Disclosure of HIV status on informed consent forms presents an ethical dilemma for protection of human subjects.

PubMed

Gray, Ronald H; Sewankambo, Nelson K; Wawer, Maria J; Serwadda, David; Kiwanuka, Noah; Lutalo, Tom

2006-02-01

The privacy of copies of consent forms provided to research participants cannot be guaranteed. Therefore, consent forms that disclose a subject's HIV status may result in breach of confidentiality and cause social harms. Under the ethical principle of beneficence defined in the Belmont Report, we recommend that disclosure of HIV status be through voluntary counseling and testing; however, whenever possible, copies of consent form should not specify HIV status.

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.

Comprehensibility of patient consent forms for radiation therapy of cervical cancer.

PubMed

MacDougall, Deborah Skinner; Connor, Ulla M; Johnstone, Peter A S

2012-06-01

The construct of Health Literacy (HL) deals with patients' capacity to understand their health-related instructions, consent forms, and other documents. A significant challenge of providing healthcare to patients with low HL is the complex nature of the disease process, and of requisite treatments. In radiation oncology specifically, the delivery of ionizing radiation is difficult enough to describe; describing radiation toxicity in terms of the underlying physics and biology is daunting. A multimodal analysis of a small sample of patient consent forms was undertaken in order to address this issue more closely, and identify the extent to which such literature contributes to the challenges faced by patients with low HL. Members of national cooperative group panels dealing with gynecologic cancer were asked to submit copies of consent forms provided to patients with stage II cervical cancer. Four such forms were submitted and reviewed by a single person with expertise in linguistics using standard tools. Three of the four consents scored within the lower portion of the "adequate" range. One consent was not suitable. Consent readability ranged from grades 12.18 to 16.13; this means that they required at least a high school education to interpret, and in two cases required post-graduate coursework. There is significant room for improvement in consent form design and structure. When considering cultural and socioeconomic appropriateness of patient consent forms, input of staff with expertise in linguistics should be sought. Copyright © 2012 Elsevier Inc. All rights reserved.

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

PubMed Central

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

2016-01-01

Abstract Background Surgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion. Methods This prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed. Results Comparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension. Conclusions Simplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding. PMID:28352847

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

PubMed

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

2016-01-01

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

A Randomized Controlled Trial of Short and Standard-Length Consent Forms for a Genetic Cohort Study: Is Longer Better?

PubMed Central

Matsui, Kenji; Lie, Reidar K.; Turin, Tanvir C.; Kita, Yoshikuni

2012-01-01

Background Although the amount of detail in informed consent documents has increased over time and the documents have therefore become very long, there is little research on whether longer informed consent documents actually result in (1) better informed research subjects or (2) higher consent rates. We therefore conducted an add-on randomized controlled trial to the Takashima Study, a prospective Japanese population-based genetic cohort study, to test the hypothesis that a shorter informed consent form would satisfy both of the above goals. Methods Standard (10 459 words, 11 pages) and short (3602 words, 5 pages) consent forms in Japanese were developed and distributed using cluster-randomization to 293 potential cohort subjects living in 9 medico-social units and 288 subjects in 8 medico-social units, respectively. Results Few differences were found between the 2 groups with regard to outcome measures, including participants’ self-perceived understanding, recall of information, concerns, voluntariness, trust, satisfaction, sense of duty, and consent rates. Conclusions A short informed consent form was no less valid than a standard form with regard to fulfilling ethical requirements and securing the scientific validity of research. PMID:22447213

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 …

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.

17 CFR 249.509 - Form 9-M, consent to service of process by a partnership nonresident broker-dealer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Form 9-M, consent to service... Forms for Statements Made in Connection With Exempt Tender Offers § 249.509 Form 9-M, consent to service...: For Federal Register citations affecting Form 9-M, see the List of CFR Sections Affected, which...

17 CFR 249.507 - Form 7-M, consent to service of process by an individual nonresident broker-dealer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Form 7-M, consent to service... Forms for Statements Made in Connection With Exempt Tender Offers § 249.507 Form 7-M, consent to service... Federal Register citations affecting Form 7-M, see the List of CFR Sections Affected, which appears in the...

Continuing review of ethics in clinical trials: a surveillance study in Iran

PubMed Central

Mohamadi, Amin; Asghari, Fariba; Rashidian, Arash

2014-01-01

In recent years, notable measures have been taken to protect the rights of participants in biomedical research in Iran. The present study examines possible trends in adherence to ethical codes regarding informed consent after the development of the National Code of Ethics in Biomedical Research (NCEBR) and establishment of research ethics committees. In this retrospective study, 126 dissertations from Tehran University of Medical Sciences were evaluated for adherence to ethical codes. These dissertations were all in clinical trial design and had been presented in the years 1999 and 2009, that is, precisely before and after the development of the NCEBR. A checklist was developed to evaluate the ethical issues associated with informed consent. A single investigator retrieved and evaluated the consent forms from the dissertations. Borderline cases were discussed with other investigators to reach a consensus decision. Based on the checklist, the Standardized Ethical Score (SES) was calculated for each consent form. The mean SES and the rate of consent form attachment were compared between the two years. In total, 70 dissertations had reported obtaining informed consent from study participants, whereas consent forms were attached in only 22 dissertations (17.50%). The percentage of dissertations with the consent form attached increased over time from 12.2% in 1999 to 20.8% in 2009 (P > 0.05), but the majority still did not include a consent form. Moreover, the mean SES of consent forms was significantly higher in 1999 (0.746) than in 2009 (0.428), highlighting the need for more training of researchers and improved surveillance by the ethics committees. A great amount of effort is still needed to make the consent process more ethical, especially for dissertations as a less visible part of academic research. As for students, more systematic training focused on research ethics should be implemented prior to thesis submission. PMID:26587202

42 CFR 2.31 - Form of written consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Form of written consent. 2.31 Section 2.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS Disclosures With Patient's Consent § 2.31 Form of written...

42 CFR 2.31 - Form of written consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Form of written consent. 2.31 Section 2.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS Disclosures With Patient's Consent § 2.31 Form of written...

42 CFR 2.31 - Form of written consent.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Form of written consent. 2.31 Section 2.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS Disclosures With Patient's Consent § 2.31 Form of written...

42 CFR 2.31 - Form of written consent.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Form of written consent. 2.31 Section 2.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS Disclosures With Patient's Consent § 2.31 Form of written...

42 CFR 2.31 - Form of written consent.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Form of written consent. 2.31 Section 2.31 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS Disclosures With Patient's Consent § 2.31 Form of written...

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.

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-01-01

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

17 CFR 249.507 - Form 7-M, consent to service of process by an individual nonresident broker-dealer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 7-M, consent to service of process by an individual nonresident broker-dealer. 249.507 Section 249.507 Commodity and... Forms for Statements Made in Connection With Exempt Tender Offers § 249.507 Form 7-M, consent to service...

17 CFR 249.509 - Form 9-M, consent to service of process by a partnership nonresident broker-dealer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 9-M, consent to service of process by a partnership nonresident broker-dealer. 249.509 Section 249.509 Commodity and... Forms for Statements Made in Connection With Exempt Tender Offers § 249.509 Form 9-M, consent to service...

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.

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

Emerging issues in paediatric health research consent forms in Canada: working towards best practices.

PubMed

Dove, Edward S; Avard, Denise; Black, Lee; Knoppers, Bartha M

2013-01-30

Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child's assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child's psychological and social perspective; (3) whether a child's ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child's perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics.

A written consent form dating back to 1524 in Bursa Ser'iye (Sharia Court) records and a proposal of a new start date for consent forms.

PubMed

Sayligil, Omur; Ozden, Hilmi

2014-01-01

Qadi registers are important documents for Ottoman medical history re.search. "Sharia Court Records (Ser'iyye Sicilleri)" are notebooks that include the records that qadis kept with regard to their decisions and deeds. These registers are the only authentic sources from which to acquire information on rural life, away from the center of the town, and to understand the daily practices of the Ottoman society. The objective of this study is to provide evidence for the fact that the concept of informed consent on medical interventions, and hence the written consent documents arranged between patients and physicians, dates back to older times in our history when compared to the Western world. A large number of Ser'iyye (Sharia Court) record originals have been surveyed. The consent form registered as A-40. 221a in Ser'iyye (Sharia Court) Records found in Bursa has been presented here as the earliest consent document found by the authors. Transcription of the original document has been performed and analyzed. The aforementioned consent form dates back to 26/Dhu al-Qi'dah/933 (August 24, 1524). The original version of the referenced consent document is the earliest consent document presented so far to the best of the authors' knowledge; it was found in Bursa Ser'iyye Records and evaluated accordingly. Based on the document, it is argued that the history of consent forms dates back about 500 years. Obtaining consent in scientific research from human beings was considered to have originated from the Nuremberg Code (1949). However, with this study, it has been shown that the concept of informed consent was already present in the Ottoman Period, during the 16th century, and that the original consent document dates back to 1524, pertaining to a surgical intervention.

Rhetoric or reality: what is the legal status of the consent form in health-related research?

PubMed

Laurie, Graeme; Postan, Emily

2013-01-01

This article addresses the unresolved conundrum of the legal status of consent forms used in research involving tissue samples or personal data. It identifies which rights participants might have by virtue of any consent form they have signed and which legal remedies might be available to them should the research depart from the terms of the original consent. The paper demonstrates that, although the legal status of consent forms is not clear in the UK, the landscape is evolving. We suggest that the growing legal protection afforded to autonomy and judicial recognition of individual property rights in tissues may offer opportunities for remedies in law where the regulatory regimes controlling uses of human tissue and personal data do not. However, we argue that in the governance of research relationships-which depend crucially on trust-resort to legal remedy may be undesirable. We suggest that treating consent as a one-off event that can be effectively captured in a written document-as the law tends to do-is an inappropriate and counter-productive approach. The aims of ethical research governance will be better served by seeing consent as continuing relational process, requiring on-going mutual respect, opportunity for communication, and accommodation of changing circumstances. The consent form is merely a framing instrument and only the starting point for a partnership that will evolve over time. Crucially, the limits of consent must be recognised in the design and governance of modern research practices. The article concludes with recommendations to reconceive consent in these terms.

RHETORIC OR REALITY: WHAT IS THE LEGAL STATUS OF THE CONSENT FORM IN HEALTH-RELATED RESEARCH?*

PubMed Central

Laurie, Graeme; Postan, Emily

2013-01-01

This article addresses the unresolved conundrum of the legal status of consent forms used in research involving tissue samples or personal data. It identifies which rights participants might have by virtue of any consent form they have signed and which legal remedies might be available to them should the research depart from the terms of the original consent. The paper demonstrates that, although the legal status of consent forms is not clear in the UK, the landscape is evolving. We suggest that the growing legal protection afforded to autonomy and judicial recognition of individual property rights in tissues may offer opportunities for remedies in law where the regulatory regimes controlling uses of human tissue and personal data do not. However, we argue that in the governance of research relationships—which depend crucially on trust—resort to legal remedy may be undesirable. We suggest that treating consent as a one-off event that can be effectively captured in a written document—as the law tends to do—is an inappropriate and counter-productive approach. The aims of ethical research governance will be better served by seeing consent as continuing relational process, requiring on-going mutual respect, opportunity for communication, and accommodation of changing circumstances. The consent form is merely a framing instrument and only the starting point for a partnership that will evolve over time. Crucially, the limits of consent must be recognised in the design and governance of modern research practices. The article concludes with recommendations to reconceive consent in these terms. PMID:23055572

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.

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

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

PubMed

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

2018-01-01

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

Work efficiency improvement of >90% after implementation of an annual inpatient blood products administration consent form

PubMed Central

Lindsay, Holly; Bhar, Saleh; Bonifant, Challice; Sartain, Sarah; Whittle, Sarah B.; Lee-Kim, Youngna; Shah, Mona D.

