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.

42 CFR 35.15 - Consent to operative procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Consent to operative procedures. 35.15 Section 35.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.15 Consent to operative procedures. Except in...

42 CFR 35.15 - Consent to operative procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Consent to operative procedures. 35.15 Section 35.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.15 Consent to operative procedures. Except in...

42 CFR 35.15 - Consent to operative procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Consent to operative procedures. 35.15 Section 35.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.15 Consent to operative procedures. Except in...

42 CFR 35.15 - Consent to operative procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Consent to operative procedures. 35.15 Section 35.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.15 Consent to operative procedures. Except in...

42 CFR 35.15 - Consent to operative procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Consent to operative procedures. 35.15 Section 35.15 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS HOSPITAL AND STATION MANAGEMENT General § 35.15 Consent to operative procedures. Except in...

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.

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.

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

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

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.

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

Readability of Invasive Procedure Consent Forms.

PubMed

Eltorai, Adam E M; Naqvi, Syed S; Ghanian, Soha; Eberson, Craig P; Weiss, Arnold-Peter C; Born, Christopher T; Daniels, Alan H

2015-12-01

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. 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. 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). 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. © 2015 Wiley Periodicals, Inc.

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

[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.

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.

An audit cycle of consent form completion: A useful tool to improve junior doctor training.

PubMed

Leng, Catherine; Sharma, Kavita

2016-01-01

Consent for surgical procedures is an essential part of the patient's pathway. Junior doctors are often expected to do this, especially in the emergency setting. As a result, the aim of our audit was to assess our practice in consenting and institute changes within our department to maintain best medical practice. An audit of consent form completion was conducted in March 2013. Standards were taken from Good Surgical Practice (2008) and General Medical Council guidelines. Inclusion of consent teaching at a formal consultant delivered orientation programme was then instituted. A re-audit was completed to reassess compliance. Thirty-seven consent forms were analysed. The re-audit demonstrated an improvement in documentation of benefits (91-100%) and additional procedures (0-7.5%). Additional areas for improvement such as offering a copy of the consent form to the patient and confirmation of consent if a delay occurred between consenting and the procedure were identified. The re-audit demonstrated an improvement in the consent process. It also identified new areas of emphasis that were addressed in formal teaching sessions. The audit cycle can be a useful tool in monitoring, assessing and improving clinical practice to ensure the provision of best patient care.

The changing face of informed surgical consent.

PubMed

Oosthuizen, J C; Burns, P; Timon, C

2012-03-01

To determine whether procedure-specific brochures improve patients' pre-operative knowledge, to determine the amount of information expected by patients during the consenting process, and to determine whether the recently proposed 'Request for Treatment' consenting process is viable on a large scale. A prospective, questionnaire-based study of 100 patients admitted for selected, elective surgical procedures. In total, 99 per cent of patients were satisfied with the information received in the out-patient department, regarding the proposed procedure. However, 38 per cent were unable to correctly state the nature of the surgery or specific procedure they were scheduled to undergo. Although the vast majority of patients were able to state the intended benefits to be gained from the procedure, only 54 per cent were able to list at least one potential complication, and 80 per cent indicated that they wished to be informed about all potential complications, even if these occurred in less than 1 per cent of cases. The introduction of procedure-specific brochures improved patients' pre-operative knowledge. Although the failings of current consenting practice are clear, the Request for Treatment consenting process would not appear to be a viable alternative because of the large number of patients unable to accurately recall the nature of the proposed surgery or potential complications, following consent counselling.

Informed Consent and Cognitive Dysfunction After Noncardiac Surgery in the Elderly.

PubMed

Hogan, Kirk J; Bratzke, Lisa C; Hogan, Kendra L

2018-02-01

Cognitive dysfunction 3 months after noncardiac surgery in the elderly satisfies informed consent thresholds of foreseeability in 10%-15% of patients, and materiality with new deficits observed in memory and executive function in patients with normal test performance beforehand. At present, the only safety step to avoid cognitive dysfunction after surgery is to forego surgery, thereby precluding the benefits of surgery with removal of pain and inflammation, and resumption of normal nutrition, physical activity, and sleep. To assure that consent for surgery is properly informed, risks of both cognitive dysfunction and alternative management strategies must be discussed with patients by the surgery team before a procedure is scheduled.

Written versus verbal consent: a qualitative study of stakeholder views of consent procedures used at the time of recruitment into a peripartum trial conducted in an emergency setting.

PubMed

Lawton, J; Hallowell, N; Snowdon, C; Norman, J E; Carruthers, K; Denison, F C

2017-05-24

Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrolment followed, later, by obtaining written consent, have been advocated by some clinicians and bioethicists but have received little empirical attention. We explored women's and staff views about the consent procedures used during the internal pilot of a trial (GOT-IT), where the protocol permitted staff to gain verbal consent at recruitment. Interviews with staff (n = 27) and participating women (n = 22). Data were analysed thematically and interviews were cross-compared to identify differences and similarities in participants' views about the consent procedures used. Women and some staff highlighted benefits to obtaining verbal consent at trial enrolment, including expediting recruitment and reducing the burden on those left exhausted by their births. However, most staff with direct responsibility for taking consent expressed extreme reluctance to proceed with enrolment until they had obtained written consent, despite being comfortable using verbal procedures in their clinical practice. To account for this resistance, staff drew a strong distinction between research and clinical care and suggested that a higher level of consent was needed when recruiting into trials. In doing so, staff emphasised the need to engage women in reflexive decision-making and highlighted the role that completing the consent form could play in enabling and evidencing this process. While most staff cited their ethical responsibilities to women, they also voiced concerns that the absence of a signed consent form at recruitment could expose them to greater risk of litigation were an individual to experience a complication during the trial. Inexperience of recruiting into peripartum trials and limited availability of staff trained to take consent also reinforced preferences for obtaining written consent at recruitment. While alternative consent pathways have an important role to play in advancing emergency medicine research, and may be appreciated by potential recruits, they may give rise to unintended ethical and logistical challenges for staff. Staff would benefit from training and support to increase their confidence and willingness to recruit into trials using alternative consent pathways. This qualitative research was undertaken as part of the GOT-IT Trial (trial registration number: ISCRTN 88609453 ). Date of registration 26/03/2014.

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.

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.

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.

Using a multimedia presentation to improve patient understanding and satisfaction with informed consent for minimally invasive vascular procedures.

PubMed

Bowers, N; Eisenberg, E; Montbriand, J; Jaskolka, J; Roche-Nagle, G

2017-02-01

As vascular procedures become more complex, patient understanding of their treatment(s) can become more difficult. We wished to evaluate the utility of multimedia presentations (MPs) to improve patient understanding of their vascular interventions. Patients undergoing endovascular aneurysm repair (EVAR), peripheral angioplasty, Hickman catheter and peripherally inserted central catheter (PICC) insertion were randomized into a control group receiving traditional verbal consent, and a MP group that were shown a two minute simplified video of their procedure on an iPad™ computer in addition to the traditional verbal consent. After obtaining consent, all patients completed a questionnaire assessing their comprehension of the procedure, and satisfaction with the consent process. Satisfaction was rated on a 5 point Likert scale with 5 being 'very helpful' in understanding the procedure. Ninety-three patients were recruited for this study, 62% of which were male. The intervention significantly increased total comprehension in all procedure types controlling for procedure type (multimedia vs. control; F = 9.14, P = .003). A second ANOVA showed there was a significant main effect by intervention (F = 44.06, p < .000) with those in the intervention group showing higher overall satisfaction scores after controlling for surgery type. This study suggests that patients find the use of MP during the consent process to be helpful in patient understanding and that there is improved satisfaction. Given the rapid rate of innovation in vascular interventions, increased regular use of MPs to help patients understand their procedures would be beneficial in the care of patients undergoing vascular interventions. Copyright © 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

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.

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/

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

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

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.

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.

Presuming consent in the ethics of posthumous sperm procurement and conception.

PubMed

Kroon, Frederick

2015-12-01

This paper compares standard conceptions of consent with the conception of consent defended by Kelton Tremellen and Julian Savulescu in their attempt to re-orient the ethical debate around posthumous sperm procurement and conception, as published in Reproductive BioMedicine Online in 2015. According to their radical proposal, the surviving partner's wishes are, in effect, the only condition that needs to be considered for there to be a legitimate moral case for these procedures: the default should be presumed consent to the procedures, whether or not the agent did consent or would have consented. The present paper argues that Tremellen and Savulescu's case for this position is flawed, but offers a reconstruction that articulates what may well be a hidden, and perhaps reasonable, assumption behind the argument. But while the new argument appears more promising, the reconstruction also suggests that the position of presumed consent is currently unlikely to be acceptable as policy.

42 CFR 50.205 - Consent form requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects § 50.205 Consent form... person who obtains the consent; and (4) The physician who will perform the sterilization procedure. (c... performing the sterilization must certify by signing the consent form, that: (i) Shortly before the...

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

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...

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

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.

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

14 CFR 13.77 - Consent order of compliance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Consent order of compliance. 13.77 Section 13.77 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES INVESTIGATIVE AND ENFORCEMENT PROCEDURES Orders of Compliance Under the Hazardous Materials...

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.

Beyond informed consent.

PubMed Central

Bhutta, Zulfiqar A.

2004-01-01

Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings. PMID:15643799

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.

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

Perceptions of potential donors in the Swedish public towards information and consent procedures in relation to use of human tissue samples in biobanks: a population-based study.

PubMed

Kettis-Lindblad, Asa; Ring, Lena; Viberth, Eva; Hansson, Mats G

2007-01-01

To assess the Swedish public's preferences for information and consent procedures when being asked for permission to use previously collected tissue samples for new research studies. Cross-sectional study employing postal questionnaires to a random sample of the Swedish general public (n = 6,000) in October 2002-February 2003. The response rate was 49% (n = 2,928). This paper includes only respondents who reportedly would approve of samples being taken and stored (n = 2,122). When potential tissue sample donors in the general public have to strike a balance between the values at stake, i.e. the autonomy of the donor versus the research value, most (72%) prefer general consent, i.e. where consent is asked for at the outset only. They want the research ethics committee (REC) alone to decide on the use of stored samples, and they would allow storage as long as the sample is useful for research. The minority of respondents who were in favour of specific consent were more likely to be young, well educated, have negative experiences of healthcare and low trust in healthcare authorities. The majority of the Swedish general public prefer general consent, and are thus willing to delegate some decisions to the RECs. However, preferences for information and consent procedures depend on the context, e.g. the risks for the donor and the purpose of the research. If feasible, procedures should be differentiated according to the preferences of individual donors, thus protecting the interests of both the minority and the majority.

A Systematic Review of Consent Procedures, Participation Rates, and Main Findings of Health-Related Research in Alternative High Schools From 2010 to 2015.

PubMed

Johnson, Karen E; Morris, Marian; Rew, Lynn; Simonton, Amanda J

2016-02-01

There is a well-established link between educational attainment and health. Alternative high schools (AHSs) serve students who are at risk for school dropout. Health-related research conducted in AHSs has been sparse. Achieving high participation rates is critical to producing generalizable results and can be challenging in research with adolescents for reasons such as using active consent. These challenges become greater when working with vulnerable populations of adolescents. In this systematic review, we examined health-related studies conducted in AHSs between 2010 and 2015. Results indicated that (1) health-related research in AHSs has increased over the past 5 years, (2) AHS students continue to experience significant disparities, (3) active consent is commonly used with AHS students, (4) 42% of studies reported participation rates or provided enough information to calculate participation rates, and (5) school nurses are missing from health-related research conducted in AHSs. Implications for future research and school nursing are discussed. © The Author(s) 2015.

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.

28 CFR 68.14 - Consent findings or dismissal.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Consent findings or dismissal. 68.14 Section 68.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PRACTICE AND PROCEDURE... procedural steps before the Administrative Law Judge; and (4) A waiver of any right to challenge or contest...

28 CFR 68.14 - Consent findings or dismissal.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Consent findings or dismissal. 68.14 Section 68.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PRACTICE AND PROCEDURE... procedural steps before the Administrative Law Judge; and (4) A waiver of any right to challenge or contest...

28 CFR 68.14 - Consent findings or dismissal.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Consent findings or dismissal. 68.14 Section 68.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PRACTICE AND PROCEDURE... procedural steps before the Administrative Law Judge; and (4) A waiver of any right to challenge or contest...

28 CFR 68.14 - Consent findings or dismissal.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Consent findings or dismissal. 68.14 Section 68.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PRACTICE AND PROCEDURE... procedural steps before the Administrative Law Judge; and (4) A waiver of any right to challenge or contest...

14 CFR 1230.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true General requirements for informed consent... of the procedures to be followed, and identification of any procedures which are experimental; (2) A... local government officials and is designed to study, evaluate, or otherwise examine: (i) Public benefit...

12 CFR 211.34 - Procedures for filing and processing notices.

Code of Federal Regulations, 2010 CFR

2010-01-01

... investors in export trading companies shall be made in accordance with the general consent or prior notice...-consent procedures with respect to any eligible investor. (b) General consent—(1) Eligibility for general... investment an export trading company: (i) If the eligible investor is well capitalized and well managed; (ii...

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.

Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

PubMed

Gitanjali, B; Raveendran, R; Pandian, D G; Sujindra, S

2003-01-01

Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. A simulated clinical trial in two tertiary health care facilities on in-patients. An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. The percentages of those consenting after full disclosure 29/102 (30%) and after partial disclosure 15/50 (30%) were the same. There was a significant (p=0.043) gender difference with a lesser percentage of females (30%) consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

Facilitating enrollment in a Cancer Registry through modified consent procedures: a pilot study.

PubMed

Mazanec, Susan; Daly, Barbara; Meropol, Neal J; Step, Mary

2012-12-01

Research registries are increasingly important in medical research and are essential to the mission of cancer centers. However, designing enrollment and data collection procedures that are consistent with ethical norms and regulatory requirements yet are efficient and cost effective is a major challenge. Current standard consent forms can be a barrier to enrollment because of their length, multiple components, and technical language. We pilot tested an IRB-approved registry booklet and simplified one-page, tiered consent form, allowing for choice of extent of participation. The booklet was mailed to patients with breast cancer as part of their routine information packet prior to the first clinic appointment. A research nurse met with 27 patients at initial treatment to review the booklet, answer questions, obtain informed consent, and collect quality of life data. The consent rate was 78% with 21 patients enrolling in the study. Twelve of the 21 patients (57%) did not read the booklet prior to the visit. The 9 patients (43%) who had read the booklet prior to arrival found it easy to understand. The multi-stage, simplified consent process and data collection were acceptable to these patients and readily integrated into clinical operations. An easy-to-read registry booklet may be an effective guide for discussion, but in-person consent procedures and further testing of the approach are required.

The use of multimedia consent programs for surgical procedures: a systematic review.

PubMed

Nehme, Jean; El-Khani, Ussamah; Chow, Andre; Hakky, Sherif; Ahmed, Ahmed R; Purkayastha, Sanjay

2013-02-01

To compare multimedia and standard consent, in respect to patient comprehension, anxiety, and satisfaction, for various surgical/interventional procedures. Electronic searches of PubMed, MEDLINE, Ovid, Embase, and Google Scholar were performed. Relevant articles were assessed by 2 independent reviewers. Comparative (randomized and nonrandomized control trials) studies of multimedia and standard consent for a variety of surgical/interventional procedures were included. Studies had to report on at least one of the outcome measures. Studies were reviewed by 2 independent investigators. The first investigator extracted all relevant data, and consensus of each extraction was performed by a second investigator to verify the data. Overall, this review suggests that the use of multimedia as an adjunct to conventional consent appears to improve patient comprehension. Multimedia leads to high patient satisfaction in terms of feasibility, ease of use, and availability of information. There is no conclusive evidence demonstrating a significant reduction in preoperative anxiety.

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.

Bioethics and power: Informed consent procedures in post-socialist Latvia.

PubMed

Putniņa, Aivita

2013-12-01

This paper explores two lines of development in the donor consent procedures in post-Soviet Latvia. The paper is based on secondary analysis of interview, focus group discussion data, and media and legal text material collected throughout three previously conducted research projects on organ transplantation, population genome project and xenotransplantation focusing on the historical development of the issues of donor consent across these three fields of medical technologies. The paper argues that the quality of consent depends not as much on political and legal change per se as on the strengthening of the position of both medical specialists and donors, facilitating bonds between the two. Copyright © 2013 Elsevier Ltd. All rights reserved.

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...

Impact and acceptability of self-consent procedures for the school-based human papillomavirus vaccine: a mixed-methods study protocol

PubMed Central

Audrey, Suzanne; Ferrie, Joanne; Evans, Karen; Bell, Michael; Yates, Julie; Roderick, Marion; MacLeod, John; Hickman, Matthew

2018-01-01

Introduction The human papillomavirus (HPV) vaccine, administered in early adolescence, can substantially reduce cervical cancer incidence and mortality. However, lack of written parental consent is a key reason why some young women do not receive the vaccine. The national legal framework allows girls to be vaccinated without parental consent provided they are deemed Gillick competent, but there is some reticence about vaccinating without written parental consent. Self-consent procedures are being implemented in Bristol and South Gloucestershire. This study will examine the implementation, acceptability and impact of these new procedures. Methods and analysis Statistical analyses of routine data from Public Health England and the Child Health Information System will test if there has been an increase in HPV vaccination uptake in two ways: (a) Is there an increase when comparing before and after the change in our intervention sites? and (b) Does the percentage change in our intervention sites differ from comparison sites (similar to our intervention sites in terms of initial HPV uptake, ethnicity and deprivation levels) in England where no such intervention took place and how? For the process evaluation, we will develop a logic model and use questionnaires, observations and audio-recorded interviews with young women, school nurses, school staff and parents to examine the context, implementation of self-consent and response to the new procedures. Ethics and dissemination The University of Bristol Faculty of Health Sciences Research Ethics Committee and the National Health Service Health Research Authority provided approvals for the study. We will produce a report with recommendations about self-consent procedures in conjunction with key stakeholders. At least two papers will be written for publication in peer-reviewed journals and for conference presentations. A summary of results will be shared with participating immunisation nurses, school staff, young people and parents as requested. Trial registration number ISRCTN49086105; Pre-results. PMID:29502095

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.

Screening the use of informed consent forms prior to procedures involving operative dentistry: ethical aspects

PubMed Central

Graziele Rodrigues, Livia; De Souza, João Batista; De Torres, Erica Miranda; Ferreira Silva, Rhonan

2017-01-01

Background. The present study aimed to screen the knowledge and attitudes of dentists toward the use of informed consent forms prior to procedures involving operative dentistry. Methods. A research tool containing questions (questionnaire) regarding the use of informed consent forms was developed. The questionnaire consisted of seven questions structured to screen the current practice in operative dentistry towards the use of informed consent forms. Results. The questionnaires were distributed among 731 dentists, of which 179 returned them with answers. Sixty-seven dentists reported not using informed consent forms. The main reasons for not using informed consent forms were: having a complete dental record signed by the patient (67.2%) and having a good relation with patients (43.6%). The dentists who reported using informed consent forms revealed that they obtained them from other dentists and made their own modifications (35.9%). Few dentists revealed contacting lawyers (1.7%) and experts in legal dentistry (0.9%) for the development of their informed consent forms. Conclusion. A high number of dentists working in the field of operative dentistry behave according to the ethical standards in the clinical practice, becoming unprotected against ethical and legal actions. PMID:28413600

Remote preenrollment checking of consent forms to reduce nonconformity.

PubMed

Journot, Valérie; Pérusat-Villetorte, Sophie; Bouyssou, Caroline; Couffin-Cadiergues, Sandrine; Tall, Aminata; Chêne, Geneviève

2013-01-01

In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participant's final enrollment. We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment. Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participant's name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participant's enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure. Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information (54%). The procedure reduced nonconformities by 81% (95% confidence interval (CI): 73%-89%) before enrollment. Nonconforming consent forms dropped from 25% to 0% over the period, indicating a rapid learning effect between trials. Fewer nonconformities were observed for participants screened later in a trial (odds ratio (95% CI): 0.5 (0.3-0.8); p = 0.004), indicating a learning effect within trials. Nonconformities were more common for participants enrolled after screening (2.4 (1.1-5.3); p = 0.03), indicating a stricter scrutiny by form checkers. Although our study had a pseudo before-and-after design, no major bias was identified. Power and generalizability of our findings were sufficient to support implementation in future trials. This procedure substantially limited nonconformity of consent forms with regulatory requirements before enrollment, thus proving a key component of a risk-based monitoring strategy that has been recommended to optimize resources for clinical research.

28 CFR 76.20 - Consent Order or settlement prior to hearing.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Consent Order or settlement prior to hearing. 76.20 Section 76.20 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PROCEDURE... waiver of any further procedural steps before the Judge; and (4) A waiver of any right to challenge or...

28 CFR 76.20 - Consent Order or settlement prior to hearing.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Consent Order or settlement prior to hearing. 76.20 Section 76.20 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PROCEDURE... waiver of any further procedural steps before the Judge; and (4) A waiver of any right to challenge or...

28 CFR 76.20 - Consent Order or settlement prior to hearing.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Consent Order or settlement prior to hearing. 76.20 Section 76.20 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PROCEDURE... waiver of any further procedural steps before the Judge; and (4) A waiver of any right to challenge or...

28 CFR 76.20 - Consent Order or settlement prior to hearing.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Consent Order or settlement prior to hearing. 76.20 Section 76.20 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) RULES OF PROCEDURE... waiver of any further procedural steps before the Judge; and (4) A waiver of any right to challenge or...

46 CFR 67.145 - Restrictions on exchange; requirement and procedure for mortgagee consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Restrictions on exchange; requirement and procedure for mortgagee consent. 67.145 Section 67.145 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) DOCUMENTATION AND MEASUREMENT OF VESSELS DOCUMENTATION OF VESSELS Application for Documentation, Exchange or Replacement of Certificate of...

Family and community concerns about post-mortem needle biopsies in a Muslim society

PubMed Central

2011-01-01

Background Post-mortem needle biopsies have been used in resource-poor settings to determine cause of death and there is interest in using them in Bangladesh. However, we did not know how families and communities would perceive this procedure or how they would decide whether or not to consent to a post-mortem needle biopsy. The goal of this study was to better understand family and community concerns and decision-making about post-mortem needle biopsies in this low-income, predominantly Muslim country in order to design an informed consent process. Methods We conducted 16 group discussions with family members of persons who died during an outbreak of Nipah virus illness during 2004-2008 and 11 key informant interviews with their community and religious leaders. Qualitative researchers first described the post-mortem needle biopsy procedure and asked participants whether they would have agreed to this procedure during the outbreak. Researchers probed participants about the circumstances under which the procedure would be acceptable, if any, their concerns about the procedure, and how they would decide whether or not to consent to the procedure. Results Overall, most participants agreed that post-mortem needle biopsies would be acceptable in some situations, particularly if they benefitted society. This procedure was deemed more acceptable than full autopsy because it would not require major delays in burial or remove organs, and did not require cutting or stitching of the body. It could be performed before the ritual bathing of the body in either the community or hospital setting. However, before consent would be granted for such a procedure, the research team must gain the trust of the family and community which could be difficult. Although consent may only be provided by the guardians of the body, decisions about consent for the procedure would involve extended family and community and religious leaders. Conclusions The possible acceptability of this procedure during outbreaks represents an important opportunity to better characterize cause of death in Bangladesh which could lead to improved public health interventions to prevent these deaths. Obstacles for research teams will include engaging all major stakeholders in decision-making and quickly building a trusting relationship with the family and community, which will be difficult given the short window of time prior to the ritual bathing of the body. PMID:21668979

21 CFR 1316.08 - Consent to inspection.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Consent to inspection. 1316.08 Section 1316.08 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.08 Consent to inspection. (a) An administrative...

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.

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.

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.

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.

Multimedia Consent for Research in People With Schizophrenia and Normal Subjects: a Randomized Controlled Trial

PubMed Central

Jeste, Dilip V.; Palmer, Barton W.; Golshan, Shahrokh; Eyler, Lisa T.; Dunn, Laura B.; Meeks, Thomas; Glorioso, Danielle; Fellows, Ian; Kraemer, Helena; Appelbaum, Paul S.

2009-01-01

Limitations of printed, text-based, consent forms have long been documented and may be particularly problematic for persons at risk for impaired decision-making capacity, such as those with schizophrenia. We conducted a randomized controlled comparison of the effectiveness of a multimedia vs routine consent procedure (augmented with a 10-minute control video presentation) as a means of enhancing comprehension among 128 middle-aged and older persons with schizophrenia and 60 healthy comparison subjects. The primary outcome measure was manifest decisional capacity (understanding, appreciation, reasoning, and expression of choice) for participation in a (hypothetical) clinical drug trial, as measured with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and the University of California San Diego (UCSD) Brief Assessment for Capacity to Consent (UBACC). The MacCAT-CR and UBACC were administered by research assistants kept blind to consent condition. Additional assessments included standardized measures of psychopathology and cognitive functioning. Relative to patients in the routine consent condition, schizophrenia patients receiving multimedia consent had significantly better scores on the UBACC and on the MacCAT-CR understanding and expression of choice subscales and were significantly more likely to be categorized as being capable to consent than those in the routine consent condition (as categorized with several previously established criteria). Among the healthy subjects, there were few significant effects of consent condition. These findings suggest that multimedia consent procedures may be a valuable consent aid that should be considered for use when enrolling participants at risk for impaired decisional capacity, particularly for complex and/or high-risk research protocols. PMID:18245061

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...

Consent, common adverse events, and post-adverse event actions in endoscopy.

PubMed

Adler, Douglas G

2015-01-01

Endoscopy constitutes a wide range of procedures with many indications. Esophagogastroduodenoscopy, colonoscopy, endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, and enteroscopy comprise the most commonly performed procedures. These examinations all carry risk to the patient, and incumbent in this is some legal risk with regard to how the procedure is conducted, decisions made based on the intraprocedure findings, and the postprocedure results, in addition to events that occur following the procedure. This article provides an overview of consent and complications of endoscopy. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

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.

41 CFR 60-30.13 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... EXECUTIVE ORDER 11246 Prehearing Procedures § 60-30.13 Consent findings and order. (a) General. At any time..., the parties may jointly move to defer the receipt of any evidence for a reasonable time to permit... result in a just disposition of the issues involved. (b) Content. Any agreement containing consent...

41 CFR 60-30.13 - Consent findings and order.

Code of Federal Regulations, 2011 CFR

2011-07-01

... result in a just disposition of the issues involved. (b) Content. Any agreement containing consent... EXECUTIVE ORDER 11246 Prehearing Procedures § 60-30.13 Consent findings and order. (a) General. At any time after the issuance of a complaint and prior to or during the reception of evidence in any proceeding...

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.

Risk-Taking: Individual and Family Interests.

PubMed

Iltis, Ana S

2015-08-01

Decisions regarding clinical procedures or research participation typically require the informed consent of individuals. When individuals are unable to give consent, the informed permission of a legally authorized representative or surrogate is required. Although many proposed procedures are aimed primarily at benefiting the individual, some are not. I argue that, particularly when individuals are asked to assume risks primarily or exclusively for the benefit of others, family members ought to be engaged in the informed consent process. Examples of procedures in which individuals are asked to assume risks primarily or exclusively for the benefit of others include living organ donation and research participation. © The Author 2015. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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.

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

A survey of doctors at a UK teaching hospital to assess understanding of recent changes to consent law.

PubMed

O'Brien, J W; Natarajan, M; Shaikh, I

2017-06-01

The UK Supreme Court recently ruled that when consenting patients for treatments or procedures, clinicians must also discuss any associated material risks. We surveyed medical staff at a large UK teaching hospital in order to ascertain knowledge of consent law and current understanding of this change. Email survey sent to medical staff in all specialities at Norfolk and Norwich University Hospital in February 2016. 245 responses (141 Consultants and 104 junior doctors, response rate 32%). 82% consent patients for procedures at least monthly and 23% daily. 31% were not familiar with the concept of material risk. 35% were familiar with the recent change in consent law, 41% were not. 18% were "very uncertain" and 64% "a little uncertain" that their consenting process meets current legal requirements. >92% think that landmark cases and changes in law should be discussed through professional bodies and circulated better locally. The majority were not familiar with the concept of material risk and recent legal changes. A majority were not confident that their practice meets current requirements, suggesting that recent changes in consent law may not be widely understood at this hospital. We suggest more guidance and education may be necessary than is currently available. Increased understanding of recent changes to consent law will reduce the risk taken by NHS trusts and offer patients a service compliant with Supreme Court guidance.

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.

Live donor transplantation--the incompetent donor: comparative law.

PubMed

Wolfman, Samuel; Shaked, Tali

2008-12-01

Informed consent of the patient to medical treatment is an essential prerequisite for any invasive medical procedure. However in emergency cases, when the patient is unable to sign a consent form due to unconsciousness or to psychotic state, than the primary medical consideration shall take place. In such a case, in order to save life or even prevent a major medical hazard to the patient, doctors are allowed, in certain cases and in accordance with well accepted medical practice, to perform invasive procedures, major surgery or risky pharmacological treatment, without the explicit consent of the patient. All the above refers to the cases when avoidance of such non-consented treatment may harm severely the health and wellbeing of the patient and there is no doubt that such treatment is for the ultimate benefit of the patient. The question, however, shall arise when such a medical procedure is not necessarily for the benefit of the patient, but rather for the benefit of somebody else. Such is the case in the transplantation area and the question of living donor-donee relationship. This paper shall analyze the legal situation in cases of non competent donors whose consent cannot be considered legal consent given in full understanding and out of free will. It will also compare three legal systems, the Israeli, the American and the traditional Jewish law, with regard to the different approaches to this human problem, where the autonomy of the donor may be sacrificed for the purpose of saving life of another person.

A half century of electronic fetal monitoring and bioethics: silence speaks louder than words.

PubMed

Sartwelle, Thomas P; Johnston, James C; Arda, Berna

2017-01-01

Bioethics abolished the prevailing Hippocratic tenet instructing physicians to make treatment decisions, replacing it with autonomy through informed consent. Informed consent allows the patient to choose treatment after options are explained by the physician. The appearance of bioethics in 1970 coincided with the introduction of electronic fetal monitoring (EFM), which evolved to become the fetal surveillance modality of choice for virtually all women in labor. Autonomy rapidly pervaded all medical procedures, but there was a clear exemption for EFM. Even today, EFM remains immune to the doctrine of informed consent despite continually mounting evidence which proves the procedure is nothing more than myth, illusion and junk science that subjects mothers and babies alike to increased risks of morbidity and mortality. And ethicists have remained utterly silent through a half century of EFM misuse. Our article explores this egregious ethical failure by reviewing EFM's lack of clinical efficacy, discussing the EFM related harm to mothers and babies, and focusing on the reasons that this obstetrical procedure eluded the revolutionary change from the Hippocratic tradition to autonomy through informed consent.

