P

1997-12-01

There is no current requirement in the United Kingdom to provide patients with information about blood transfusion or to seek their written consent to transfusion. To study patients' attitudes to these questions, a questionnaire survey was carried out on 51 patients during an admission to hospital in which they received a blood transfusion. The patients in this survey, although mostly satisfied about the information they were given before they were transfused, would have welcomed more general information about transfusion, mainly because of concerns about the risk of viral infections. Nearly 40% of patients thought that written consent should be obtained before transfusion, but the ethical and practical aspects of this issue are complex. Further debate would be required before implementation of written consent to transfusion could be considered as a routine policy.

Negligence in securing informed consent and medical malpractice.

PubMed

Perry, C

1988-01-01

The doctrine of informed consent requires that the patient must act voluntarily and in the light of adequate information in order to give legally valid consent to medical care. Different models have been developed by various courts to determine whether the informational requirement, what the physician must disclose to the patient about the potential risks of the proposed treatment, has been met under the tort theory of negligence. To prevail, the patient plaintiff must show that a particular jurisdiction's disclosure standard has been breached, that harm has resulted, and that the defendant physician's negligent failure to discuss certain risks was causally responsible for the patient's failure to withhold consent. Perry discusses possible problems of redundancy or inconsistency concerning the relationship between different models for disclosure and causality, and notes that these problems may have serious implications for patient autonomy.

Developing competency in post-graduate students of anaesthesiology for taking informed consent for elective caesarean section.

PubMed

Mehta, Kamla Harshad; Shah, Vandana Saurin; Patel, Kirti Dhirajlal

2017-02-01

Post-graduate medical students (residents) generally lack effective communication skills required to obtain informed consent. The aim of this study was to assess role play and group discussion as teaching/learning tools for improving residents' knowledge on informed consent and competency in communicating while taking informed consent. This prospective, observational study was conducted on 30 anaesthesia residents. They were first observed while obtaining informed consent and their basic knowledge regarding communication skills was checked with a pre-test questionnaire. Then, lecture and group discussion were carried out to increase the knowledge base, and their knowledge gain was checked by the same questionnaire as a post-test. Communication skills were demonstrated by role play and residents were assessed by direct unobtrusive observation using a checklist. Feedback regarding effectiveness of programme was taken from students. Statistical analyses were done using Microsoft Office Excel and SPSS software. Percentage gain was 122.37% for knowledge domain. For communication skills, mean ± standard deviation for checklist was 8.93 ± 1.43 before role play and it improved to 17.96 ± 1.29 after role play. Regarding effectiveness of role play as a teaching/learning tool, 76.66% of residents said they strongly agreed and 23.33% of residents said they agreed. Likert scale for evaluation of programme was graded 4 or 5 by all residents. The knowledge and communication skills required for obtaining informed consent was improved significantly after role playing.

Simplifying informed consent for biorepositories: stakeholder perspectives.

PubMed

Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

2010-09-01

Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.

Health Information Exchange: What do patients want?

PubMed

Medford-Davis, Laura N; Chang, Lawrence; Rhodes, Karin V

2017-12-01

To determine whether emergency department patients want to share their medical records across health systems through Health Information Exchange and if so, whether they prefer to sign consent or share their records automatically, 982 adult patients presenting to an emergency department participated in a questionnaire-based interview. The majority (N = 906; 92.3%) were willing to share their data in a Health Information Exchange. Half (N = 490; 49.9%) reported routinely getting healthcare outside the system and 78.6 percent reported having records in other systems. Of those who were willing to share their data in a Health Information Exchange, 54.3 percent wanted to sign consent but 90 percent of those would waive consent in the case of an emergency. Privacy and security were primary concerns of patients not willing to participate in Health Information Exchange and preferring to sign consent. Improved privacy and security protections could increase participation, and findings support consideration of "break-the-glass" provider access to Health Information Exchange records in an emergent situation.

Informed consent and moral integrity.

PubMed Central

Gillett, G R

1989-01-01

Informed consent is required for any medical procedure although the situations in which it is given are beset by uncertainties and indeterminacies. These make medicolegal scrutiny of such situations very difficult. Although some people find the decision in the Sidaway case incomprehensible because of its continuing regard for a 'professional practice standard' in informed consent, I will argue that an important fact in many cases is the moral integrity of the doctor concerned and the pattern of his practice. This may provide the only morally principled and legally accessible evidence enabling a correct decision to be made in a difficult case. Although the epistemological significance of a professional practice standard is thereby defended the 'prudent patient standard' for what counts as consent is left intact. PMID:2795625

Understandings of genomic research in developing countries: a qualitative study of the views of MalariaGEN participants in Mali.

PubMed

Traore, Karim; Bull, Susan; Niare, Alassane; Konate, Salimata; Thera, Mahamadou A; Kwiatkowski, Dominic; Parker, Michael; Doumbo, Ogobara K

2015-06-16

Obtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data. This study investigated researchers' and participants' parents' experiences of a consent process and understandings of a genome-wide association study of malaria involving children aged five and under in Mali. It aimed to inform best practices in recruiting participants into genomic research. A qualitative rapid ethical assessment was undertaken. Fifty-five semi-structured interviews were conducted with the parents of research participants. An additional nine semi-structured interviews were conducted with senior research scientists, research assistants and with a member of an ethics committee. A focus group with five parents of research participants and direct observations of four consent processes were also conducted. French and translated English transcripts were descriptively and thematically coded using OpenCode software. Participants' parents in the MalariaGEN study had differing understandings of the causes of malaria, the rationale for collecting blood samples, the purposes of the study and the kinds of information the study would generate. Genomic aspects of the research, including the gene/environment interaction underlying susceptibility or resistance to severe malaria, proved particularly challenging to explain and understand. This study identifies a number of areas to be addressed in the design of consent processes for genomic research, some of which require careful ethical analysis. These include determining how much information should be provided about differing aspects of the research and how best to promote understandings of genomic research. We conclude that it is important to build capacity in the design and conduct of effective and appropriate consent processes for genomic research in low and middle-income settings. Additionally, consideration should be given to the role of review committees and community consultation activities in protecting the interests of participants in genomic research.