2018-01-01

Paediatric haematology, oncology and bone marrow transplant (BMT) patients frequently require transfusion of blood products. Our institution required a new transfusion consent be obtained every admission. The objectives of this project were to: revise inpatient blood products consent form to be valid for 1 year, decrease provider time spent consenting from 15 to <5 min per admission, and improve provider frustration with the consent process. Over 6 months, we determined the average number of hospitalisations requiring transfusions in a random sampling of haematology/oncology/BMT inpatients. We surveyed nurses and providers regarding frustration levels and contact required regarding consents. Four and 12 months after implementation of the annual consent, providers and nurses were resurveyed, and new inpatient cohorts were assessed. Comparison of preintervention and postintervention time data allowed calculation of provider time reduction, a surrogate measure of improved work efficiency. Prior to the annual consent, >33 hours were spent over 6 months obtaining consent on 40 patients, with >19 hours spent obtaining consent when no transfusions were administered during admission. Twelve months after annual consent implementation, 97.5% (39/40) of analysed patients had a completed annual blood products transfusion consent and provider work efficiency had improved by 94.6% (>30 hours). Although several surveyed variables improved following annual consent implementation, provider frustration with consent process remained 6 out of a max score of 10, the same level as prior to the intervention. Development of an annual inpatient blood products consent form decreased provider time from 15 to <1 min per admission, decreased consenting numbers and increased work efficiency by >90%. PMID:29333497

Work efficiency improvement of >90% after implementation of an annual inpatient blood products administration consent form.

PubMed

Lindsay, Holly; Bhar, Saleh; Bonifant, Challice; Sartain, Sarah; Whittle, Sarah B; Lee-Kim, Youngna; Shah, Mona D

2018-01-01

Paediatric haematology, oncology and bone marrow transplant (BMT) patients frequently require transfusion of blood products. Our institution required a new transfusion consent be obtained every admission. The objectives of this project were to: revise inpatient blood products consent form to be valid for 1 year, decrease provider time spent consenting from 15 to <5 min per admission, and improve provider frustration with the consent process. Over 6 months, we determined the average number of hospitalisations requiring transfusions in a random sampling of haematology/oncology/BMT inpatients. We surveyed nurses and providers regarding frustration levels and contact required regarding consents. Four and 12 months after implementation of the annual consent, providers and nurses were resurveyed, and new inpatient cohorts were assessed. Comparison of preintervention and postintervention time data allowed calculation of provider time reduction, a surrogate measure of improved work efficiency. Prior to the annual consent, >33 hours were spent over 6 months obtaining consent on 40 patients, with >19 hours spent obtaining consent when no transfusions were administered during admission. Twelve months after annual consent implementation, 97.5% (39/40) of analysed patients had a completed annual blood products transfusion consent and provider work efficiency had improved by 94.6% (>30 hours). Although several surveyed variables improved following annual consent implementation, provider frustration with consent process remained 6 out of a max score of 10, the same level as prior to the intervention. Development of an annual inpatient blood products consent form decreased provider time from 15 to <1 min per admission, decreased consenting numbers and increased work efficiency by >90%.

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

PubMed Central

2011-01-01

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

Emerging issues in paediatric health research consent forms in Canada: working towards best practices

PubMed Central

2013-01-01

Background Obtaining a research participant’s voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008–2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child’s assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child’s psychological and social perspective; (3) whether a child’s ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child’s perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed. Results The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study. Conclusions The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics. PMID:23363554

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

PubMed

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

2017-12-01

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

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

PubMed

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

2015-01-01

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

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

PubMed Central

Madeira, Jody Lyneé; Andraka-Christou, Barbara

2016-01-01

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

46 CFR Exhibit No. 2 to Subpart S... - Respondent's Consent Form for Informal Adjudication

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 9 2010-10-01 2010-10-01 false Respondent's Consent Form for Informal Adjudication No. Exhibit No. 2 to Subpart S [§ 502.304(e)] of Part 502 Shipping FEDERAL MARITIME COMMISSION GENERAL AND.... 502, Subpt. S, Exh. 2 Exhibit No. 2 to Subpart S [§ 502.304(e)] of Part 502—Respondent's Consent Form...

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.

Informed consent and standard of care: what must be disclosed.

PubMed

Macklin, Ruth; Shepherd, Lois

2013-01-01

The Office for Human Research Protections (OHRP) was correct in determining that the consent forms for the National Institutes of Health (NIH)-sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: (1) how risks and benefits should be described in informed consent documents; (2) the meaning and application of the concept of "standard of care" in the context of research; and (3) the proper role of OHRP. Examination of the consent forms reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of "standard of care" may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements.

Informed consent for clinical trials: a comparative study of standard versus simplified forms.

PubMed

Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

1998-05-06

A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (P<.0001). However, the degree to which the participants understood the forms was essentially the same for the LSU form (58%; 95% CI = 48.6%-67.0%) and the SWOG form (56%; 95% CI = 43.8%-66.8%). These findings raise serious questions regarding the adequacy of the design of written informed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

Medicaid Consent to Sterilization forms: historical, practical, ethical, and advocacy considerations.

PubMed

Block-Abraham, Dana; Arora, Kavita S; Tate, Danielle; Gee, Rebekah E

2015-06-01

The US government developed a Medicaid Consent to Sterilization form in the mid-1970s to protect vulnerable populations from coerced sterilization. US health care practices have evolved significantly since that time. The form, however, has not changed, and may be preventing access to desired services for the same vulnerable populations it was originally created to protect. This paper discusses the relevant historical, practical use, ethical, and advocacy considerations of the Medicaid sterilization consent form and proposes changes to make the form more pertinent to today's medical environment.

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

17 CFR 249.510 - Form 10-M, consent to service of process by a nonresident general partner of a broker-dealer firm.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., consent to service of process by a nonresident general partner of a broker-dealer firm. This form shall be... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 10-M, consent to service of process by a nonresident general partner of a broker-dealer firm. 249.510 Section 249.510...

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.

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

PubMed

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

2006-08-01

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

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2011 CFR

2011-10-01

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

42 CFR 441.257 - Informed consent.

Code of Federal Regulations, 2010 CFR

2010-10-01

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

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.

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.

Written informed consent for living liver donor evaluation: compliance with Centers for Medicare and Medicaid Services and Organ Procurement and Transplantation Network Guidelines and alibi offers.

PubMed

Thiessen, Carrie; Kim, Yunsoo A; Yoo, Peter S; Rodriguez-Davalos, Manuel; Mulligan, David; Kulkarni, Sanjay

2014-04-01

We examined written informed consent forms for living liver donor evaluations to determine whether they incorporated elements required by the Centers for Medicare and Medicaid Services (CMS) and suggested by the Organ Procurement and Transplantation Network (OPTN). We contacted each of the 41 US centers that performed at least 1 living donor liver transplant in 2011; 37 centers reported active living donor evaluation programs. Twenty-six centers shared their consent form for living donor evaluation (response rate = 70%). Each document was double-coded for consent element content. We found that 57% of the centers included the 9 mandated CMS elements. Although the OPTN guidelines are non-binding, 78% of the centers used consent forms that addressed at least two-thirds of the elements recommended by OPTN. Only 17% of the centers provided written offers of an alibi to donors who withdrew from the evaluation. On the basis of our findings, we offer suggestions that may be relevant to ongoing revisions to the OPTN living liver donor consent policy and may help centers to improve the clarity of their written consent forms. © 2014 American Association for the Study of Liver Diseases.

A novel metadata management model to capture consent for record linkage in longitudinal research studies.

PubMed

McMahon, Christiana; Denaxas, Spiros

2017-11-06

Informed consent is an important feature of longitudinal research studies as it enables the linking of the baseline participant information with administrative data. The lack of standardized models to capture consent elements can lead to substantial challenges. A structured approach to capturing consent-related metadata can address these. a) Explore the state-of-the-art for recording consent; b) Identify key elements of consent required for record linkage; and c) Create and evaluate a novel metadata management model to capture consent-related metadata. The main methodological components of our work were: a) a systematic literature review and qualitative analysis of consent forms; b) the development and evaluation of a novel metadata model. We qualitatively analyzed 61 manuscripts and 30 consent forms. We extracted data elements related to obtaining consent for linkage. We created a novel metadata management model for consent and evaluated it by comparison with the existing standards and by iteratively applying it to case studies. The developed model can facilitate the standardized recording of consent for linkage in longitudinal research studies and enable the linkage of external participant data. Furthermore, it can provide a structured way of recording consent-related metadata and facilitate the harmonization and streamlining of processes.

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

PubMed

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

2017-02-01

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

How do consent forms for diagnostic high-throughput sequencing address unsolicited and secondary findings? A content analysis.

PubMed

Vears, D F; Niemiec, E; Howard, H C; Borry, P

2018-06-10

Whole exome and whole genome sequencing are increasingly being offered to patients in the clinical setting. Yet, the question of whether, and to what extent, unsolicited findings (UF) and/or secondary findings (SF) should be returned to patients remains open and little is known about how diagnostic consent forms address this issue. We systematically identified consent forms for diagnostic genomic sequencing online and used inductive content analysis to determine if and how they discuss reporting of UF and SF, and whether patients are given options regarding the return of these results. Fifty-four forms representing 38 laboratories/clinics were analyzed. A quarter of the forms did not mention UF or SF. Forms used a variety of terms to discuss UF and SF, sometimes using these interchangeably or incorrectly. Reporting policies for UF varied: five forms stated that UF will not be returned, 15 indicated UF may be returned, and 28 did not specify their policy. One-third indicated their laboratory returns SF. Addressing inconsistent terminology and providing sufficient information about UF/SF in consent forms will increase patient understanding and help ensure adequate informed consent. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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.

[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.

Effect of social support on informed consent in older adults with Parkinson disease and their caregivers.

PubMed

Ford, M E; Kallen, M; Richardson, P; Matthiesen, E; Cox, V; Teng, E J; Cook, K F; Petersen, N J

2008-01-01

To evaluate the effects of social support on comprehension and recall of consent form information in a study of Parkinson disease patients and their caregivers. Comparison of comprehension and recall outcomes among participants who read and signed the consent form accompanied by a family member/friend versus those of participants who read and signed the consent form unaccompanied. Comprehension and recall of consent form information were measured at one week and one month respectively, using Part A of the Quality of Informed Consent Questionnaire (QuIC). The mean age of the sample of 143 participants was 71 years (SD = 8.6 years). Analysis of covariance was used to compare QuIC scores between the intervention group (n = 70) and control group (n = 73). In the 1-week model, no statistically significant intervention effect was found (p = 0.860). However, the intervention status by patient status interaction was statistically significant (p = 0.012). In the 1-month model, no statistically significant intervention effect was found (p = 0.480). Again, however, the intervention status by patient status interaction was statistically significant (p = 0.040). At both time periods, intervention group patients scored higher (better) on the QuIC than did intervention group caregivers, and control group patients scored lower (worse) on the QuIC than did control group caregivers. Social support played a significant role in enhancing comprehension and recall of consent form information among patients.

The ethics of HIV "cure" research: what can we learn from consent forms?

PubMed

Henderson, Gail E

2015-01-01

The advent of HIV "cure" research has generated enormous attention, but also concern about its potential to engender false hope, leading to overestimation of benefits and underestimation of risks, and about recruiting relatively healthy participants to studies with uncertain or serious risks. Currently, little is known about potential ethical problems in the ways that informed consent for HIV cure research is described to potential participants. As a first step to address this question, early phase, HIV "cure" research consent forms were analyzed to assess how study aims and potential risks and benefits are presented. Thirteen consent forms from a diverse group of clinical studies were selected to represent the major categories of cure research, including 11 interventional (gene transfer, vaccine intensification, treatment interruption, and latency reversing) and two observational. Consent forms were coded using seven categories, abstracting data on study purpose and design, participant selection criteria, presentation of risks and benefits of participation, and potential return of research results. Findings demonstrate variation and deficiencies that merit attention, but that can largely be addressed by turning to existing guidance about early phase research and specific study designs from other research contexts. The most challenging of these is ensuring that clear, specific, and consistent language is used to describe study aims, risks, benefits, and possible return of results. Informed consent for HIV "cure" research represents an opportunity to apply relevant existing guidance, measure the effectiveness of its application, and develop standardized best-practice policies for consent forms and processes.

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.

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.

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.

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

PubMed

Foe, Gabriella; Larson, Elaine L

2016-02-01

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

Simplifying informed consent for biorepositories: stakeholder perspectives.