"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.

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.

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.

Assessment of children's capacity to consent for research: a descriptive qualitative study of researchers' practices.

PubMed

Gibson, Barbara E; Stasiulis, Elaine; Gutfreund, Shawna; McDonald, Maria; Dade, Lauren

2011-08-01

In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a 'family decision-making' model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family.

Differential recall of consent information and parental decisions about enrolling children in research studies.

PubMed

Boccia, Maria L; Campbell, Frances A; Goldman, Barbara D; Skinner, Martie

2009-01-01

In the present simulation research, the authors examined the relations between the type of information that low-income parents (N = 116) recalled from informed-consent materials and their hypothetical decision to enroll a child in a clinical study. The authors gave parents or guardians of Head Start children information about a medical protocol involving high risk and significant potential benefit to child participants. Differential recall of the various categories of information (procedures, benefits, risks and costs, rights, and other) showed that relative to all consent information conveyed to them, participants recalled most about procedures and least about their child's rights as a study participant. Relative to their own recall, they also recounted most about procedures, slightly more about benefits than risks, and least about research rights. The pattern of recall differed among those who agreed to enroll and those who declined. The ratio of recalled risks to benefits predicted enrollment decisions.

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.

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

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

Teaching endotracheal intubation on the recently deceased: opinion of patients and families

PubMed Central

Mirzazadeh, Azim; Ostadrahimi, Nima; Ghalandarpoorattar, Seyedeh Mojgan; Asghari, Fariba

2014-01-01

This study was done to explore the views of patients and their companions concerning endotracheal intubation training on newly deceased patients and the necessity of obtaining their consent in this regard. In this cross-sectional descriptive analytical study, we used a questionnaire to collect data through structured interviews conducted by the researcher on patient discharge day. A convenient sample of over 18 year old patients hospitalized at a teaching hospital were enrolled, and after receiving patient consent, one of each patient’s companions was enrolled in the study as well. In this study, 150 of the approached patients agreed to participate (response rate = 85.0%); of those, 92 (61.3%) allowed their companions to be enrolled as well. Eighty-three persons (55.3%) in the patient group and 68 persons (73.9%) in the companion group agreed to have endotracheal intubation training on their own bodies after death. Among these consenting patients and companions, 75.9% (n = 63) and 91.2% (n = 62) believed it was necessary to acquire patient consent for this procedure. Obtaining relatives’ consent was thought to be necessary by 69.9% (n = 72) of the patients and 72.1% (n = 49) of the companions, even when there was patient prior consent. Therefore it seems that asking the patient’s consent for doing educational procedures on their dead body is crucial. PMID:25512826

Teaching endotracheal intubation on the recently deceased: opinion of patients and families.

PubMed

Mirzazadeh, Azim; Ostadrahimi, Nima; Ghalandarpoorattar, Seyedeh Mojgan; Asghari, Fariba

2014-01-01

This study was done to explore the views of patients and their companions concerning endotracheal intubation training on newly deceased patients and the necessity of obtaining their consent in this regard. In this cross-sectional descriptive analytical study, we used a questionnaire to collect data through structured interviews conducted by the researcher on patient discharge day. A convenient sample of over 18 year old patients hospitalized at a teaching hospital were enrolled, and after receiving patient consent, one of each patient's companions was enrolled in the study as well. In this study, 150 of the approached patients agreed to participate (response rate = 85.0%); of those, 92 (61.3%) allowed their companions to be enrolled as well. Eighty-three persons (55.3%) in the patient group and 68 persons (73.9%) in the companion group agreed to have endotracheal intubation training on their own bodies after death. Among these consenting patients and companions, 75.9% (n = 63) and 91.2% (n = 62) believed it was necessary to acquire patient consent for this procedure. Obtaining relatives' consent was thought to be necessary by 69.9% (n = 72) of the patients and 72.1% (n = 49) of the companions, even when there was patient prior consent. Therefore it seems that asking the patient's consent for doing educational procedures on their dead body is crucial.

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers Through Evidence-Based Ethics.

PubMed

Fisher, Celia B; Arbeit, Miriam R; Dumont, Melissa S; Macapagal, Kathryn; Mustanski, Brian

2016-02-01

This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational, and voluntary self-consent. Sixty sexually active SGMY (ages 14-17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian permission as a significant barrier to research participation, especially for those not "out" to families. Youth demonstrated understanding of research benefits, medical side effects, confidentiality risks, and random assignment and felt comfortable asking questions and declining participation. Reasoning about participation indicated consideration of health risks and benefits, personal sexual behavior, ability to take pills every day, logistics, and post-trial access to PrEP. Results demonstrate youth's ability to self-consent to age- and population-appropriate procedures, and underscore the value of empirical studies for informing institutional review board (IRB) protections of SGMY research participants. © The Author(s) 2016.

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers through Evidence-based Ethics

PubMed Central

Fisher, Celia B.; Arbeit, Miriam R.; Dumont, Melissa S.; Macapagal, Kathryn; Mustanski, Brian

2016-01-01

This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational and voluntary self-consent. Sixty sexually active SGMY (ages 14–17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian permission as a significant barrier to research participation, especially for those not “out” to families. Youth demonstrated understanding of research benefits, medical side effects, confidentiality risks, and random assignment and felt comfortable asking questions and declining participation. Reasoning about participation indicated consideration of health risks and benefits, personal sexual behavior, ability to take pills everyday, logistics, and post-trial access to PrEP. Results demonstrate youth’s ability to self-consent to age- and population- appropriate procedures, and underscore the value of empirical studies for informing IRB protections of SGMY research participants. PMID:26956988

An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank.

PubMed

Cervo, Silvia; Rovina, Jane; Talamini, Renato; Perin, Tiziana; Canzonieri, Vincenzo; De Paoli, Paolo; Steffan, Agostino

2013-07-30

Efforts to improve patients' understanding of their own medical treatments or research in which they are involved are progressing, especially with regard to informed consent procedures. We aimed to design a multisource informed consent procedure that is easily adaptable to both clinical and research applications, and to evaluate its effectiveness in terms of understanding and awareness, even in less educated patients. We designed a multisource informed consent procedure for patients' enrolment in a Cancer Institute Biobank (CRO-Biobank). From October 2009 to July 2011, a total of 550 cancer patients admitted to the Centro di Riferimento Oncologico IRCCS Aviano, who agreed to contribute to its biobank, were consecutively enrolled. Participants were asked to answer a self-administered questionnaire aim at exploring their understanding of biobanks and their needs for information on this topic, before and after study participation. Chi-square tests were performed on the questionnaire answers, according to gender or education. Of the 430 patients who returned the questionnaire, only 36.5% knew what a biobank was before participating in the study. Patients with less formal education were less informed by some sources (the Internet, newspapers, magazines, and our Institute). The final assessment test, taken after the multisource informed consent procedure, showed more than 95% correct answers. The information received was judged to be very or fairly understandable in almost all cases. More than 95% of patients were aware of participating in a biobank project, and gave helping cancer research (67.5%), moral obligation, and supporting cancer care as main reasons for their involvement. Our multisource informed consent information system allowed a high rate of understanding and awareness of study participation, even among less-educated participants, and could be an effective and easy-to-apply model for others to consider to contribute to a well-informed decision making process in several fields, from clinical practice to research.Further studies are needed to explore the effects on the study comprehension by each source of information, and by other sources suggested by participants in the questionnaire.

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)

23 CFR 1327.6 - Conditions and procedures for other authorized users of the NDR.

Code of Federal Regulations, 2010 CFR

2010-04-01

... shall sign a written consent authorizing the third party to act in this role. The written consent must.../or Social Security Number (SSN) (provision of SSN is optional); (ix) Full address; (x) Signature; (xi...

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

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.

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 Influence of Partner Status and Sexual Behavior on College Women's Consent Communication and Feelings.

PubMed

Marcantonio, Tiffany; Jozkowski, Kristen N; Wiersma-Mosley, Jackie

2018-05-09

Sexual consent has permeated mainstream discourse as a mechanism used to decrease rates of sexual assault and increase sex-positive communication. Women's external consent behaviors are frequently examined; however, research exploring their internal consent and feelings associated with sexual activity are understudied. The purpose of this study was to understand how partner status and sexual behavior at most recent sexual activity influence women's external/internal consent and feelings during sexual activity. Three-hundred and ninety women completed a survey on consent, partner status, and most recent sexual behavior. Internal and external consent differed by partner status for women who engaged in vaginal-penile sex, but not genital and oral sex. Feelings associated with the sexual act were different within each behavior group and partner status. Women with a serious dating partner reported stronger feelings related to sexual activity, higher internal consent feelings, and increased use of non-verbal external consent cues. Partner status appears to influence factors of interest for vaginal-penile sex, but not genital and oral sex. Findings from this study can inform prevention efforts to increase sex-positive communication around consent.

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.

The need for a standardized informed consent procedure in live donor nephrectomy: a systematic review.

PubMed

Kortram, Kirsten; Lafranca, Jeffrey A; IJzermans, Jan N M; Dor, Frank J M F

2014-12-15

Informed consent in live donor nephrectomy is a topic of great interest. Safety and transparency are key items increasingly getting more attention from media and healthcare inspection. Because live donors are not patients, but healthy individuals undergoing elective interventions, they justly insist on optimal conditions and guaranteed safety. Although transplant professionals agree that consent should be voluntary, free of coercion, and fully informed, there is no consensus on which information should be provided, and how the donors' comprehension should be ascertained. Comprehensive searches were conducted in Embase, Medline OvidSP, Web-of-Science, PubMed, CENTRAL (The Cochrane Library 2014, issue 1) and Google Scholar, evaluating the informed consent procedure for live kidney donation. The methodology was in accordance with the Cochrane Handbook for Interventional Systematic Reviews and written based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The initial search yielded 1,009 hits from which 21 articles fell within the scope of this study. Procedures vary greatly between centers, and transplant professionals vary in the information they disclose. Although research has demonstrated that donors often make their decision based on moral reasoning rather than balancing risks and benefits, providing them with accurate, uniform information remains crucial because donors report feeling misinformed about or unprepared for donation. Although a standardized procedure may not provide the ultimate solution, it is vital to minimize differences in live donor education between transplant centers. There is a definite need for a guideline on how to provide information and obtain informed consent from live kidney donors to assist the transplant community in optimally preparing potential donors.

Assessing physician-parent communication during emergency medical procedures in children: an observational study in a low-literacy Latino patient population.

PubMed

Dahl, Aaron; Sinha, Madhumita; Rosenberg, David I; Tran, Melissa; Valdez, André

2015-05-01

Effective physician-patient communication is critical to the clinical decision-making process. We studied parental recall of information provided during an informed consent discussion process before performance of emergency medical procedures in a pediatric emergency department of an inner-city hospital with a large bilingual population. Fifty-five parent/child dyads undergoing emergency medical procedures were surveyed prospectively in English/Spanish postprocedure for recall of informed consent information. Exact logistic regression was used to predict the ability to name a risk, benefit, and alternative to the procedure based on a parent's language, education, and acculturation. Among English-speaking parents, there tended to be higher proportions that could name a risk, benefit, or alternative. Our regression models showed overall that the parents with more than a high school education tended to have nearly 5 times higher odds of being able to name a risk. A gap in communication may exist between physicians and patients (or parents of patients) during the consent-taking process, and this gap may be impacted by socio-demographic factors such as language and education level.

Dead in the water--are we killing the hospital autopsy with poor consent practices?

PubMed

Henry, Jaimie; Nicholas, Nick

2012-07-01

It is now a recognized fact that the practice of conducting a consent (or hospital) post-mortem examination is in decline. There have been many reasons put forth to explain this demise, but the quality of the consenting process is frequently cited as having a high impact. This article focuses on consent practices for post-mortem examinations in England and Wales, and considers if our consent techniques are adversely affecting post-mortem examination uptake. We examine the regulatory compliance of trusts with their statutory obligations by analyzing the Human Tissue Authority's compliance and inspection reports. We further analyze 21 publicly available NHS Trust policies on post-mortem examination consent procedures, and consider whether these are fit for the purpose of meeting the dual needs of clinicians and the bereaved. Despite more Human Tissue Authority inspections, there is a disproportionate rise in enforcement actions, with up to 48% of sampled Trusts exhibiting shortcomings in their legal duties. Additionally, only 52.4% of sampled trusts follow the Human Tissue Authority best-practice model, with 23.8% having no documented procedures. Despite the well founded evidence base for best-practice models, consent practices for post-mortem examinations remains poor and is likely to have a gross adverse effect on the rate of post-mortem examinations. We recommend that NHS Trusts rigorously review their protocols and introduce a team-approach between clinicians and trained bereavement staff in core-consent teams, as the Human Tissue Authority suggests, whilst at the same time placing a strong emphasis on education for junior and senior colleagues alike.

16 CFR 1118.20 - Procedures for consent order agreements.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... 1118.20 Section 1118.20 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INVESTIGATIONS, INSPECTIONS AND INQUIRIES UNDER THE CONSUMER PRODUCT SAFETY ACT... Commission's regulations relating to substantial product hazards (16 CFR part 1115). For all other consent...

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.

Guideline for obtaining valid consent for gastrointestinal endoscopy procedures.

PubMed

Everett, Simon M; Griffiths, Helen; Nandasoma, U; Ayres, Katie; Bell, Graham; Cohen, Mike; Thomas-Gibson, Siwan; Thomson, Mike; Naylor, Kevin M T

2016-10-01

Much has changed since the last guideline of 2008, both in endoscopy and in the practice of obtaining informed consent, and it is vital that all endoscopists who are responsible for performing invasive and increasingly risky procedures are aware of the requirements for obtaining valid consent. This guideline is restricted to GI endoscopy but we cover elective and acute or emergency procedures. Few clinical trials have been carried out in relation to informed consent but most areas are informed by guidance from the General Medical Counsel (GMC) and/or are enshrined in legislation. Following an iterative voting process a series of recommendations have been drawn up that cover the majority of situations that will be encountered by endoscopists. This is not exhaustive and where doubt exists we have described where legal advice is likely to be required. This document relates to the law and endoscopy practice in the UK-where there is variation between the four devolved countries this is pointed out and endoscopists must be aware of the law where they practice. The recommendations are divided into consent for patients with and without capacity and we provide sections on provision of information and the consent process for patients in a variety of situations. This guideline is intended for use by all practitioners who request or perform GI endoscopy, or are involved in the pathway of such patients. If followed, we hope this document will enhance the experience of patients attending for endoscopy in UK units. 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/

The accompanying adult: authority to give consent in the UK.

PubMed

Lal, Seema Madhur Lata; Parekh, Susan; Mason, Carol; Roberts, Graham

2007-05-01

Children may be accompanied by various people when attending for dental treatment. Before treatment is started, there is a legal requirement that the operator obtain informed consent for the proposed procedure. In the case of minors, the person authorized to give consent (parental responsibility) is usually a parent. To ascertain if accompanying persons of children attending the Department of Paediatric Dentistry at the Eastman Dental Hospital, London were empowered to give consent for the child's dental treatment. A total of 250 accompanying persons of children attending were selected, over a 6-month period. A questionnaire was used to establish whether the accompanying person(s) were authorized to give consent. The study showed that 12% of accompanying persons had no legal authority to give consent for the child's dental treatment. Clinicians need to be aware of the status of persons accompanying children to ensure valid consent is obtained.

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

[Deferred consent for inclusion of patients unable to give their consent in studies in the field of emergency medicine].

PubMed

Kompanje, E J O; Jansen, T C; Le Noble, J L M L; de Geus, H R; Bakker, J

2008-09-20

Respect for individual autonomy, expressed in the concept of informed consent, is a basic principle in research with humans. Many patients in intensive care are unable to give consent because of mental incapacity, and this can be further complicated in emergency research, in which the treatment or experiment needs to be initiated without delay. In those situations consent can be deferred. Randomization is done without prior consent, followed by patients' or relatives' consent at a later stage. Butwhat should one do with the data if the patient dies at an early stage after randomization before consent could be obtained? Should the data be used or not? Should the relatives be asked for consent for using the data? The Dutch Central Committee on Research involving Human Subjects (CCMO) states that asking for consent after the patient has died makes no sense, because with the death of the patient the research has ended. Relatives do not have the authority to give consent for the use of medical data after the patient has died. Data can be used anonymously in the final analysis of the trial. We propose a flowchart for this procedure.

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.

[Under-age girl as a patient of pediatric and adolescent ginecology outpatient clinic].

PubMed

Sowińska-Przepiera, Elzbieta; Andrysiak-Mamos, Elzbieta; Syrenicz, Anhelli

2008-01-01

The research carried out in Poland reflected that sexual initiation before 18 years of age is a common phenomenon and refers to roughly 80% of teenagers. In Poland there is no uniform standing of medical and legal environments with regard to dealing with a juvenile patient who has become sexually active and expects the advice of a gynaecologist, gynaecologic examination and often asks for prescribing contraceptives. The procedures must take into account the fact that in Poland, until 18 years of age, a juvenile functions under the parental or tutelary authority, while a consent for medical service requires beside of the consent of legal guardian also the consent of a juvenile who is 16 years of age and becomes a full-right patient. According to the Act on Health Care Institutions, a patient has the right to self-decisions, the respect of physical and mental integrity and the respect of privacy, while the participation of a statutory representative post 16th year of age refers practically to co-deciding on a medical service provision. Therefore, the information received from such juvenile patient in subjective and objective examination does not have to be passed to the statutory representative, if the juvenile patient requires confidentiality and if this does not affect the patient's health and the planned medical procedures (e.g. the necessity of making an operation). The knowledge of conduct procedures with regard to a juvenile patient as a carrier of rights shall enable doctors to make aware choices of conduct and provide services or, in most cases, only advice, without the necessity to breach the laws of Poland.

12 CFR 980.6 - Finance Board consent.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to undertake a particular new business activity and...

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.

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 .

29 CFR 1921.8 - Consent findings and order.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... WORKERS' COMPENSATION ACT Prehearing Procedures § 1921.8 Consent findings and order. (a) General. At any... disposing of a proceeding shall also provide: (1) That the order shall have the same force and effect as an...

12 CFR 303.221 - Filing procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Filing procedures. 303.221 Section 303.221 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF PRACTICE FILING PROCEDURES Section 19 of the FDI Act (Consent to Service of Persons Convicted of Certain Criminal Offenses...

Consenting to invasive contraceptives: an ethical analysis of adolescent decision-making authority for long-acting reversible contraception.

PubMed

Behmer Hansen, Rosemary Talbot; Arora, Kavita Shah

2018-06-14

Since USA constitutional precedent established in 1976, adolescents have increasingly been afforded the right to access contraception without first obtaining parental consent or authorisation. There is general agreement this ethically permissible. However, long-acting reversible contraception (LARC) methods have only recently been prescribed to the adolescent population. They are currently the most effective forms of contraception available and have high compliance and satisfaction rates. Yet unlike other contraceptives, LARCs are associated with special procedural risks because they must be inserted and removed by trained healthcare providers. It is unclear whether the unique invasive nature of LARC changes the traditional ethical calculus of permitting adolescent decision-making in the realm of contraception. To answer this question, we review the risk-benefit profile of adolescent LARC use. Traditional justifications for permitting adolescent contraception decision-making authority are then considered in the context of LARCs. Finally, analogous reasoning is used to evaluate potential differences between permitting adolescents to consent for LARC procedures versus for emergency and pregnancy termination procedures. Ultimately, we argue that the invasive nature of LARCs does not override adolescents' unique and compelling need for safe and effective forms of contraception. In fact, LARCs may oftentimes be in the best interest of adolescent patients who wish to prevent unintended pregnancy. We advocate for the specific enumeration of adolescents' ability to consent to both LARC insertion and removal procedures within state policies. Given the provider-dependent nature of LARCs and the stigma regarding adolescent sexuality, special political and procedural safeguards to protect adolescent autonomy are warranted. © 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.

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.

32 CFR 770.57 - Entry procedures.

Code of Federal Regulations, 2013 CFR

2013-07-01

... ACCESS TO PARTICULAR INSTALLATIONS Entry Regulations for Portsmouth Naval Shipyard, Portsmouth, New Hampshire § 770.57 Entry procedures. (a) Any person or group desiring the advance consent of the Commander...

32 CFR 770.57 - Entry procedures.

Code of Federal Regulations, 2014 CFR

2014-07-01

... ACCESS TO PARTICULAR INSTALLATIONS Entry Regulations for Portsmouth Naval Shipyard, Portsmouth, New Hampshire § 770.57 Entry procedures. (a) Any person or group desiring the advance consent of the Commander...

32 CFR 770.57 - Entry procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... ACCESS TO PARTICULAR INSTALLATIONS Entry Regulations for Portsmouth Naval Shipyard, Portsmouth, New Hampshire § 770.57 Entry procedures. (a) Any person or group desiring the advance consent of the Commander...

32 CFR 770.57 - Entry procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... ACCESS TO PARTICULAR INSTALLATIONS Entry Regulations for Portsmouth Naval Shipyard, Portsmouth, New Hampshire § 770.57 Entry procedures. (a) Any person or group desiring the advance consent of the Commander...

Legal aspects of deaths associated with diagnostic and therapeutic procedures.

PubMed

Puxon, M

1984-01-01

Informed voluntary consent in relation to the charge of assault and battery is examined. The full implication of informed consent is set out. The legal aspects of negligence is also examined in relation to obtaining consent and the possibility of a wrong diagnosis. Where reasonable doubt exist about the correctness of a diagnosis the position of a second opinion is discussed. Guidelines on the handling of errors in treatment and anaesthetic deaths in relation to negligence is clearly set out.

12 CFR 980.6 - Finance Board consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Finance Board consent. 980.6 Section 980.6 Banks and Banking FEDERAL HOUSING FINANCE BOARD NEW FEDERAL HOME LOAN BANK ACTIVITIES NEW BUSINESS ACTIVITIES § 980.6 Finance Board consent. The Finance Board may at any time provide consent for a Bank to...

A cognitive approach for design of a multimedia informed consent video and website in pediatric research.

PubMed

Antal, Holly; Bunnell, H Timothy; McCahan, Suzanne M; Pennington, Chris; Wysocki, Tim; Blake, Kathryn V

2017-02-01

Poor participant comprehension of research procedures following the conventional face-to-face consent process for biomedical research is common. We describe the development of a multimedia informed consent video and website that incorporates cognitive strategies to enhance comprehension of study related material directed to parents and adolescents. A multidisciplinary team was assembled for development of the video and website that included human subjects professionals; psychologist researchers; institutional video and web developers; bioinformaticians and programmers; and parent and adolescent stakeholders. Five learning strategies that included Sensory-Modality view, Coherence, Signaling, Redundancy, and Personalization were integrated into a 15-min video and website material that describes a clinical research trial. A diverse team collaborated extensively over 15months to design and build a multimedia platform for obtaining parental permission and adolescent assent for participant in as asthma clinical trial. Examples of the learning principles included, having a narrator describe what was being viewed on the video (sensory-modality); eliminating unnecessary text and graphics (coherence); having the initial portion of the video explain the sections of the video to be viewed (signaling); avoiding simultaneous presentation of text and graphics (redundancy); and having a consistent narrator throughout the video (personalization). Existing conventional and multimedia processes for obtaining research informed consent have not actively incorporated basic principles of human cognition and learning in the design and implementation of these processes. The present paper illustrates how this can be achieved, setting the stage for rigorous evaluation of potential benefits such as improved comprehension, satisfaction with the consent process, and completion of research objectives. New consent strategies that have an integrated cognitive approach need to be developed and tested in controlled trials. Copyright © 2017 Elsevier Inc. All rights reserved.

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 24 Housing and Urban Development 1 2013-04-01 2013-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 24 Housing and Urban Development 1 2012-04-01 2012-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

24 CFR 5.232 - Penalties for failing to sign consent forms.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 24 Housing and Urban Development 1 2014-04-01 2014-04-01 false Penalties for failing to sign consent forms. 5.232 Section 5.232 Housing and Urban Development Office of the Secretary, Department of... Procedures for Obtaining Income Information About Applicants and Participants § 5.232 Penalties for failing...

10 CFR 745.116 - General requirements for informed consent.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 745.116 Energy DEPARTMENT OF ENERGY PROTECTION OF HUMAN SUBJECTS § 745.116 General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as... particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject...

19 CFR 181.74 - Verification visit procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... consent of the Canadian or Mexican exporter or producer of the good or producer of the material whose... otherwise provided in paragraph (d) of this section, where a Canadian or Mexican exporter or producer of a good, or a Canadian or Mexican producer of a material, has not given its written consent to a proposed...

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…

Parental Consent for Abortion and the Judicial Bypass Option in Arkansas: Effects and Correlates

PubMed Central

Joyce, Ted

2010-01-01

CONTEXT In 2005, Arkansas changed its parental notification requirement for minors seeking an abortion to a parental consent law, under which a minor can obtain an abortion without consent after obtaining a judicial waiver. METHODS Using state Department of Health data on 7,463 abortions among 15–19-year-olds over the period 2001–2007, an analysis of abortion and second-trimester abortion rates among Arkansas minors relative to rates among older teenagers evaluated the influence of the 2005 change in the law. Linear and logistic regression analyses estimated the changes in rates among different age-groups, and assessed the likelihood of minors’ using the bypass procedure or having a second-trimester abortion. RESULTS No association was found between the change in the law and either the abortion rate or the second-trimester abortion rate among minors in the state. Ten percent of all abortions among minors were obtained through the judicial bypass procedure, and minors aged 15 or younger who had an abortion were less likely than those aged 17 to get a waiver (odds ratio, 0.2). Minors who used the bypass option were less likely than those who obtained parental consent to have a second-trimester abortion (0.5), and they terminated the pregnancy 1.1 weeks earlier, on average, than did minors who had gotten such consent. CONCLUSIONS States that convert a parental notification statute to a parental consent statute are unlikely to experience a decrease in abortions among minors. PMID:20887286

Parental consent for abortion and the judicial bypass option in Arkansas: effects and correlates.

PubMed

Joyce, Ted

2010-09-01

In 2005, Arkansas changed its parental notification requirement for minors seeking an abortion to a parental consent law, under which a minor can obtain an abortion without consent after obtaining a judicial waiver. Using state health department data on 7,463 abortions among 15-19-year-olds over the period 2001-2007, an analysis of abortion and second-trimester abortion rates among Arkansas minors relative to rates among older teenagers evaluated the influence of the 2005 change in the law. Linear and logistic regression analyses estimated the changes in rates among different age-groups, and assessed the likelihood of minors' using the bypass procedure or having a second-trimester abortion. No association was found between the change in the law and either the abortion rate or the second-trimester abortion rate among minors in the state. Ten percent of all abortions among minors were obtained through the judicial bypass procedure, and minors aged 15 or younger who had an abortion were less likely than those aged 17 to get a waiver (odds ratio, 0.2). Minors who used the bypass option were less likely than those who obtained parental consent to have a second-trimester abortion (0.5), and they terminated the pregnancy 1.1 weeks earlier, on average, than did minors who had gotten such consent. States that convert a parental notification statute to a parental consent statute are unlikely to experience a decrease in abortions among minors. Copyright © 2010 by the Guttmacher Institute.

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.

Informed consent instead of assent is appropriate in children from the age of twelve: Policy implications of new findings on children's competence to consent to clinical research.

PubMed

Hein, Irma M; De Vries, Martine C; Troost, Pieter W; Meynen, Gerben; Van Goudoever, Johannes B; Lindauer, Ramón J L

2015-11-09

For many decades, the debate on children's competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children's competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children's competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives. Although assessment of children's competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad. Previous research outcomes showed that children's medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children's competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated.

Organ donation after cardiac death: legal and ethical justifications for antemortem interventions.

PubMed

Richards, Bernadette; Rogers, Wendy A

2007-08-06

Organ donation after cardiac death increases organ availability, but raises several legal and ethical issues, including consent. Medical interventions for people who are unconscious usually require guardian consent and must meet patients' best-interests standards. Antemortem procedures can improve the success of organ transplant after cardiac death, but do not serve the patient's medical interests, and it is contentious whether consent for antemortem interventions is legal under current Australian guardianship legislation. We argue that consent decisions should take patients' wishes as well as their medical interests into account. Antemortem interventions are ethically and legally justified if the interventions are not harmful and the person concerned wished to be an organ donor.

"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.

Sterilizing the mentally-handicapped: who can give consent?

PubMed

1980-01-26

Due to the vulnerable position of the mentally handicapped individual, the question of whether the state or any other interested 3rd party should intervene in procreative rights even with consent will depend to a great extent on the ability and autonomy of the individual to make the decision. There are 3 elements to consent: 1) it must be voluntary; 2) it requires that the individual has sufficient information to make a decision; and 3) it is imperative that the person providing the consent have the mental competence to appreciate exactly what is being consented to and the implication of the consent. Consent can be either personal consent or it may be "3rd party" consent. The 3rd party consent is used when an individual is incapable of providing personal consent. It is crucially important that those mentally handicapped individuals who are capable of making a decision do make such a decision when they agree to undergo sterilization. There is nothing inherent in mental handicap that prevents an individual from providing competent consent to a sterilization. The situation when someone other than the individual to be sterilized consents to the procedure poses more problems. Some glaring problems that arise when 3rd party consent on behalf of full-time residents in state institutions is allowed are the following: 1) state coercion behind such decisions is too easily concealed; 2) persuasion can be brought to bear on parents who already bear the stigma of a mentally handicapped child; and 3) administrative convenience may too easily be substituted for the benefit to the individual.

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

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.

Women lose suit over involuntary sterilizations (California).

PubMed

1978-10-01

Federal Judge Jesse W. Curtis dismissed a suit brought by 10 Mexican-American women, who charged that between 1971-1974 they were sterilized without their voluntary and informed consent by physicians at the USC-Los Angeles County General Medical Center. Judge Curtis considered the case a communications breakdown between doctor and patient based on the patients' limited ability to speak English. Many women testified that they were pressured by hospital staff to consent to sterilization while they were in labor. Subsequent regulations passed by the California health department prohibit obtaining sterilization consent from a woman in labor or 24 hours postpartum. It further requires the consent form be written in the patient's preferred language. 8 of the plaintiffs had signed consent forms; 2 of the plaintiffs' husbands had signed. In the future, doctors must fully explain the procedure and its effects.

From the Form to the Face to Face: IRBs, Ethnographic Researchers, and Human Subjects Translate Consent

ERIC Educational Resources Information Center

Metro, Rosalie

2014-01-01

Based on my fieldwork with Burmese teachers in Thailand, I describe the drawbacks of using IRB-mandated written consent procedures in my cross-cultural collaborative ethnographic research on education. Drawing on theories of intersubjectivity (Mikhail Bakhtin), ethics (Emmanuel Levinas), and translation (Naoki Sakai), I describe face-to-face…

78 FR 45068 - Commission's Rules of Practice and Procedure; Practice Before the Commission, Parties to...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-26

... amendments. Section 502.42--Bureau of Enforcement Section 502.42 is amended to simplify the language... proceeding. (e) If an attorney wishes to withdraw from representing a party, and written consent is not... simplification of the issues by consent of the parties or by the use of alternative means of dispute resolution...

Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery.

PubMed

Zarnegar, Roxaneh; Brown, Matthew R D; Henley, Matthew; Tidman, Victoria; Pathmanathan, Ahilan

2015-11-01

In Britain, consent for surgery is documented using a Department of Health form signed by the surgeon and the patient. In contrast, anaesthetic procedures have no formalised consent process. Evidence on the process of consent for regional anaesthesia, and patient perceptions of this, is scarce outside obstetric practice. We aimed to determine patient recall and perceptions of consent for interscalene brachial plexus block and compared this to surgical consent for shoulder arthroplasty. Prospective observational survey. A specialist musculoskeletal centre, UK. Forty-six patients (female:male 30:16, mean age 61 years) undergoing shoulder arthroplasty with interscalene brachial plexus block. Recall and understanding of consent for regional anaesthesia and surgery was examined using a semi-structured questionnaire 1-2 days after arthroplasty. Surgical consent forms and discussions recorded by the anaesthetist were examined in participants' medical notes to compare against the level of recall. Analysis to determine statistical significance was conducted using McNemar's test. Recall of surgical risks was overall significantly better than recall of brachial plexus block risks. Compared to their recollections of surgical risk, patients remembered fewer specific risks for brachial plexus block (p < 0.001). There were more patients unable to recall any risks when questioned about brachial plexus block than about their surgery (p < 0.05). One-third of patients did not regard the consent discussion about regional anaesthesia as important as consent for surgery and over one-quarter had not recognised the preoperative discussion about the brachial plexus block as a consent process similar to that conducted for surgery. Fundamental misunderstandings about the consent process are prevalent. Future work in this area should seek to investigate how documentation of the consent process and patients' understanding of consent for regional anaesthesia can be improved. © The Royal Society of Medicine.

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.

Patient Education and Informed Consent for Preimplantation Genetic Diagnosis: Health Literacy for Genetics and Assisted Reproductive Technology

PubMed Central

McGowan, Michelle L.; Burant, Chris; Moran, Rocio; Farrell, Ruth

2013-01-01

Introduction Innovative applications of genetic testing have emerged within the field of assisted reproductive technology through preimplantation genetic diagnosis (PGD). As in all forms of genetic testing, adequate genetic counseling and informed consent are critical. Despite the growing recognition of the role of informed consent in genetic testing, there is little data available about how this process occurs in the setting of PGD. Methods A cross sectional study of IVF clinics offering PGD in the U.S. was conducted to assess patient education and informed consent practices. Descriptive data were collected with a self-administered survey instrument. Results More than half of the clinics offering PGD required genetic counseling prior to PGD (56%). Genetic counseling was typically performed by certified genetic counselors (84 %). Less than half (37%) of the clinics required a separate informed consent process for genetic testing of embryonic cells. At a majority of those clinics requiring a separate informed consent for genetic testing (54%), informed consent for PGD and genetic testing took place as a single event before beginning IVF procedures. Conclusions The results suggest that patient education and informed consent practices for PGD have yet to be standardized. These findings warrant the establishment of professional guidelines for patient education and informed consent specific to embryonic genetic testing. PMID:19652605

Should informed consent be based on rational beliefs?

PubMed Central

Savulescu, J; Momeyer, R W

1997-01-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences. PMID:9358347

Should informed consent be based on rational beliefs?

PubMed

Savulescu, J; Momeyer, R W

1997-10-01

Our aim is to expand the regulative ideal governing consent. We argue that consent should not only be informed but also based on rational beliefs. We argue that holding true beliefs promotes autonomy. Information is important insofar as it helps a person to hold the relevant true beliefs. But in order to hold the relevant true beliefs, competent people must also think rationally. Insofar as information is important, rational deliberation is important. Just as physicians should aim to provide relevant information regarding the medical procedures prior to patients consenting to have those procedures, they should also assist patients to think more rationally. We distinguish between rational choice/action and rational belief. While autonomous choice need not necessarily be rational, it should be based on rational belief. The implication for the doctrine of informed consent and the practice of medicine is that, if physicians are to respect patient autonomy and help patients to choose and act more rationally, not only must they provide information, but they should care more about the theoretical rationality of their patients. They should not abandon their patients to irrationality. They should help their patients to deliberate more effectively and to care more about thinking rationally. We illustrate these arguments in the context of Jehovah's Witnesses refusing life-saving blood transfusions. Insofar as Jehovah's Witnesses should be informed of the consequences of their actions, they should also deliberate rationally about these consequences.

14 CFR 16.237 - Waiver of procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Waiver of procedures. 16.237 Section 16.237 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES RULES OF... of this issue on appeal. (c) The parties may not by consent waive the obligation of the hearing...

14 CFR 16.237 - Waiver of procedures.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Waiver of procedures. 16.237 Section 16.237 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES RULES OF... of this issue on appeal. (c) The parties may not by consent waive the obligation of the hearing...

14 CFR 16.237 - Waiver of procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Waiver of procedures. 16.237 Section 16.237 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES RULES OF... of this issue on appeal. (c) The parties may not by consent waive the obligation of the hearing...

14 CFR 16.237 - Waiver of procedures.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Waiver of procedures. 16.237 Section 16.237 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES RULES OF... of this issue on appeal. (c) The parties may not by consent waive the obligation of the hearing...

14 CFR 16.237 - Waiver of procedures.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Waiver of procedures. 16.237 Section 16.237 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL RULES RULES OF... of this issue on appeal. (c) The parties may not by consent waive the obligation of the hearing...

47 CFR 1.6004 - Answers.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Implementation of Section 325(e) of the Communications Act: Procedures Governing Complaints Filed by Television Broadcast Stations Against Satellite Carriers for Retransmission Without Consent § 1.6004 Answers. Within five (5) business...

Reconciling the principle of patient autonomy with the practice of informed consent: decision-making about prognostication in uveal melanoma.

PubMed

Cook, Sharon A; Damato, Bertil; Marshall, Ernie; Salmon, Peter

2011-12-01

Influential views on how to protect patient autonomy in clinical care have been greatly shaped by rational and deliberative models of decision-making. Our aim was to understand how the general principle of respecting autonomy can be reconciled with the local reality of obtaining consent in a clinical situation that precludes extended deliberation. We interviewed 22 patients with intraocular melanoma who had been offered cytogenetic tumour typing to indicate whether the tumour was likely to shorten life considerably. They were interviewed before and/or up to 36 months after receiving cytogenetic results. Patients described their decision-making about the test and how they anticipated and used the results. Their accounts were analysed qualitatively, using inconsistencies at a descriptive level to guide interpretative analysis. Patients did not see a decision to be made. For those who accepted testing, their choice reflected trust of what the clinicians offered them. Patients anticipated that a good prognosis would be reassuring, but this response was not evident. Although they anticipated that a poor prognosis would enable end-of-life planning, adverse results were interpreted hopefully. In general, the meaning of the test for patients was not separable from ongoing care. Models of decision-making and associated consent procedures that emphasize patients' active consideration of isolated decision-making opportunities are invalid for clinical situations such as this. Hence, responsibility for ensuring that a procedure protects patients' interests rests with practitioners who offer it and cannot be delegated to patients. © 2010 Blackwell Publishing Ltd.

Involving parents from the start: formative evaluation for a large randomised controlled trial with Botswana Junior Secondary School students.

PubMed

Vig, Jessica; Miller, Kim S; Chirwa-Motswere, Catherine; Winskell, Kate; Stallcup, Elizabeth

2016-01-01

While HIV prevention research conducted among adolescent populations may encounter parental resistance, the active engagement of parents from inception to trial completion may alleviate opposition. In preparation for implementing a large randomised controlled trial (RCT) examining the efficacy of a behavioural intervention targeting adolescent sexual risk behaviours, a formative evaluation was undertaken to assess parental reactions to the proposed trial. Six focus groups were conducted with parents of adolescents (aged 13-17) from rural, peri-urban and urban junior secondary schools in Botswana. Focus groups explored comprehension and acceptability among parents of the forthcoming trial including HSV-2 testing, the return of results to the adolescent (not the parent), trial information materials and the parental consent process. Parents welcomed the study and understood and accepted its moral and ethical considerations. Their reactions regarding return of HSV-2 results only to adolescents (not the parent) were mixed. Parents understood the consent process and most agreed to consent, while indicating their desire to remain informed and involved throughout the RCT. The focus group discussions (FGDs) provided valuable information and insights that helped strengthen the study. As a result of parents' feedback, counselling procedures were strengthened and direct linkages to local services and care were made. Informational materials were revised to increase clarity, and materials and procedures were developed to encourage and support parental involvement and parent-child dialogue. Ultimately, parental feedback led to a decision by the Government of Botswana to allow parents to access their child's HSV-2 test results.

Involving parents from the start: Formative evaluation for a large RCT with Botswana Junior Secondary School students

PubMed Central

Miller, Kim S.; Chirwa-Motswere, Catherine; Winskell, Kate; Stallcup, Elizabeth

2016-01-01

While HIV prevention research conducted among adolescent populations may encounter parental resistance, the active engagement of parents from inception to trial completion may alleviate opposition. In preparation for implementing a large randomized controlled trial (RCT) examining the efficacy of a behavioural intervention targeting adolescent sexual risk behaviours, a formative evaluation was undertaken to assess parental reactions to the proposed trial. Six focus groups were conducted with parents of adolescents (aged 13–17) from rural, peri-urban, and urban Botswana junior secondary schools. Focus groups explored comprehension and acceptability among parents of the forthcoming trial including HSV-2 testing, the return of results to the adolescent (not the parent), trial information materials and the parental consent process. Parents welcomed the study and understood and accepted its moral and ethical considerations. Their reactions regarding return of HSV-2 results only to adolescents (not the parent) were mixed. Parents understood the consent process and most agreed to consent, while indicating their desire to remain informed and involved throughout the RCT. The FGDs provided valuable information and insights that helped strengthen the study. As a result of parents’ feedback, counselling procedures were strengthened and direct linkages to local services and care were made. Informational materials were revised to increase clarity, and materials and procedures were developed to encourage and support parental involvement and parent-child dialogue. Ultimately, parental feedback led to a decision by the Government of Botswana to allow parents to access their child’s HSV-2 test results. PMID:27002354

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

Statewide Survey of Drug and Alcohol Use among California Students in Grades 7, 9, and 11. Winter 1995-96. Sixth Biennial.

ERIC Educational Resources Information Center

Austin, Gregory; Skager, Rodney

The California Student Substance Use Survey marks a milestone in the state's efforts to monitor, understand, and prevent adolescent substance use and abuse. Chapter 1 presents the methodology. This survey follows a shift in California policy to a written parental consent requirement. Sample characteristics, consent procedures, and methods of data…

Patient Privacy, Consent, and Identity Management in Health Information Exchange

PubMed Central

Hosek, Susan D.; Straus, Susan G.

2013-01-01

Abstract The Military Health System (MHS) and the Veterans Health Administration (VHA) have been among the nation's leaders in health information technology (IT), including the development of health IT systems and electronic health records that summarize patients' care from multiple providers. Health IT interoperability within MHS and across MHS partners, including VHA, is one of ten goals in the current MHS Strategic Plan. As a step toward achieving improved interoperability, the MHS is seeking to develop a research roadmap to better coordinate health IT research efforts, address IT capability gaps, and reduce programmatic risk for its enterprise projects. This article contributes to that effort by identifying gaps in research, policy, and practice involving patient privacy, consent, and identity management that need to be addressed to bring about improved quality and efficiency of care through health information exchange. Major challenges include (1) designing a meaningful patient consent procedure, (2) recording patients' consent preferences and designing procedures to implement restrictions on disclosures of protected health information, and (3) advancing knowledge regarding the best technical approaches to performing patient identity matches and how best to monitor results over time. Using a sociotechnical framework, this article suggests steps for overcoming these challenges and topics for future research. PMID:28083296

Healthy participants in phase I clinical trials: the quality of their decision to take part.

PubMed

Rabin, Cheryl; Tabak, Nili

2006-08-01

This study was set out to test the quality of the decision-making process of healthy volunteers in clinical trials. Researchers fear that the decision to volunteer for clinical trials is taken inadequately and that the signature on the consent forms, meant to affirm that consent was 'informed', is actually insubstantial. The study design was quasi-experimental, using a convenience quota sample. Over a period of a year, candidates were approached during their screening process for a proposed clinical trial, after concluding the required 'Informed Consent' procedure. In all, 100 participants in phase I trials filled out questionnaires based ultimately on the Janis and Mann model of vigilant information processing, during their stay in the research centre. Only 35% of the participants reached a 'quality decision'. There is a definite correlation between information processing and quality decision-making. However, many of the healthy research volunteers (58%) do not seek out information nor check alternatives before making a decision. Full disclosure is essential to a valid informed consent procedure but not sufficient; emphasis must be put on having the information understood and assimilated. Research nurses play a central role in achieving this objective.

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 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.

Gillick, bone marrow and teenagers.

PubMed

Cherkassky, Lisa

2015-09-01

The Human Tissue Authority can authorise a bone marrow harvest on a child of any age if a person with parental responsibility consents to the procedure. Older children have the legal capacity to consent to medical procedures under Gillick, but it is unclear if Gillick can be applied to non-therapeutic medical procedures. The relevant donation guidelines state that the High Court shall be consulted in the event of a disagreement, but what is in the best interests of the teenage donor under s.1 of the Children Act 1989? There are no legal authorities on child bone marrow harvests in the United Kingdom. This article considers the best interests of the older saviour sibling and questions whether, for the purposes of welfare, the speculative benefits could outweigh the physical burdens. © The Author(s) 2015.

Information disclosure in clinical informed consent: "reasonable" patient's perception of norm in high-context communication culture.

PubMed

Hammami, Muhammad M; Al-Jawarneh, Yussuf; Hammami, Muhammad B; Al Qadire, Mohammad

2014-01-10

The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures. We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues. Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure's name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a "reasonable" patient's standard is to be met.

30 CFR 44.22 - Administrative law judges; powers and duties.

Code of Federal Regulations, 2014 CFR

2014-07-01

... ends of justice would be served; (5) To provide for discovery and determine its scope; (6) To regulate... procedural requests; (8) To hold conferences for settlement or simplification of issues by consent of the... record of the hearing. (d) Referral to Federal Rules of Civil Procedure and Evidence. On any procedural...

30 CFR 44.22 - Administrative law judges; powers and duties.

Code of Federal Regulations, 2012 CFR

2012-07-01

... ends of justice would be served; (5) To provide for discovery and determine its scope; (6) To regulate... procedural requests; (8) To hold conferences for settlement or simplification of issues by consent of the... record of the hearing. (d) Referral to Federal Rules of Civil Procedure and Evidence. On any procedural...

Surgical informed consent in obstetric and gynecologic surgeries: experience from a comprehensive teaching hospital in Southern Ethiopia.

PubMed

Teshome, Million; Wolde, Zenebe; Gedefaw, Abel; Tariku, Mequanent; Asefa, Anteneh

2018-05-24

Surgical Informed Consent (SIC) has long been recognized as an important component of modern medicine. The ultimate goals of SIC are to improve clients' understanding of the intended procedure, increase client satisfaction, maintain trust between clients and health providers, and ultimately minimize litigation issues related to surgical procedures. The purpose of the current study is to assess the comprehensiveness of the SIC process for women undergoing obstetric and gynecologic surgeries. A hospital-based cross-sectional study was undertaken at Hawassa University Comprehensive Specialized Hospital (HUCSH) in November and December, 2016. A total of 230 women who underwent obstetric and/or gynecologic surgeries were interviewed immediately after their hospital discharge to assess their experience of the SIC process. Thirteen components of SIC were used based on international recommendations, including the Royal College of Surgeon's standards of informed consent practices for surgical procedures. Descriptive summaries are presented in tables and figures. Forty percent of respondents were aged between 25 and 29 years. Nearly a quarter (22.6%) had no formal education. More than half (54.3%) of respondents had undergone an emergency surgical procedure. Only 18.4% of respondents reported that the surgeon performing the operation had offered SIC, while 36.6% of respondents could not recall who had offered SIC. All except one respondent provided written consent to undergo a surgical procedure. However, 8.3% of respondents received SIC service while already on the operation table for their procedure. Only 73.9% of respondents were informed about the availability (or lack thereof) of alternative treatment options. Additionally, a majority of respondents were not informed about the type of anesthesia to be used (88.3%) and related complications (87.4%). Only 54.2% of respondents reported that they had been offered at least six of the 13 SIC components used by the investigators. There is gap in the provision of comprehensive and standardized pre-operative counseling for obstetric and gynecologic surgeries in the study hospital. This has a detrimental effect on the overall quality of care clients receive, specifically in terms of client expectations and information needs.

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.

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.

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.

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.

Perception on Informed Consent Regarding Nursing Care Practices in a Tertiary Care Center.

PubMed

Paudel, B; Shrestha, G K

Background Consent for care procedures is mandatory after receipt of adequate information. It maintains patient's rights and autonomy to make thoughtful decisions. Poor communication often leads to poor health quality. Objective To assess hospitalized patients' perception on informed consent regarding nursing care practices in a tertiary care center. Method This is a descriptive cross-sectional study among 113 admitted patients conducted in February 2012 at Dhulikhel Hospital, Nepal. Patients of various wards were selected using purposive non-probability sampling with at least 3 days of hospitalization. Close ended structured questionnaire was used to assess patients' perception on three different areas of informed consent (information giving, opportunity to make decision and taking prior consent). Result Among the participants 71.6% perceived positively regarding informed consent towards nursing care practices with a mean score of 3.32 ± 1.28. Patients' perception on various areas of informed consent viz. information giving, opportunities to make specific decision and taking prior consent were all positive with mean values of 3.43±1.12, 2.88±1.23, 3.65±1.49 respectively. Comparison of mean perception of informed consent with various variables revealed insignificant correlation (p-value >0.05) for age, educational level and previous hospitalization while it was significant (p-value < 0.05) for communication skills of nurses. Conclusion Majority of patients have positive perception on informed consent towards nursing care practices. Communication skills of nurses affect the perception of patients' regardless of age, education level and past experiences.

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

Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

PubMed

Das, Debashish; Cheah, Phaik Yeong; Akter, Fateha; Paul, Dulal; Islam, Akhterul; Sayeed, Abdullah A; Samad, Rasheda; Rahman, Ridwanur; Hossain, Amir; Dondorp, Arjen; Day, Nicholas P; White, Nicholas J; Hasan, Mahtabuddin; Ghose, Aniruddha; Ashley, Elizabeth A; Faiz, Abul

2014-06-04

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. In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. 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. 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.

Pastoral power and gynaecological examinations: a Foucauldian critique of clinician accounts of patient-centred consent.

PubMed

Cook, Catherine; Brunton, Margaret

2015-05-01

Invasive non-sedated clinical procedures such as gynaecological examinations are normalised; however, there is limited research highlighting the relational and technical skills required for clinicians to ensure patients' continued consent. A considerable body of research emphasises that women dislike examinations, leading to their non-compliance or a delayed follow up for gynaecological and sexual health problems. However, medical research focuses on 'problem' women; the role of clinicians receives limited appraisal. This article draws on interviews with sexual health clinicians in New Zealand, from metropolitan and provincial locations. The gynaecological care of women in New Zealand attained international notoriety with the 1988 publication of Judge Cartwright's inquiry into ethical shortcomings in cervical cancer research at the National Women's Hospital. Judge Cartwright's recommendations included patient-centred care in order to ensure informed consent had been received for clinical procedures and research participation. This article's critical analysis is that, although clinicians' language draws on humanistic notions of patient-centredness, Foucault's notion of secularised pastoral power enables a more nuanced appreciation of the ethical work undertaken by clinicians when carrying out speculum examinations. The analysis highlights both the web of power relations present during examination practices and the strategies clinicians use to negotiate women's continued consent; which is significant because consent is usually conceptualised as an event, rather than an unfolding, unstable process. © 2015 The Authors. Sociology of Health & Illness © 2015 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd.

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.

Is ‘informed consent’ an ‘understood consent’ in hematopoietic cell transplantation?

PubMed Central

D'Souza, A; Pasquini, M; Spellecy, R

2015-01-01

Hematopoietic cell transplantation (HCT) is a complex and highly specialized medical treatment that is associated with significant risks, including death. Furthermore, transplantation is offered to patients who often have no other curative treatment alternatives. The routine-consent process for HCT typically occurs before HCT and is influenced by many factors related to patients, physicians and the transplant per se. These factors can impede the consent process and subsequently result in a failure of proper engagement in and an understanding of the procedure with resultant adverse consequences influencing patients and even the patient–physician relationship. We contend that informed consent is a dynamic and ongoing process and that better patient education can assist in the decision making, fulfill the ethical principle of respect for autonomy and engage the patient to maximize compliance and adherence to therapy. This manuscript reviews the key literature pertaining to the decision-making and consent process in HCT and proposes guidelines for improving the consent process. Strategies for improving patient comprehension, engagement and enhancing consent forms are discussed. PMID:25243618

Law on consent and confidentiality in India: a need for clarity.

PubMed

Mathiharan, Karunakaran

2014-01-01

The concept of informed consent specific to medical research and treatment is still alien to many medical researchers and practitioners and to millions of Indians. The doctor-patient relationship in India is governed more by trust where the doctor is the authoritative person. Therefore, the benefit of informed consent does not reach all patients in day-to-day medical practice. To complicate the issue, the Indian law is not specific about the age at which a person can give valid consent. The Indian Penal Code is silent about the legal validity of consent given by persons between 12 and 18 years of age. Similarly, the age at which the 'Right to Confidentiality' begins is yet to be defined either by the statute or by the courts. Hence, there is a need for a clear statutory provision to remove the anomalies and ambiguities regarding the age of consent to undergo invasive therapeutic or investigative procedures, participate in clinical trials, as well as define the age at which a person's right to medical confidentiality begins.

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.

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

Developing a pharmaceutical purchasing strategy.

PubMed

Hynniman, C E

1992-09-01

The process commonly used by group purchasing organizations to contract for multisource pharmaceuticals and a strategic approach for the director of pharmacy in working with the purchasing group and the P & T Committee is described. The pharmacist should be knowledgeable concerning the group's contract commitment requirements, product specifications, terms and conditions and procedures for vendor selection, product award, contract implementation, and performance monitoring. To ensure results that meet the needs of the medical staff, it is important that the P & T Committee actively participate. The P & T Committee should understand the reasons for selecting a particular purchasing group, understand the necessary steps in obtaining the most favorable economic advantage, review products with potential brand interchange concerns, recommend product specifications, and reaffirm formulary procedures regarding the principle of current 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.

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.

Patient Privacy, Consent, and Identity Management in Health Information Exchange: Issues for the Military Health System.

PubMed

Hosek, Susan D; Straus, Susan G

2013-01-01

The Military Health System (MHS) and the Veterans Health Administration (VHA) have been among the nation's leaders in health information technology (IT), including the development of health IT systems and electronic health records that summarize patients' care from multiple providers. Health IT interoperability within MHS and across MHS partners, including VHA, is one of ten goals in the current MHS Strategic Plan. As a step toward achieving improved interoperability, the MHS is seeking to develop a research roadmap to better coordinate health IT research efforts, address IT capability gaps, and reduce programmatic risk for its enterprise projects. This article contributes to that effort by identifying gaps in research, policy, and practice involving patient privacy, consent, and identity management that need to be addressed to bring about improved quality and efficiency of care through health information exchange. Major challenges include (1) designing a meaningful patient consent procedure, (2) recording patients' consent preferences and designing procedures to implement restrictions on disclosures of protected health information, and (3) advancing knowledge regarding the best technical approaches to performing patient identity matches and how best to monitor results over time. Using a sociotechnical framework, this article suggests steps for overcoming these challenges and topics for future research.

Guidelines for medical research in children.

PubMed

Papadatos, C J

1989-01-01

Nearly everyone agrees that violations in research occur. Nobody knows how often. But if Pediatrics is to progress children must be the subjects of research carried out in an acceptable way. The following guidelines should be followed in childhood experimentation: (1) Research should not be done on children if the same investigation can be done in adults. (2) All research projects must be evaluated by ethics committees having as members lay people and investigators possessing the qualities of competence and judgement. (3) The degree of benefit from a research procedure should be assessed against the risk of disturbance, discomfort or pain. (4) Statements regarding consent are meaningless and consent is still only partially informed. Although a parental signature does not mean that consent is informed, nevertheless parental consent must still remain as a key requirement in childhood experimentation.

First Implementation of Transfusion Consent Policy in Oman: Audit of compliance from a tertiary care university hospital.

PubMed

Al-Riyami, Arwa Z; Al-Ghafri, Naif; Zia, Fehmida; Al-Huneini, Mohammed; Al-Rawas, Abdul-Hakeem; Al-Kindi, Salam; Jose, Sachin; Al-Khabori, Murtadha; Al-Sabti, Hilal; Daar, Shahina

2016-08-01

Transfusions are a common medical intervention. Discussion of the benefits, risks and alternatives with the patient is mandated by many legislations prior to planned transfusions. At the Sultan Qaboos University Hospital (SQUH), Muscat, Oman, a written transfusion consent policy was introduced in March 2014. This was the first time such a policy was implemented in Oman. This study therefore aimed to assess adherence to this policy among different specialties within SQUH. The medical records of patients who underwent elective transfusions between June and August 2014 were reviewed to assess the presence of transfusion consent forms. If present, the consent forms were examined for completeness of patient, physician and witness information. In total, the records of 446 transfused patients (299 adult and 147 paediatric patients) were assessed. Haematology patients accounted for 50% of adult patients and 71% of paediatric patients. Consent was obtained for 75% of adult and 91% of paediatric patients. The highest adherence rate was observed among adult and paediatric haematology specialists (95% and 97%, respectively). Consent forms were correctly filled out with all details provided for 51% and 52% of adult and paediatric patients, respectively. Among inadequately completed forms, the most common error was a lack of witness details (20-25%). In most cases, the pre-transfusion consent policy was successfully adhered to at SQUH. However, further work is required to ensure full compliance with the consent procedure within different specialties. Implementation of transfusion consent in other hospitals in the country is recommended.

Collections of human biological samples for scientific purposes. Why do current regulation need to be clarified and how?

PubMed

Deplanque, Dominique; Birraux, Guillaume; Bertoye, Pierre-Henri; Postaire, Eric

2009-01-01

The collection of human biological samples is of major importance for future research in France and Europe. In recent years, new regulatory procedures have been designed to monitor these activities; but they are somewhat complex and some clarifications are needed. The law needs also to be amended. The definition of biobanking activities should be clarified, and regulatory procedures, including consultation of the Ethics Committee, declarations to the Ministry of Research and the protection of personal data, should be simplified. It is also of great importance to correctly define the modalities in which Biobanks are granted their authorisations. The role of Ethics Committees regarding the evaluation of information and the consent procedures should also be clarified, particularly when samples from children are used, or when the samples are used for genetic analyses. As well as scientific and public health aspects, the storage of human biological samples may also have important economic consequences. It is hence crucial to adapt the procedure for submitting patents, particularly when several public or private partners are working together. The possible changes to both French and European laws planned in the next months would be an ideal time to introduce these changes.

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.

A comprehensive and efficient process for counseling patients desiring sterilization.

PubMed

Haws, J M; Butta, P G; Girvin, S

1997-06-01

To optimize the time spent counseling a sterilization patient, this article presents a 10-step process that includes all steps necessary to ensure a comprehensive counseling session: (1) Discuss current contraception use and all available methods; (2) assess the client's interest in/readiness for sterilization; (3) emphasize that the procedure is meant to be permanent, but there is a possibility of failure; (4) explain the surgical procedure using visuals, and include a discussion of benefits and risks; (5) explain privately to the client the need to use condoms if engaging in risky sexual activity; (6) have the client read and sign an informed consent form; (7) schedule an appointment for the procedure and provide the patient with a copy of all necessary paperwork; (8) discuss cost and payment method; (9) provide written preoperative and postoperative instructions; and (10) schedule a postoperation visit, or a postoperation semen analysis.

Dynamic Consent: a potential solution to some of the challenges of modern biomedical research.

PubMed

Budin-Ljøsne, Isabelle; Teare, Harriet J A; Kaye, Jane; Beck, Stephan; Bentzen, Heidi Beate; Caenazzo, Luciana; Collett, Clive; D'Abramo, Flavio; Felzmann, Heike; Finlay, Teresa; Javaid, Muhammad Kassim; Jones, Erica; Katić, Višnja; Simpson, Amy; Mascalzoni, Deborah

2017-01-25

Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment. An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach. Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies. Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.

12 CFR 1272.6 - FHFA consent.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 9 2013-01-01 2013-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

12 CFR 1272.6 - FHFA consent.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 10 2014-01-01 2014-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

12 CFR 1272.6 - FHFA consent.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 9 2012-01-01 2012-01-01 false FHFA consent. 1272.6 Section 1272.6 Banks and Banking FEDERAL HOUSING FINANCE AGENCY FEDERAL HOME LOAN BANKS NEW BUSINESS ACTIVITIES § 1272.6 FHFA consent. The FHFA may at any time provide consent for a Bank to undertake a particular new business...

78 FR 22040 - Proposed Collection; Comment Request for Revenue Procedure 2001-24

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-12

... comments concerning Revenue Procedure 2001-24, Advanced Insurance Commissions. DATES: Written [email protected] . SUPPLEMENTARY INFORMATION: Title: Advanced Insurance Commissions. OMB Number: 1545-1736... consent to change its method of accounting for cash advances on commissions paid to its agents must agree...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

16 CFR 2.32 - Agreement.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Agreement. 2.32 Section 2.32 Commercial... Consent Order Procedure § 2.32 Agreement. Every agreement in settlement of a Commission complaint shall... of findings of fact and conclusions of law. Every agreement also shall waive further procedural steps...

Amnioinfusion in preterm PROM: effects on amnion and cord histology.

PubMed

Locatelli, A; Andreani, M; Ghidini, A; Verderio, M; Pizzardi, A; Vergani, P; Salafia, C M

2008-02-01

To investigate the effects of transabdominal amnioinfusion (TA) on the histology of amnion (A) and umbilical cord (UC). From a cohort of 56 singleton pregnancies with premature rupture of membranes (PROM) at

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.

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.

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.

Addressing challenges of clinical trials in acute pain: The Pain Management of Vaso-occlusive Crisis in Children and Young Adults with Sickle Cell Disease Study.