PubMed

Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

2010-09-01

Complex and sometimes controversial information must be conveyed during the consent process for participation in biorepositories, and studies suggest that consent documents in general are growing in length and complexity. As a first step toward creating a simplified biorepository consent form, we gathered data from multiple stakeholders about what information was most important for prospective participants to know when making a decision about taking part in a biorepository. We recruited 52 research participants, 12 researchers, and 20 institutional review board representatives from Durham and Kannapolis, NC. These subjects were asked to read a model biorepository consent form and highlight sentences they deemed most important. On average, institutional review board representatives identified 72.3% of the sentences as important; researchers selected 53.0%, and participants 40.4% (P = 0.0004). Participants most often selected sentences about the kinds of individual research results that might be offered, privacy risks, and large-scale data sharing. Researchers highlighted sentences about the biorepository's purpose, privacy protections, costs, and participant access to individual results. Institutional review board representatives highlighted sentences about collection of basic personal information, medical record access, and duration of storage. The differing mandates of these three groups can translate into widely divergent opinions about what information is important and appropriate to include a consent form. These differences could frustrate efforts to move simplified forms--for biobanking as well as for other kinds of research--into actual use, despite continued calls for such forms.

Improving consent in patients undergoing surgery for fractured neck of femur.

PubMed

Thiruchandran, Gajendiran; McKean, Andrew R; Rudran, Branavan; Imam, Mohamed A; Yeong, Keefai; Hassan, Abdel

2018-05-02

Background Neck of femur fractures and their subsequent operative fixation are associated with high rates of perioperative morbidity and mortality. Consenting in this setting is suboptimal with the Montgomery court ruling changing the perspective of consent. This quality improvement project assessed the adequacy of consenting against British Orthopaedic Association-endorsed guidance and implemented a series of changes to improve the documentation of risks associated with surgery for fractured neck of femur. Methods Seventy consecutive patients who underwent any operative fixation of a neck of femur fracture were included over a 6-month period at a single centre. Patients unable to consent or without electronic notes were excluded. Consent forms were analysed and the documented potential risks or complications associated with surgery were compared to British Orthopaedic Association-endorsed guidance. A series of changes (using the plan, do study, act (PDSA) approach) was implemented to improve the adequacy of consent. Results Documentation of four out of 12 potential risks or complications was recorded in <50% of cases for patients with intracapsular fractures (n=35), and documentation of seven out of 12 potential risks or complications was recorded in <50% of cases for patients with extracapsular fractures (n=35). Re-audit following raising awareness and attaching consent guidance showed 100% documentation of potential risks or complications in patients with intracapsular and extracapsular fractures (n=70). A neck of femur fracture-specific consent form has been implemented which will hopefully lead to sustained improvement. Conclusions Consenting patients with fractured neck of femur for surgery in the authors' unit was suboptimal when compared to British Orthopaedic Association-endorsed consent guidance. This project has shown that ensuring such guidance is readily available has improved the adequacy of consent. The authors hope that introduction of a neck of femur fracture-specific consent form within their unit will lead to sustained adequate documentation of risks associated with surgery.

The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms?

PubMed Central

2015-01-01

Abstract The advent of HIV “cure” research has generated enormous attention, but also concern about its potential to engender false hope, leading to overestimation of benefits and underestimation of risks, and about recruiting relatively healthy participants to studies with uncertain or serious risks. Currently, little is known about potential ethical problems in the ways that informed consent for HIV cure research is described to potential participants. As a first step to address this question, early phase, HIV “cure” research consent forms were analyzed to assess how study aims and potential risks and benefits are presented. Thirteen consent forms from a diverse group of clinical studies were selected to represent the major categories of cure research, including 11 interventional (gene transfer, vaccine intensification, treatment interruption, and latency reversing) and two observational. Consent forms were coded using seven categories, abstracting data on study purpose and design, participant selection criteria, presentation of risks and benefits of participation, and potential return of research results. Findings demonstrate variation and deficiencies that merit attention, but that can largely be addressed by turning to existing guidance about early phase research and specific study designs from other research contexts. The most challenging of these is ensuring that clear, specific, and consistent language is used to describe study aims, risks, benefits, and possible return of results. Informed consent for HIV “cure” research represents an opportunity to apply relevant existing guidance, measure the effectiveness of its application, and develop standardized best-practice policies for consent forms and processes. PMID:25406579

Development of a consent resource for genomic data sharing in the clinical setting.

PubMed

Riggs, Erin Rooney; Azzariti, Danielle R; Niehaus, Annie; Goehringer, Scott R; Ramos, Erin M; Rodriguez, Laura Lyman; Knoppers, Bartha; Rehm, Heidi L; Martin, Christa Lese

2018-06-13

Data sharing between clinicians, laboratories, and patients is essential for improvements in genomic medicine, but obtaining consent for individual-level data sharing is often hindered by a lack of time and resources. To address this issue, the Clinical Genome Resource (ClinGen) developed tools to facilitate consent, including a one-page consent form and online supplemental video with information on key topics, such as risks and benefits of data sharing. To determine whether the consent form and video accurately conveyed key data sharing concepts, we surveyed 5,162 members of the general public. We measured comprehension at baseline, after reading the form and watching the video. Additionally, we assessed participants' attitudes toward genomic data sharing. Participants' performance on comprehension questions significantly improved over baseline after reading the form and continued to improve after watching the video. Results suggest reading the form alone provided participants with important knowledge regarding broad data sharing, and watching the video allowed for broader comprehension. These materials are now available at http://www.clinicalgenome.org/share . These resources will provide patients a straightforward way to share their genetic and health information, and improve the scientific community's access to data generated through routine healthcare.

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

PubMed

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

2009-10-01

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

A template for broad consent in biobank research. Results and explanation of an evidence and consensus-based development process.

PubMed

Strech, D; Bein, S; Brumhard, M; Eisenmenger, W; Glinicke, C; Herbst, T; Jahns, R; von Kielmansegg, S; Schmidt, G; Taupitz, J; Tröger, H D

2016-06-01

Biobanks increasingly presume long-term storage of biomaterials and data that shall be used for future research projects which are today unspecified. Appropriate consent documents for sample donors must therefore explain the breadth of consent and other elements of the biobank governance framework. Recent reviews demonstrated high variability in what issues these documents mention or not and how the issues are explained. This might undermine the protection of sample donors, complicate networked biobank research, create research waste and impact on public trust. A systematic analysis of international research guidelines and existing broad consent templates was performed. Based on this information an interdisciplinary expert group from the AKMEK (Permanent Working Party of German RECs) developed a draft template and organized a comprehensive stakeholder consultation. After revision the final template was consented by all 53 German RECs. This paper briefly explores the spectrum of potentially relevant issues for broad consent forms. It then elaborates the template and how it was designed to be applicable in different types of biobanks. To further improve the validity and applicability of broad consent forms in biobank and other big data research, practice evaluations are needed. We hope that in this regard the presented template supports the development of new consent forms as well as the evaluation and revision of existing ones. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

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

PubMed

Taylor, H E; Bramley, D E P

2012-11-01

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

Universal donor education and consent: what we know and where we should go.

PubMed

Wehrli, Gay; Sazama, Kathleen

2010-11-01

Each day thousands of blood donors across the country are given educational materials and sign a consent form, thus fulfilling two blood collection accreditation requirements. Very few donors will experience a documented adverse event, although a disproportionate number of these events occur in the youngest donor cohort. The literature reflects this disproportion and suggests mitigation strategies. Studies describe subjective, undocumented donor reactions and decreased donor return rates after a documented or subjective reaction. Additionally, studies have shown donor consent form variability among blood collection facilities and that donor comprehension of the educational materials and consent is limited. There are few standardized donor education materials or consent documents. Current accreditation standards for educational materials are limited to aspects of transfusion-transmitted diseases and for donor consent process and documentation are vague and nonspecific. Recent experiences with young donors and current research compel our community to engage in creating standardized, expanded donor educational materials and standardized donor consent processes and documents. © 2010 American Association of Blood Banks.

[Knowledge and willingness to participate in research: a descriptive study of volunteers in a clinical trial].

PubMed

Lobato, Lucas; Gazzinelli, Maria Flávia; Gazzinelli, Andréa; Soares, Amanda Nathale

2014-06-01

The aim of this study was to evaluate volunteers' knowledge of the information on the free informed consent form and their willingness to participate in a clinical trial. This was a quantitative, descriptive, cross-sectional study conducted in November 2011 with subjects from a clinical trial in Americaninhas, northeast Minas Gerais State, Brazil. A convenience sample included 143 adults of both sexes, 18 to 45 years of age. A structured questionnaire was applied one week after signing the free informed consent form. Most participants signed the free informed consent without sufficient knowledge of the research information and were influenced in their decision to participate in the trial. The authors conclude that signing the free informed consent form fails to express all participants' autonomy in clinical trials.

48 CFR 1352.235-70 - Protection of human subjects.

Code of Federal Regulations, 2010 CFR

2010-10-01

... investigation, including research development, testing and evaluation, designed to develop or contribute to... subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms..., questionnaires, surveys, advertisements, and informed consent forms by the cognizant IRB; (3) Documentation of...

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.

12 CFR 226.5 - General disclosure requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... conspicuously in writing, 7 in a form that the consumer may keep. 8 The disclosures required by this subpart may be provided to the consumer in electronic form, subject to compliance with the consumer consent and... to the consumer in electronic form without regard to the consumer consent or other provisions of the...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

40 CFR 52.1190 - Original Identification of plan section.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Plan for the General Motors Corporation Buick Motor Division in the form of an Alteration of... is in the form of a Stipulation for Entry of Consent Order and Final Order (No. 23-1984). The Consent... suspended particulates (TSP). The revision, in the form of Air Pollution Control Act (APCA) No. 65, revises...

How IRBs View and Make Decisions About Consent Forms

PubMed Central

Klitzman, Robert L.

2013-01-01

IRBs have been criticized for long and complicated consent forms, but how IRBs make decisions about these issues hasn’t been examined. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%), and 13 members and administrators. IRBs confront challenges and dilemmas regarding these documents: what and how much these forms should include (e.g., how “perfect” forms should be). While IRBs generally seek to decrease the length and complexity, institutions and industry funders often want these forms to be legal documents. IRBs may also “nitpick” these documents without realizing the costs. This study, the first to explore how IRBs view and make decisions about consent forms, suggests underlying tensions, ambiguities, and subjectivities that have important implications for future policy, practice, education, and research. PMID:23485667

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.

Prevention of Posttraumatic Contractures with Ketotifen (PERK)

DTIC Science & Technology

2016-10-01

the Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA), W81XWH-16-PRORP-CTA, was submitted. Database development and Pre...and Safety Months Identify database and partner – Clinical Research Unit 1-2 Completed Develop Case Report Forms, consent forms 6-12 Case...report forms completed, consent forms pending – 80% completed Develop database and multicenter submission process 12-18 In progress, 30% completed

Organ procurement organizations Internet enrollment for organ donation: Abandoning informed consent

PubMed Central

Woien, Sandra; Rady, Mohamed Y; Verheijde, Joseph L; McGregor, Joan

2006-01-01

Background Requirements for organ donation after cardiac or imminent death have been introduced to address the transplantable organs shortage in the United States. Organ procurement organizations (OPOs) increasingly use the Internet for organ donation consent. Methods An analysis of OPO Web sites available to the public for enrollment and consent for organ donation. The Web sites and consent forms were examined for the minimal information recommended by the United States Department of Health and Human Services for informed consent. Content scores were calculated as percentages of data elements in four information categories: donor knowledge, donor consent reinforcement, donation promotion, and informed consent. Results There were 60 Web sites for organ donation enrollment serving the 52 states. The median percent (10 percentile-90 percentile) content scores of the Web sites for donor knowledge, donor consent reinforcement, and donation promotion were 33% (20–47), 79% (57–86), and 75% (50–100), respectively. The informed consent score was 0% (0–33). The content scores for donor knowledge and informed consent were significantly lower than donor consent reinforcement and donation promotion for all Web sites (P < .05). The content scores for the four categories were similar among the 11 regions of the United Network for Organ Sharing. Conclusion The Web sites and consent forms for public enrollment in organ donation do not fulfill the necessary requirements for informed consent. The Web sites predominantly provide positive reinforcement and promotional information rather than the transparent disclosure of organ donation process. Independent regulatory oversight is essential to ensure that Internet enrollment for organ donation complies with legal and ethical standards for informed consent. PMID:17187671

Improving informed consent: Stakeholder views.

PubMed

Anderson, Emily E; Newman, Susan B; Matthews, Alicia K

2017-01-01

Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders-research participants and those responsible for obtaining informed consent-to inform potential development of a multimedia informed consent "app." This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms.

INFORMED CONSENT: THE MEDICAL AND LEGAL CHALLENGE OF OUR TIME

PubMed Central

Séllos Simões, Luiz Carlos

2015-01-01

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

Informed consent for genetic research.

PubMed

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

2004-06-01

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

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.

17 CFR 249.508 - Form 8-M, consent to service of process by a corporation which is a nonresident broker-dealer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 17 Commodity and Securities Exchanges 4 2014-04-01 2014-04-01 false Form 8-M, consent to service... and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) FORMS, SECURITIES EXCHANGE ACT...-dealer. This form shall be filed pursuant to Rule 15b1-5 (§ 240.15b1-5 of this chapter) by each corporate...

17 CFR 249.508 - Form 8-M, consent to service of process by a corporation which is a nonresident broker-dealer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 17 Commodity and Securities Exchanges 3 2013-04-01 2013-04-01 false Form 8-M, consent to service... and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) FORMS, SECURITIES EXCHANGE ACT...-dealer. This form shall be filed pursuant to Rule 15b1-5 (§ 240.15b1-5 of this chapter) by each corporate...

17 CFR 249.508 - Form 8-M, consent to service of process by a corporation which is a nonresident broker-dealer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 17 Commodity and Securities Exchanges 3 2012-04-01 2012-04-01 false Form 8-M, consent to service... and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) FORMS, SECURITIES EXCHANGE ACT...-dealer. This form shall be filed pursuant to Rule 15b1-5 (§ 240.15b1-5 of this chapter) by each corporate...

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.

Improving informed consent: Stakeholder views

PubMed Central

Anderson, Emily E.; Newman, Susan B.; Matthews, Alicia K.

2017-01-01

Purpose Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders—research participants and those responsible for obtaining informed consent—to inform potential development of a multimedia informed consent “app.” Methods This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. Results We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Conclusions Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms. PMID:28949896

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

PubMed

Krishnamurti, Tamar; Argo, Nichole

2016-08-01

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

A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

PubMed

Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

2011-01-04

The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

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

PubMed Central

2013-01-01

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

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

PubMed

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

2013-07-23

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

78 FR 63566 - Proposed Collection; Comment Request for Form 8838

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... concerning Form 8838, Consent To Extend the Time To Assess Tax Under Section 367-Gain Recognition Agreement... . SUPPLEMENTARY INFORMATION: Title: Consent To Extend the Time To Assess Tax Under Section 367- Gain Recognition... the transferor makes a gain recognition agreement. This agreement allows the transferor to defer the...

17 CFR 249.508 - Form 8-M, consent to service of process by a corporation which is a nonresident broker-dealer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 17 Commodity and Securities Exchanges 3 2011-04-01 2011-04-01 false Form 8-M, consent to service... and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION (CONTINUED) FORMS, SECURITIES EXCHANGE ACT... pursuant to Rule 15b1-5 (§ 240.15b1-5 of this chapter) by each corporate nonresident broker-dealer...

17 CFR 249.508 - Form 8-M, consent to service of process by a corporation which is a nonresident broker-dealer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... to service of process by a corporation which is a nonresident broker-dealer. This form shall be filed... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Form 8-M, consent to service of process by a corporation which is a nonresident broker-dealer. 249.508 Section 249.508 Commodity...

Good eggs? Evaluating consent forms for egg donation.

PubMed

Cattapan, Alana Rose

2016-07-01

Beyond gaps in the provision of information, the informed consent process for egg donation is complicated by conflicts of interest, payment and a lack of longitudinal data about physiological and psychological risks. Recent scholarship has suggested that egg donation programmes could improve the informed consent process by revising consent documents. At a minimum, these documents should include information about eight key criteria: the nature and objectives of treatment; the benefits, risks and inconveniences of egg donation; the privacy of donors and their anonymity (where applicable); disclosure that participation is voluntary (withdrawal); the availability of counselling; financial considerations; the possibility of an unsuccessful cycle and potential uses of the eggs retrieved. This study evaluates the incorporation of these minimum criteria in consent forms for egg donation, obtained through requests to Canadian fertility clinics. Even when clinics were considered to have met criteria simply by mentioning them, among the eight consent forms assessed, none met the minimum standards. Only half of clinics addressed privacy/anonymity concerns, financial issues and the possibility of a future cycle. Improving the quality of consent documentation to meet the minimum standards established by this study may not be an onerous task. For some, this will include re-evaluating how they include one or two elements of disclosure, and for others, this will require a substantial overhaul. Using the criteria provided by this study as the minimum standard for consent could ensure that donors have the basic information they need to make informed decisions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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.

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...

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

42 CFR Appendix to Subpart F of... - Required Consent Form

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Required Consent Form Appendix to Subpart F of Part 441 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL ASSISTANCE PROGRAMS SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES Sterilizations Pt. 441, Subpt. F, App....

Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns

PubMed Central

2015-01-01

Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants’ rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants’ considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research. PMID:25993308

Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns.

PubMed

Cummings, Jorden A; Zagrodney, Jessica M; Day, T Eugene

2015-01-01

Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants' rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants' considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research.

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

PubMed

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

2015-03-01

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

Using computer agents to explain medical documents to patients with low health literacy.

PubMed

Bickmore, Timothy W; Pfeifer, Laura M; Paasche-Orlow, Michael K

2009-06-01

Patients are commonly presented with complex documents that they have difficulty understanding. The objective of this study was to design and evaluate an animated computer agent to explain research consent forms to potential research participants. Subjects were invited to participate in a simulated consent process for a study involving a genetic repository. Explanation of the research consent form by the computer agent was compared to explanation by a human and a self-study condition in a randomized trial. Responses were compared according to level of health literacy. Participants were most satisfied with the consent process and most likely to sign the consent form when it was explained by the computer agent, regardless of health literacy level. Participants with adequate health literacy demonstrated the highest level of comprehension with the computer agent-based explanation compared to the other two conditions. However, participants with limited health literacy showed poor comprehension levels in all three conditions. Participants with limited health literacy reported several reasons, such as lack of time constraints, ability to re-ask questions, and lack of bias, for preferring the computer agent-based explanation over a human-based one. Animated computer agents can perform as well as or better than humans in the administration of informed consent. Animated computer agents represent a viable method for explaining health documents to patients.

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

"I understood…but some parts were confusing and hard to grasp": Patients' perception of informed consent forms and clinical trials in Eldoret, Kenya.

PubMed

Naanyu, Violet; Some, Fatma F; Siika, Abraham M

2014-01-01

A signed informed consent (IC) form proves voluntary participation in a study. Yet the development of accessible and understandable IC forms comes with its own set of challenges, particularly when conducting international research. This study explores understanding by participants in an Eldoret-based clinical trial of IC and its implications as well as whether they will volunteer for future trials. In mid-2010, in-depth interviews with trial participants were recorded in audio format. Content analysis provides a description of trial participants' experiences and thoughts. All participants were informed about the trial and its voluntariness and they consented. However, some were too ill to scrutinize trial details. Thus, they relied on their health care provider's advice, or on their guardians. In general, participants understood their role and were happy to volunteer or invite others to participate in future trials. They also emphasised the importance of an open on-going dialogue in order for participants to be able to ask questions. Clinical trial participants in Eldoret seem to understand their role, but rely on providers and guardians when consenting. They are very willing to participate in future trials. Evaluation of research participants' opinions may improve trial protocols, increase comprehension and guard against manipulation of study participants. In addition, this research focus should guide development of consent forms and process that facilitates a truly IC.

REALIZATION OF INFORMED CONSENT AS ONE OF PATIENT'S RIGHTS: CURRENT SITUATION IN AZERBAIJAN.

PubMed

Rustamova, F A; Mammadov, V G; Munir, K M

Azerbaijan is a country in which the law is based on democratic principles. The mentioned principles underlie the national health care law. Democratic values, such as respect for human rights and freedoms, human dignity, as well as universal bioethical principles that are widely implemented in the national law, create conditions for the implementation of the patient's rights. The basic law governing the doctor-patient relationship, Law on Protection of Health of Population in Azerbaijan, reflects the basic patients' rights and obligations of doctors and medical institutions. Informed consent, which is a key component of patient rights, is also reflected, however, to date, a significant drawback of the Azerbaijan medical legislation is described in the article in this field. For example, at the moment there is no single standardized informed consent form in the country's different medical institutions. Due to the absence of any legally approved standards for informed consent forms, public and private health care institutions individually develop such forms, which sometimes can differ significantly. At the moment, one of the important directions in the field of healthcare is its improvement in accordance with international standards. The research made it possible to make conclusions about the necessary measures to improve and unify the informed consent form. The authors also analyzed the main provisions of the medical law of Azerbaijan and identified the main trends of its further development.

Assessing usefulness and researcher satisfaction with consent form templates.

PubMed

Larson, Elaine L; Teller, Alan; Aguirre, Alejandra N; Jackson, Jhia; Meyer, Dodi

2017-08-01

We aimed to improve the research consenting process by developing and evaluating simplified consent forms. Four templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates. At baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them ( p <0.001). Consent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.

10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program Informed...

10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program Informed...

10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 4 2013-01-01 2013-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program Informed...

10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program Informed...

10 CFR Appendix A to Part 850 - Chronic Beryllium Disease Prevention Program Informed Consent Form

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Chronic Beryllium Disease Prevention Program Informed Consent Form A Appendix A to Part 850 Energy DEPARTMENT OF ENERGY CHRONIC BERYLLIUM DISEASE PREVENTION PROGRAM Pt. 850, App. A Appendix A to Part 850—Chronic Beryllium Disease Prevention Program Informed...

31 CFR 363.42 - How will my interest income be reported for tax purposes?

Code of Federal Regulations, 2010 CFR

2010-07-01

... TreasuryDirect § 363.42 How will my interest income be reported for tax purposes? When you open your TreasuryDirect ® account, you consent to receive the appropriate tax reporting forms by electronic means... printable form through your TreasuryDirect account. If you withdraw your consent to receive tax reporting...

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.

Enhancing informed consent for research and treatment.

PubMed

Dunn, L B; Jeste, D V

2001-06-01

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

The Appropriateness of Language Found in Research Consent Form Templates: A Computational Linguistic Analysis.

PubMed

Villafranca, Alexander; Kereliuk, Stephanie; Hamlin, Colin; Johnson, Andrea; Jacobsohn, Eric

2017-01-01

To facilitate informed consent, consent forms should use language below the grade eight level. Research Ethics Boards (REBs) provide consent form templates to facilitate this goal. Templates with inappropriate language could promote consent forms that participants find difficult to understand. However, a linguistic analysis of templates is lacking. We reviewed the websites of 124 REBs for their templates. These included English language medical school REBs in Australia/New Zealand (n = 23), Canada (n = 14), South Africa (n = 8), the United Kingdom (n = 34), and a geographically-stratified sample from the United States (n = 45). Template language was analyzed using Coh-Metrix linguistic software (v.3.0, Memphis, USA). We evaluated the proportion of REBs with five key linguistic outcomes at or below grade eight. Additionally, we compared quantitative readability to the REBs' own readability standards. To determine if the template's country of origin or the presence of a local REB readability standard influenced the linguistic variables, we used a MANOVA model. Of the REBs who provided templates, 0/94 (0%, 95% CI = 0-3.9%) provided templates with all linguistic variables at or below the grade eight level. Relaxing the standard to a grade 12 level did not increase this proportion. Further, only 2/22 (9.1%, 95% CI = 2.5-27.8) REBs met their own readability standard. The country of origin (DF = 20, 177.5, F = 1.97, p = 0.01), but not the presence of an REB-specific standard (DF = 5, 84, F = 0.73, p = 0.60), influenced the linguistic variables. Inappropriate language in templates is an international problem. Templates use words that are long, abstract, and unfamiliar. This could undermine the validity of participant informed consent. REBs should set a policy of screening templates with linguistic software.

Readability and Understanding of Informed Consent Among Participants With Low Incomes: A Preliminary Report.

PubMed

Ittenbach, Richard F; Senft, Elizabeth C; Huang, Guixia; Corsmo, Jeremy J; Sieber, Joan E

2015-12-01

With passage and implementation of the Affordable Health Care Act, more vulnerable segments of the U.S. population will now have access to regular health care and increased opportunities to participate in biomedical research. Yet, access to new groups brings with it new responsibilities for investigators, most importantly, reducing burdens for participants. Data collected through this small pilot study suggest several preliminary but potentially important findings when working with adults from low-income populations: First, while all participants read some parts of the consent forms (55%), only a minority reported reading the entire form (45%); second, 73% of participants reported understanding the study very well whereas only 27% reported understanding the study "a little"; third, there was a slight reported advantage of the simplified form over the regular form; however, this difference varied by section. Relatedly, other research has shown a high incidence of persons reading none of the consent form, but signing a statement that they have read and understood the study. Why does this occur? What are we teaching people when we request that they sign a consent form they have chosen not to read? What are the ethical and regulatory implications? Embedded ethics studies such as this one, although pilot and preliminary in nature, offer a number of advantages, such as stimulating additional scientific inquiry as well as challenging established institutional practices. © The Author(s) 2015.