PubMed

Nottage, Kerri A; Hankins, Jane S; Faughnan, Lane G; James, Dustin M; Richardson, Julie; Christensen, Robbin; Kang, Guolian; Smeltzer, Matthew; Cancio, Maria I; Wang, Winfred C; Anghelescu, Doralina L

2016-08-01

Neuropathic pain is a known component of vaso-occlusive pain in sickle cell disease; however, drugs targeting neuropathic pain have not been studied in this population. Trials of acute pain are complicated by the need to obtain consent, to randomize participants expeditiously while optimally treating pain. We describe the challenges in designing and implementing the Pain Management of Vaso-occlusive Crisis in Children and Young Adults with Sickle Cell Disease Study (NCT01954927), a phase II, randomized, double-blind, placebo-controlled trial to determine the effect of gabapentin for vaso-occlusive crisis. In the Pain Management of Vaso-occlusive Crisis in Children and Young Adults with Sickle Cell Disease Study, we aim to assess the analgesic effect of gabapentin during vaso-occlusive crisis. Difficulties we identified included avoiding delay of notification of study staff of potential participants which we resolved by automated notification. Concern for rapid randomization and drug dispensation was addressed through careful planning with an investigational pharmacy and a single liquid formulation. We considered obtaining consent during well-visits to avoid the time constraints with acute presentations, but the large number of patients and limited duration that consent is valid made this impractical. In all, 79% of caregivers/children approached have agreed to participate. The trial is currently active, and enrollment is at 45.8% of that targeted (76 of 166) and expected to continue for two more years. Maintaining staff availability after-hours remains problematic, with 8% of screened patients missed for lack of available staff. Lessons learned in designing a trial to expedite procedures in the acute pain setting include (1) building study evaluations upon a standard-of-care backbone; (2) implementing a simple study design to facilitate consent and data capture; (3) assuring ample, well-trained study staff; and (4) utilizing technology to automate procedures whenever possible. This study design has circumvented many of the logistical barriers usually associated with acute pain trials and may serve as a prototype for future studies. © The Author(s) 2016.

12 CFR 303.222 - Service at another insured depository institution.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Service at another insured depository institution. 303.222 Section 303.222 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF PRACTICE FILING PROCEDURES Section 19 of the FDI Act (Consent to Service of Persons Convicted...

12 CFR 303.224-303.239 - [Reserved

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false [Reserved] 303.224-303.239 Section 303.224-303.239 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF PRACTICE FILING PROCEDURES Section 19 of the FDI Act (Consent to Service of Persons Convicted of Certain Criminal Offenses...

12 CFR 303.220 - Scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Scope. 303.220 Section 303.220 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF PRACTICE FILING PROCEDURES Section 19 of the FDI Act (Consent to Service of Persons Convicted of Certain Criminal Offenses) § 303.220 Scope...

28 CFR 19.6 - Responsibility of DOJ organizational units for program implementation and implementation procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

... consent to use the photograph and biographical information. See 28 CFR 0.1, Organizational Structure of... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Responsibility of DOJ organizational... Responsibility of DOJ organizational units for program implementation and implementation procedures. (a) The...

International Guidelines for Privacy in Genomic Biobanking (or the Unexpected Virtue of Pluralism).

PubMed

Thorogood, Adrian; Zawati, Ma'n H

2015-01-01

This article reviews international privacy norms governing human genomic biobanks and databases, and how they address issues related to consent, secondary use, de- identification, access, security, and governance. A range of international instruments were identified, varying in substance - e.g., human rights, data protection, research ethics, biobanks, and genetics - and legal character. Some norms detail processes for broad consent, namely, that even where potential participants cannot consent to specific users and uses, they should be given clear information on access policies, procedures, and governance structures. Some also give guidance about the conditions under which secondary use of data and samples without consent is appropriate, e.g., where consent is impracticable. International norms exhibit a confusing range of terminology relating to de-identification. They also continue to rely heavily on consent and anonymity as the basis for privacy protection, though governance is becoming more prominent. It may not be fatal that such a plurality of norms apply to biobanking; what is essential is that governance be built on shared values, our common interest in the success of genomic research, and practical tools that incentivize responsible, global sharing. © 2015 American Society of Law, Medicine & Ethics, Inc.

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.

Macao Report: Informed Consent in a Multilingual and Multicultural Region, a Bioethical Challenge.

PubMed

Raposo, Vera Lúcia

2018-07-01

Complying with the requirements of informed consent for medical procedures can sometimes be problematic, even when the hospitals are located in countries that are uniform in their language and cultural values. However, when hospitals are located in countries with diverse linguistic and ethnic communities, it becomes particularly challenging. This article examines how Macao, with four predominant languages-Mandarin, Portuguese, Cantonese and English-and two very strong cultures, Western and Chinese, strives to meet the challenges of informed consent. The situation is made even more complicated by a healthcare delivery in Macao that is mostly guided by Chinese ethical and cultural perspectives, whereas its law is inspired by the Western model.

Penile prosthesis implantation compares favorably in malpractice outcomes to other common urological procedures: findings from a malpractice insurance database.

PubMed

Chason, Juddson; Sausville, Justin; Kramer, Andrew C

2009-08-01

Some urologists choose not to offer penile prostheses because of concern over malpractice liability. The aim of this study was to assess whether urologists performing penile prosthesis surgery are placed at a greater malpractice risk. Percentage of malpractice suits from prosthesis surgery and other urological procedures that result in payment, average resulting payout from these cases, and category of legal issue that ultimately resulted in payout. A database from the Physician Insurers Association of America, an association of malpractice insurance companies covering physicians in North America, was analyzed to quantitatively compare penile implant surgery to other urological procedures in medicolegal terms. Compared to other common urological procedures, penile implant is comparable and on the lower end of the spectrum in terms of both the percentage of malpractice suits that result in payment and the amount ultimately paid in indemnity from those cases. Additionally, issues of informed consent play the largest role in indemnities for all urological procedures, whereas surgical technique is the most important issue for prosthesis surgery. Urologists who are adequately trained in prosthetic surgery should not avoid penile implant procedures for fear of malpractice suits. A focus on communication and informed consent can greatly reduce malpractice risk for urological procedures.

Federally funded sterilization: time to rethink policy?

PubMed

Borrero, Sonya; Zite, Nikki; Creinin, Mitchell D

2012-10-01

In the 1970s, concern about coercive sterilization of low-income and minority women in the United States led the US Department of Health, Education, and Welfare to create strict regulations for federally funded sterilization procedures. Although these policies were instituted to secure informed consent and protect women from involuntary sterilization, there are significant data indicating that these policies may not, in fact, ensure that consent is truly informed and, further, may prevent many low-income women from getting a desired sterilization procedure. Given the alarmingly high rates of unintended pregnancy in the United States, especially among low-income populations, we feel that restrictive federal sterilization policies should be reexamined and modified to simultaneously ensure informed decision-making and honor women's reproductive choices.

Federally Funded Sterilization: Time to Rethink Policy?

PubMed Central

Zite, Nikki; Creinin, Mitchell D.

2012-01-01

In the 1970s, concern about coercive sterilization of low-income and minority women in the United States led the US Department of Health, Education, and Welfare to create strict regulations for federally funded sterilization procedures. Although these policies were instituted to secure informed consent and protect women from involuntary sterilization, there are significant data indicating that these policies may not, in fact, ensure that consent is truly informed and, further, may prevent many low-income women from getting a desired sterilization procedure. Given the alarmingly high rates of unintended pregnancy in the United States, especially among low-income populations, we feel that restrictive federal sterilization policies should be reexamined and modified to simultaneously ensure informed decision-making and honor women’s reproductive choices. PMID:22897531

Ethics guidelines for research with the recently dead.

PubMed

Pentz, Rebecca D; Cohen, Cynthia B; Wicclair, Mark; DeVita, Michael A; Flamm, Anne Lederman; Youngner, Stuart J; Hamric, Ann B; McCabe, Mary S; Glover, Jacqueline J; Kittiko, Winona J; Kinlaw, Kathy; Keller, James; Asch, Adrienne; Kavanagh, John J; Arap, Wadih

2005-11-01

The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.

Surgical Informed Consent Process in Neurosurgery

PubMed Central

Park, Jaechan; Park, Hyojin

2017-01-01

The doctrine of informed consent, as opposed to medical paternalism, is intended to facilitate patient autonomy by allowing patient participation in the medical decision-making process. However, regrettably, the surgical informed consent (SIC) process is invariably underestimated and reduced to a documentary procedure to protect physicians from legal liability. Moreover, residents are rarely trained in the clinical and communicative skills required for the SIC process. Accordingly, to increase professional awareness of the SIC process, a brief history and introduction to the current elements of SIC, the obstacles to patient autonomy and SIC, benefits and drawbacks of SIC, planning of an optimal SIC process, and its application to cases of an unruptured intracranial aneurysm are all presented. Optimal informed consent process can provide patients with a good comprehension of their disease and treatment, augmented autonomy, a strong therapeutic alliance with their doctors, and psychological defenses for coping with stressful surgical circumstances. PMID:28689386

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights.

PubMed

Ekmekci, Perihan Elif; Arda, Berna

2017-01-01

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family - usually men - over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects.

Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights

PubMed Central

Ekmekci, Perihan Elif; Arda, Berna

2018-01-01

Interventions in medicine require multicenter clinical trials on a large rather than limited number of subjects from various genetic and cultural backgrounds. International guidelines to protect the rights and well-being of human subjects involved in clinical trials are criticized for the priority they place on Western cultural values. These discussions become manifest especially with regard to the content and methodology of the informed consent procedure. The ethical dilemma emerges from the argument that there are fundamental differences about the concept of respect for the autonomy of individuals in different cultures and religions. Some communities prioritize the consent of community leaders or the head of family – usually men – over the voluntary and free consent of the individual. The aim of this work is to discuss this ethical dilemma to determine a base for a consensus that satisfies the sensibilities of different cultures without damaging the rights and autonomy of human subjects. PMID:29645014

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.

New Evaluation of the Electronically Activated Recorder (EAR): Obtrusiveness, Compliance, and Participant Self-selection Effects.

PubMed

Manson, Joseph H; Robbins, Megan L

2017-01-01

The Electronically Activated Recorder (EAR) is a method for collecting periodic brief audio snippets of participants' daily lives using a portable recording device. The EAR can potentially intrude into people's privacy, alter their natural behavior, and introduce self-selection biases greater than in other types of social science methods. Previous research (Mehl and Holleran, 2007, hereafter M&H) has shown that participant non-compliance with, and perceived obtrusiveness of, an EAR protocol are both low. However, these questions have not been addressed in jurisdictions that require the consent of all parties to recording conversations. This EAR study required participants to wear a button bearing a microphone icon and the words "This conversation may be recorded" to comply with California's all-party consent law. Results revealed self-reported obtrusiveness and non-compliance were actually lower in the present study than in the M&H study. Behaviorally assessed non-compliance did not differ between the two studies. Participants in the present study talked more about being in the study than participants in the M&H study, but such talk still comprised <2% of sampled conversations. Another potential problem with the EAR, participant self-selection bias, was addressed by comparing the EAR volunteers' HEXACO personality dimensions to a non-volunteer sample drawn from the same student population. EAR volunteers were significantly and moderately higher in Conscientiousness, and lower in Emotionality, than non-volunteers. In conclusion, the EAR method can be successfully implemented in at least one all-party consent state (California). Interested researchers are encouraged to review this procedure with their own legal counsel.

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

Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

PubMed

Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica

2018-02-27

Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs.

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.

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).

[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.

12 CFR 303.242 - Exercise of trust powers.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Exercise of trust powers. 303.242 Section 303... PROCEDURES Other Filings § 303.242 Exercise of trust powers. (a) Scope. This section contains the procedures to be followed by a state nonmember bank to seek the FDIC's prior consent to exercise trust powers...

12 CFR 303.242 - Exercise of trust powers.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Exercise of trust powers. 303.242 Section 303... PROCEDURES Other Filings § 303.242 Exercise of trust powers. (a) Scope. This section contains the procedures to be followed by a state nonmember bank to seek the FDIC's prior consent to exercise trust powers...

12 CFR 303.242 - Exercise of trust powers.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Exercise of trust powers. 303.242 Section 303... PROCEDURES Other Filings § 303.242 Exercise of trust powers. (a) Scope. This section contains the procedures to be followed by a state nonmember bank to seek the FDIC's prior consent to exercise trust powers...

12 CFR 303.242 - Exercise of trust powers.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Exercise of trust powers. 303.242 Section 303... PROCEDURES Other Filings § 303.242 Exercise of trust powers. (a) Scope. This section contains the procedures to be followed by a state nonmember bank to seek the FDIC's prior consent to exercise trust powers...

43 CFR 7.35 - Permitting procedures for Indian lands.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Permitting procedures for Indian lands. 7... Indian lands. (a) If the lands involved in a permit application are Indian lands, the consent of the appropriate Indian tribal authority or individual Indian landowner is required by the Act and these...

43 CFR 7.35 - Permitting procedures for Indian lands.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 43 Public Lands: Interior 1 2014-10-01 2014-10-01 false Permitting procedures for Indian lands. 7... Indian lands. (a) If the lands involved in a permit application are Indian lands, the consent of the appropriate Indian tribal authority or individual Indian landowner is required by the Act and these...

43 CFR 7.35 - Permitting procedures for Indian lands.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 43 Public Lands: Interior 1 2013-10-01 2013-10-01 false Permitting procedures for Indian lands. 7... Indian lands. (a) If the lands involved in a permit application are Indian lands, the consent of the appropriate Indian tribal authority or individual Indian landowner is required by the Act and these...

43 CFR 7.35 - Permitting procedures for Indian lands.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Permitting procedures for Indian lands. 7... Indian lands. (a) If the lands involved in a permit application are Indian lands, the consent of the appropriate Indian tribal authority or individual Indian landowner is required by the Act and these...

12 CFR 303.223 - Applicant's right to hearing following denial.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Applicant's right to hearing following denial. 303.223 Section 303.223 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF PRACTICE FILING PROCEDURES Section 19 of the FDI Act (Consent to Service of Persons Convicted of Certain...

Research Disclosure Procedures for the Kamehameha Early Education Project. Technical Report #21.

ERIC Educational Resources Information Center

Omori, Sharon; And Others

This report describes research disclosure procedures and materials developed for the Kamehameha Early Education Program (KEEP) to fulfill the informed consent principle of the ethical guidelines of the American Psychological Association. A requirement for registration of children in the program is that parents attend one of two disclosure…

12 CFR 303.242 - Exercise of trust powers.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Exercise of trust powers. 303.242 Section 303... PROCEDURES Other Filings § 303.242 Exercise of trust powers. (a) Scope. This section contains the procedures to be followed by a state nonmember bank to seek the FDIC's prior consent to exercise trust powers...

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.

48 CFR 244.202-2 - Considerations.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF DEFENSE CONTRACT MANAGEMENT SUBCONTRACTING POLICIES AND PROCEDURES Consent to Subcontracts 244.202-2 Considerations. (a) Where other than lowest price is the basis for subcontractor selection, has...

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

Retrospective Consent to Hemicraniectomy after Malignant Stroke among the Elderly, Despite Impaired Functional Outcome.

PubMed

Ragoschke-Schumm, Andreas; Junk, Christina; Lesmeister, Martin; Walter, Silke; Behnke, Stefanie; Schumm, Julia; Fassbender, Klaus

2015-01-01

Decompressive hemicraniectomy (DHC) after space-occupying strokes among patients older than 60 years has been shown to reduce mortality rates but at the cost of severe disability. There is an ongoing debate about what could be considered an acceptable outcome for these patients. Data about retrospective consent to the procedure after lengthy time periods are lacking. This study included 79 consecutive patients who underwent DHC during a 7.75-year period. Surviving patients were assessed for functional and psychological outcome, quality of life (QoL) and retrospective consent for the procedure. Patients younger than 60 years were compared with older patients. Of our 79 patients, 44 were younger than 60 years (median 50 years, interquartile range (IQR) 19-59 years) and 35 were older (median 68 years, interquartile range 60-87 years). The 30-day mortality rate was higher for the older group, but the difference was not statistically significant. Functional outcome was significantly better in the younger group: 31% of the patients in this group vs. 10% in the older group had a modified Rankin Scale score of 0-3 (p = 0.046). The mean National Institutes of Health Stroke Scale score was 17 ± 14 for the younger group and 29 ± 15 for the older group (p = 0.002). On the 36-Item Short Form Health Survey, with the exception of the item 'General health', the older group reported higher values for all items, with statistically significant differences between the 2 groups on the items 'Role limitation emotional' (p = 0.0007) and 'Vitality' (p = 0.02). In the younger group, 29% of patients retrospectively declined consent for DHC opposed to 0% of patients in the older group (p = 0.07). Despite impaired functional outcome after DHC, indicators of QoL and retrospective consent are higher for patients older than 60 years over the long term. This finding should be taken into account by those who counsel patients and caregivers with regard to this serious procedure. © 2015 S. Karger AG, Basel.

UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications, and Consent

PubMed Central

Horst, Jeremy A; Ellenikiotis, Hellene; Milgrom, Peter M

2016-01-01

The Food and Drug Administration recently cleared silver diamine fluoride for reducing tooth sensitivity. Clinical trials document arrest and prevention of dental caries by silver diamine fluoride; this off-label use is now permissible and appropriate under U.S. law. A CDT code was approved for caries arresting medicaments for 2016 to facilitate documentation and billing. We present a systematic review, clinical indications, clinical protocol, and consent procedure to guide application for caries arrest treatment. PMID:26897901

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.

Assessing the quality of informed consent in a resource-limited setting: a cross-sectional study.

PubMed

Kiguba, Ronald; Kutyabami, Paul; Kiwuwa, Stephen; Katabira, Elly; Sewankambo, Nelson K

2012-08-21

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies had been administered to each study participant. Of the 600 participants interviewed, two thirds (64.2%, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9%, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7%, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7%, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50% less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95% CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care.

32 CFR 806b.1 - Summary of revisions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... are new or have major changes; changes appeal processing from Air Force Communications and Information... procedures on complaints; and provides guidance on recall rosters; social rosters; consent statements...

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.

Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention.

PubMed

Beskow, Laura M; Lin, Li; Dombeck, Carrie B; Gao, Emily; Weinfurt, Kevin P

2017-05-01

To determine the individual and combined effects of a simplified form and a review/retest intervention on biobanking consent comprehension. We conducted a national online survey in which participants were randomized within four educational strata to review a simplified or traditional consent form. Participants then completed a comprehension quiz; for each item answered incorrectly, they reviewed the corresponding consent form section and answered another quiz item on that topic. Consistent with our first hypothesis, comprehension among those who received the simplified form was not inferior to that among those who received the traditional form. Contrary to expectations, receipt of the simplified form did not result in significantly better comprehension compared with the traditional form among those in the lowest educational group. The review/retest procedure significantly improved quiz scores in every combination of consent form and education level. Although improved, comprehension remained a challenge in the lowest-education group. Higher quiz scores were significantly associated with willingness to participate. Ensuring consent comprehension remains a challenge, but simplified forms have virtues independent of their impact on understanding. A review/retest intervention may have a significant effect, but assessing comprehension raises complex questions about setting thresholds for understanding and consequences of not meeting them.Genet Med advance online publication 13 October 2016.

Barriers and facilitators to uptake of the school-based HPV vaccination programme in an ethnically diverse group of young women.

PubMed

Batista Ferrer, Harriet; Trotter, Caroline L; Hickman, Matthew; Audrey, Suzanne

2016-09-01

To identify the barriers and facilitators to uptake of the HPV vaccine in an ethnically diverse group of young women in the south west of England. Three school-based vaccination sessions were observed. Twenty-three young women aged 12 to 13 years, and six key informants, were interviewed between October 2012 and July 2013. Data were analysed using thematic analysis and the Framework method for data management. The priority given to preventing cervical cancer in this age group influenced whether young women received the HPV vaccine. Access could be affected by differing levels of commitment by school staff, school nurses, parents and young women to ensure parental consent forms were returned. Beliefs and values, particularly relevant to minority ethnic groups, in relation to adolescent sexual activity may affect uptake. Literacy and language difficulties undermine informed consent and may prevent vaccination. The school-based HPV vaccination programme successfully reaches the majority of young women. However, responsibility for key aspects remain unresolved which can affect delivery and prevent uptake for some groups. A multi-faceted approach, targeting appropriate levels of the socio-ecological model, is required to address procedures for consent and cultural and literacy barriers faced by minority ethnic groups, increase uptake and reduce inequalities. © The Author 2015. Published by Oxford University Press on behalf of Faculty of Public Health.

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.

Parent's Guide to Special Education in Washington State, 1985-86 [and] Guia para Padres: Para Educacion Especial en el Estado de Washington.

ERIC Educational Resources Information Center

Washington Office of the State Superintendent of Public Instruction, Olympia.

This pamphlet guides parents of children with disabilities through the procedures for acquiring special education services in the state of Washington. Following an overview of special education, the pamphlet presents information on notice and consent procedures, confidentiality of records, individualized education programs (IEP), the placement…

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...

42 CFR 422.508 - Modification or termination of contract by mutual consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM MEDICARE ADVANTAGE PROGRAM Application Procedures and Contracts for Medicare Advantage Organizations § 422.508 Modification or termination of contract...

Juridical and liability reflexes of bone marrow processing.

PubMed

Flores, A

1991-03-01

Author analyzes bone marrow processing procedures and points out juridical and forensic-medicine reflexes of this therapeutical act. The aspects of informed consent and professional liability of hematologist are clarified.

Gender differences in heterosexual college students' conceptualizations and indicators of sexual consent: implications for contemporary sexual assault prevention education.

PubMed

Jozkowski, Kristen N; Peterson, Zoë D; Sanders, Stephanie A; Dennis, Barbara; Reece, Michael

2014-01-01

Because sexual assault is often defined in terms of nonconsent, many prevention efforts focus on promoting the clear communication of consent as a mechanism to reduce assault. Yet little research has specifically examined how sexual consent is being conceptualized by heterosexual college students. In this study, 185 Midwestern U.S. college students provided responses to open-ended questions addressing how they define, communicate, and interpret sexual consent and nonconsent. The study aimed to assess how college students define and communicate consent, with particular attention to gender differences in consent. Results indicated no gender differences in defining consent. However, there were significant differences in how men and women indicated their own consent and nonconsent, with women reporting more verbal strategies than men and men reporting more nonverbal strategies than women, and in how they interpreted their partner's consent and nonconsent, with men relying more on nonverbal indicators of consent than women. Such gender differences may help to explain some misunderstandings or misinterpretations of consent or agreement to engage in sexual activity, which could partially contribute to the occurrence of acquaintance rape; thus, a better understanding of consent has important implications for developing sexual assault prevention initiatives.

Unexpected Complications of Novel Deep Brain Stimulation Treatments: Ethical Issues and Clinical Recommendations

PubMed Central

Cheeran, Binith; Pugh, Jonathan; Pycroft, Laurie; Boccard, Sandra; Prangnell, Simon; Green, Alexander L.; FitzGerald, James; Savulescu, Julian; Aziz, Tipu

2017-01-01

Background Innovative neurosurgical treatments present a number of known risks, the natures and probabilities of which can be adequately communicated to patients via the standard procedures governing obtaining informed consent. However, due to their novelty, these treatments also come with unknown risks, which require an augmented approach to obtaining informed consent. Objective This paper aims to discuss and provide concrete procedural guidance on the ethical issues raised by serious unexpected complications of novel deep brain stimulation treatments. Approach We illustrate our analysis using a case study of the unexpected development of recurrent stereotyped events in patients following the use of deep brain stimulation (DBS) to treat severe chronic pain. Examining these unexpected complications in light of medical ethical principles, we argue that serious complications of novel DBS treatments do not necessarily make it unethical to offer the intervention to eligible patients. However, the difficulty the clinician faces in determining whether the intervention is in the patient's best interests generates reasons to take extra steps to promote the autonomous decision making of these patients. Conclusion and recommendations We conclude with clinical recommendations, including details of an augmented consent process for novel DBS treatment. PMID:28557242

Abortion, breast cancer, and informed consent.

PubMed

Kindley, J

2000-01-01

The purpose of this article is to show that the current level of scientific evidence linking induced abortion with increased breast cancer risk is sufficient to support an ethical and legal duty to disclose fully the risk to women who are considering induced abortion. The article examines the relationship between this evidence and the elements of a medical malpractice claim alleging failure to obtain informed consent. The first part focuses on the elements of informed consent, which require the plaintiff to establish that the physician had a duty to disclose information, which he failed to disclose, that this failure to disclose was a legal cause of the plaintiff's decision to undergo the procedure, and the procedure was a legal cause of the plaintiff's injury. The second part compares two prevalent standards for determining which risks a physician has a duty to disclose. Part three reviews the scientific evidence of the abortion/breast cancer (ABC) link and explains why it survives both the Frye and the Daubert tests for admissibility of expert testimony. The fourth part assesses the materiality of the risk posed by the ABC link. Parts five and six discuss evidentiary issues and the possibility of punitive damage awards.

May we practise endotracheal intubation on the newly dead?

PubMed Central

Ardagh, M

1997-01-01

Endotracheal intubation (ETI) is a valuable procedure which must be learnt and practised, and performing ETI on cadavers is probably the best way to do this, although lesser alternatives do exist. Performing ETI on a cadaver is viewed with a real and reasonable repugnance and if it is done without proper authorisation it might be illegal. Some form of consent is required. Presumed consent would preferably be governed by statute and should only occur if the community is well informed and therefore in a position of being able to decline. Currently neither statute nor adequate informing exists. Endotracheal intubation on the newly dead may be justifiable according to a Guttman scale if the patient has already consented to organ donation and if further research supports the relevance of the Guttman scale to this question. A "mandated choice" with prior individual consent as a matter of public policy is the best of these solutions, however until such a solution is in place we may not practise endotracheal intubation on the newly dead. PMID:9358348

First-in-human cell transplant trials in Parkinson's disease: The need for an improved informed consent process.

PubMed

de Melo-Martín, Inmaculada; Hellmers, Natalie; Henchcliffe, Claire

2015-08-01

First-in-human clinical trials of innovative medical procedures, such as cell transplantation for Parkinson's disease, present a variety of ethical challenges. In an era of rapidly developing stem cell technologies likely to be translated into clinical trials over the next few years, it is critical that ethical concerns be fully considered. One important undertaking is ensuring that research participants give free and truly informed consent. This will necessitate adequate disclosure of risks and benefits at a time when these are incompletely defined; ensuring understanding of a complex research protocol when there is significant possibility of therapeutic misconception; and careful determination of capacity for informed consent in patients with a neurodegenerative disorder that is known to affect cognition. Here we call attention to the ethical issues that researchers conducting these types of trials will face when trying to obtain a genuinely informed consent, and we suggest possible solutions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Alfuzosin to relieve ureteral stent discomfort: a prospective, randomized, placebo controlled study.

PubMed

Beddingfield, Richard; Pedro, Renato N; Hinck, Bryan; Kreidberg, Carly; Feia, Kendall; Monga, Manoj

2009-01-01

We assessed the impact of alfuzosin on ureteral stent discomfort. A total of 66 patients scheduled for unilateral retrograde ureteroscopy with stent placement provided consent for the study. Patients were randomized between placebo and the study medication, and investigators and patients were blinded to the randomization scheme. To evaluate pain and urinary symptoms patients were asked to complete the Ureteral Stent Symptom Questionnaire (Stone Management Unit, Southmead Hospital, Westbury-on-Trym, United Kingdom) before ureteroscopy and 3 days after the procedure to minimize the confounding impact of procedural discomfort due to surgery. Patients were also asked to maintain a use log of pain medication each day that the ureteral stent was in place. Procedure outcome and complications were recorded, as were patient study medication use and vital health information before the procedure and at the time of stent removal. Statistical analysis was performed using the Student t, chi-square and Wilcoxon rank sum tests, as appropriate, with p <0.05 considered significant. Of 66 patients who provided consent 55 successfully completed the study. In 3 of the 11 failed cases surgery was not done due to spontaneous stone passage, surgery was performed in 3 but no ureteral stent was placed, 4 were excluded from study after obtaining consent due to exclusion criteria and 1 was voluntarily removed from study after obtaining consent but before surgery. Regarding stent type, procedure complications and baseline questionnaire results there were no significant differences between the placebo and alfuzosin arms. When comparing post-procedure questionnaire results, patients in the alfuzosin arm reported less overall pain in the kidney/back/loin area and less pain in the kidney area while passing urine (p = 0.017 and 0.007, respectively). Men in the alfuzosin arm also reported a lesser incidence of excessive urination (p = 0.040). When comparing changes from baseline questionnaire results, the alfuzosin arm experienced a decrease in kidney pain during sleep (p = 0.017), less frequent use of painkillers to control kidney pain (p = 0.020) and a decrease in how much kidney associated pain interfered with life (p = 0.045). There was no significant difference in the amount of narcotics used per day, as reported in patient medication logs. Alfuzosin improves the patient discomfort associated with ureteral stents by decreasing urinary symptoms and kidney pain but it does not affect the amount of narcotics that patients use while the stent is in place.

Capacity to consent to research among patients with bipolar disorder.

PubMed

Misra, Sahana; Ganzini, Linda

2004-06-01

Experts have debated the influence of mental illness on decision-making capacity. This paper reviews concepts of decision-making capacity and existing research on the influence of mental illness on capacity to consent to research. We propose how bipolar disorder, especially mania, may have an effect on consent capacity. The current conceptualization of capacity utilizes legal standards of 'choice', 'understanding', 'appreciation' and 'rational reasoning', as well as voluntarism, or the assurance that the patient is free to agree or to decline to participate in research. Studies of patients with schizophrenia suggest impaired cognition influences 'understanding' and is more important than severity of psychosis in affecting decision-making abilities. There are no studies of sources and extent of impairment to consent to research among manic patients. Mania may influence a patient's understanding of the research protocol, but also alter the patient's views, values and level of insight, thus impairing decision-making abilities at the 'appreciation' standard even when the patient understands the relevant information. Mania may impact freedom to decide, yet paradoxically, manic patients may be less influenced by others and less vulnerable to coercion, undue influence and undue incentives compared to patients without mental illness. We suggest that in patients with mood disorders, the legal standard of appreciation be thoroughly probed during the consent procedure. Studies of the effect of mania and depression on consent capacity and voluntarism are needed in order to develop processes that increase safeguards in the informed consent process.

Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding.