42 CFR Appendix to Subpart B of... - Required Consent Form

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Required Consent Form Appendix to Subpart B of Part 50 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects Pt. 50, Subpt. B, App. Appendix to Subpart B of Part 50...

42 CFR Appendix to Subpart B of... - Required Consent Form

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Required Consent Form Appendix to Subpart B of Part 50 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects Pt. 50, Subpt. B, App. Appendix to Subpart B of Part 50...

42 CFR Appendix to Subpart B of... - Required Consent Form

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Required Consent Form Appendix to Subpart B of Part 50 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects Pt. 50, Subpt. B, App. Appendix to Subpart B of Part 50...

42 CFR Appendix to Subpart B of... - Required Consent Form

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Required Consent Form Appendix to Subpart B of Part 50 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects Pt. 50, Subpt. B, App. Appendix to Subpart B of Part 50...

42 CFR Appendix to Subpart B of... - Required Consent Form

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Required Consent Form Appendix to Subpart B of Part 50 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GRANTS POLICIES OF GENERAL APPLICABILITY Sterilization of Persons in Federally Assisted Family Planning Projects Pt. 50, Subpt. B, App. Appendix to Subpart B of Part 50...

A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination

PubMed Central

Forster, Alice S; Cornelius, Victoria; Rockliffe, Lauren; Marlow, Laura AV; Bedford, Helen; Waller, Jo

2017-01-01

Background: Uptake of human papillomavirus (HPV) vaccination is suboptimal among some groups. We aimed to determine the feasibility of undertaking a cluster randomised controlled trial (RCT) of incentives to improve HPV vaccination uptake by increasing consent form return. Methods: An equal-allocation, two-arm cluster RCT design was used. We invited 60 London schools to participate. Those agreeing were randomised to either a standard invitation or incentive intervention arm, in which Year 8 girls had the chance to win a £50 shopping voucher if they returned a vaccination consent form, regardless of whether consent was provided. We collected data on school and parent participation rates and questionnaire response rates. Analyses were descriptive. Results: Six schools completed the trial and only 3% of parents opted out. The response rate was 70% for the girls’ questionnaire and 17% for the parents’. In the intervention arm, 87% of girls returned a consent form compared with 67% in the standard invitation arm. The proportion of girls whose parents gave consent for vaccination was higher in the intervention arm (76%) than the standard invitation arm (61%). Conclusions: An RCT of an incentive intervention is feasible. The intervention may improve vaccination uptake but a fully powered RCT is needed. PMID:28829766

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.

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

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

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

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

WASP (Write a Scientific Paper): Informed consent in research.

PubMed

Mallia, Pierre

2018-05-03

The autonomy of patients participating in research means that a proper informed consent process must take place. This means that information must be given according to a reasonable person standard implying what legally and ethical a reasonable person participating in the research would want to know. The research must assure that the patient has understood all the information given and that a voluntary choice has been made. This means that no form of coercion must take place and that information must not be manipulated in such a way as to influence the participant. No undue pressure or persuasion must either occur. Particular attention must be paid to vulnerable groups and participants must be competent and have the capacity to consent. Where necessary the use of a proxy to act on behalf of a patient who does not have legal capacity must be used and the best interests of the patient must be asserted. In research consent must always include a signed consent form which again is duly explained and authorized by the research ethics committee. Copyright © 2018. Published by Elsevier B.V.

Developing a simplified consent form for biobanking.

PubMed

Beskow, Laura M; Friedman, Joëlle Y; Hardy, N Chantelle; Lin, Li; Weinfurt, Kevin P

2010-10-08

Consent forms have lengthened over time and become harder for participants to understand. We sought to demonstrate the feasibility of creating a simplified consent form for biobanking that comprises the minimum information necessary to meet ethical and regulatory requirements. We then gathered preliminary data concerning its content from hypothetical biobank participants. We followed basic principles of plain-language writing and incorporated into a 2-page form (not including the signature page) those elements of information required by federal regulations and recommended by best practice guidelines for biobanking. We then recruited diabetes patients from community-based practices and randomized half (n = 56) to read the 2-page form, first on paper and then a second time on a tablet computer. Participants were encouraged to use "More information" buttons on the electronic version whenever they had questions or desired further information. These buttons led to a series of "Frequently Asked Questions" (FAQs) that contained additional detailed information. Participants were asked to identify specific sentences in the FAQs they thought would be important if they were considering taking part in a biorepository. On average, participants identified 7 FAQ sentences as important (mean 6.6, SD 14.7, range: 0-71). No one sentence was highlighted by a majority of participants; further, 34 (60.7%) participants did not highlight any FAQ sentences. Our preliminary findings suggest that our 2-page form contains the information that most prospective participants identify as important. Combining simplified forms with supplemental material for those participants who desire more information could help minimize consent form length and complexity, allowing the most substantively material information to be better highlighted and enabling potential participants to read the form and ask questions more effectively.

Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing.

PubMed

Roberts, Laura Weiss; Warner, Teddy D; Anderson, Charles T; Smithpeter, Megan V; Rogers, Melinda K

2004-04-01

To examine the perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing of people with schizophrenia who volunteered for research protocols. A structured interview to assess research-related views of people with schizophrenia was developed and piloted. Data collection occurred at three sites. For this analysis, we examined the subset of responses from schizophrenia patients currently enrolled in a protocol. Data from 28 schizophrenia research volunteers were analyzed. Of these, 22 were men and 11 were voluntary inpatients. Most (n=23) recalled speaking with someone before enrolling in the protocol, and most (n=26) reported trusting the person who told them about it. Participants reported a moderate understanding of their protocols. All but one person (n=27) remembered signing a consent form. Twenty-one volunteers indicated that consent forms are meant to help both the patient and the researcher. Most (n=23) reported making the enrollment decision alone, with 22 making this decision prior to reviewing the consent form. The decision was described as relatively easy. Respondents felt some pressure to enroll, with women experiencing more pressure. Debriefing practices were strongly endorsed by participants. All 28 of the volunteers wished to be informed if a health problem (i.e., "something wrong") was discovered during the protocol. The persons living with schizophrenia who were interviewed for this project expressed interesting perspectives and preferences regarding ethically important aspects of recruitment, consent, and debriefing in clinical research that may help guide efforts to make research processes more attuned to participants and merit further inquiry.

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

PubMed

Gillies, Katie; Elwyn, Glyn; Cook, Jonathan

2014-07-30

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

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

PubMed Central

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

2016-01-01

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

Exploring the Readability of Consent Forms in Human Research in the United States Army

DTIC Science & Technology

2005-03-01

subjects: autonomy (respect for persons), beneficence, and justice. Readability of consent forms 12 The report also defined how these principles apply to...Regional Medical Command, Fort Sam Houston, Texas CPT Heidi P. Mon) U.S. Army-Baylor University Graduate Program in Health Care Administration March...United States v. Karl Brandt, 1947). The opinion in that case included 10 basic principles for human research, called the Nuremberg Code

Risk management in clinical practice. Part 2. Getting to 'yes'--the matter of consent.

PubMed

D'Cruz, L

2010-07-24

Consent is an integral part of delivering the care patients want. In order to consent to treatment, patients must have the legal capacity to give valid consent. If this three stage test is satisfied, the patient can elect to have any treatment they wish even if it is not in their best interest. Before a patient is able to consent to treatment they must have adequate knowledge about the risks, benefits and alternatives to the treatment. The amount of information provided to the patient by the dentist is determined to some degree by the legal system prevailing. The patient must voluntarily agree to treatment without being coerced by the dentist or other parties and if things change during treatment the patient needs to be advised. Written consent is very useful in the defence of cases but simply signing the consent form does not mean that the patient knows or understands the treatment to which they have agreed.

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.

Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

PubMed

Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

2006-05-01

To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Informed consent and federal funding for stem cell research.

PubMed

Streiffer, Robert

2008-01-01

A review of the consent forms signed by those who donated embryos for the NIH-approved embryonic stem cell lines reveals several problems, providing ethical as well as scientific reasons to overturn the Bush administration's restrictions on federal funding for stem cell research.

The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente Nationwide Health Information Network Exchange in San Diego: Patient Selection, Consent, and Identity Matching

PubMed Central

Bouhaddou, Omar; Bennett, Jamie; Cromwell, Tim; Nixon, Graham; Teal, Jennifer; Davis, Mike; Smith, Robert; Fischetti, Linda; Parker, David; Gillen, Zachary; Mattison, John

2011-01-01

The Nationwide Health Information Network allow for the secure exchange of Electronic Health Records over the Internet. The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente, participated in an implementation of the NwHIN specifications in San Diego, California. This paper focuses primarily on patient involvement. Specifically, it describes how the shared patients were identified, were invited to participate and to provide consent for disclosing parts of their medical record, and were matched across organizations. A total 1,144 were identified as shared patients. Invitation letters containing consent forms were mailed and resulted in 42% participation. Invalid consent forms were a significant issue (25%). Initially, the identity matching algorithms yielded low success rate (5%). However, elimination of certain traits and abbreviations and probabilistic algorithms have significantly increased matching rate. Access to information from external sources better informs providers, improves decisions and efficiency, and helps meet the meaningful use criteria. PMID:22195064

The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente Nationwide Health Information Network exchange in San Diego: patient selection, consent, and identity matching.

PubMed

Bouhaddou, Omar; Bennett, Jamie; Cromwell, Tim; Nixon, Graham; Teal, Jennifer; Davis, Mike; Smith, Robert; Fischetti, Linda; Parker, David; Gillen, Zachary; Mattison, John

2011-01-01

The Nationwide Health Information Network allow for the secure exchange of Electronic Health Records over the Internet. The Department of Veterans Affairs, Department of Defense, and Kaiser Permanente, participated in an implementation of the NwHIN specifications in San Diego, California. This paper focuses primarily on patient involvement. Specifically, it describes how the shared patients were identified, were invited to participate and to provide consent for disclosing parts of their medical record, and were matched across organizations. A total 1,144 were identified as shared patients. Invitation letters containing consent forms were mailed and resulted in 42% participation. Invalid consent forms were a significant issue (25%). Initially, the identity matching algorithms yielded low success rate (5%). However, elimination of certain traits and abbreviations and probabilistic algorithms have significantly increased matching rate. Access to information from external sources better informs providers, improves decisions and efficiency, and helps meet the meaningful use criteria.

Building and evaluating an ontology-based tool for reasoning about consent permission

PubMed Central

Grando, Adela; Schwab, Richard

2013-01-01

Given the lack of mechanisms for specifying, sharing and checking the compliance of consent permissions, we focus on building and testing novel approaches to address this gap. In our previous work, we introduced a “permission ontology” to capture in a precise, machine-interpretable form informed consent permissions in research studies. Here we explain how we built and evaluated a framework for specifying subject’s permissions and checking researcher’s resource request in compliance with those permissions. The framework is proposed as an extension of an existing policy engine based on the eXtensible Access Control Markup Language (XACML), incorporating ontology-based reasoning. The framework is evaluated in the context of the UCSD Moores Cancer Center biorepository, modeling permissions from an informed consent and a HIPAA form. The resulting permission ontology and mechanisms to check subject’s permission are implementation and institution independent, and therefore offer the potential to be reusable in other biorepositories and data warehouses. PMID:24551354

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.

Broad Consent for Research on Biospecimens: The Views of Actual Donors at Four U.S. Medical Centers.

PubMed

Warner, Teddy D; Weil, Carol J; Andry, Christopher; Degenholtz, Howard B; Parker, Lisa; Carithers, Latarsha J; Feige, Michelle; Wendler, David; Pentz, Rebecca D

2018-04-01

Commentators are concerned that broad consent may not provide biospecimen donors with sufficient information regarding possible future research uses of their tissue. We surveyed with interviews 302 cancer patients who had recently provided broad consent at four diverse academic medical centers. The majority of donors believed that the consent form provided them with sufficient information regarding future possible uses of their biospecimens. Donors expressed very positive views regarding tissue donation in general and endorsed the use of their biospecimens in future research across a wide range of contexts. Concerns regarding future uses were limited to for-profit research and research by investigators in other countries. These results support the use of broad consent to store and use biological samples in future research.

77 FR 43086 - Agency Information Collection Request; 60-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-23

...; Sterilization of Persons in Federally Assisted Family Planning Projects--OMB No. 0937- 0166--Extension--OPHS..., subpart B (``Sterilization of Persons in Federally Assisted Family Planning Projects''). The consent form solicits information to assure voluntary and informed consent to persons undergoing sterilization in...

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...

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

Scientists' perspectives on consent in the context of biobanking research

PubMed Central

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

2015-01-01

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

Easy-to-Read Informed Consent Forms for Hematopoietic Cell Transplantation Clinical Trials

PubMed Central

Denzen, Ellen M; Santibáñez, Martha E Burton; Moore, Heather; Foley, Amy; Gersten, Iris D; Gurgol, Cathy; Majhail, Navneet S; Spellecy, Ryan; Horowitz, Mary M; Murphy, Elizabeth A

2011-01-01

Informed consent is essential to ethical research and is requisite to participation in clinical research. Yet most hematopoietic cell transplantation (HCT) informed consent forms (ICFs) are written at reading levels that are above the ability of the average person in the US. The recent development of ICF templates by the National Cancer Institute, National Institutes of Health and the National Heart Blood and Lung Instituthas not resulted in increased patient comprehension of information. Barriers to creating Easy-to-Read ICFs that meet US federal requirements and pass Institutional Review Board (IRB) review are the result of multiple interconnected factors. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) formed an ad hoc review team to address concerns regarding the overall readability and length of ICFs used for BMT CTN trials. This paper summarizes recommendations of the review team for the development and formatting of Easy-to-Read ICFs for HCT multicenter clinical trials, the most novel of which is the use of a two-column layout. These recommendations intend to guide the ICF writing process, simplify local IRB review of the ICF, enhance patient comprehension and improve patient satisfaction. The BMT CTN plans to evaluate the impact of the Easy-to-Read format compared to the traditional format on the informed consent process. PMID:21806948

Autonomy, consent and responsability. Part 1: limitations of the principle of autonomy as a foundation of informed consent.

PubMed

Mellado, J M

2016-01-01

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

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

PubMed Central

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

2017-01-01

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

From "a Fair Game" to "a Form of Covert Research": Research Ethics Committee Members' Differing Notions of Consent and Potential Risk to Participants Within Social Media Research.

PubMed

Hibbin, R A; Samuel, G; Derrick, G E

2018-04-01

Social media (SM) research presents new challenges for research ethics committees (RECs) who must balance familiar ethical principles with new notions of public availability. This article qualitatively examines how U.K. REC members view this balance in terms of risk and consent. While it found significant variance overall, there were discernible experience-based trends. REC members with less experience of reviewing SM held inflexible notions of consent and risk that could be categorized as either relying on traditional notions of requiring direct consent, or viewing publicly available data as "fair game." More experienced REC members took a more nuanced approach to data use and consent. We conclude that the more nuanced approach should be best practice during ethical review of SM research.

Autonomy, consent and responsibility. Part II. Informed consent in medical care and in the law.

PubMed

Mellado, J M

Legal recognition of patient's rights aspired to change clinical relationship and medical lex artis. However, its implementation has been hampered by the scarcity of resources and the abundance of regulations. For several years, autonomy, consent, and responsibility have formed one of the backbones of the medical profession. However, they have sparked controversy and professional discomfort. In the first part of this article, we examine the conceptual and regulatory limitations of the principle of autonomy as the basis of informed consent. We approach the subject from philosophical, historical, legal, bioethical, deontological, and professional standpoints. In the second part, we cover the viability of informed consent in health care and its relationship with legal responsibility. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

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

Educational pelvic exams on anesthetized women: Why consent matters.

PubMed

Friesen, Phoebe

2018-06-01

It is argued here that the practice of medical students performing pelvic exams on women who are under anesthetic and have not consented is immoral and indefensible. This argument begins by laying out the ethical justification for the practice of informed consent, which can be found in autonomy and basic rights. Foregoing the process of consent within medicine can result in violations of both autonomy and basic rights, as well as trust, forming the basis of the wrong of unauthorized pelvic examinations. Several objections to this argument are considered, all of which stem from the idea that this practice constitutes an exception to the general requirement of informed consent. These objections suggest that nonconsensual pelvic examinations on women under anesthetic are ethically acceptable on utilitarian grounds, in that they offer benefits either to the patient or to society, or on the grounds of triviality, in that consent is already presumed, or the practice is insignificant. Each of these objections is rejected and the practice is deemed indefensible. © 2018 John Wiley & Sons Ltd.

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

PubMed

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

2016-10-22

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

Testing an alternate informed consent process.

PubMed

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

2009-01-01

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

75 FR 37806 - Twitter, Inc.; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... FEDERAL TRADE COMMISSION [File No. 092 3093] Twitter, Inc.; Analysis of Proposed Consent Order to... in paper form. Comments should refer to``Twitter, Inc., File No. 092 3093'' to facilitate the... weblink: ( http://public.commentworks.com/ftc/twitter ) and following the instructions on the web-based...

Use, Readability, and Content of Written Informed Consent for Treatment.

ERIC Educational Resources Information Center

Handelsman, Mitchell M.; And Others

As psychology has recognized the rights of clients and subjects to exercise a rational, voluntary choice about participation in research, assessment, and treatment, the use of written informed consent forms has increased. A sample of 196 psychologists in private practice were mailed questionnaires which examined their use of, and rationale for,…

75 FR 80809 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-23

... Department of Air Quality to the Tennessee Valley Authority's Paradise Fossil Plant in Drakesboro, Kentucky... and any form of encryption, and may be mailed to the mailing address above. FOR FURTHER INFORMATION... Fossil Plant in Drakesboro, Kentucky. Under the terms of the proposed consent decree, EPA has agreed to...

75 FR 67719 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-03

... ENVIRONMENTAL PROTECTION AGENCY [FRL-9220-1] Proposed Consent Decree, Clean Air Act Citizen Suit... suit to compel the Administrator to take final action under section 110(k) of the Act on Imperial... special characters and any form of encryption, and may be mailed to the mailing address above. FOR FURTHER...

77 FR 48980 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

... ENVIRONMENTAL PROTECTION AGENCY [FRL-9716-2] Proposed Consent Decree, Clean Air Act Citizen Suit... 16, 2011, Plaintiff filed a deadline suit to compel the Administrator to respond to an administrative..., avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address...

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.

The challenge of informed consent and return of results in translational genomics: empirical analysis and recommendations.

PubMed

Henderson, Gail E; Wolf, Susan M; Kuczynski, Kristine J; Joffe, Steven; Sharp, Richard R; Parsons, D Williams; Knoppers, Bartha M; Yu, Joon-Ho; Appelbaum, Paul S

2014-01-01

As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations. © 2014 American Society of Law, Medicine & Ethics, Inc.

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

PubMed

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

2010-07-01

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

[Schizophrenia and informed consent to research].

PubMed

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

2015-10-01

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

From “a Fair Game” to “a Form of Covert Research”: Research Ethics Committee Members’ Differing Notions of Consent and Potential Risk to Participants Within Social Media Research

PubMed Central

Derrick, G. E.

2018-01-01

Social media (SM) research presents new challenges for research ethics committees (RECs) who must balance familiar ethical principles with new notions of public availability. This article qualitatively examines how U.K. REC members view this balance in terms of risk and consent. While it found significant variance overall, there were discernible experience-based trends. REC members with less experience of reviewing SM held inflexible notions of consent and risk that could be categorized as either relying on traditional notions of requiring direct consent, or viewing publicly available data as “fair game.” More experienced REC members took a more nuanced approach to data use and consent. We conclude that the more nuanced approach should be best practice during ethical review of SM research. PMID:29350083

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.

A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States.

PubMed

Garrison, Nanibaa' A; Sathe, Nila A; Antommaria, Armand H Matheny; Holm, Ingrid A; Sanderson, Saskia C; Smith, Maureen E; McPheeters, Melissa L; Clayton, Ellen W

2016-07-01

In 2011, an Advanced Notice of Proposed Rulemaking proposed that de-identified human data and specimens be included in biobanks only if patients provide consent. The National Institutes of Health Genomic Data Sharing policy went into effect in 2015, requiring broad consent from almost all research participants. We conducted a systematic literature review of attitudes toward biobanking, broad consent, and data sharing. Bibliographic databases included MEDLINE, Web of Science, EthxWeb, and GenETHX. Study screening was conducted using DistillerSR. The final 48 studies included surveys (n = 23), focus groups (n = 8), mixed methods (n = 14), interviews (n = 1), and consent form analyses (n = 2). Study quality was characterized as good (n = 19), fair (n = 27), and poor (n = 2). Although many participants objected, broad consent was often preferred over tiered or study-specific consent, particularly when broad consent was the only option, samples were de-identified, logistics of biobanks were communicated, and privacy was addressed. Willingness for data to be shared was high, but it was lower among individuals from under-represented minorities, individuals with privacy and confidentiality concerns, and when pharmaceutical companies had access to data. Additional research is needed to understand factors affecting willingness to give broad consent for biobank research and data sharing in order to address concerns to enhance acceptability.Genet Med 18 7, 663-671.

Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?

PubMed Central

Steinsbekk, Kristin Solum; Kåre Myskja, Bjørn; Solberg, Berge

2013-01-01

In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor–biobank relationship meet high ethical standards. Up until now, a ‘broad consent' model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top–down governance. Recently, an approach termed ‘dynamic consent' has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach. PMID:23299918

76 FR 68757 - Information Collection Being Reviewed by the Federal Communications Commission

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... Number: 3060-0573. Title: Application for Franchise Authority Consent to Assignment or Transfer of Control of Cable Television Franchise, FCC Form 394. Form Number: FCC Form 394. Type of Review: Extension...

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.

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.

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.

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

ERIC Educational Resources Information Center

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

2007-01-01

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

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…

75 FR 35120 - 60-Day Notice of Proposed Information Collection: Form DS-3053, Statement of Consent or Special...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

...-3053, Statement of Consent or Special Circumstances: Issuance of a Passport to a Minor Under Age 16... a Passport to a Minor Under Age 16. OMB Control Number: 1405-0129. Type of Request: Revision of a Currently Approved Collection. Originating Office: Bureau of Consular Affairs, Passport Services CA/PPT...

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2016-01-01

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

Assessing chronic stroke survivors with aphasia sheds light on prevalence of spatial neglect

PubMed Central

Hreha, Kimberly; Mulry, Claire; Gross, Melissa; Jedziniak, Tarah; Gramas, Natanya; Ohevshalom, Leora; Sheridan, Alisha; Szabo, Gretchen; Davison, Christina; Barrett, A. M.

2016-01-01

Background Stroke is a chronic disease. Standardized assessment is essential in order to determine areas for treatment. Individuals with aphasia are often excluded from research, because it is believed that their language impairments may impact their ability to provide informed consent. Thus, right spatial neglect could be under-diagnosed. Objective This study was developed to (1) determine the frequency of spatial neglect in chronic left-brain stroke survivors with aphasia, (2) determine the clinical utility of an aphasia-friendly consent form, and (3) determine any differences between neglect and no-neglect groups regarding activities of daily living (ADL) performance and community independence. Methods Forty-six people were consented at community center. Three were screen failures secondary to the exclusion criteria. A novel, aphasia-friendly consent form was developed to facilitate participation of individuals with aphasia. This enabled 93% or 40 out of the 43 recruited participants to be included in this study. The Behavioral Inattention Test-conventional and the Catherine Bergego Scale via Kessler Foundation Neglect Assessment Process (CBS via KF-NAP) were utilized to determine neglect. The Life Space Questionnaire was used to determine community mobility and independence. The Barthel Index (BI) was used for objective clarification of performance in ADL. Results Successful use of the consent form resulted in determination that five out of 40 (12.5%) met criteria for spatial neglect; (on the CBS via KF-NAP). The neglect group had lower scores on the Life Space, suggesting less community mobility and independence, however, it was not statistically significant (p = 0.16). Differences in BI scores were also not significant (p = .013) but the neglect group did have reduced independence. Conclusions This study demonstrates the need to administer functional neglect assessments in left-brain stroke and to include individuals with aphasia in research. PMID:27322860

Assessing chronic stroke survivors with aphasia sheds light on prevalence of spatial neglect.