PubMed

Tait, Alan R; Voepel-Lewis, Terri; Malviya, Shobha; Philipson, Sandra J

2005-04-01

To examine whether a consent document modified to conform with the federal guidelines for readability and processability would result in greater parental understanding compared with a standard form. Randomized clinical study. The preoperative waiting area of a larger tertiary care children's hospital. A total of 305 parents of children scheduled for minor elective surgical procedures. Parents were randomized to receive information about a clinical study in 1 of 4 ways: (1) standard consent form alone, (2) standard consent form with verbal disclosure, (3) modified form alone (standard form modified to meet the federal guidelines for readability and processability), and (4) modified form with verbal disclosure. Parents were interviewed to determine their understanding of 11 elements of consent, including study purpose, protocol, risks, benefits to child (direct), benefit to others (indirect), freedom to withdraw, alternatives, duration of study, voluntariness, confidentiality, and whom to contact. Their responses were scored by 2 independent assessors. Understanding of the protocol, study duration, risks, and direct benefits, together with overall understanding, was greater among parents who received the modified form (P<.001). Additionally, parents reported that the modified form had greater clarity (P = .009) and improved layout compared with the standard form (P<.001). When parents were shown both forms, 81.2% preferred the modified version. Results suggest that a consent form written according to federal guidelines for readability and processability can improve parent understanding and thus will be important in enhancing the informed consent process.

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

PubMed

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

2015-02-01

Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

27 CFR 71.97 - Powers.

Code of Federal Regulations, 2010 CFR

2010-04-01

... evidence; (d) take or cause depositions to be taken whenever the ends of justice would be served thereby... the issues by consent of the parties; (g) dispose of procedural requests or similar matters; (h...

27 CFR 71.97 - Powers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... evidence; (d) take or cause depositions to be taken whenever the ends of justice would be served thereby... the issues by consent of the parties; (g) dispose of procedural requests or similar matters; (h...

27 CFR 71.97 - Powers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... evidence; (d) take or cause depositions to be taken whenever the ends of justice would be served thereby... the issues by consent of the parties; (g) dispose of procedural requests or similar matters; (h...

27 CFR 71.97 - Powers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... evidence; (d) take or cause depositions to be taken whenever the ends of justice would be served thereby... the issues by consent of the parties; (g) dispose of procedural requests or similar matters; (h...

27 CFR 71.97 - Powers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... evidence; (d) take or cause depositions to be taken whenever the ends of justice would be served thereby... the issues by consent of the parties; (g) dispose of procedural requests or similar matters; (h...

5 CFR 180.107 - Claims procedure.

Code of Federal Regulations, 2010 CFR

2010-01-01

... General Counsel, Office of Personnel Management, 1900 E Street NW., Washington, DC 20415. Claims shall be... the performance of official business at the request of, or with the knowledge and consent of, superior...

New Evaluation of the Electronically Activated Recorder (EAR): Obtrusiveness, Compliance, and Participant Self-selection Effects

PubMed Central

Manson, Joseph H.; Robbins, Megan L.

2017-01-01

The Electronically Activated Recorder (EAR) is a method for collecting periodic brief audio snippets of participants’ daily lives using a portable recording device. The EAR can potentially intrude into people’s privacy, alter their natural behavior, and introduce self-selection biases greater than in other types of social science methods. Previous research (Mehl and Holleran, 2007, hereafter M&H) has shown that participant non-compliance with, and perceived obtrusiveness of, an EAR protocol are both low. However, these questions have not been addressed in jurisdictions that require the consent of all parties to recording conversations. This EAR study required participants to wear a button bearing a microphone icon and the words “This conversation may be recorded” to comply with California’s all-party consent law. Results revealed self-reported obtrusiveness and non-compliance were actually lower in the present study than in the M&H study. Behaviorally assessed non-compliance did not differ between the two studies. Participants in the present study talked more about being in the study than participants in the M&H study, but such talk still comprised <2% of sampled conversations. Another potential problem with the EAR, participant self-selection bias, was addressed by comparing the EAR volunteers’ HEXACO personality dimensions to a non-volunteer sample drawn from the same student population. EAR volunteers were significantly and moderately higher in Conscientiousness, and lower in Emotionality, than non-volunteers. In conclusion, the EAR method can be successfully implemented in at least one all-party consent state (California). Interested researchers are encouraged to review this procedure with their own legal counsel. PMID:28503162

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

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.

Recruitment of representative samples for low incidence cancer populations: Do registries deliver?

PubMed Central

2011-01-01

Background Recruiting large and representative samples of adolescent and young adult (AYA) cancer survivors is important for gaining accurate data regarding the prevalence of unmet needs in this population. This study aimed to describe recruitment rates for AYAs recruited through a cancer registry with particular focus on: active clinician consent protocols, reasons for clinicians not providing consent and the representativeness of the final sample. Methods Adolescents and young adults aged 14 to19 years inclusive and listed on the cancer registry from January 1 2002 to December 31 2007 were identified. An active clinician consent protocol was used whereby the registry sent a letter to AYAs primary treating clinicians requesting permission to contact the survivors. The registry then sent survivors who received their clinician's consent a letter seeking permission to forward their contact details to the research team. Consenting AYAs were sent a questionnaire which assessed their unmet needs. Results The overall consent rate for AYAs identified as eligible by the registry was 7.8%. Of the 411 potentially eligible survivors identified, just over half (n = 232, 56%) received their clinician's consent to be contacted. Of those 232 AYAs, 65% were unable to be contacted. Only 18 AYAs (7.8%) refused permission for their contact details to be passed on to the research team. Of the 64 young people who agreed to be contacted, 50% (n = 32) completed the questionnaire. Conclusions Cancer registries which employ active clinician consent protocols may not be appropriate for recruiting large, representative samples of AYAs diagnosed with cancer. Given that AYA cancer survivors are highly mobile, alternative methods such as treatment centre and clinic based recruitment may need to be considered. PMID:21235819

Different perception of surgical risks between physicians and patients undergoing laparoscopic cholecystectomy.

PubMed

Tuveri, Massimiliano; Caocci, Giovanni; Efficace, Fabio; Medas, Fabio; Collins, Gary S; Pisu, Salvatore

2009-08-01

Data on the quality of communication during informed consent for surgery is sparse; we investigated this issue in a cohort of patients undergoing laparoscopic cholecystectomy (LC). Two hundred and seven consecutive patients with benign biliary disease who had undergone LC completed 2 questionnaires. We investigated the patient choice to undergo the surgical procedure along with perceptions of risk complications presented by the surgeon. Nineteen attending surgeons also completed a questionnaire giving information on their recall perception on the information they provided. Multiple logistic regression analyses determined the predictors of perceived communication factors during the informed consent process. One hundred eighty-one patients (87.4%) returned questionnaires. Younger patients (<50 y) with lower education perceived higher level of risk complications compared with older and higher educated patients (P=0.04 and P<0.001). Younger patients felt psychologic support was necessary (P<0.001) and that quality of life issues related to the interventions were under addressed (P=0.018). Differences were observed between patients' recalled risk of complications and the risk to convert LC to open laparotomy and physicians' perception of information provided to patients regarding these aspects (P<0.01). Although informed consent for surgical procedures requires that the procedures are explained and that the patient understands the procedures and risks, our data suggest different perceptions of the quality of information provided during this process between patients and physicians. Physicians should be aware that surgical risks might be perceived differently by patients and this perception might be influenced, for example, by patients' age and education. Major efforts should be directed to improve communications skills in surgical laparoscopy.

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...

"Consent Is Good, Joyous, Sexy": A Banner Campaign to Market Consent to College Students

ERIC Educational Resources Information Center

Thomas, Kristie A.; Sorenson, Susan B.; Joshi, Manisha

2016-01-01

Objective: This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. Participants: A stratified random…

A qualitative study of participants' views on re-consent in a longitudinal biobank.

PubMed

Dixon-Woods, Mary; Kocman, David; Brewster, Liz; Willars, Janet; Laurie, Graeme; Tarrant, Carolyn

2017-03-23

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or "biobanks" over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants' perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation.

46 CFR 502.304 - Procedure and filing fee.

Code of Federal Regulations, 2010 CFR

2010-10-01

... capital “I” in parentheses. All further correspondence pertaining to such claims must refer to the... raised by the respondent. (f) If the respondent refuses to consent to the claim being informally...

Interpretation of Do Not Attempt Resuscitation Orders for Children Requiring Anesthesia and Surgery.

PubMed

Fallat, Mary E; Hardy, Courtney

2018-05-01

This clinical report addresses the topic of pre-existing do not attempt resuscitation or limited resuscitation orders for children and adolescents undergoing anesthesia and surgery. Pertinent considerations for the clinician include the rights of children, decision-making by parents or legally approved representatives, the process of informed consent, and the roles of surgeon and anesthesiologist. A process of re-evaluation of the do not attempt resuscitation orders, called "required reconsideration," should be incorporated into the process of informed consent for surgery and anesthesia, distinguishing between goal-directed and procedure-directed approaches. The child's individual needs are best served by allowing the parent or legally approved representative and involved clinicians to consider whether full resuscitation, limitations based on procedures, or limitations based on goals is most appropriate. Copyright © 2018 by the American Academy of Pediatrics.

Response to Orr and Siegler--collective intentionality and procreative desires: the permissible view on consent to posthumous conception.

PubMed

Parker, M

2004-08-01

Orr and Siegler have recently defended a restrictive view concerning posthumous sperm retrieval and conception, which would limit insemination to those cases where the deceased man has provided explicit consent for such a procedure. The restrictive view dominates current law and practice. A permissible view, in contrast, would allow insemination and conception in all but those cases where the posthumous procedure has been explicitly refused, or where there is no reasonable evidence that the deceased person desired children. I describe a phenomenology of procreative desires which supports the permissible view, and which is compatible with requirements concerning the interests of the decedent, concepts of medical infertility, and the welfare of the future child. The account illustrates how our current obsession with individual rights and autonomy can be self-defeating and repressive.

"Consent is Good, Joyous, Sexy": A banner campaign to market consent to college students.

PubMed

Thomas, Kristie A; Sorenson, Susan B; Joshi, Manisha

2016-01-01

This study assessed the recall of, reaction to, and understanding of a brief campus banner campaign promoting consent in sexual relationships, and determined whether campaign exposure was associated with subsequent engagement in activities related to sexual assault education, awareness, and prevention. A stratified random sample of 1,200 undergraduates was recruited during fall of 2010; 628 (52.3%) participated. To account for history and maturation, an experimental research design was employed with an online survey. Direct and indirect campaign exposure was associated with increased action. Students expressed primarily positive reactions to and appeared to understand the consent message. The campaign appealed to and was associated with increased activity among a wide range of students with one exception: a negative effect was observed for business students. Colorful banners with pithy, upbeat messages hold promise for engaging undergraduates in conversations and proactive activities related to sexual assault prevention.

WHEN PARENTS CHOOSE GENDER: INTERSEX, CHILDREN, AND THE LAW.

PubMed

Newbould, Melanie

2017-01-05

In England and Wales, it is usually lawful for those with parental responsibility to consent to treatment on children who have not acquired legal capacity, providing that they are acting in the child's best interests. Whilst in most instances this process is unproblematic and the decisions made are non-controversial, there are troubling examples where this is more problematic. The difficulties for a family with a child who has an intersex condition will be considered to illustrate that there may be cases of medical and surgical treatment where even though both parents and doctors agree on a course of action in good faith, the treatment administered may not necessarily be in the best interests of the child. Sometimes, procedures carried out on an infant apparently in their best interests may later be a cause of regret to the child as an adult. The law in England and Wales will be examined to investigate other examples of controversial treatments of young children involving legal interventions to consider whether there are any parallels and what the implications of these might be to the intersex child. A model suggested by a Columbian legal case from 1995 is discussed. The courts ruled that infantile sex assignment surgery is lawful only following very stringent consent procedures. The possibility is considered that guidelines defining the consent procedure may afford some protection for the intersex child. © The Author 2017. Published by Oxford University Press; all rights reserved. For Permissions, please email: journals.permissions@oup.com.

PERTINENT DRY NEEDLING CONSIDERATIONS FOR MINIMIZING ADVERSE EFFECTS – PART ONE

PubMed Central

Halle, Rob J.

2016-01-01

ABSTRACT Background Dry needling is an evidence-based treatment technique that is accepted and used by physical therapists in the United States. This treatment approach focuses on releasing or inactivating muscular trigger points to decrease pain, reduce muscle tension, and assist patients with an accelerated return to active rehabilitation. Issue While commonly used, the technique has some patient risk and value of the treatment should be based on benefit compared to the potential risk. Adverse effects (AEs) with dry needling can be mild or severe, with overall incidence rates varying from zero to rates of approximately 10 percent. While mild AEs are the rule, any procedure that involves a needle insertion has the potential for an AE, with select regions and the underlying anatomy increasing the risk. Known significant AEs from small diameter needle insertion include pneumothorax, cardiac tamponade, hematoma, infection, central nervous system injury, and other complications. Purpose/Objective Underlying anatomy across individuals has variability, requiring an in-depth knowledge of anatomy prior to any needle placement. This commentary is an overview of pertinent anatomy in the region of the thorax, with a ‘part two’ that addresses the abdomen, pelvis, back, vasovagal response, informed consent and other pertinent issues. The purpose of the commentary is to minimize the risk of a dry needling AE. Conclusions/Implications Dry needling is an effective adjunct treatment procedure that is within the recognized scope of physical therapy practice. Physical therapy education and training provides practitioners with the anatomy, basic sciences, and clinical foundation to use this intervention safely and effectively. A safe and evidenced-based implementation of the procedure is based on a thorough understanding of the underlying anatomy and the potential risks, with risks coordinated with patients via informed consent. Levels of Evidence Level 5 PMID:27525188

Barriers and Opportunities in Consent and Access Procedures in Low- and Middle-Income Country Biobanks: Meeting Notes from the BCNet Training and General Assembly.

PubMed

Zawati, Ma'n H; Tassé, Anne Marie; Mendy, Maimuna; Caboux, Elodie; Lang, Michael

2018-04-18

As biobanking research in low- and middle-income countries (LMICs) continues to grow, novel legal and policy considerations have arisen. Also, while an expansive literature has developed around these issues, the views and concerns of individual researchers in these contexts have been less actively studied. These meeting notes aim to contribute to the growing literature on biobanking in LMICs by communicating a number of challenges and opportunities identified by biobank researchers themselves. Specifically, we describe concerns that emerge in consent and access policy domains. First, we present a review of the literature on distinct policy and legal concerns faced in LMICs, giving special attention to the general absence of practitioner perspectives. From there, we outline and discuss considerations that were raised by meeting participants at a Biobank and Cohort Building Network (BCNet) Ethical, Legal, and Social Issues training program. We conclude by proposing that the unique perspectives of biobank researchers in LMICs should be given serious attention and further research on these perspectives should be conducted.

In re Visbeck.

PubMed

1986-02-04

The Superior Court of New Jersey ordered the appointment of a guardian to consent to implantation of a feeding tube for a 90-year-old patient who had suffered a severely disabling stroke, though her son had not agreed to the proposed procedure. The court reasoned that a patient who becomes incompetent does not lose the right to accept or refuse medical treatment; instead, a substitute or surrogate decision maker exercises the patient's right of consent. Without the surgical implantation of a feeding tube in the patient's stomach, she would have suffered death from dehydration and starvation.

Improving biobank consent comprehension: a national randomized survey to assess the effect of a simplified form and review/retest intervention

PubMed Central

Beskow, Laura M.; Lin, Li; Dombeck, Carrie B.; Gao, Emily; Weinfurt, Kevin P.

2017-01-01

Purpose: To determine the individual and combined effects of a simplified form and a review/retest intervention on biobanking consent comprehension. Methods: We conducted a national online survey in which participants were randomized within four educational strata to review a simplified or traditional consent form. Participants then completed a comprehension quiz; for each item answered incorrectly, they reviewed the corresponding consent form section and answered another quiz item on that topic. Results: Consistent with our first hypothesis, comprehension among those who received the simplified form was not inferior to that among those who received the traditional form. Contrary to expectations, receipt of the simplified form did not result in significantly better comprehension compared with the traditional form among those in the lowest educational group. The review/retest procedure significantly improved quiz scores in every combination of consent form and education level. Although improved, comprehension remained a challenge in the lowest-education group. Higher quiz scores were significantly associated with willingness to participate. Conclusion: Ensuring consent comprehension remains a challenge, but simplified forms have virtues independent of their impact on understanding. A review/retest intervention may have a significant effect, but assessing comprehension raises complex questions about setting thresholds for understanding and consequences of not meeting them. Genet Med advance online publication 13 October 2016 PMID:27735922

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.

Biobanking research on oncological residual material: a framework between the rights of the individual and the interest of society

PubMed Central

2013-01-01

Background The tissue biobanking of specific biological residual materials, which constitutes a useful resource for medical/scientific research, has raised some ethical issues, such as the need to define which kind of consent is applicable for biological residual materials biobanks. Discussion Biobank research cannot be conducted without considering arguments for obtaining the donors’ consent: in this paper we discuss to what extent consent in biobank research on oncological residual materials has to be required, and what type of consent would be appropriate in this context, considering the ethical principles of donation, solidarity, protection of the donors’ rights and the requirements of scientific progress. Regarding the relationship between informed consent and tissue collection, storage and research, we have focused on two possible choices related to the treatment of data and samples in the biobank: irreversible and reversible anonymization of the samples, distinguishing between biobank research on residual materials for which obtaining consent is necessary and justified, and biobank research for which it is not. The procedures involve different approaches and possible solutions that we will seek to define. The consent for clinical research reported in the Helsinki Declaration regards research involving human beings and for this reason it is subordinate to specific and detailed information on the research projects. Summary An important ethical aspect in regard to the role of Biobanks is encouraging sample donation. For donors, seeing human samples being kept rather than discarded, and seeing them become useful for research highlights the importance of the human body and improves the attitude towards donation. This process might also facilitate the giving of informed consent more willingly, and with greater trust. PMID:23547565

Are Data Sharing and Privacy Protection Mutually Exclusive?

PubMed

Joly, Yann; Dyke, Stephanie O M; Knoppers, Bartha M; Pastinen, Tomi

2016-11-17

We review emerging strategies to protect the privacy of research participants in international epigenome research: open consent, genome donation, registered access, automated procedures, and privacy-enhancing technologies. Copyright © 2016 Elsevier Inc. All rights reserved.

Consent Form Return Rates for Third-Grade Urban Elementary Students

ERIC Educational Resources Information Center

Ji, Peter; Flay, Brian R.; Phil, D.; DuBois, David L.; Brechling, Vanessa; Day, Joseph; Cantillon, Dan

2006-01-01

Objective: To maximize active parent consent form return rates for third-grade minority, urban students enrolled in predominantly low-income elementary schools in Chicago, Ill. Methods: Research staff used a class incentive and class visits to retrieve consent forms from students. Results: Of the 811 third-grade students, 98% returned a form and …

Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board.

PubMed

Zia, Mohammad I; Heslegrave, Ronald; Newton, Gary E

2011-12-01

The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

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.

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.

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.

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

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.

Challenges in conducting psychiatry studies in India

PubMed Central

Kharawala, Saifuddin; Dalal, Jeroze

2011-01-01

A large number of psychiatry studies are conducted in India. Psychiatry studies are complex and present unique challenges in the Indian setting. Ethical issues pertaining to the risk of worsening of illness, use of placebo and validity of informed consents are commonly faced. Site selection can be difficult due to the relative paucity of ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) trained psychiatry investigators in India. Recruitment can be challenging due to issues such as strict eligibility criteria, (lack of) availability of caregiver, illness-related considerations, etc. Assessment of the consent capacity of patients is not simple, while structured assessments are not commonly employed. As the illness fluctuates, the consent capacity may change, thus requiring continued assessment of consent capacity. Study patients run the risk of worsening of illness and suicide due to exposure to inactive treatments; this risk is counterbalanced by use of appropriate study designs, as well as the indirect psychotherapeutic support received. Psychiatry studies are associated with a high placebo response. This necessitates conduct of placebo-controlled studies despite the attendant difficulties. Also, the high placebo response is often the cause of failed trials. Rating scales are essential for assessment of drug response. Some rating instruments as well as some rater training procedures may not be suitable for the Indian setting. Technological advancements may increase the procedural complexity but improve the quality of ratings. Psychiatry studies present monitors and auditors with unique scenarios too. Utilization of psychiatry specific training and expertise is recommended to ensure successful conduct of these studies in India. PMID:21584176

Patient predictors of colposcopy comprehension of consent among English- and Spanish-speaking women.

PubMed

Krankl, Julia Tatum; Shaykevich, Shimon; Lipsitz, Stuart; Lehmann, Lisa Soleymani

2011-01-01

patients with limited English proficiency may be at increased risk for diminished understanding of clinical procedures. This study sought to assess patient predictors of comprehension of colposcopy information during informed consent and to assess differences in understanding between English and Spanish speakers. between June and August 2007, English- and Spanish-speaking colposcopy patients at two Boston hospitals were surveyed to assess their understanding of the purpose, risks, benefits, alternatives, and nature of colposcopy. Patient demographic information was collected. there were 183 women who consented to participate in the study. We obtained complete data on 111 English speakers and 38 Spanish speakers. English speakers were more likely to have a higher education, greater household income, and private insurance. Subjects correctly answered an average of 7.91 ± 2.16 (72%) of 11 colposcopy survey questions. English speakers answered more questions correctly than Spanish speakers (8.50 ± 1.92 [77%] vs 6.21 ± 1.93 [56%]; p < .001). Using linear regression to adjust for confounding variables, we found that language was not significantly associated with greater understanding (p = .46). Rather, education was the most significant predictor of colposcopy knowledge (p < .001). many colposcopy patients did not understand the procedure well enough to give informed consent. The observed differences in colposcopy comprehension based on language were a proxy for differences in education. Education, not language, predicted subjects' understanding of colposcopy. These results demonstrate the need for greater attention to patients' educational background to ensure adequate understanding of clinical information. 2011 Jacobs Institute of Women's Health. Published by Elsevier Inc.

[Statement: Requirements for the assessment of surgical innovations].

PubMed

Seidel, Dörthe; Pieper, Dawid; Neugebauer, Edmund

2015-01-01

The term "innovation" refers to new products, but also to the process of developing and distributing new products and procedures. The operative disciplines are often associated with innovations because of their continuous, stepwise adaptation of daily practice to established procedures. Medical devices play a significant role in integrating surgical technology with surgical experience. The success of a surgical innovation and other invasive treatments does not only depend on the surgical procedure, but also on the context of the whole treatment process including the pre- and postoperative phase, the interaction of the surgical team and the setting. High standards have been set for the assessment of surgical innovations in terms of patient safety, efficacy and patient benefit, which will be discussed in the present paper. A stepwise approach to evaluation will be used, split into preclinical development, clinical development (feasibility and safety), evaluation phase (efficacy and patient benefit) and longtime surveillance. Our paper is based on the expert-based consented IDEAL approach as well as the consented recommendations of the European Association of Endoscopic Surgery (EAES). (As supplied by publisher). Copyright © 2015. Published by Elsevier GmbH.

Challenges in the Ethical Review of Peer Support Interventions

PubMed Central

Simmons, David; Bunn, Christopher; Nakwagala, Fred; Safford, Monika M.; Ayala, Guadalupe X.; Riddell, Michaela; Graffy, Jonathan; Fisher, Edwin B.

2015-01-01

PURPOSE Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the “4+1 ethical framework” (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees’ reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of “light touch” consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support. PMID:26304976

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

24 CFR 26.2 - Hearing officer, powers, and duties.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the interests of justice may require; (5) To regulate the course of the hearing and the conduct of the... consent of the parties; (7) To consider and rule upon all procedural and other motions appropriate in...

24 CFR 26.2 - Hearing officer, powers, and duties.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the interests of justice may require; (5) To regulate the course of the hearing and the conduct of the... consent of the parties; (7) To consider and rule upon all procedural and other motions appropriate in...

24 CFR 26.2 - Hearing officer, powers, and duties.

Code of Federal Regulations, 2012 CFR

2012-04-01

... the interests of justice may require; (5) To regulate the course of the hearing and the conduct of the... consent of the parties; (7) To consider and rule upon all procedural and other motions appropriate in...

24 CFR 26.2 - Hearing officer, powers, and duties.

Code of Federal Regulations, 2013 CFR

2013-04-01

... the interests of justice may require; (5) To regulate the course of the hearing and the conduct of the... consent of the parties; (7) To consider and rule upon all procedural and other motions appropriate in...

22 CFR 1422.12 - Duties and powers of the Hearing Officer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... stipulations of fact; (c) Take or cause depositions or interrogatories to be taken whenever the ends of justice... consent of the parties or upon the Hearing Officer's own motion; (h) Dispose of procedural requests...

24 CFR 26.2 - Hearing officer, powers, and duties.

Code of Federal Regulations, 2014 CFR

2014-04-01

... the interests of justice may require; (5) To regulate the course of the hearing and the conduct of the... consent of the parties; (7) To consider and rule upon all procedural and other motions appropriate in...

[Medical negligence in surgery: 112 cases retrospective analysis].

PubMed

Xiang, Jian; Chang, Lin; Wang, Xu; Zhang, Feng-Qin

2013-06-01

To explore the general characteristics of medical negligence in surgery in order to provide the reference for forensic practices. One hundred and twelve cases of medical negligence in surgical department were retrospectively analyzed in Fada Institute of Forensic Medicine and Science from 2008 to 2010. The common types of medical negligence cases in the surgery were improper operation procedure (28.57%), failure of consent (26.79%), and inadequate monitoring (22.32%). The results of complications included disability or functional impairment (61.61%), death (31.25%) and transient impairment with no obvious adverse reactions (7.14%). The most common roles played by the medical negligence cases were minor role (26.79%), equal role (19.64%), and slight role (14.29%). Significant attention should be paid to the operation procedure, consent, and monitoring. It should be cautious to not make assessment on involvement degree of medical negligence.

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

Interpreting the Clinical Significance of Capacity Scores for Informed Consent in Alzheimer Disease Clinical Trials

PubMed Central

Karlawish, Jason; Kim, Scott Y. H.; Knopman, David; van Dyck, Christopher H.; James, Bryan D.; Bioethics, M.; Marson, Daniel

2014-01-01

Objective Among Alzheimer disease (AD) patients enrolled in a clinical trial, the authors assessed the ability of a standardized capacity assessment procedure to identify persons who are capable of giving their own informed consent. Design Cross-sectional interview. Setting Thirteen sites participating in a randomized and placebo controlled study of simvastatin for the treatment of mild to moderate AD. Participants Persons with mild to moderate AD and their study partners enrolled in the simvastatin clinical trial. Measurements Interviews to assess decision-making capacity using the MacArthur Competency Assessment Tool for Clinical Research (MacCAT-CR). Results Judges blinded to the subject’s clinical status had a high rate of agreement on patients capable of giving their own informed consent (κ = 0.73). The understanding subscale had the best receiver operator characteristic and an analysis of positive and negative predictive values over a range of hypothetical prevalences of incapacity to consent demonstrated the value of a range of understanding cut-points. Conclusion Among mild to moderate AD patients, enrolled in an actual clinical trial, these results suggest evidence based guidelines for using the MacCAT-CR understanding subscale to help guide judgments about whether a patient has the capacity to consent. PMID:18556397

Legal and psychological considerations for obtaining informed consent for reverse total shoulder arthroplasty.

PubMed

Blackwood, Craig; Dixon, Jen; Reilly, Peter; Emery, Roger J

2017-01-01

This paper seeks to outline recent legal developments and requirements pertinent to obtaining informed consent. We argue that this is of particular relevance to patients considering a reverse total shoulder arthroplasty, due to the high complication rate associated with this procedure. By examining the cognitive processes involved in decision-making, and other clinician-related factors such as delivery of information, gender bias and conflict of interest, we explore some of the barriers that can undermine the processes of shared decision-making and obtaining genuine informed consent. We argue that these issues highlight the importance for surgeons in understanding the cognitive processes and other influential factors involved in patients' comprehension and decision-making. We recommend, based on strong evidence, that decision aids could prove useful in overcoming such challenges and could provide one way of mitigating the ethical, professional and legal consequences of failing to obtain proper informed consent. They are not widely used in orthopaedics at present, although it would be in the interests of both the surgeon and patient for such measures to be explored.

Legal and psychological considerations for obtaining informed consent for reverse total shoulder arthroplasty

PubMed Central

Blackwood, Craig; Reilly, Peter; Emery, Roger J

2016-01-01

This paper seeks to outline recent legal developments and requirements pertinent to obtaining informed consent. We argue that this is of particular relevance to patients considering a reverse total shoulder arthroplasty, due to the high complication rate associated with this procedure. By examining the cognitive processes involved in decision-making, and other clinician-related factors such as delivery of information, gender bias and conflict of interest, we explore some of the barriers that can undermine the processes of shared decision-making and obtaining genuine informed consent. We argue that these issues highlight the importance for surgeons in understanding the cognitive processes and other influential factors involved in patients’ comprehension and decision-making. We recommend, based on strong evidence, that decision aids could prove useful in overcoming such challenges and could provide one way of mitigating the ethical, professional and legal consequences of failing to obtain proper informed consent. They are not widely used in orthopaedics at present, although it would be in the interests of both the surgeon and patient for such measures to be explored. PMID:28572846

[Informed consent consultation as a part of patient safety in pediatric traumatology].

PubMed

Kraus, R; Heberer, J

2013-10-01

In pediatric traumatology as in any other surgical specialty, every treatment measure has to be protected by an adequate clarification. A legally effective clarification has to cover various aspects, such as diagnosis, treatment, risk and safety clarification and leads to an informed consent consultation. The contents of this informed consent discussion must be documented. The nature and extent of clarification, among other things depend on the urgency of the procedure and in an emergency it can be dispensed with in pediatric traumatology. In the case of minors the conversation must be conducted basically in the presence of both parents as they alone are legally entitled to give approval. General treatment proxies are not allowed. If it is not possible to talk to both parents the physician is allowed to trust that the parent present represents the will of the absent parent. Intervention cannot be carried out against the will of adolescents capable of self-determination even with the consent of the parents. The application of these rules is illustrated by means of practical examples.

Information disclosure in clinical informed consent: “reasonable” patient’s perception of norm in high-context communication culture

PubMed Central

2014-01-01

Background The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients’ norm perception of information disclosure in other cultures. Methods We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners’ details, benefits, risks, complications’ management, available alternatives, procedure’s description, and post-procedure’s issues. Results Respondents’ mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee’s name). Overall, items related to benefits and post-procedure’s issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure’s name) to 13.9% (lead practitioner’s training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). Conclusions 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure’s issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a “reasonable” patient’s standard is to be met. PMID:24406055

A qualitative study of experience of parents of adolescents who received ECT.