PubMed

Hreha, Kimberly; Mulry, Claire; Gross, Melissa; Jedziniak, Tarah; Gramas, Natanya; Ohevshalom, Leora; Sheridan, Alisha; Szabo, Gretchen; Davison, Christina; Barrett, A M

2017-03-01

Stroke is a chronic disease. Standardized assessment is essential in order to determine areas for treatment. Individuals with aphasia are often excluded from research, because it is believed that their language impairments may impact their ability to provide informed consent. Thus, right spatial neglect could be under-diagnosed. This study was developed to (1) determine the frequency of spatial neglect in chronic left-brain stroke survivors with aphasia, (2) determine the clinical utility of an aphasia-friendly consent form, and (3) determine any differences between neglect and no-neglect groups regarding activities of daily living (ADL) performance and community independence. Forty-six people were consented at community center. Three were screen failures secondary to the exclusion criteria. A novel, aphasia-friendly consent form was developed to facilitate participation of individuals with aphasia. This enabled 93% or 40 out of the 43 recruited participants to be included in this study. The Behavioral Inattention Test-conventional and the Catherine Bergego Scale via Kessler Foundation Neglect Assessment Process (CBS via KF-NAP) were utilized to determine neglect. The Life Space Questionnaire was used to determine community mobility and independence. The Barthel Index (BI) was used for objective clarification of performance in ADL. Successful use of the consent form resulted in determination that five out of 40 (12.5%) met criteria for spatial neglect; (on the CBS via KF-NAP). The neglect group had lower scores on the Life Space, suggesting less community mobility and independence, however, it was not statistically significant (p = 0.16). Differences in BI scores were also not significant (p = .013) but the neglect group did have reduced independence. This study demonstrates the need to administer functional neglect assessments in left-brain stroke and to include individuals with aphasia in research.

Reasons for resubmission of research projects to the research ethics committee of a university hospital in São Paulo, Brazil.

PubMed

Bueno, Mariana; Brevidelli, Maria Meimei; Cocarelli, Thaís; Santos, Gianni Mara Silva dos; Ferraz, Maria Auxiliadora; Mion, Décio

2009-01-01

It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5% concerned research with new drugs, vaccines and diagnostic tests, 48.5% consisted of undergraduate students' research projects, 68.9% of the research had no sponsorship, and 97.5% were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2%), lack of information about the protocol at the informed consent form (25.8%), as well as doubts regarding methodological and statistical issues of the protocol (77.1%). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. Among the research projects that were returned to the researchers for additional clarification, the main reasons were inadequacies or doubts about the terms used in the informed consent form as well as lack of information regarding the research at the informed consent form and methodological and statistical issues regarding the protocol.

Medical research using governments' health claims databases: with or without patients' consent?

PubMed

Tsai, Feng-Jen; Junod, Valérie

2018-03-01

Taking advantage of its single-payer, universal insurance system, Taiwan has leveraged its exhaustive database of health claims data for research purposes. Researchers can apply to receive access to pseudonymized (coded) medical data about insured patients, notably their diagnoses, health status and treatments. In view of the strict safeguards implemented, the Taiwanese government considers that this research use does not require patients' consent (either in the form of an opt-in or in the form of an opt-out). A group of non-governmental organizations has challenged this view in the Taiwanese Courts, but to no avail. The present article reviews the arguments both against and in favor of patients' consent for re-use of their data in research. It concludes that offering patients an opt-out would be appropriate as it would best balance the important interests at issue.

Addressing Consent Issues in Donation After Circulatory Determination of Death.

PubMed

Overby, Kim J; Weinstein, Michael S; Fiester, Autumn

2015-01-01

Given the widening gap between the number of individuals on transplant waiting lists and the availability of donated organs, as well as the recent plateau in donations based on neurological criteria (i.e., brain death), there has been a growing interest in expanding donation after circulatory determination of death. While the prevalence of this form of organ donation continues to increase, many thorny ethical issues remain, often creating moral distress in both clinicians and families. In this article, we address one of these issues, namely, the challenges surrounding patient and surrogate informed consent for donation after circulatory determination of death. First we discuss several general concerns regarding consent related to this form of organ donation, and then we address additional issues that are unique to three different patient categories: adult patients with medical decision-making capacity or potential capacity, adult patients who lack capacity, and pediatric patients.

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

26 CFR 301.7216-3 - Disclosure or use permitted only with the taxpayer's consent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... tax return preparation services for employees of Company C. An employee of Company C, Employee E... return in the Form 1040 series may be in any format, including an engagement letter to a client, as long..., Taxpayer C, an engagement letter. Part of the engagement letter requests the consent of Taxpayer C for the...

26 CFR 301.7216-3 - Disclosure or use permitted only with the taxpayer's consent.

Code of Federal Regulations, 2011 CFR

2011-04-01

... tax return preparation services for employees of Company C. An employee of Company C, Employee E... return in the Form 1040 series may be in any format, including an engagement letter to a client, as long..., Taxpayer C, an engagement letter. Part of the engagement letter requests the consent of Taxpayer C for the...

A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital.

PubMed

Shah, Pruthak C; Panchasara, Ashwin K; Barvaliya, Manish J; Tripathi, C B

2016-09-01

Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents. Total 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases. Our study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.

Informed Consent in the Changing Landscape of Research.

PubMed

Hammer, Marilyn J

2016-09-01

The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration. 
.

An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting

PubMed Central

Madathil, Kapil Chalil; Koikkara, Reshmi; Obeid, Jihad; Greenstein, Joel S.; Sanderson, Iain C.; Fryar, Katrina; Moskowitz, Jay; Gramopadhye, Anand K.

2013-01-01

Purpose Ethical and legal requirements for healthcare providers in the United States, stipulate that patients sign a consent form prior to undergoing medical treatment or participating in a research study. Currently, the majority of the hospitals obtain these consents using paper-based forms, which makes patient preference data cumbersome to store, search and retrieve. To address these issues, Health Sciences of South Carolina (HSSC), a collaborative of academic medical institutions and research universities in South Carolina, is developing an electronic consenting system, the Research Permissions Management System (RPMS). This article reports the findings of a study conducted to investigate the efficacy of the two proposed interfaces for this system – an iPad-based and touchscreen-based by comparing them to the paper-based and Topaz-based systems currently in use. Methods This study involved 50 participants: 10 hospital admission staff and 40 patients. The four systems were compared with respect to the time taken to complete the consenting process, the number of errors made by the patients, the workload experienced by the hospital staff and the subjective ratings of both patients and staff on post-test questionnaires. Results The results from the empirical study indicated no significant differences in the time taken to complete the tasks. More importantly, the participants found the new systems more usable than the conventional methods with the registration staff experiencing the least workload in the iPad and touchscreen-based conditions and the patients experiencing more privacy and control during the consenting process with the proposed electronic systems. In addition, they indicated better comprehension and awareness of what they were signing using the new interfaces. Discussion The results indicate the two methods proposed for capturing patient consents are at least as effective as the conventional methods, and superior in several important respects. While more research is needed, these findings suggest the viability of cautious adoption of electronic consenting systems, especially because these new systems appear to address the challenge of identifying the participants required for the complex research being conducted as the result of advances in the biomedical sciences. PMID:23757370

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.

Qualitative thematic analysis of consent forms used in cancer genome sequencing.

PubMed

Allen, Clarissa; Foulkes, William D

2011-07-19

Large-scale whole genome sequencing (WGS) studies promise to revolutionize cancer research by identifying targets for therapy and by discovering molecular biomarkers to aid early diagnosis, to better determine prognosis and to improve treatment response prediction. Such projects raise a number of ethical, legal, and social (ELS) issues that should be considered. In this study, we set out to discover how these issues are being handled across different jurisdictions. We examined informed consent (IC) forms from 30 cancer genome sequencing studies to assess (1) stated purpose of sample collection, (2) scope of consent requested, (3) data sharing protocols (4) privacy protection measures, (5) described risks of participation, (6) subject re-contacting, and (7) protocol for withdrawal. There is a high degree of similarity in how cancer researchers engaged in WGS are protecting participant privacy. We observed a strong trend towards both using samples for additional, unspecified research and sharing data with other investigators. IC forms were varied in terms of how they discussed re-contacting participants, returning results and facilitating participant withdrawal. Contrary to expectation, there were no consistent trends that emerged over the eight year period from which forms were collected. Examining IC forms from WGS studies elucidates how investigators are handling ELS challenges posed by this research. This information is important for ensuring that while the public benefits of research are maximized, the rights of participants are also being appropriately respected.

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

PubMed Central

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

2017-01-01

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

Informed consent 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.

[Formal quality assessment of informed consent documents in 9 hospitals].

PubMed

Calle-Urra, J E; Parra-Hidalgo, P; Saturno-Hernández, P J; Martínez-Martínez, M J; Navarro-Moya, F J

2013-01-01

Informed consent forms are very important in the process of medical information. The aim of this study is to design reliable formal quality criteria of these documents and their application in the evaluation of those used in the hospitals of a regional health service. Criteria have been designed from the analysis of existing regulations, previous studies and consultation with key experts. The interobserver concordance was assessed using the kappa index. Criteria evaluation was performed on 1425 documents of 9 hospitals. A total of 19 criteria used in the evaluation of the quality of informed consent forms have been obtained. Kappa values were higher than 0,60 in 17 of them and higher than 0,52 in the other 2. The average number of defects per document was 7.6, with a high-low ratio among hospitals of 1.84. More than 90% of the documents had defects in the information on consequences and contraindications, and in about 90% it did not mention the copy to the patient. More than 60% did not comply with stating the purpose of the procedure, a statement of having understood and clarified doubts, and the treatment options. A tool has been obtained to reliably assess the formal quality of the informed consent forms. The documents assessed have a wide margin for improvement related to giving a copy to the patient, and some aspects of the specific information that patients should receive. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

47 CFR 5.59 - Forms to be used.

Code of Federal Regulations, 2010 CFR

2010-10-01

... submitted on this form. (e) Application for consent to transfer control of Corporation holding experimental... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL EXPERIMENTAL RADIO SERVICE (OTHER THAN BROADCAST) Applications and Licenses § 5.59 Forms to be used. (a) Application for experimental radio license. Entities...

47 CFR 5.59 - Forms to be used.

Code of Federal Regulations, 2011 CFR

2011-10-01

... submitted on this form. (e) Application for consent to transfer control of Corporation holding experimental... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL EXPERIMENTAL RADIO SERVICE (OTHER THAN BROADCAST) Applications and Licenses § 5.59 Forms to be used. (a) Application for experimental radio license. Entities...

47 CFR 5.59 - Forms to be used.

Code of Federal Regulations, 2012 CFR

2012-10-01

... submitted on this form. (e) Application for consent to transfer control of Corporation holding experimental... Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL EXPERIMENTAL RADIO SERVICE (OTHER THAN BROADCAST) Applications and Licenses § 5.59 Forms to be used. (a) Application for experimental radio license. Entities...

Securing recruitment and obtaining informed consent in minority ethnic groups in the UK.

PubMed

Lloyd, Cathy E; Johnson, Mark R D; Mughal, Shanaz; Sturt, Jackie A; Collins, Gary S; Roy, Tapash; Bibi, Rukhsana; Barnett, Anthony H

2008-03-30

Previous health research has often explicitly excluded individuals from minority ethnic backgrounds due to perceived cultural and communication difficulties, including studies where there might be language/literacy problems in obtaining informed consent. This study addressed these difficulties by developing audio-recorded methods of obtaining informed consent and recording data. This report outlines 1) our experiences with securing recruitment to a qualitative study investigating alternative methods of data collection, and 2) the development of a standardised process for obtaining informed consent from individuals from minority ethnic backgrounds whose main language does not have an agreed written form. Two researchers from South Asian backgrounds recruited adults with Type 2 diabetes whose main language was spoken and not written, to attend a series of focus groups. A screening tool was used at recruitment in order to assess literacy skills in potential participants. Informed consent was obtained using audio-recordings of the patient information and recording patients' verbal consent. Participants' perceptions of this method of obtaining consent were recorded. Recruitment rates were improved by using telephone compared to face-to-face methods. The screening tool was found to be acceptable by all potential participants. Audio-recorded methods of obtaining informed consent were easy to implement and accepted by all participants. Attrition rates differed according to ethnic group. Snowballing techniques only partly improved participation rates. Audio-recorded methods of obtaining informed consent are an acceptable alternative to written consent in study populations where literacy skills are variable. Further exploration of issues relating to attrition is required, and a range of methods may be necessary in order to maximise response and participation rates.