PubMed

Grover, Sandeep; Varadharajan, Natarajan; Avasthi, Ajit

2017-12-01

To evaluate the experience of parents of adolescents who received ECT for severe mental illness. Using qualitative methods, 6 parents of 5 adolescents were interviewed by using a self-designed semi-structured interview after the completion of ECT course. The clinicians involved in the ECT procedure, i.e., seeking informed consent and administration of ECT were not aware about the study. All the interviews were recorded and the content was analysed and themes were generated. Parents of all the 5 adolescents expressed that their children were considered for ECT only after the patient had not responded to medication and were unmanageable. Prior to ECT the treating doctors did explain to them about the ECT procedure, they were given information booklet and they were not coerced to consent for ECT. Some of the parents reported that they had dilemma prior to giving consent and were scared prior to the first ECT. However, as the clinical condition of their children improved, they felt that ECT was a good treatment. Majority of the parents felt that ECT was delayed for their children. When asked about restriction in use of ECT in children and adolescents, the parents expressed that it is important for law makers to understand the distress of the parents,when their children are acutely ill. They expressed that decision of administration of ECT must be left to the family and the treating clinicians. Parents of adolescents considered for ECT are generally satisfied with the treatment procedure. Copyright © 2017 Elsevier B.V. All rights reserved.

Treatment for gender dysphoria in children: the new legal, ethical and clinical landscape.

PubMed

Smith, Malcolm K; Mathews, Ben

2015-02-02

Gender dysphoria is a condition in which a child's subjectively felt identity and gender are not congruent with her or his biological sex. Because of this, the child suffers clinically significant distress or impairment in social functioning. The Family Court of Australia has recently received an increasing number of applications seeking authorisation for the provision of hormones to treat gender dysphoria in children. Some medical procedures and interventions performed on children are of such a grave nature that court authorisation must be obtained to render them lawful. These procedures are referred to as special medical procedures. Hormonal therapy for the treatment of gender dysphoria in children is provided in two stages occurring years apart. Until recently, both stages of treatment were regarded by courts as special medical treatments, meaning court authorisation had to be provided for both stages. In a significant recent development, courts have drawn a distinction between the two stages of treatment, permitting parents to consent to the first stage. In addition, it has been held that a child who is determined by a court to be Gillick competent can consent to stage 2 treatment. The new legal developments concerning treatment for gender dysphoria are of ethical, clinical and practical importance to children and their families, and to medical practitioners treating children with gender dysphoria. Medical practitioners should benefit from an understanding of the recent developments in legal principles. This will ensure that they have up-to-date information about the circumstances under which treatment may be conducted with parental consent, and those in which they must seek court authorisation.

A day in the life of a junior doctor: everyday ethical encounters.

PubMed

Quarini, Catherine J

2010-11-01

This paper presents a hypothetical 'day in the life' of junior doctors working on a busy hospital ward. It illustrates the fact that, although the everyday ethical encounters faced by doctors are generally not as dramatic as some of the ethical issues discussed at medical school, the underlying principles, such as consent, confidentiality and resource allocation, are highly relevant to daily practice. After presenting some of the ethical challenges faced by junior doctors, from patients confused by poor explanations to inadequate consent procedures, the paper ends with suggestions on how to improve the situation.

Improving the informed consent process in international collaborative rare disease research: effective consent for effective research

PubMed Central

Gainotti, Sabina; Turner, Cathy; Woods, Simon; Kole, Anna; McCormack, Pauline; Lochmüller, Hanns; Riess, Olaf; Straub, Volker; Posada, Manuel; Taruscio, Domenica; Mascalzoni, Deborah

2016-01-01

The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia – a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects. PMID:26860059

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.

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.

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2010 CFR

2010-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2014 CFR

2014-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2013 CFR

2013-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2012 CFR

2012-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

29 CFR 18.9 - Consent order or settlement; settlement judge procedure.

Code of Federal Regulations, 2011 CFR

2011-07-01

... shall not be appointed when— (i) A party objects to referral of the matter to a settlement judge; (ii... as the Black Lung Benefits Act. (3) Selection of settlement judge. (i) The selection of a settlement...

78 FR 44599 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-24

... plugs at Defendant's existing and new natural gas wells within EPA Region 3; implementation of standard operating procedures for tank loading and unloading; and an obligation to increase recycling of produced...

Pilot Testing a Couples-focused Intervention for Mild Cognitive Impairment

PubMed Central

Lu, Yvonne Yueh-Feng; Haase, Joan E.; Weaver, Michael

2014-01-01

The purpose of this pilot study was to evaluate the acceptability, feasibility, and potential benefits of the multi-component Daily Enhancement of Meaningful Activity (DEMA) intervention, which was tailored to help couples facing mild cognitive impairment (MCI) work together to meet goals, remain engaged in meaningful activities, and adapt to changes over time. Using a single-group design, 10 persons with MCI and their family caregivers were recruited to receive DEMA over six bi-weekly sessions. Data were collected pre- and at one week and three months post-intervention. Consent, session, and questionnaire completion rates indicated the program and study procedures were well accepted. Qualitative and quantitative findings indicated positive trends in meaningful activity performance and maintenance of health-related outcomes, as well as high program satisfaction. The DEMA is a potentially promising intervention that will need further testing in a randomized clinical trial. PMID:23767062

Malodorous consequences: what comprises negligence in anosmia litigation?

PubMed

Svider, Peter F; Mauro, Andrew C; Eloy, Jean Anderson; Setzen, Michael; Carron, Michael A; Folbe, Adam J

2014-03-01

Our objectives were to evaluate factors raised in malpractice litigation in which plaintiffs alleged that physician negligence led to olfactory dysfunction. We analyzed publically available federal and court records using Westlaw, a widely used computerized legal database. Pertinent jury verdicts and settlements were comprehensively examined for alleged causes of malpractice (including procedures for iatrogenic causes), defendant specialty, patient demographics, and other factors raised in legal proceedings. Of 25 malpractice proceedings meeting inclusion criteria, 60.0% were resolved for the defendant, 12.0% were settled, and 28.0% had jury-awarded damages. Median payments were significant ($300,000 and $412,500 for settlements and awards, respectively). Otolaryngologists were the most frequently named defendants (68.0%), with the majority of iatrogenic cases (55.0%) related to rhinologic procedures. Associated medical events accompanying anosmia included dysgeusia, cerebrospinal fluid leaks, and meningitis. Other alleged factors included requiring additional surgery (80.0%), unnecessary procedures (47.4% of iatrogenic procedural cases), untimely diagnosis leading to anosmia (44.0%), inadequate informed consent (35.0%), dysgeusia (56.0%), and psychological sequelae (24.0%). Olfactory dysfunction can adversely affect quality of life and thus is a potential area for malpractice litigation. This is particularly true for iatrogenic causes of anosmia, especially following rhinologic procedures. Settlements and damages awarded were considerable, making an understanding of factors detailed in this analysis of paramount importance for the practicing otolaryngologist. This analysis reinforces the importance of explicitly including anosmia in a comprehensive informed consent process for any rhinologic procedure. © 2013 ARS-AAOA, LLC.

Perception and duration of pain after office-based vocal fold injection augmentation.

PubMed

Crawley, Brianna K; Dehom, Salem; Kutzner, Emily; Murry, Thomas; Krishna, Priya; Hata, Justin

2018-04-01

In-office laryngology procedures are important in the treatment of voice and swallowing disorders. Patient tolerance determines which procedures can be performed without sedation or formal anesthesia. This study examines pain perception during and after in-office vocal fold injection augmentation. Prospective cohort study. Patients scheduled for office-based vocal fold injection augmentation were prospectively enrolled at an academic voice center. The short-form McGill Pain Questionnaire was administered before, during, and after the procedure and on postprocedure days 1, 3, and 7. Pre- and postprocedure vital signs were recorded and heart rate was continuously monitored. Telephone questionnaires were completed on postprocedure days 1 and 3. Forty-five patients consented to participate in our study (24 males, mean age 61 years). Most patients experienced mild to moderate pain with increasing heart rate during the procedure. Pain remained or increased 20 minutes after the procedure and improved but persisted for 1 day. Sensory and affective discomfort was endorsed by the majority. A minority of patients experienced bruising and changes in swallowing with diet modification for 3 days after the procedure. Sixteen percent had discomfort after 1 week. This is the first prospective study examining patient perception of pain during and after in-office injection augmentation using a validated scale and pain descriptors with extended follow-up. The results may offer guidance for patient counseling, consent, and treatment to improve tolerance and success. 4. Laryngoscope, 128:929-934, 2018. © 2018 The American Laryngological, Rhinological and Otological Society, Inc.

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.

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

The family v. the family court: sterilisation issues.

PubMed

Petersen, K

1992-06-01

Parents as guardians of minor children have the right and duty to give and withhold consent to medical treatment when the treatment is neither routine nor urgent. Parental authority, however, is not absolute and dwindles as the child gradually matures. In general, teenagers can give consent to medical treatment if they understand the nature and consequences of the proposed treatment. The diminution of parental authority is based on the premise that the child will eventually become autonomous. In cases where a sterilisation or hysterectomy procedure is being considered for a severely intellectually disabled teenager the question of consent is most contentious. Should this power belong to parents or the state? This paper examines some recent Family Court cases concerning this issue and also addresses questions about human rights, medical autonomy and the role of the Family Court. Finally, a proposal for an alternative means of decision-making in these cases is briefly outlined.

Consent to autopsy for neonates.

PubMed

McHaffie, H E; Fowlie, P W; Hume, R; Laing, I A; Lloyd, D J; Lyon, A J

2001-07-01

To determine parents' views on autopsy after treatment withdrawal. Face to face interviews with 59 sets of bereaved parents (108 individual parents) for whose 62 babies there had been discussion of treatment withdrawal. All except one couple were asked for permission for postmortem examination; 38% refused. The main reasons for declining were concerns about disfigurement, a wish to have the child left in peace, and a feeling that an autopsy was unnecessary because the parents had no unanswered questions. The diagnosis, the age of the child, and the approach of the consultant appeared to influence consent rates. Of those who agreed to autopsies, 92% were given the results by the neonatologist concerned. Whether or not they had agreed to the procedure, at 13 months no parent expressed regrets about their decision. Autopsy rates in the East of Scotland stand at 62%. Parents' perceptions are an important element in consent to postmortem examination.

A qualitative study exploring the acceptability of the McNulty-Zelen design for randomised controlled trials evaluating educational interventions.

PubMed

McNulty, Cliodna; Ricketts, Ellie J; Rugman, Claire; Hogan, Angela; Charlett, Andre; Campbell, Rona

2015-11-17

Traditional randomised controlled trials evaluating the effect of educational interventions in general practice may produce biased results as participants know they are being evaluated. We aimed to explore the acceptability of a McNulty-Zelen Cluster Randomised Control Trial (CRT) design which conceals from educational participants that they are in a RCT. Consent is obtained from a trusted third party considered appropriate to give consent on participants' behalf, intervention practice staff then choose whether to attend the offered education as would occur with normal continuing professional development. We undertook semi structured telephone interviews in England with 16 general practice (GP) staff involved in a RCT evaluating an educational intervention aimed at increasing chlamydia screening tests in general practice using the McNulty-Zelen design, 4 Primary Care (PC) Research Network officers, 5 Primary Care Trust leads in Public or sexual health, and one Research Ethics committee Chair. Interviews were undertaken by members of the original intervention evaluation McNulty-Zelen design RCT study team. These experienced qualitative interviewers used an agreed semi-structured interview schedule and were careful not to lead the participants. To further mitigate against bias, the data analysis was undertaken by a researcher (CR) not involved in the original RCT. We reached data saturation and found five main themes; Support for the design: All found the McNulty-Zelen design acceptable because they considered that it generated more reliable evidence of the value of new educational interventions in real life GP settings. Lack of familiarity with study design: The design was novel to all. GP staff likened the evaluation using the McNulty-Zelen design to audit of their activities with feedback, which were to them a daily experience and therefore acceptable. Ethical considerations: Research stakeholders considered the consent procedure should be very clear and that these trial designs should go through at least a proportionate ethical review. GP staff were happy for the PCT leads to give consent on their behalf. GP research capacity and trial participation: GP staff considered the design increased generalisability, as staff who would not normally volunteer to participate in research due to perceived time constraints and paperwork might do so. Design 'worth it': All interviewees agreed that the advantages of the "more accurate" or "truer" results and information gained about uptake of workshops within Primary Care Trusts (PCTs) outweighed any disadvantages of the consent procedure. Our RCT was evaluating the effect of an educational intervention to increase chlamydia screening tests in general practices where there was routine monitoring of testing rates; our participants may have been less enthusiastic about the design if it had been evaluating a more controversial educational area, or if data monitoring was not routine. The McNulty-Zelen design should be considered for the evaluation of educational interventions, but these designs should have clear consent protocols and proportionate ethical review. The trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN9722 .

48 CFR 2944.202 - Contracting officer's evaluation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 7 2010-10-01 2010-10-01 false Contracting officer's evaluation. 2944.202 Section 2944.202 Federal Acquisition Regulations System DEPARTMENT OF LABOR CONTRACT MANAGEMENT SUBCONTRACTING POLICIES AND PROCEDURES Consent To Subcontract 2944.202 Contracting officer's...

Law & Order, CSI, and NCIS: The Association Between Exposure to Crime Drama Franchises, Rape Myth Acceptance, and Sexual Consent Negotiation Among College Students.

PubMed

Hust, Stacey J T; Marett, Emily Garrigues; Lei, Ming; Ren, Chunbo; Ran, Weina

2015-01-01

Previous research has identified that exposure to the crime drama genre lowers rape myth acceptance and increases sexual assault prevention behaviors such as bystander intervention. However, recent content analyses have revealed marked differences in the portrayal of sexual violence within the top three crime drama franchises. Using a survey of 313 college freshmen, this study explores the influence of exposure to the three most popular crime drama franchises: Law & Order, CSI, and NCIS. Findings indicate that exposure to the Law & Order franchise is associated with decreased rape myth acceptance and increased intentions to adhere to expressions of sexual consent and refuse unwanted sexual activity; whereas exposure to the CSI franchise is associated with decreased intentions to seek consent and decreased intentions to adhere to expressions of sexual consent. Exposure to the NCIS franchise was associated with decreased intentions to refuse unwanted sexual activity. These results indicate that exposure to the specific content of each crime drama franchise may have differential results on sexual consent negotiation behaviors.

The role of consent in medical research: breaking or building walls? A call for legislative reform.

PubMed

Dangata, Yohanna Yanshiyi

2011-12-01

Research has been integral to the practice of medicine for almost as long as the discipline has existed. Until fairly recently research used to be conducted on human subjects without mandatory requirement for their consent. However, over time medical research became associated with significant cruelty resulting in an outcry for regulation of research actives. This resulted in significant legislation in place for monitoring. Today it is mandatory to obtain consent from subjects before embarking on medical research, and indeed treatment. Its significant regulatory role notwithstanding, the issue of consent at times becomes a hindrance to research. This paper examines the issue of consent in relation to medical research in the context of present legislation. It lays out the background to medical research with respect to purpose, scope, standard protocol and related issues; it then addresses the issue of consent in various scenarios, highlighting problems and the need for legislative reform. It is maintained that while regulatory measures have brought a lot of sanity to medical research and the medical profession, some measures are building walls inhibitory to research activities. Research being integral to the development and growth of healthcare delivery, there is need for reformation of current medical law for balance between patient protectionism and progress in medical research for effective patient care.

Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study.

PubMed

Wilhelm, Marcel; Rief, Winfried; Doering, Bettina K

2018-05-21

Informing patients about treatment side effects increases the occurrence and intensity of side effects. Since the obligatory informed consent procedure in drug treatments requires transparency and nocebo research suggests that the informed consent of a drug leads to an increased occurrence of the mentioned side effects, the aim of this proof of concept study was to determine the effect of two different framings of informed consent on the occurrence, intensity, and perceived threat of side effects. Healthy male participants (n = 80) were randomized to one of two framing groups. The positive framing group was informed that the common side effect dizziness was a sign that the drug had started to work, while the neutral framing group was told that dizziness is an unpleasant but well-known side effect. Side effects were measured after the administration of metoprolol, an antihypertensive agent. Post hoc moderator analyses investigated the effect of pre-existing negative beliefs about the general harm of medication on the framing manipulation. Metoprolol-specific drug-attributed side effects were rated significantly less threatening in the positive framing group. The between-group effect size (Cohen's d) was small (d = 0.38, p = 0.049). Exploratory post hoc moderator analyses suggest that participants who believed that medication is a source of harmful effects benefited from positive framing, compared to neutral framing of drug-attributed side effects. Positive framing was partially effective in decreasing specific side effect measures, particularly among participants with a tendency to believe that medicine is harmful. Informed consent procedures should therefore be personalized, focusing on patients with negative treatment beliefs.

Current practice and recommendations in UK epilepsy monitoring units. Report of a national survey and workshop.

PubMed

Hamandi, Khalid; Beniczky, Sandor; Diehl, Beate; Kandler, Rosalind H; Pressler, Ronit M; Sen, Arjune; Solomon, Juliet; Walker, Matthew C; Bagary, Manny

2017-08-01

Inpatient video-EEG monitoring (VEM) is an important investigation in patients with seizures or blackouts, and in the pre-surgical workup of patients with epilepsy. There has been an expansion in the number of Epilepsy Monitoring Units (EMU) in the UK offering VEM with a necessary increase in attention on quality and safety. Previous surveys have shown variation across centres on issues including consent and patient monitoring. In an effort to bring together healthcare professionals in the UK managing patients on EMU, we conducted an online survey of current VEM practice and held a one-day workshop convened under the auspices of the British Chapter of the ILAE. The survey and workshop aimed to cover all aspects of VEM, including pre-admission, consent procedures, patient safety, drug reduction and reinstatement, seizure management, staffing levels, ictal testing and good data recording practice. This paper reports on the findings of the survey, the workshop presentations and workshop discussions. 32 centres took part in the survey and there were representatives from 22 centres at the workshop. There was variation in protocols, procedures and consent processes between units, and levels of observation of monitored patients. Nevertheless, the workshop discussion found broad areas of agreement on points. A survey and workshop of UK epilepsy monitoring units found that some variability in practice is inevitable due to different local arrangements and patient groups under investigation. However, there were areas of clear consensus particularly in relation to consent and patient safety that can be applied to most units and form a basis for setting minimum standards. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

ORACLE Stroke Study: Opinion Regarding Acceptable Outcome Following Decompressive Hemicraniectomy for Ischemic Stroke.

PubMed

Honeybul, Stephen; Ho, Kwok M; Blacker, David W

2016-08-01

There continues to be considerable interest in the use of decompressive hemicraniectomy in the management of malignant cerebral artery infarction; however, concerns remain about long-term outcome. To assess opinion on consent and acceptable outcome among a wide range of healthcare workers. Seven hundred seventy-three healthcare workers at the 2 major public neurosurgical centers in Western Australia participated. Participants were asked to record their opinion on consent and acceptable outcome based on the modified Rankin Score (mRS). The evidence for clinical efficacy of the procedure was presented, and participants were then asked to reconsider their initial responses. Of the 773 participants included in the study, 407 (52.7%) initially felt that they would provide consent for a decompressive craniectomy as a lifesaving procedure, but only a minority of them considered an mRS score of 4 or 5 an acceptable outcome (for mRS score ≤4, n = 67, 8.7%; for mRS score = 4, n = 57, 7.4%). After the introduction of the concept of the disability paradox and the evidence for the clinical efficacy of decompressive craniectomy, more participants were unwilling to accept decompressive craniectomy (18.1% vs 37.8%), but at the same time, more were willing to accept an mRS score ≤4 as an acceptable outcome (for mRS score ≤4, n = 92, 11.9%; for mRS score = 4, n = 79, 10.2%). Most participants felt survival with dependency to be unacceptable. However, many would be willing to provide consent for surgery in the hopes that they may survive with some degree of independence. DESTINY, Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral ArterymRS, modified Rankin Scale.

"Informed" Consent: An Audit of Informed Consent of Cesarean Section Evaluating Patient Education and Awareness.

PubMed

Kirane, Akhilesh G; Gaikwad, Nandkishor B; Bhingare, Prashant E; Mule, Vidya D

2015-12-01

Better diagnosis and early referral due to increased health care coverage have increased the cesarean deliveries at tertiary-care hospitals of India. Improvements in the health care system raise many concerns and need of cross-checking system in place to counter the problems pertaining to patient education and participation of patient. While most of the cesarean sections are done in good faith for the patient, it does not escape the purview of consumer awareness and protection. This cross-sectional study was undertaken at a tertiary level government institution to understand the level of awareness of 220 patients regarding the various aspects of cesarean delivery which are essential for women to know before giving an informed consent. 71 % of the women had knowledge about the indication and need to do cesarean delivery. Of these, only one-third (25 % of total women) were properly explained about procedure and complications. Other demographic and social characteristics were also evaluated. While the health care schemes have had their improved results, the onus lies upon the caregivers to improve and maintain the quality of health care in these tertiary-care government hospitals in proportion to the increase in patient load. The results of this study highlight the need for proper counseling of patients regarding complications of cesarean section. The fact that only 25 % of total cases were explained proper procedure and complication as opposed to 71 % of patients having proper knowledge about the indication of cesarean section points out the lack of information in seemingly "informed" consent. To bring about awareness about the risks and complications of cesarean section, there is a need that patients be counseled during the antenatal visits, specifically when patients visit near term for antenatal check up.

Impact on Patient Safety and Satisfaction of Implementation of an Outpatient Clinic in Interventional Radiology (IPSIPOLI-Study): A Quasi-Experimental Prospective Study

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

Lutjeboer, Jacob, E-mail: j.lutjeboer@lumc.nl; Burgmans, Mark Christiaan, E-mail: m.c.burgmans@lumc.nl, E-mail: mburgmans@hotmail.com; Chung, Kaman, E-mail: kaman.chung10@gmail.com

PurposeInterventional radiology (IR) procedures are associated with high rates of preparation and planning errors. In many centers, pre-procedural consultation and screening of patients is performed by referring physicians. Interventional radiologists have better knowledge about procedure details and risks, but often only get acquainted with the patient in the procedure room. We hypothesized that patient safety (PS) and patient satisfaction (PSAT) in elective IR procedures would improve by implementation of a pre-procedural visit to an outpatient IR clinic.Material and MethodsIRB approval was obtained and informed consent was waived. PS and PSAT were measured in patients undergoing elective IR procedures before (controlmore » group; n = 110) and after (experimental group; n = 110) implementation of an outpatient IR clinic. PS was measured as the number of process deviations. PSAT was assessed using a questionnaire measuring Likert scores of three dimensions: interpersonal care aspects, information/communication, and patient participation. Differences in PS and PSAT between the two groups were compared using an independent t test.ResultsThe average number of process deviations per patient was 0.39 in the control group compared to 0.06 in the experimental group (p < 0.001). In 9.1 % patients in the control group, no legal informed consent was obtained compared to 0 % in the experimental group. The mean overall Likert score was significantly higher in the experimental group compared to the control group: 2.68 (SD 0.314) versus 2.48 (SD 0.381) (p < 0.001).ConclusionPS and PSAT improve significantly if patients receive consultation and screening in an IR outpatient clinic prior to elective IR procedures.« less

Informed consent for innovative surgery: a survey of patients and surgeons.

PubMed

Lee Char, Susan J; Hills, Nancy K; Lo, Bernard; Kirkwood, Kimberly S

2013-04-01

Unlike new drugs and medical devices, most surgical procedures are developed outside clinical trials and without regulatory oversight. Surgical professional organizations have discussed how new procedures should be introduced into practice without agreement on what topics informed consent discussions must include. To provide surgeons with more specific guidance, we wanted to determine what information patients and surgeons consider essential to disclose before an innovative surgical procedure. Of those approached, 85 of 113 attending surgeons and 383 of 541 adult postoperative patients completed surveys; responses to the surveys were 75% and 71%, respectively. Using a 6-point Likert scale, participants rated the importance of discussing 16 types of information preoperatively for 3 techniques (standard open, laparoscopic, robotic) offered for a hypothetic partial hepatectomy. Compared with surgeons, patients placed more importance on nearly all types of information, particularly volumes and outcomes. For all 3 techniques, approximately 80% of patients indicated that they could not decide on surgery without being told whether it would be the surgeon's first time doing the procedure. When considering an innovative robotic surgery, a clear majority of both patients and surgeons agreed that it was essential to disclose the novel nature of the procedure, potentially unknown risks and benefits, and whether it would be the surgeon's first time performing the procedure. To promote informed decision-making and autonomy among patients considering innovative surgery, surgeons should disclose the novel nature of the procedure, potentially unknown risks and benefits, and whether the surgeon would be performing the procedure for the first time. When accurate volumes and outcomes data are available, surgeons should also discuss these with patients. Copyright © 2013 Mosby, Inc. All rights reserved.

Feasibility of Obtaining Measures of Lifestyle From a Smartphone App: The MyHeart Counts Cardiovascular Health Study.

PubMed

McConnell, Michael V; Shcherbina, Anna; Pavlovic, Aleksandra; Homburger, Julian R; Goldfeder, Rachel L; Waggot, Daryl; Cho, Mildred K; Rosenberger, Mary E; Haskell, William L; Myers, Jonathan; Champagne, Mary Ann; Mignot, Emmanuel; Landray, Martin; Tarassenko, Lionel; Harrington, Robert A; Yeung, Alan C; Ashley, Euan A

2017-01-01

Studies have established the importance of physical activity and fitness, yet limited data exist on the associations between objective, real-world physical activity patterns, fitness, sleep, and cardiovascular health. To assess the feasibility of obtaining measures of physical activity, fitness, and sleep from smartphones and to gain insights into activity patterns associated with life satisfaction and self-reported disease. The MyHeart Counts smartphone app was made available in March 2015, and prospective participants downloaded the free app between March and October 2015. In this smartphone-based study of cardiovascular health, participants recorded physical activity, filled out health questionnaires, and completed a 6-minute walk test. The app was available to download within the United States. The feasibility of consent and data collection entirely on a smartphone, the use of machine learning to cluster participants, and the associations between activity patterns, life satisfaction, and self-reported disease. From the launch to the time of the data freeze for this study (March to October 2015), the number of individuals (self-selected) who consented to participate was 48 968, representing all 50 states and the District of Columbia. Their median age was 36 years (interquartile range, 27-50 years), and 82.2% (30 338 male, 6556 female, 10 other, and 3115 unknown) were male. In total, 40 017 (81.7% of those who consented) uploaded data. Among those who consented, 20 345 individuals (41.5%) completed 4 of the 7 days of motion data collection, and 4552 individuals (9.3%) completed all 7 days. Among those who consented, 40 017 (81.7%) filled out some portion of the questionnaires, and 4990 (10.2%) completed the 6-minute walk test, made available only at the end of 7 days. The Heart Age Questionnaire, also available after 7 days, required entering lipid values and age 40 to 79 years (among 17 245 individuals, 43.1% of participants). Consequently, 1334 (2.7%) of those who consented completed all fields needed to compute heart age and a 10-year risk score. Physical activity was detected for a mean (SD) of 14.5% (8.0%) of individuals' total recorded time. Physical activity patterns were identified by cluster analysis. A pattern of lower overall activity but more frequent transitions between active and inactive states was associated with equivalent self-reported cardiovascular disease as a pattern of higher overall activity with fewer transitions. Individuals' perception of their activity and risk bore little relation to sensor-estimated activity or calculated cardiovascular risk. A smartphone-based study of cardiovascular health is feasible, and improvements in participant diversity and engagement will maximize yield from consented participants. Large-scale, real-world assessment of physical activity, fitness, and sleep using mobile devices may be a useful addition to future population health studies.

‘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

Finland on a road towards a modern legal biobanking infrastructure.

PubMed

Soini, Sirpa

2013-06-01

Finland has enacted a Biobank Act that will come into force on 1 September 2013. Finland is regarded as a highly successful environment for medical research using population samples and data for many reasons. One of the rationales behind the new legislation was to solve the problems due to the overly strict informed consent doctrine hindering access to old samples and data and asking for multi-purpose consents. Yet although consent is the primary justification to use biobank samples and data, the Biobank Act allows asking for a consent for several unspecified future research purposes. The guiding principles of the Biobank Act are promotion of trust, equal access to data and samples, protection of privacy, acceleration of innovation activities, and bringing biobank activities under public scrutiny. To the author's knowledge, this is the first "all purpose" Biobank Act in Europe applied to all biobanks in one country.

Genebanks: a comparison of eight proposed international genetic databases.

PubMed

Austin, Melissa A; Harding, Sarah; McElroy, Courtney

2003-01-01

To identify and compare population-based genetic databases, or "genebanks", that have been proposed in eight international locations between 1998 and 2002. A genebank can be defined as a stored collection of genetic samples in the form of blood or tissue, that can be linked with medical and genealogical or lifestyle information from a specific population, gathered using a process of generalized consent. Genebanks were identified by searching Medline and internet search engines with key words such as "genetic database" and "biobank" and by reviewing literature on previously identified databases such as the deCode project. Collection of genebank characteristics was by an electronic and literature search, augmented by correspondence with informed individuals. The proposed genebanks are located in Iceland, the United Kingdom, Estonia, Latvia, Sweden, Singapore, the Kingdom of Tonga, and Quebec, Canada. Comparisons of the genebanks were based on the following criteria: genebank location and description of purpose, role of government, commercial involvement, consent and confidentiality procedures, opposition to the genebank, and current progress. All of the groups proposing the genebanks plan to search for susceptibility genes for complex diseases while attempting to improve public health and medical care in the region and, in some cases, stimulating the local economy through expansion of the biotechnology sector. While all of the identified plans share these purposes, they differ in many aspects, including funding, subject participation, and organization. The balance of government and commercial involvement in the development of each project varies. Genetic samples and health information will be collected from participants and coded in all of the genebanks, but consent procedures range from presumed consent of the entire eligible population to recruitment of volunteers with informed consent. Issues regarding confidentiality and consent have resulted in opposition to some of the more publicized projects. None of the proposed databases are currently operational and at least one project was terminated due to opposition. Ambitious genebank projects have been proposed in numerous countries and provinces. The characteristics of the projects vary, but all intend to map genes for common diseases and hope to improve the health of the populations involved. The impact of these projects on understanding genetic susceptibility to disease will be increasingly apparent if the projects become operational. The ethical, legal, and social implications of the projects should be carefully considered during their development. Copyright 2003 S. Karger AG, Basel

20 CFR 361.2 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

...' Benefits RAILROAD RETIREMENT BOARD INTERNAL ADMINISTRATION, POLICY AND PROCEDURES RECOVERY OF DEBTS OWED TO THE UNITED STATES GOVERNMENT BY GOVERNMENT EMPLOYEES § 361.2 Scope. (a) Coverage. This part applies to... apply in recovering certain debts by administrative offset, except where the employee consents to the...

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.

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

The Ethics of Stem Cell-Based Aesthetic Surgery: Attitudes and Perceptions of the Plastic Surgery Community.

PubMed

Nayar, Harry S; Caplan, Arthur L; Eaves, Felmont F; Rubin, J Peter

2014-08-01

The emerging field of stem cell-based aesthetics has raised ethical concerns related to advertising campaigns and standards for safety and efficacy. The authors sought to characterize the attitudes of plastic surgeons regarding the ethics of stem cell-based aesthetics. A cross-sectional electronic survey was distributed to 4592 members of the American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons. Statements addressed ethical concerns about informed consent, conflicts of interest, advertising, regulation, and stem cell tourism. An agreement score (AS) from 0 to 100 was calculated for each statement. Majority agreement was designated as ≥60 and majority disagreement as ≤40. A total of 770 questionnaires were received (16.7%). The majority of respondents indicated that knowledge regarding the risks and benefits of stem cell procedures is insufficient to obtain valid informed consent (AS, 29) and that direct-to-consumer advertising for these technologies is inappropriate and unethical (AS, 23). Most respondents reported that patients should be actively warned against traveling abroad to receive aesthetic cell therapies (AS, 86) and that registries and evaluations of these clinics should be made publicly available (AS, 71). Even more respondents noted that financial conflicts of interest should be disclosed to patients (AS, 96) and that professional societies should participate in establishing regulatory standards (AS, 93). The plastic surgeons surveyed in this study support a well-regulated, evidence-based approach to aesthetic procedures involving stem cells. © 2014 The American Society for Aesthetic Plastic Surgery, Inc.

Prehospital thrombolysis in acute stroke: results of the PHANTOM-S pilot study.

PubMed

Weber, Joachim E; Ebinger, Martin; Rozanski, Michal; Waldschmidt, Carolin; Wendt, Matthias; Winter, Benjamin; Kellner, Philipp; Baumann, André; Fiebach, Jochen B; Villringer, Kersten; Kaczmarek, Sabina; Endres, Matthias; Audebert, Heinrich J

2013-01-08

Beneficial effects of IV tissue plasminogen activator (tPA) in acute ischemic stroke are strongly time-dependent. In the Pre-Hospital Acute Neurological Treatment and Optimization of Medical care in Stroke (PHANTOM-S) study, we undertook stroke treatment using a specialized ambulance, the stroke emergency mobile unit (STEMO), to shorten call-to-treatment time. The ambulance was staffed with a neurologist, paramedic, and radiographer and equipped with a CT scanner, point-of-care laboratory, and a teleradiology system. It was deployed by the dispatch center whenever a specific emergency call algorithm indicated an acute stroke situation. Study-specific procedures were restricted to patients able to give informed consent. We report feasibility, safety, and duration of procedures regarding prehospital tPA administration. From February 8 to April 30, 2011, 152 subjects were treated in STEMO. Informed consent was given by 77 patients. Forty-five (58%) had an acute ischemic stroke and 23 (51%) of these patients received tPA. The mean call-to-needle time was 62 minutes compared with 98 minutes in 50 consecutive patients treated in 2010. Two (9%) of the tPA-treated patients had a symptomatic intracranial hemorrhage and 1 of these patients (4%) died in hospital. Technical failures encountered were 1 CT dysfunction and 2 delayed CT image transmissions. The data suggest that prehospital stroke care in STEMO is feasible. No safety concerns have been raised so far. This new approach using prehospital tPA may be effective in reducing call-to-needle times, but this is currently being scrutinized in a prospective controlled study.

The use of reconsent in a national evaluation of adolescent reproductive health programs.

PubMed

Palen, Lori-Ann; Ashley, Olivia Silber; Jones, Sarah B; Lyons, Jeffrey D; Derecho, Azucena A; Kan, Marni L; Richmond Scott, Alicia

2012-08-01

Reconsent involves asking research participants to reaffirm their consent for study participation when there have been significant changes in the study's procedures, risks, or benefits. We described the reconsent process, identified the reconsent rate, and examined the comparability of youths enrolled via consent and reconsent in a national evaluation of adolescent reproductive health programs. Evaluation participants from five abstinence education projects (N = 2,176) and nine projects serving pregnant or parenting adolescents (N = 878) provided either parent or youth consent or reconsent to participate in the national evaluation. Participants completed surveys that included demographic characteristics; sexual intentions, norms and behaviors; and pregnancy history. Multivariate logistic regression was used to examine associations between consent status, demographic characteristics, and risk indicators. The reconsent rates in the abstinence education and pregnant or parenting samples were 45% and 58%, respectively. Participant's age was positively associated with reconsent. Hispanic adolescents (and, for abstinence education, other racial/ethnic minorities) were underrepresented among youth with reconsent. Among abstinence education study participants, risk indicators were not associated with consent status. Among pregnant or parenting teens, those who had experienced repeat pregnancy were less likely than those who had experienced only one pregnancy to have been enrolled via reconsent. Reconsent can bolster sample size but may introduce bias by missing some racial/ethnic and age-groups. Among high-risk adolescents, reconsent may also yield a sample that differs from consented samples on risk characteristics, necessitating statistical adjustments when analyzing data. Copyright © 2012 Society for Adolescent Health and Medicine. All rights reserved.

Consent: a Cartesian ideal? Human neural transplantation in Parkinson's disease.

PubMed

Lopes, Manuel; Meningaud, Jean-Paul; Behin, Anthony; Hervé, Christian

2003-01-01

The grafting of human embryonic cells in Parkinson's disease is an innovative and hopefully useful therapeutic approach. However, it still concerns a very small number of patients and is only suggested as a research protocol. We present here a study of the problems of information and consent to research within the framework of this disease in which the efficacy of medical treatment is shortlived. The only French center to use this treatment (Hôpital H. Mondor in Créteil) has received authorization from the Comité Consultatif National d'Ethique (Consultative National Committee on Ethics). Eleven patients were treated between 1991 and 1998. The study of the results of a questionnaire sent to those patients showed the difficulties met in evaluating the perception of information despite intact intellectual capacities in people "prepared to risk everything." In France, the duty to inform patients during research procedures is regulated by the Huriet Act. However, it is not easy to guarantee genuine consent when preliminary information is given to patients psychologically impaired by the slow and ineluctable course of their disease. In these borderline cases, a valid consent seems to be a myth in terms of pure autonomy when considered with the Cartesian aim of elimination of uncertainty. The relevance of this concept of genuine consent probably makes more sense as aiming at a Cartesian ideal which is perhaps more in the spirit rather than in the letter. It is in that same spirit that, from the outset, we propose to define t he practical ways of answering the patients' request for information, even sometimes after consent has been given.

What constitutes consent when parents and daughters have different views about having the HPV vaccine: qualitative interviews with stakeholders.

PubMed

Wood, Fiona; Morris, Lucy; Davies, Myfanwy; Elwyn, Glyn

2011-08-01

The UK Human Papillomavirus (HPV) vaccine programme commenced in the autumn of 2008 for year 8 (age 12-13 years) schoolgirls. We examine whether the vaccine should be given when there is a difference of opinion between daughters and parents or guardians. Qualitative study using semi-structured interviews. A sample of 25 stakeholders: 14 professionals involved in the development of the HPV vaccination programme and 11 professionals involved in its implementation. Overriding the parents' wishes was perceived as problematic and could damage the relationship between school and parents. A number of practical problems were raised in relation to establishing whether parents were genuinely against their daughter receiving the vaccine. Although many respondents recognised that the Gillick guidelines were relevant in establishing whether a girl could provide consent herself, they still felt that there were significant problems in establishing whether girls could be assessed as Gillick competent. In some areas school nurses had been advised not to give the vaccine in the absence of parental consent. None of the respondents suggested that a girl should be vaccinated against her consent even if her parents wanted her to have the vaccine. While the Gillick guidelines provide a legal framework to help professionals make judgements about adolescents consenting to medical treatment, in practice there appears to be variable and confused interpretation of this guidance. Improved legal structures, management procedures and professional advice are needed to support those who are assessing competence and establishing consent to vaccinate adolescents in a school setting.

Talking to the people that really matter about their participation in pandemic clinical research: A qualitative study in four European countries.

PubMed

Gobat, Nina H; Gal, Micaela; Butler, Christopher C; Webb, Steve A R; Francis, Nicholas A; Stanton, Helen; Anthierens, Sibyl; Bastiaens, Hilde; Godycki-Ćwirko, Maciek; Kowalczyk, Anna; Pons-Vigués, Mariona; Pujol-Ribera, Enriqueta; Berenguera, Anna; Watkins, Angela; Sukumar, Prasanth; Moore, Ronald G; Hood, Kerenza; Nichol, Alistair

2018-02-01

Pandemics of new and emerging infectious diseases are unpredictable, recurrent events that rapidly threaten global health and security. We aimed to identify public views regarding provision of information and consent to participate in primary and critical care clinical research during a future influenza-like illness pandemic. Descriptive-interpretive qualitative study, using focus groups (n = 10) and semi-structured interviews (n = 16), with 80 members of the public (>18 years) in Belgium, Spain, Poland and the UK. Local qualitative researchers followed a scenario-based topic guide to collect data. Data were transcribed verbatim, translated into English and subject to framework analysis. Public understandings of pandemics were shaped by personal factors (illness during the previous H1N1 pandemic, experience of life-threatening illness) and social factors (historical references, media, public health information). Informants appreciated safeguards provided by ethically robust research procedures, but current enrolment procedures were seen as a barrier. They proposed simplified enrolment processes for higher risk research and consent waiver for certain types of low-risk research. Decision making about research participation was influenced by contextual, research and personal factors. Informants generally either carefully weighed up various approaches to research participation or responded instinctively. They supported the principle of using routinely collected, anonymized clinical biological samples for research without explicit consent, but regarded this as less acceptable if researchers were motivated primarily by commercial gain. This bottom-up approach to ascertaining public views on pandemic clinical research has identified support for more proportionate research protection procedures for publically funded, low-risk studies. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

A cross-sectional pilot study to investigate patient attitudes and perception regarding the use of real time digital recording of urological procedures for research and teaching purposes

PubMed Central

Sharp, Gary; Mazzon, Giorgio; Thilagarajah, Ranjan

2015-01-01

Little conclusive evidence exists regarding the best way to educate and evaluate skill acquisition of advanced surgical trainees, despite it being recognised as one of the most important aspects of training. Many laparoscopic trainers have been produced with complex engineering at great cost, but, there seems to be a reluctance to use the most precious entity available to us; the patient. We thus propose the use of real time digital recording of urological procedures for research and teaching purposes. This study was prompted by the lack of literature regarding such issues. A 19 question questionnaire was circulated at a single urology out-patient department (Essex, England) over a 6 month period to evaluate attitudes and perceptions of urological patients on potentially having their procedure digitally recorded for educational and research purposes. 11 patients declined, 187 questionnaires were included in the final analysis. Male patients are more willing to consent than female patients. Older patients resulted to have a higher propensity in being recorded for medical teaching. Greater than 50% believe being recorded is intrusive but the majority do not think privacy is an issue. Lastly, the vast majority require a formal debrief post operatively. Our results show that a percentage of the public are potentially willing to be digitally recorded but many financial and social barriers exist. We have also highlighted areas of possible future research, namely the reluctance behind young urology patients to consent and questions regarding how best to educate possible study participants to ensure proper informed consent is gained. PMID:26005568

Remedies by competitors for false advertising.

PubMed

Hirsch, B D; Wilcox, D P

1990-05-01

Patients who are victimized as a consequence of false medical advertising are not the only ones who can sue for damages. Under section 43(a) of the Lanham Act, effective November 17, 1989, anyone "who believes that he or she is or is likely to be damaged" by deceptive advertising may bring a civil action for damages (1). Competing physicians may sue other physicians who falsely advertise that they possess unique skills and achieve better results than other physicians because they employ exclusive methods of treatment or claim that certain surgical procedures they perform in the office are absolutely safe and without risk or who advertise false professional credentials to lure patients. Voluntary informed consent excludes the use of deceit. Misrepresentation through advertising deprives a patient of the right to exercise an informed consent (2). A patient who relies on a doctor's false advertising in agreeing to a procedure that causes the patient injury may sue for malpractice even if the procedure was performed without negligence. False medical advertising also exposes the advertiser to litigation by competitors for unfair competition. This article is concerned with the remedy that may be available for instituting private litigation against physicians and other health care providers who engage in untruthful advertising.

Testing an online, dynamic consent portal for large population biobank research.

PubMed

Thiel, Daniel B; Platt, Jodyn; Platt, Tevah; King, Susan B; Fisher, Nicole; Shelton, Robert; Kardia, Sharon L R

2015-01-01

Michigan's BioTrust for Health, a public health research biobank comprised of residual dried bloodspot (DBS) cards from newborn screening contains over 4 million samples collected without written consent. Participant-centric initiatives are IT tools that hold great promise to address the consent challenges in biobank research. Working with Private Access Inc., a pioneer in patient-centric web solutions, we created and pilot tested a dynamic informed consent simulation, paired with an educational website, focusing on consent for research utilizing DBSs in Michigan's BioTrust for Health. Out of 187 pilot testers recruited in 2 groups, 137 completed the consent simulation and exit survey. Over 50% indicated their willingness to set up an account if the simulation went live and to recommend it to others. Participants raised concerns about the process of identity verification and appeared to have little experience with sharing health information online. Applying online, dynamic approaches to address the consent challenges raised by biobanks with legacy sample collections should be explored, given the positive reaction to our pilot test and the strong preference for active consent. Balancing security and privacy with accessibility and ease of use will continue to be a challenge. © 2014 S. Karger AG, Basel.

Expanding the boundaries of informed consent: disclosing alcoholism and HIV status to patients.

PubMed

Spielman, B

1992-08-01

Since informed consent became legally required in the therapeutic setting, the risks physicians were to disclose have been limited to the risks of particular procedures. Two recent court decisions in which disclosure of surgeons' alcoholism and positive human immunodeficiency virus status was required may begin to erode that limit. The grounds for this expansion of disclosure requirements were inherent in the 20-year-old "materiality" standard for disclosure; nevertheless, the change they signal is profound. These cases may signal a trend that, in the long term, could result in a shift in physician-patient communication and a significant loss of privacy for physicians.

Standard Versus Simplified Consent Materials for Biobank Participation: Differences in Patient Knowledge and Trial Accrual.

PubMed

Garrett, Sarah B; Murphy, Marie; Wiley, James; Dohan, Daniel

2017-12-01

Replacing standard consent materials with simplified materials is a promising intervention to improve patient comprehension, but there is little evidence on its real-world implementation. We employed a sequential two-arm design to compare the effect of standard versus simplified consent materials on potential donors' understanding of biobank processes and their accrual to an active biobanking program. Participants were female patients of a California breast health clinic. Subjects from the simplified arm answered more items correctly ( p = .064), reported "don't know" for fewer items ( p = .077), and consented to donate to the biobank at higher rates ( p = .025) than those from the standard arm. Replacing an extant consent form with a simplified version is feasible and may benefit patient comprehension and study accrual.

Research ethics committee auditing: the experience of a university hospital.

PubMed

Marchetti, Daniela; Spagnolo, Angelico; Cicerone, Marina; Cascini, Fidelia; La Monaca, Giuseppe; Spagnolo, Antonio G

2013-09-01

The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC's compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009-February 2011) divided into quarters to better value the influence of the new insurance coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC's opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place.

Surgical innovation: the ethical agenda: A systematic review.

PubMed

Broekman, Marike L; Carrière, Michelle E; Bredenoord, Annelien L

2016-06-01

The aim of the present article was to systematically review the ethics of surgical innovation and introduce the components of the learning health care system to guide future research and debate on surgical innovation.Although the call for evidence-based practice in surgery is increasingly high on the agenda, most surgeons feel that the format of the randomized controlled trial is not suitable for surgery. Innovation in surgery has aspects of, but should be distinguished from both research and clinical care and raises its own ethical challenges.To answer the question "What are the main ethical aspects of surgical innovation?", we systematically searched PubMed and Embase. Papers expressing an opinion, point of view, or position were included, that is, normative ethical papers.We included 59 studies discussing ethical aspects of surgical innovation. These studies discussed 4 major themes: oversight, informed consent, learning curve, and vulnerable patient groups. Although all papers addressed the ethical challenges raised by surgical innovation, surgeons hold no uniform view of surgical innovation, and there is no agreement on the distinction between innovation and research. Even though most agree to some sort of oversight, they offer different alternatives ranging from the formation of new surgical innovation committees to establishing national registries. Most agree that informed consent is necessary for innovative procedures and that surgeons should be adequately trained to assure their competence to tackle the learning curve problem. All papers agree that in case of vulnerable patients, alternatives must be found for the informed consent procedure.We suggest that the concept of the learning health care system might provide guidance for thinking about surgical innovation. The underlying rationale of the learning health care system is to improve the quality of health care by embedding research within clinical care. Two aspects of a learning health care system might particularly enrich the necessary future discussion on surgical innovation: integration of research and practice and a moral emphasis on "learning activities." Future research should evaluate whether the learning health care system and its adjacent moral framework provides ethical guidance for evidence-based surgery.

Testing with feedback improves recall of information in informed consent: A proof of concept study.

PubMed

Roberts, Katherine J; Revenson, Tracey A; Urken, Mark L; Fleszar, Sara; Cipollina, Rebecca; Rowe, Meghan E; Reis, Laura L Dos; Lepore, Stephen J

2016-08-01

This study investigates whether applying educational testing approaches to an informed consent video for a medical procedure can lead to greater recall of the information presented. Undergraduate students (n=120) were randomly assigned to watch a 20-min video on informed consent under one of three conditions: 1) tested using multiple-choice knowledge questions and provided with feedback on their answers after each 5-min segment; 2) tested with multiple choice knowledge questions but not provided feedback after each segment; or 3) watched the video without knowledge testing. Participants who were tested and provided feedback had significantly greater information recall compared to those who were tested but not provided feedback and to those not tested. The effect of condition was stronger for moderately difficult questions versus easy questions. Inserting knowledge tests and providing feedback about the responses at timed intervals in videos can be effective in improving recall of information. Providing informed consent information through a video not only standardizes the material, but using testing with feedback inserted within the video has the potential to increase recall and retention of this material. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Informed consent for innovative surgery: A survey of patients and surgeons

PubMed Central

Lee Char, Susan J.; Hills, Nancy K.; Lo, Bernard; Kirkwood, Kimberly S.

2012-01-01

Background Unlike new drugs and medical devices, most surgical procedures are developed outside clinical trials, without regulatory oversight. Surgical professional organizations have discussed how new procedures should be introduced into practice, without agreement on what topics informed consent discussions must include. To provide surgeons with more specific guidance, we wanted to determine what information patients and surgeons consider essential to disclose before an innovative surgical procedure. Methods 85 attending surgeons and 383 adult postoperative patients completed surveys. Using a 6-point Likert scale, participants rated the importance of discussing 16 types of information preoperatively for 3 techniques (standard open, laparoscopic, robotic) offered for a hypothetical partial hepatectomy. Results Compared with surgeons, patients placed more importance on nearly all types of information, particularly volumes and outcomes. For all 3 techniques, around 80% of patients indicated that they could not decide on surgery without being told whether it would be the surgeon’s first time doing the procedure. When considering an innovative robotic surgery, a clear majority of both patients and surgeons agreed that it was essential to disclose the procedure’s novel nature, potentially unknown risks and benefits, and whether it would be the surgeon’s first time performing the procedure. Conclusions To promote informed decision making and autonomy among patients considering innovative surgery, surgeons should disclose the procedure’s novel nature, potentially unknown risks and benefits, and whether the surgeon would be performing the procedure for the first time. When accurate volumes and outcomes data are available, surgeons should also discuss these with patients. PMID:23218878

49 CFR 209.209 - Hearing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 false Hearing. 209.209 Section 209.209 Transportation... TRANSPORTATION RAILROAD SAFETY ENFORCEMENT PROCEDURES Compliance Orders § 209.209 Hearing. (a) When a respondent... and the respondent fail to agree upon an acceptable consent order, the hearing officer designated by...

14 CFR 13.37 - Hearing Officer's powers.

Code of Federal Regulations, 2013 CFR

2013-01-01

....37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL... for the submission of evidence in written form; (e) Issue subpoenas and take depositions or cause them... hearing; (i) Hold conferences, before and during the hearing, to settle and simplify issues by consent of...

14 CFR 13.37 - Hearing Officer's powers.

Code of Federal Regulations, 2010 CFR

2010-01-01

....37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL... for the submission of evidence in written form; (e) Issue subpoenas and take depositions or cause them... hearing; (i) Hold conferences, before and during the hearing, to settle and simplify issues by consent of...

14 CFR 13.37 - Hearing Officer's powers.

Code of Federal Regulations, 2012 CFR

2012-01-01

....37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL... for the submission of evidence in written form; (e) Issue subpoenas and take depositions or cause them... hearing; (i) Hold conferences, before and during the hearing, to settle and simplify issues by consent of...

14 CFR 13.37 - Hearing Officer's powers.

Code of Federal Regulations, 2011 CFR

2011-01-01

....37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL... for the submission of evidence in written form; (e) Issue subpoenas and take depositions or cause them... hearing; (i) Hold conferences, before and during the hearing, to settle and simplify issues by consent of...

14 CFR 13.37 - Hearing Officer's powers.

Code of Federal Regulations, 2014 CFR

2014-01-01

....37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURAL... for the submission of evidence in written form; (e) Issue subpoenas and take depositions or cause them... hearing; (i) Hold conferences, before and during the hearing, to settle and simplify issues by consent of...

49 CFR 209.209 - Hearing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 4 2010-10-01 2010-10-01 false Hearing. 209.209 Section 209.209 Transportation... TRANSPORTATION RAILROAD SAFETY ENFORCEMENT PROCEDURES Compliance Orders § 209.209 Hearing. (a) When a respondent... and the respondent fail to agree upon an acceptable consent order, the hearing officer designated by...

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.

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness.

PubMed

Gobat, Nina H; Gal, Micaela; Francis, Nick A; Hood, Kerenza; Watkins, Angela; Turner, Jill; Moore, Ronald; Webb, Steve A R; Butler, Christopher C; Nichol, Alistair

2015-12-29

A rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research. We conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis. We screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented. Third-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes. CRD42014014000.

Recommendations of the Polish Gynecological Society concerning child sexual abuse.

PubMed

Skrzypulec, Violetta; Kotarski, Jan; Drosdzol, Agnieszka; Radowicki, Stanislaw

2010-01-01

The World Health Organisation defines child sexual abuse as the involvement of a child in sexual activity that he or she does not fully comprehend, is unable to give informed consent to, or for which the child is not developmentally prepared and cannot give consent, or that violates the laws or social taboos of society. Child sexual abuse is evidenced by this activity between a child and an adult or another child who by age or development is in a relationship of responsibility, trust or power, the activity being intended to gratify or satisfy the needs of the other person. It is estimated that in the world on average one in 3-4 women and one in 6-10 men were victims of sexual abuse in childhood. In Poland, according to the estimates of the Child's Rights Protection Committee, approximately 20% of girls and 5-6% of boys under the age of 15 years has suffered sexual abuse. In 2007 there was an increase in violence victims in all age categories, but the most alarming data concerned minors under 13 years. Girls fall victim to sexual abuse three times more frequently than boys. Sexual abuse of boys frequently involves violence. Data show that there are fewer women than men who execute such actions against a minor. Most victims (49-84%) know the perpetrator, and approximately 14-20% of acts of violence take place within the family. This article presents recommendations of the Polish Gynecological Society concerning procedures in cases of suspected sexual abuse of children.

Prediction of recidivism in extrafamilial child molesters based on court-related assessments.

PubMed

Firestone, P; Bradford, J M; McCoy, M; Greenberg, D M; Curry, S; Larose, M R

2000-07-01

One hundred ninety-two convicted extrafamilial child molesters were followed for an average of 7.8 years after their conviction. The percentage of men who had committed a sexual, a violent, or any criminal offense by the 12th year was 15.1, 20.3, and 41.6, respectively. The sexual recidivists, compared with the nonrecidivists; demonstrated more problems with alcohol and showed greater sexual arousal to assaultive stimuli involving children than to mutually consenting stimuli with children. The violent recidivists, compared with the nonrecidivists, were more likely to have a history of violence in the families in which they were raised and were rated significantly more psychopathic on the Psychopathy Checklist--Revised (PCL-R). They also showed more sexual arousal to stimuli depicting mutually consenting sexual interactions with children than to adult stimuli. In terms of any criminal recidivism, recidivists were younger, had completed fewer years of school, and were raised in psychologically more harmful family environments compared with nonrecidivists. They also reported that, before 16 years of age, they were more likely to have been physically abused and were more likely to have been removed from their homes compared to those that did not recidivate. In addition, recidivists demonstrated more general hostility on the Buss-Durkee Hostility Inventory and were rated significantly more psychopathic on the PCL-R. The phallometric assessments revealed, that the criminal recidivists, compared to the nonrecidivists, showed more sexual arousal to stimuli depicting coercive sexual activity with children than consenting sexual activities with children. In addition, they showed more sexual arousal to scenes depicting adult rape then adult mutually consenting sex. Finally, the recidivists also had more charges or convictions for violence and any criminal acts. The small number of significant differences between recidivists and nonrecidivists in the sexual and violent categories precluded an attempt to determine which combination of factors meaningfully predicted reoffending. However, for criminal recidivism, a stepwise discriminant function analysis to assess the combination of factors that most successfully distinguished between groups in terms of criminal recidivism was significant, with subjects' age, total number of criminal convictions, and pedophile assault index being retained for optimal prediction. The procedure correctly classified 70.6% of the original group, 82.8% of the nonrecidivists, and 52.6% of the recidivists. PCL-R Total Score alone was equally successful in a similar discriminant function.

Percutaneous endoscopic colostomy: a useful technique when surgery is not an option.

PubMed

Tun, Gloria; Bullas, Dominic; Bannaga, Ayman; Said, Elmuhtady M

2016-01-01

Percutaneous endoscopic colostomy (PEC) is a minimally invasive endoscopic procedure that offers an alternative treatment for high-risk patients with sigmoid volvulus or intestinal pseudo-obstruction who have tried conventional treatment options without success or those who are unfit for surgery. The procedure acts as an irrigation or decompressing channel and provides colonic 'fixation' to the anterior abdominal wall. The risk of complications highlights the importance of informed consent for patients and relatives.

Strengthening the Role of Families in States' Early Intervention Systems: Policy Guide to Procedural Safeguards for Infants and Toddlers and Their Families under Part H of the Education of the Handicapped Act.

ERIC Educational Resources Information Center

Burnim, Ira A.

This book presents recommended policies and procedural safeguards for programs serving infants, toddlers and their families under Part H of the Education of the Handicapped Act. Policies are presented in five chapters covering: (1) consent to assessment, evaluation and services; (2) notice of parents' rights and of proposed actions; (3) right to…

Use of Metallic Endosseous Implants as a Tooth Substitute.

DTIC Science & Technology

1979-06-01

exposed in the oral cavity and placed in function with the opposing dentition iBACKGROUND The development of a dental implant that will serve as a...contract year was spent in testing the dental implant as a single tooth replacement. The ultimate goal of this implant study was to develop a free-standing...to read and sign an informed consent form. SURGICAL PROCEDURES The dental implant was inserted into the edentulous area using the exact procedures as

Parental and youth understanding of the informed consent process for pediatric endoscopy.

PubMed

Jubbal, Kevin; Chun, Stanford; Chang, Jeremy; Zhang, Sherry; Terrones, Laura; Huang, Jeannie S

2015-06-01

Informed consent (IC) is an essential communication between patient/representative and physician that acknowledges patient autonomy; assent is the equivalent process performed between youth and physician. For clinical procedures involving youth, only the IC process between guardian/parent and physician is required to be performed. Nevertheless, experts recommend that youth undergo assent whenever possible. In the present study, we explored both parental and youth understanding of required IC elements in IC discussions before pediatric endoscopy. Following signing of IC documents on the day of endoscopy at a tertiary care academic medical center, youth and their parents underwent structured interviews to assess comprehension of key elements of the IC process. A total of 88 children and adolescents and their parents were evaluated. Two youth and 12 parents demonstrated comprehensive understanding of key IC elements for pediatric endoscopy. Suboptimal youth understanding was demonstrated for nature of the procedure (25% with adequate understanding) and related risks (17%), and alternatives (14%) to the procedure. Suboptimal parental understanding was demonstrated for procedure alternatives (24%). Youth overall understanding of IC varied by age, whereas parental global understanding of IC varied by physician. Understanding of IC performed for pediatric endoscopy could be improved in both parents and youth. Our findings suggest that interventions targeting parents, youth, and physicians may be helpful. Further study is needed to determine whether our findings are representative of IC understanding at other pediatric endoscopy centers.

48 CFR 1233.214 - Alternative dispute resolution (ADR).

Code of Federal Regulations, 2010 CFR

2010-10-01

... resolution (ADR). 1233.214 Section 1233.214 Federal Acquisition Regulations System DEPARTMENT OF... Alternative dispute resolution (ADR). (c) The Administrative Dispute Resolution Act (ADRA) of 1990, Public Law... purposes. ADR procedures may be used when: (1) There is mutual consent by the parties to participate in the...

48 CFR 1233.214 - Alternative dispute resolution (ADR).

Code of Federal Regulations, 2011 CFR

2011-10-01

... resolution (ADR). 1233.214 Section 1233.214 Federal Acquisition Regulations System DEPARTMENT OF... Alternative dispute resolution (ADR). (c) The Administrative Dispute Resolution Act (ADRA) of 1990, Public Law... purposes. ADR procedures may be used when: (1) There is mutual consent by the parties to participate in the...

Medical Decision-Making Among Elderly People in Long Term Care.

ERIC Educational Resources Information Center

Tymchuk, Alexander J.; And Others

1988-01-01

Presented informed consent information on high and low risk medical procedures to elderly persons in long term care facility in standard, simplified, or storybook format. Comprehension was significantly better for simplified and storybook formats. Ratings of decision-making ability approximated comprehension test results. Comprehension test…

18 CFR 358.7 - Transparency rule.

Code of Federal Regulations, 2010 CFR

2010-04-01

... information that was disclosed on its Internet Web site. (2) If a transmission provider discloses, in a manner... marketing function employees, the transmission provider must post notice on its Internet Web site of that..., in exchange for that voluntary consent. (d) Posting written procedures on the public Internet. A...

17 CFR 140.24 - Control and accountability procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the risk of compromise and reduce storage costs. (2) Top Secret documents, except for the controlled...) Records shall be maintained to show the number and distribution of reproduced copies to all Top Secret... the consent of the originator. (3) Unless restricted by the originating agency, Secret and...

29 CFR 1955.22 - Summary decision.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 9 2010-07-01 2010-07-01 false Summary decision. 1955.22 Section 1955.22 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) PROCEDURES FOR WITHDRAWAL OF APPROVAL OF STATE PLANS Consent Findings and Summary Decisions § 1955.22 Summary...

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.

Consent, competence and lies to children: veracity in paediatric care.

PubMed

McMurdo, Maeve; Gillett, Grant

2013-12-01

Principles of consent and autonomy based on adult-oriented bioethics must be modified to take account of the cognitive development occurring in childhood. That development differentially affects executive and more theoretical intelligence and is greatly influenced by experience. Thus, a judgment about a matter of degree is required by clinicians dealing with children, particularly when children diverge from the choices that would be endorsed by the adults and clinicians surrounding them. If we accept that partnership and the evolution of consent away from a formal procedure are both indicative of current ethical and medico-legal thinking, then it follows that the involvement of a child in an open-ended conversation taking account of the realistic prospects and the subjective experiences associated with treatment is the right way to proceed and that it should reflect the ability of the child to understand what is at stake and how it will affect her or him. That carries implications for the child's access to adequate information about the condition, the treatment, and the decisions being made.

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.

Progressive Consent and Specimen Accrual Models to Address Sustainability: A Decade's Experience at an Oregon Biorepository.

PubMed

Ost, John A; Newton, Paul W; Neilson, Duncan R; Cioffi, Joseph A; Wackym, P Ashley; Perkins, R Serene

2017-02-01

The Legacy Biorepository is a College of American Pathologists-accredited biorepository operating within a seven-hospital healthcare system, with a decade's experience in specimen accrual, storage, and distribution. While standardization of our practices through accreditation remains a priority, we along with others face challenges with regard to sustainability. Purposeful changes in our consent process, which we term "progressive consent," are expected to improve sustainability and operational flexibility while increasing our scientific impact. Until 2015, informed consent was performed primarily by biorepository staff at an estimated time of 1 hour per case. After a process improvement exercise, we successfully changed our informed consent process to a modified front-door model, with use of material and data for research as an opt-in or opt-out selection on the institutional patient informed consent form provided to surgery patients in the healthcare system. Successful implementation of this change required the engagement and participation of multiple stakeholders in healthcare system leadership, hospital administration, research, legal, regulatory, and patient care levels. A modified front-door consent enabled us to collect an additional 38 specimens in the first two quarters of 2016, with a time commitment of 15.75 hours, a time savings per specimen increasing in Q2 over Q1. We estimate a potential savings of 43 hours in 2016. This progressive model allowed us to maintain our frozen sample collection while increasing the availability of paraffin-embedded tissue and bodily fluids. Augmenting our tissue collection added little expense per case (approximately half that of each frozen tissue aliquot) and increased the range of biospecimens collected. Biorepository financial sustainability is a critical issue. Thorough evaluation and modification of existing procedures and collection models, as well as cost recovery initiatives, can translate into savings. Sustainability, process improvement, and scientific impact broadly overlap and continue to require operational critique and implementation of strategic changes.

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

PubMed

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

Do editorial policies support ethical research? A thematic text analysis of author instructions in psychiatry journals.

PubMed

Strech, Daniel; Metz, Courtney; Knüppel, Hannes

2014-01-01

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. 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. 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.

Parental decision making around perinatal autopsy: a qualitative investigation.

PubMed

Meaney, Sarah; Gallagher, Stephen; Lutomski, Jennifer E; O'Donoghue, Keelin

2015-12-01

Decades of decline in uptake rates of perinatal autopsies has limited investigation into the causes and risk factors for stillbirth. This study aimed to qualitatively explore perinatal autopsy decision-making processes in parents who experienced antepartum and intrapartum stillbirths. A qualitative semi-structured interview format was utilized. The line of questioning centred on how parents came to decide on consenting or declining to have a perinatal autopsy undertaken. Interpretative phenomenological analysis was employed as the analytic strategy. Purposive sampling was used to recruit 10 parents who either consented or declined autopsy from a large tertiary maternity hospital in Cork Ireland, where there were 30 stillbirths in 2011. Findings revealed four superordinate themes influencing parents' decision-making which varied with type of stillbirth experienced. Those parents who experienced antepartum stillbirths were more likely to consent; thus, knowing that the child was stillborn prior to delivery rather than on the day of delivery was associated with consent. In fact, these parents had more time for meaning-making; those consenting wanted to rule out self-blame and were fearful about future pregnancies. Parents who declined autopsy wanted to protect their infant from further harm. Interestingly, parents' knowledge and understanding of the autopsy itself were acquired primarily from public discourse. Parents' decision-making regarding autopsy is profoundly affected by their emotional response to stillbirth; clinicians and other health professionals may play a key role, especially if they can address parental concerns regarding the invasiveness of the autopsy procedure. © 2014 John Wiley & Sons Ltd.

77 FR 76072 - Notice of Extension to Public Comment Period for Remedial Design/Remedial Action Consent Decree...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-26

... activities, the RD/RA Consent Decree requires the Defendants to reimburse EPA for its oversight of work... Decree Library, U.S. DOJ--ENRD, P.O. Box 7611, Washington, DC 20044-7611. Please enclose a check or money...

HIV vaccine trials: critical issues in informed consent.

PubMed

Lindegger, G; Richter, L M

2000-06-01

Informed consent (IC), a fundamental principle of ethics in medical research, is recognized as a vital component of HIV vaccine trials. There are different notions of IC, some legally based and others based on ethics. It is argued that, though legal indemnity is necessary, vaccine trials should be founded on fully ethical considerations. Various contentious aspects of IC are examined, especially the problem of social desirability and of adequate comprehension. The need for sensitivity to cultural norms in implementing IC procedures is critically reviewed, and some of the potential conflict between ethos and ethics is considered. The transmission of information is examined as a particular aspect of IC in HIV vaccine trials.

75 FR 56472 - Amendments to Enforceable Consent Agreement Procedural Rules

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-16

... process that EPA is changing include when and how to initiate negotiations and inserting a firm deadline at which negotiations will terminate. EPA is also deleting, modifying, or consolidating several... Committee (ITC) provisions in a separate section, to make it clearer that there is one ECA negotiation...

The Hatch Amendment: A Primer for Counselors, Part II.

ERIC Educational Resources Information Center

Kaplan, Leslie S.; Geoffroy, Kevin

1987-01-01

Explores the legislative decisions concerning parental versus state control of education in light of the Hatch Amendment. Suggests ways for educators and counselors to deal with the amendment by recognizing limitations of the amendment, developing procedures for determining when written parental consent is required, and developing and publishing a…

75 FR 13208 - Proposed Collection; Comment Request for Revenue Procedure 2006-42

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-18

... to the Apportionment of Interest Expense, Research and Experimental Expenditures Under Section 1.861... Certain Elections Relating to the Apportionment of Interest Expense, Research and Experimental... automatic consent to change (a) from the fair market value method or from the alternative tax book method to...

5 CFR 1215.1 - Purpose and scope.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Purpose and scope. 1215.1 Section 1215.1 Administrative Personnel MERIT SYSTEMS PROTECTION BOARD ORGANIZATION AND PROCEDURES DEBT MANAGEMENT Salary Offset... the employee consents to recovery from his/her current pay account. (b) This regulation does not apply...

5 CFR 1215.1 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Purpose and scope. 1215.1 Section 1215.1 Administrative Personnel MERIT SYSTEMS PROTECTION BOARD ORGANIZATION AND PROCEDURES DEBT MANAGEMENT Salary Offset... the employee consents to recovery from his/her current pay account. (b) This regulation does not apply...

Research Ethics for Mental Health Science Involving Ethnic Minority Children and Youths.

ERIC Educational Resources Information Center

Fisher, Celia B.; Hoagwood, Kimberly; Boyce, Cheryl; Duster, Troy; Frank, Deborah A.; Grisso, Thomas; Levine, Robert J.; Macklin, Ruth; Spencer, Margaret Beale; Takanishi, Ruby; Trimble, Joseph E.; Zayas, Luis H.

2002-01-01

Summarizes key recommendations resulting from a meeting of national leaders in bioethics, multicultural research, and ethnic minority mental health. The recommendations focus on applying a cultural perspective to the evaluation of research risks and benefits; developing and implementing respectful informed consent procedures; developing and…

32 CFR 744.6 - Authorization for release without consent of the owner.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROCUREMENT, PROPERTY, PATENTS, AND CONTRACTS POLICIES AND PROCEDURES FOR THE PROTECTION OF PROPRIETARY RIGHTS IN TECHNICAL INFORMATION PROPOSED FOR RELEASE TO FOREIGN GOVERNMENTS § 744.6 Authorization for... foreign governments in accord with § 264.4(d)(3) without further legal authorization, provided such...

14 CFR 13.220 - Discovery.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Discovery. 13.220 Section 13.220... INVESTIGATIVE AND ENFORCEMENT PROCEDURES Rules of Practice in FAA Civil Penalty Actions § 13.220 Discovery. (a) Initiation of discovery. Any party may initiate discovery described in this section, without the consent or...

14 CFR 13.220 - Discovery.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Discovery. 13.220 Section 13.220... INVESTIGATIVE AND ENFORCEMENT PROCEDURES Rules of Practice in FAA Civil Penalty Actions § 13.220 Discovery. (a) Initiation of discovery. Any party may initiate discovery described in this section, without the consent or...

14 CFR 13.220 - Discovery.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Discovery. 13.220 Section 13.220... INVESTIGATIVE AND ENFORCEMENT PROCEDURES Rules of Practice in FAA Civil Penalty Actions § 13.220 Discovery. (a) Initiation of discovery. Any party may initiate discovery described in this section, without the consent or...

14 CFR 13.220 - Discovery.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Discovery. 13.220 Section 13.220... INVESTIGATIVE AND ENFORCEMENT PROCEDURES Rules of Practice in FAA Civil Penalty Actions § 13.220 Discovery. (a) Initiation of discovery. Any party may initiate discovery described in this section, without the consent or...

32 CFR 242a.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PUBLIC MEETING PROCEDURES OF THE BOARD OF REGENTS, UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES... of the Uniformed Services University of the Health Sciences as specified in Title 10, U.S. Code 2113... civilian life by the President, by and with the advice and consent of the Senate; (2) The Secretary of...

14 CFR 13.220 - Discovery.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Discovery. 13.220 Section 13.220... INVESTIGATIVE AND ENFORCEMENT PROCEDURES Rules of Practice in FAA Civil Penalty Actions § 13.220 Discovery. (a) Initiation of discovery. Any party may initiate discovery described in this section, without the consent or...

12 CFR 19.131 - Notice of charges and answer.

Code of Federal Regulations, 2010 CFR

2010-01-01

... PROCEDURE Disciplinary Proceedings Involving the Federal Securities Laws § 19.131 Notice of charges and... associated person. The notice must indicate the type of disciplinary action being contemplated and the... representative shall be deemed to have consented to the issuance of a disciplinary order. (b) All proceedings...

32 CFR 242a.2 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PUBLIC MEETING PROCEDURES OF THE BOARD OF REGENTS, UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES... of the Uniformed Services University of the Health Sciences as specified in Title 10, U.S. Code 2113... civilian life by the President, by and with the advice and consent of the Senate; (2) The Secretary of...

32 CFR 242a.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PUBLIC MEETING PROCEDURES OF THE BOARD OF REGENTS, UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES... of the Uniformed Services University of the Health Sciences as specified in Title 10, U.S. Code 2113... civilian life by the President, by and with the advice and consent of the Senate; (2) The Secretary of...

32 CFR 242a.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PUBLIC MEETING PROCEDURES OF THE BOARD OF REGENTS, UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES... of the Uniformed Services University of the Health Sciences as specified in Title 10, U.S. Code 2113... civilian life by the President, by and with the advice and consent of the Senate; (2) The Secretary of...

32 CFR 242a.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PUBLIC MEETING PROCEDURES OF THE BOARD OF REGENTS, UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES... of the Uniformed Services University of the Health Sciences as specified in Title 10, U.S. Code 2113... civilian life by the President, by and with the advice and consent of the Senate; (2) The Secretary of...

Parent Knowledge and Attitudes About School-Based Hepatitis B Immunization Programs.

ERIC Educational Resources Information Center

Middleman, Amy B.; Guajardo, Andrea D.; Sunwoo, Edward; Sansaricq, Kim M.

2002-01-01

Surveyed parents of students in the Houston Independent School District to determine preferences regarding immunization clinic site and preferred consent procedures for a Hepatitis B immunization program. Results indicated a significant lack of parent knowledge regarding the Hepatitis B virus. Demographic variables influenced parents' knowledge…

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2013 CFR

2013-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2012 CFR

2012-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

40 CFR 790.50 - Submission of study plans.

Code of Federal Regulations, 2014 CFR

2014-07-01

... no letter of intent to conduct the test had been submitted as described in § 790.45(e) and (f). (e... CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation, Enforcement, and Modification of Test Rules § 790.50 Submission of study plans. (a) Who must submit study...

50 CFR 11.23 - Hearings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... the right to a hearing and consent to the making of a decision on the record made at the hearing..., TRANSPORTATION, SALE, PURCHASE, BARTER, EXPORTATION, AND IMPORTATION OF WILDLIFE AND PLANTS CIVIL PROCEDURES... accorded by law and necessary to preside over the parties and the proceedings and to make decisions in...

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.

Percutaneous endoscopic colostomy: a useful technique when surgery is not an option

PubMed Central

Tun, Gloria; Bullas, Dominic; Bannaga, Ayman; Said, Elmuhtady M.

2016-01-01

Percutaneous endoscopic colostomy (PEC) is a minimally invasive endoscopic procedure that offers an alternative treatment for high-risk patients with sigmoid volvulus or intestinal pseudo-obstruction who have tried conventional treatment options without success or those who are unfit for surgery. The procedure acts as an irrigation or decompressing channel and provides colonic ‘fixation’ to the anterior abdominal wall. The risk of complications highlights the importance of informed consent for patients and relatives. PMID:27708513

Establishing and adhering to sexual consent: the association between reading magazines and college students' sexual consent negotiation.

PubMed

Hust, Stacey J T; Marett, Emily Garrigues; Ren, Chunbo; Adams, Paula M; Willoughby, Jessica F; Lei, Ming; Ran, Weina; Norman, Cassie

2014-01-01

Content analyses have cataloged the sexual scripts present in magazines largely because of their perceived value to readers and their potential role as sex educators. Although it is generally agreed that magazines have the potential to influence sexual attitudes and behavioral intentions, the effects of this medium are not as frequently researched as are other forms of media. The current study tested whether exposure to magazines was associated with intentions related to sexual consent negotiation. A survey of 313 college students indicated that exposure to men's magazines was significantly associated with lower intentions to seek sexual consent and lower intentions to adhere to decisions about sexual consent. In contrast, exposure to women's magazines was significantly associated with greater intentions to refuse unwanted sexual activity. Overall, the findings of this study further reinforce the critical need for responsible and realistic portrayals of sex in entertainment media, specifically magazines.

From the operating room to the courtroom: a comprehensive characterization of litigation related to facial plastic surgery procedures.

PubMed

Svider, Peter F; Keeley, Brieze R; Zumba, Osvaldo; Mauro, Andrew C; Setzen, Michael; Eloy, Jean Anderson

2013-08-01

Malpractice litigation has increased in recent decades, contributing to higher health-care costs. Characterization of complications leading to litigation is of special interest to practitioners of facial plastic surgery procedures because of the higher proportion of elective cases relative to other subspecialties. In this analysis, we comprehensively examine malpractice litigation in facial plastic surgery procedures and characterize factors important in determining legal responsibility, as this information may be of great interest and use to practitioners in several specialties. Retrospective analysis. The Westlaw legal database was examined for court records pertaining to facial plastic surgery procedures. The term "medical malpractice" was searched in combination with numerous procedures obtained from the American Academy of Facial Plastic and Reconstructive Surgery website. Of the 88 cases included, 62.5% were decided in the physician's favor, 9.1% were resolved with an out-of-court settlement, and 28.4% ended in a jury awarding damages for malpractice. The mean settlement was $577,437 and mean jury award was $352,341. The most litigated procedures were blepharoplasties and rhinoplasties. Alleged lack of informed consent was noted in 38.6% of cases; other common complaints were excessive scarring/disfigurement, functional considerations, and postoperative pain. This analysis characterized factors in determining legal responsibility in facial plastic surgery cases. Several factors were identified as potential targets for minimizing liability. Informed consent was the most reported entity in these malpractice suits. This finding emphasizes the importance of open communication between physicians and their patients regarding expectations as well as documentation of specific risks, benefits, and alternatives. © 2013 The American Laryngological, Rhinological, and Otological Society, Inc.

Professional liability in orthopaedics and traumatology in Italy.

PubMed

Tarantino, Umberto; Giai Via, Alessio; Macrì, Ernesto; Eramo, Alessandro; Marino, Valeria; Marsella, Luigi Tonino

2013-10-01

Interest in medical errors has increased during the last few years owing to the number of medical malpractice claims. Reasons for the increasing number of claims may be related to patients' higher expectations, iatrogenic injury, and the growth of the legal services industry. Claims analysis provides helpful information in specialties in which a higher number of errors occur, highlighting areas where orthopaedic care might be improved. We determined: (1) the number of claims involving orthopaedics and traumatology in Rome; (2) the risk of litigation in elective and trauma surgery; (3) the most common surgical procedures involved in claims and indemnity payments; (4) the time between the adverse medical event and the judgment date; and (5) issues related to informed consent. We analyzed 1925 malpractice judgments decided in the Civil Court of Rome between 2004 and 2010. In total, 243 orthopaedics claims were filed, and in 75% of these cases surgeons were found liable; 149 (61%) of these resulted from elective surgery. Surgical teams were sued in 30 claims and found liable in 22. The total indemnity payment ordered was more than €12,350,000 (USD 16,190,000). THA and spinal surgery were the most common surgical procedures involved. Inadequate informed consent was reported in 5.3% of cases. Our study shows that careful medical examination, accurate documentation in medical records, and adequate informed consent might reduce the number of claims. We suggest monitoring of court judgments would be useful to develop prevention strategies to reduce claims.

Age of Legal Capacity (Scotland) Act 1991. [Excerpt. 25 July 1991].

PubMed

1991-01-01

Section 1 of this Act provides as a general rule that persons under the age of 16 shall have no legal capacity to enter into transactions, but that persons over the age of 16 shall have such legal capacity. Section 1 also provides that this general rule does not apply to cases involving transactions entered into before the commencement of the Act, does not affect the criminal responsibility of any person or legislation in which specific ages are stipulated, and does not prevent a person under age 16 from receiving or holding any right, title, or interest or exercising parental rights with respect to his or her child. Section 2 makes further exceptions to this rule for persons under the age of 16 with respect to reasonable transactions commonly entered into by children, making a will, consenting to adoption, and consenting to medical treatment. Among other things, it provides that "a person under the age of 16 years shall have legal capacity to consent on his own behalf to any surgical, medical, or dental procedure or treatment where, in the opinion of a qualified medical practitioner attending him, he is capable of understanding the nature and possible consequences of the procedure or treatment." Further provisions of the Act authorize a court to set aside transactions made by a person between the ages of 16 and 18 that are prejudicial transactions (Section 3) and to ratify proposed transactions by persons of the same age (Section 4). This Act is applicable only to Scotland.

[Introduction of an accreditation system for hospital informed consent forms].

PubMed

López-Picazo, J J; Tomás-Garcia, N; Calle-Urra, J E; Parra-Hidalgo, P; Valverde-Iniesta, J J

2015-01-01

To describe an accreditation system for informed consent forms (ICF) in a tertiary hospital, as an intervention to improve their quality, and to check the improvements achieved. Following an external evaluation of the ICF quality in a public hospital in Murcia (Spain), an accreditation committee set the ICF requirements and associated procedures. Effectiveness is assessed by comparing two external evaluations carried out by the EMCA Program (2011 and 2013) and based on 19 criteria and a sample of 60 ICF for every public hospital in Murcia Region. To be accredited, every ICF must meet the 19 external criteria plus 5 based on legibility, readability and scientific and technical validity. A form to fill in the contents of every ICF was agreed, which would be reviewed, approved and validated for five years. Before the implementation, 8.2 defects/ICF were detected. The accreditation system obtained an 89% improvement (0.9 defects/ICF) and achieved significant improvements in 18 criteria, 16 of which are benchmarked. The accreditation system achieved a substantial improvement in the ICF (obtaining a better result in external evaluations) and guarantees their contents, legibility and readability. This system needs to be extended to other hospitals, since it is not clear whether common ICFs would be suitable. However, this improvement is structural and does not guarantee that the overall information/consent procedure is done properly, thus complementary strategies for measurement and improvement are required. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

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

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...

75 FR 27781 - Agency Information Collection Activities: Proposed Collection Renewals; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... respondent burden, invites the general public and other Federal agencies to take this opportunity to comment... information titled: Application For Consent to Exercise Trust Powers (3064-0025), and Insurance Sales Consumer...: 1. Title: Application for Consent to Exercise Trust Powers. OMB Number: 3064-0025. Form Number: FDIC...

Moral conflict and competing duties in the initiation of a biomedical HIV prevention trial with minor adolescents.

PubMed

Knopf, Amelia S; Gilbert, Amy Lewis; Zimet, Gregory D; Kapogiannis, Bill G; Hosek, Sybil G; Fortenberry, J Dennis; Ott, Mary A

2017-01-01

Biomedical HIV prevention research with minors is complicated by the requirement of parental consent, which may disclose sensitive information to parents. We examine the experience of principal investigators (PIs) and study personnel who faced this complex ethical issue in the first biomedical HIV prevention study that allowed minors to self-consent for enrollment. We conducted in-depth interviews with PIs and study personnel from 13 medical trial sites in cities across the United States. Data were analyzed using a conventional content analysis. Participants experienced moral conflict as they struggled to fulfill conflicting duties in this trial involving minor adolescents with multiple vulnerabilities. Our participants experienced conflict between the two types of duties-protective and scientific-previously identified by Merritt. Protective duties were owed to the child, the parents, and the institution, and participants expressed tension between the actions that would protect these subgroups and the actions necessary to fulfill their scientific duties. Moral conflict was resolved in a variety of ways, including reflecting on the protocol's alignment with federal regulations, modifying consent language, considering each individual for enrollment carefully, and accepting institutional review board (IRB) decisions. Potential solutions for future studies are discussed, and include flexible protocol consent procedures and centralized IRB reviews.

A study of warning letters issued to clinical investigators and institutional review boards by the United States Food and Drug Administration.

PubMed

Gogtay, N J; Doshi, B M; Kannan, S; Thatte, U

2011-01-01

Warning letters (WLs) issued by the US FDA (United States Food and Drug Administration) mention the nature of violations by clinical investigators and institutional review boards (IRBS) and can help as training tools. WLs issued by the US FDA between January 2005 and December 2010 to clinical investigators and IRBs were reviewed for various violation themes. A total of 129 WLs were issued to investigators and 40 to IRBs. Among the WLs issued to investigators, 67 (51.95%) were issued for drug-related research and 62 (48.06%) were for device-related research. For investigators, deviation from the investigational plan was the most common violation (81%) followed by failure to maintain accurate and adequate case histories (58.1%) and then informed consent issues (48.06%). Among WLs issued to IRBs, failure to have and follow standard operating procedures (SOPs) was seen in 93.89% followed by issues pertaining to membership (59.4%). When compared to a similar study published in 2004, for clinical investigators, no improvement was seen with respect to deviation from the investigational plan and study supervision. However, a significant improvement was seen in reporting of adverse events to IRBs, and some improvement was seen in the area of informed consent. For IRBs, no improvement was seen in most areas which included maintaining and following SOPs, membership, quorum requirements, misuse of expedited review and informed consent. WLs serve as indicators of an active regulatory agency which should translate into greater safety for participants in clinical trials. For developing countries with weak regulatory systems, these can serve as useful learning tools to help improve systems and put in patient safeguards.

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.

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.

Mental competence and surrogate decision-making towards the end of life.

PubMed

Strätling, M; Scharf, V E; Schmucker, P

2004-01-01

German legislation demands that decisions about the treatment of mentally incompetent patients require an 'informed consent'. If this was not given by the patient him-/herself before he/she became incompetent, it has to be sought by the physician from a guardian, who has to be formally legitimized before. Additionally this surrogate has to seek the permission of a Court of Guardianship (Vormundschaftsgericht), if he/she intends to consent to interventions, which pose significant risks to the health or the life of the person under his/her care. This includes 'end-of-life decisions'. Deviations from this procedure are only allowed in acute emergencies or cases of 'medical futility'. On the basis of epidemiological and demographical data it can be shown that the vast majority of surrogate decisions on incompetent patients in Germany is not covered by legally valid consent. Moreover, the data suggests that if consent were to be requested according to the legal regulations, both the legal and medical system could realistically never cope with the practical consequences of this. Additionally, empiric research has revealed serious deficits concerning medical 'end of life-decisions' and practical performance in palliative care. As a consequence a multidisciplinary discussion has developed in Germany about the reform of present legislation with respect to key-issues like the assessment of mental competence, the options for exercising patient self-determination via advance directives and durable powers of attorney, the improvement of palliative care facilities, the clarification of formal procedures for surrogate decision-making in health care and towards the end of life and the possibilities and their limitations of controlling these decision-making processes 'externally' (e.g., by Guardianship Courts or committees). The authors discuss those proposals, which clearly dominate the present debate: They all aim to comply with the scientific basis of German law, jurisdiction and the European traditions of philosophy of health care and bioethics.

32 CFR 644.117 - Procedure prior to trial.

Code of Federal Regulations, 2010 CFR

2010-07-01

... personnel without the knowledge and consent of the United States Attorney. If the property owner is... proceeding, it is desirable to settle by stipulation, or to go to trial, on the “unit” basis. Many United... that the Corps has full knowledge of the appraisal reports on which settlement negotiations or trial...

Approval Procedures and Passive Consent Considerations in Research among Young People

ERIC Educational Resources Information Center

de Meyrick, Julian

2005-01-01

Purpose: The intention of this paper is to encourage debate among ethical researchers on this very important issue. Research necessary to underpin health education and health promotion is often controversial and often involves vulnerable populations such as young people and children. It is essential that the rights of these respondents are…

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 33 2012-07-01 2012-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 33 2013-07-01 2013-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

40 CFR 790.55 - Modification of test standards or schedules during conduct of test.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 32 2014-07-01 2014-07-01 false Modification of test standards or schedules during conduct of test. 790.55 Section 790.55 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROCEDURES GOVERNING TESTING CONSENT AGREEMENTS AND TEST RULES Implementation,...

25 CFR 226.9 - Rental and drilling obligations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false Rental and drilling obligations. 226.9 Section 226.9... RESERVATION LANDS FOR OIL AND GAS MINING Leasing Procedure, Rental and Royalty § 226.9 Rental and drilling... in the lease terms, or 12 months from the date the Superintendent consents to drilling on any...

25 CFR 226.9 - Rental and drilling obligations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 1 2012-04-01 2011-04-01 true Rental and drilling obligations. 226.9 Section 226.9... RESERVATION LANDS FOR OIL AND GAS MINING Leasing Procedure, Rental and Royalty § 226.9 Rental and drilling... in the lease terms, or 12 months from the date the Superintendent consents to drilling on any...

25 CFR 226.9 - Rental and drilling obligations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false Rental and drilling obligations. 226.9 Section 226.9... RESERVATION LANDS FOR OIL AND GAS MINING Leasing Procedure, Rental and Royalty § 226.9 Rental and drilling... in the lease terms, or 12 months from the date the Superintendent consents to drilling on any...

Practical Guidelines for Health Care Management in Secondary School Athletics.

ERIC Educational Resources Information Center

Laire, Dean E.

1981-01-01

Offers advice to schools that need to provide adequate health care for student athletes without benefit of a certified athletic trainer. Covers written policy concerning athletic trauma, maintenance of playing fields, medical records and consent forms, and equipment needed for injury prevention and care. Includes samples of forms and procedures.…

39 CFR 952.12 - Amendment of pleadings.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Postal Service UNITED STATES POSTAL SERVICE PROCEDURES RULES OF PRACTICE IN PROCEEDINGS RELATIVE TO FALSE... with the presiding officer. (b) By consent of the parties a pleading may be amended at any time. Also, a party may move to amend a pleading at any time prior to the close of the hearing and, provided...

39 CFR 959.11 - Amendment of pleadings.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Postal Service UNITED STATES POSTAL SERVICE PROCEDURES RULES OF PRACTICE IN PROCEEDINGS RELATIVE TO THE... officer. (b) By consent of the parties, a pleading may be amended at any time. Also, a party may move to amend a pleading at any time prior to the close of the hearing and, provided that the amendment is...

49 CFR 1503.657 - Appeal from initial decision.

Code of Federal Regulations, 2010 CFR

2010-10-01

... AND ENFORCEMENT PROCEDURES Rules of Practice in TSA Civil Penalty Actions § 1503.657 Appeal from... order of the TSA decision maker have been entered on the record. (b) Issues on appeal. A party may... appeal with the consent of the TSA decision maker. If the TSA decision maker grants an extension of time...

12 CFR 313.49 - Coordinating salary offset with other agencies.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Coordinating salary offset with other agencies... PRACTICE PROCEDURES FOR CORPORATE DEBT COLLECTION Salary Offset § 313.49 Coordinating salary offset with... employee has consented to the salary offset in writing or has signed a statement acknowledging receipt of...

16 CFR 1605.13 - Procedures for Consent Order Agreements.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... 1605.13 Section 1605.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT... including any rights to seek judicial review or otherwise challenge or contest the validity of the....), the Flammable Fabrics Act (15 U.S.C. 1191 et seq.), and the Consumer Product Safety Act (15 U.S.C...

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...

77 FR 71713 - Policies To Promote Rural Radio Service and To Streamline Allotment and Assignment Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

...: Control Number: 3060-0031. Title: Application for Consent to Assignment of Broadcast Station Construction... Station Construction Permit or License, FCC Form 315; Section 73.3580, Local Public Notice of Filing of... construction permits designed primarily to serve Tribal Lands (the ``Tribal Priority''). Tribal affiliated...

40 CFR 24.02 - Issuance of initial orders; definition of final orders and orders on consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROTECTION AGENCY GENERAL RULES GOVERNING ISSUANCE OF AND ADMINISTRATIVE HEARINGS ON INTERIM STATUS... following a final decision by the Regional Administrator, or after thirty days from issuance if no hearing... in these procedures to the Regional Administrator shall be understood to be to the Assistant...

38 CFR 17.32 - Informed consent and advance care planning.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2013-07-01 2013-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

38 CFR 17.32 - Informed consent and advance care planning.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2014-07-01 2014-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

38 CFR 17.32 - Informed consent and advance care planning.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2012-07-01 2012-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

38 CFR 17.32 - Informed consent and advance care planning.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2010-07-01 2010-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...

38 CFR 17.32 - Informed consent and advance care planning.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 38 Pensions, Bonuses, and Veterans' Relief 1 2011-07-01 2011-07-01 false Informed consent and... patient's activities, health, religious beliefs and values, and who has presented a signed written...) [62 FR 53961, Oct. 17, 1997, as amended at 70 FR 71774, Nov. 30, 2005; 71 FR 68740, Nov. 28, 2006; 72...