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

PubMed

Cox, Cheryl; Macpherson, CNL

1996-07-01

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

Challenges to obtaining parental permission for child participation in a school-based waterpipe tobacco smoking prevention intervention in Qatar.

PubMed

Nakkash, Rima T; Al Mulla, Ahmad; Torossian, Lena; Karhily, Roubina; Shuayb, Lama; Mahfoud, Ziyad R; Janahi, Ibrahim; Al Ansari, Al Anoud; Afifi, Rema A

2014-09-30

Involving children in research studies requires obtaining parental permission. A school-based intervention to delay/prevent waterpipe use for 7th and 8th graders in Qatar was developed, and parental permission requested. Fifty three percent (2308/4314) of the parents returned permission forms; of those 19.5% of the total (840/4314) granted permission. This paper describes the challenges to obtaining parental permission. No research to date has described such challenges in the Arab world. A random sample of 40 schools in Doha, Qatar was selected for inclusion in the original intervention. Permission forms were distributed to parents for approval of their child's participation. The permission forms requested that parents indicate their reasons for non-permission if they declined. These were categorized into themes. In order to understand reasons for non-permission, interviews with parents were conducted. Phone numbers of parents were requested from the school administration; 12 of the 40 schools (30%) agreed to provide the contact information. A random sample of 28 parents from 12 schools was interviewed to reach data saturation. Thematic analysis was used to analyze their responses. Reasons for non-permission documented in both the forms and interviews included: poor timing; lack of interest; the child not wanting to participate; and the child living in a smoke-free environment. Interviews provided information on important topics to include in the consent forms, parents' decision-making processes regarding their child's participation, and considerations for communicating with parents. Many parents also indicated that this was the first time they had been asked to give an informed consent for their child's participation in a study. Results indicate that more attention needs to be given to the informed parental consent process. Researchers should consider enhancing both the methods of communicating information as well the specific information provided. Before embarking on recruitment of children for studies, formative research on the parental consent process is suggested.

Blockchain protocols in clinical trials: Transparency and traceability of consent.

PubMed

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2017-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.

Blockchain protocols in clinical trials: Transparency and traceability of consent

PubMed Central

Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

2018-01-01

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility. PMID:29167732

Naming it 'nano': Expert views on 'nano' terminology in informed consent forms of first-in-human nanomedicine trials.

PubMed

Satalkar, Priya; Elger, Bernice Simone; Shaw, David

2016-04-01

Obtaining valid informed consent (IC) can be challenging in first-in-human (FIH) trials in nanomedicine due to the complex interventions, the hype and hope concerning potential benefits, and fear of harms attributed to 'nano' particles. We describe and analyze the opinions of expert stakeholders involved in translational nanomedicine regarding explicit use of 'nano' terminology in IC documents. We draw on content analysis of 46 in-depth interviews with European and North American stakeholders. We received a spectrum of responses (reluctance, ambivalence, absolute insistence) on explicit mention of 'nano' in IC forms with underlying reasons. We conclude that consistent, clear and honest communication regarding the 'nano' dimension of investigational product is critical in IC forms of FIH trials.

Readability of informed consent forms in clinical trials conducted in a skin research center

PubMed Central

Samadi, Aniseh; Asghari, Fariba

2016-01-01

Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

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.

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)

Qualitative thematic analysis of consent forms used in cancer genome sequencing

PubMed Central

2011-01-01

Background Large-scale whole genome sequencing (WGS) studies promise to revolutionize cancer research by identifying targets for therapy and by discovering molecular biomarkers to aid early diagnosis, to better determine prognosis and to improve treatment response prediction. Such projects raise a number of ethical, legal, and social (ELS) issues that should be considered. In this study, we set out to discover how these issues are being handled across different jurisdictions. Methods We examined informed consent (IC) forms from 30 cancer genome sequencing studies to assess (1) stated purpose of sample collection, (2) scope of consent requested, (3) data sharing protocols (4) privacy protection measures, (5) described risks of participation, (6) subject re-contacting, and (7) protocol for withdrawal. Results There is a high degree of similarity in how cancer researchers engaged in WGS are protecting participant privacy. We observed a strong trend towards both using samples for additional, unspecified research and sharing data with other investigators. IC forms were varied in terms of how they discussed re-contacting participants, returning results and facilitating participant withdrawal. Contrary to expectation, there were no consistent trends that emerged over the eight year period from which forms were collected. Conclusion Examining IC forms from WGS studies elucidates how investigators are handling ELS challenges posed by this research. This information is important for ensuring that while the public benefits of research are maximized, the rights of participants are also being appropriately respected. PMID:21771309

Are Parents of Preschool Children Inclined to Give Consent for Participation in Nutritional Clinical Trials?

PubMed

Nimbalkar, Somashekhar Marutirao; Patel, Dipen Vasudev; Phatak, Ajay Gajanan

2016-01-01

Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study. After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return. Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents' willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children. The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population's motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base.

31 CFR 341.10 - Reissue.

Code of Federal Regulations, 2012 CFR

2012-07-01

... the case of a bond registered in beneficiary form upon the owner's request on Form PD 3564. No consent..., Parkersburg, WV 26101. [28 FR 405, Jan 16, 1963, as amended at 42 FR 21611, Apr. 28, 1977; 42 FR 57123, Nov. 1...

31 CFR 341.10 - Reissue.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the case of a bond registered in beneficiary form upon the owner's request on Form PD 3564. No consent..., Parkersburg, WV 26101. [28 FR 405, Jan 16, 1963, as amended at 42 FR 21611, Apr. 28, 1977; 42 FR 57123, Nov. 1...

31 CFR 341.10 - Reissue.

Code of Federal Regulations, 2011 CFR

2011-07-01

... the case of a bond registered in beneficiary form upon the owner's request on Form PD 3564. No consent..., Parkersburg, WV 26101. [28 FR 405, Jan 16, 1963, as amended at 42 FR 21611, Apr. 28, 1977; 42 FR 57123, Nov. 1...

Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

PubMed

Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

2017-11-01

Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P < 0.0005), highest in infection (96.1%) and lowest in recurrence (52.3%). For patient recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients <65 years old recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to <2 days before their surgeries had higher recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

Voluntary Informed Consent in Paediatric Oncology Research.

PubMed

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

2016-07-01

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

Rites of consent: negotiating research participation in diverse cultures.

PubMed

Barrett, Robert J; Parker, Damon B

2003-04-01

The significance of informed consent in research involving humans has been a topic of active debate in the last decade. Much of this debate, we submit, is predicated on an ideology of individualism. We draw on our experiences as anthropologists working in Western and non Western (Iban) health care settings to present ethnographic data derived from diverse scenes in which consent is gained. Employing classical anthropological ritual theory, we subject these observational data to comparative analysis. Our article argues that the individualist assumptions underlying current bioethics guidelines do not have universal applicability, even in Western research settings. This is based on the recognition that the social world is constitutive of personhood in diverse forms, just one of which is individualistic. We submit that greater attention must be paid to the social relations the researcher inevitably engages in when conducting research involving other people, be this in the context of conventional medical research or anthropological field work. We propose, firstly, that the consenting process continues throughout the life of any research project, long after the signature has been secured, and secondly, that both group and individual dimensions of consent, and the sequence in which these dimensions are addressed, should be carefully considered in all cases where consent is sought.

Big Data and Health Research-The Governance Challenges in a Mixed Data Economy.

PubMed

Holm, Søren; Ploug, Thomas

2017-12-01

Denmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported by facilitative regulation that allows data to be used without the consent of data subjects. However, in the future much of the data will not be held by public authorities but by private companies. What are the implications of this shift for the governance of the research use of the data? This paper will argue that increased involvement of Research Ethics Committees and better training of researchers are necessary; and that some form of consent will have to be re-introduced. Four different consent models will be discussed: Opt-Out, Broad/Blanket consent, Dynamic consent, and Meta consent. It will be argued that a governance model including a possibility for citizens to make meta-choices strikes the best balance between individual and public interests.

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

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

PubMed Central

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

2017-01-01

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

Consent for Brain Tissue Donation after Intracerebral Haemorrhage: A Community-Based Study.

PubMed

Samarasekera, Neshika; Lerpiniere, Christine; Fonville, Arthur F; Farrall, Andrew J; Wardlaw, Joanna M; White, Philip M; Torgersen, Antonia; Ironside, James W; Smith, Colin; Al-Shahi Salman, Rustam

2015-01-01

Spontaneous intracerebral haemorrhage is a devastating form of stroke and its incidence increases with age. Obtaining brain tissue following intracerebral haemorrhage helps to understand its cause. Given declining autopsy rates worldwide, the feasibility of establishing an autopsy-based collection and its generalisability are uncertain. We used multiple overlapping sources of case ascertainment to identify every adult diagnosed with intracerebral haemorrhage between 1st June 2010-31st May 2012, whilst resident in the Lothian region of Scotland. We sought consent from patients with intracerebral haemorrhage (or their nearest relative if the patient lacked mental capacity) to conduct a research autopsy. Of 295 adults with acute intracerebral haemorrhage, 110 (37%) could not be approached to consider donation. Of 185 adults/relatives approached, 91 (49%) consented to research autopsy. There were no differences in baseline demographic variables or markers of intracerebral haemorrhage severity between consenters and non-consenters. Adults who died and became donors (n = 46) differed from the rest of the cohort (n = 249) by being older (median age 80, IQR 76-86 vs. 75, IQR 65-83, p = 0.002) and having larger haemorrhages (median volume 23 ml, IQR 13-50 vs. 13 ml, IQR 4-40; p = 0.002). Nearly half of those approached consent to brain tissue donation after acute intracerebral haemorrhage. The characteristics of adults who gave consent were comparable to those in an entire community, although those who donate early are older and have larger haemorrhage volumes.

To What did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka, Zambia.

PubMed

Munalula-Nkandu, Esther; Ndebele, Paul; Siziya, Seter; Munthali, J C

2015-12-01

We conducted a study to review the consenting process in a vaginal microbicide feasibility study conducted in Mazabuka, Zambia. Participants were drawn from those participating in the microbicide study. A questionnaire and focus group discussion were used to collect information on participants' understanding of study aims, risks and benefits. Altogether, 200 participants took part in this study. The results of the study showed that while all participants signed or endorsed their thumbprints to the consent forms, full informed consent was not attained from most of the participants since 77% (n = 154) of the participants had numerous questions about the study and 34% (n = 68) did not know who to get in touch with concerning the study. Study objectives were not fully understood by over 61% of the participants. Sixty four percent of the participants were not sure of the risks of taking part in the microbicide study. A significant number thought the study was all about determining their HIV status. Some participants were concerned that their partners were not on the trial as they were convinced that being on the study meant that that they had a lifetime protection from HIV infection. The process of obtaining consent was inadequate as various phases of the study were not fully understood. We recommend the need for researchers to reinforce the consenting process in all studies and more so when studies are conducted in low literacy populations. © 2014 John Wiley & Sons Ltd.

Medical records and privacy: empirical effects of legislation.

PubMed

McCarthy, D B; Shatin, D; Drinkard, C R; Kleinman, J H; Gardner, J S

1999-04-01

To determine the effects of state legislation requiring patient informed consent prior to medical record abstraction by external researchers for a specific study. Informed consent responses obtained from November 1997 through April 1998 from members of a Minnesota-based IPA model health plan. Descriptive case study of consent to gain access to medical records for a pharmaco-epidemiologic study of seizures associated with use of a pain medication that was conducted as part of the FDA's post-marketing safety surveillance program to evaluate adverse events associated with approved drugs. The informed consent process approved by an institutional review board consisted of three phases: (1) a letter from the health plan's medical director requesting participation, (2) a second mailing to nonrespondents, and (3) a follow-up telephone call to nonrespondents. Of 140 Minnesota health plan members asked to participate in the medical records study, 52 percent (73) responded and 19 percent (26) returned a signed consent form authorizing access to their records for the study. For 132 study subjects enrolled in five other health plans in states where study-specific consent was not required, health care providers granted access to patient medical records for 93 percent (123) of the members. Legislation requiring patient informed consent to gain access to medical records for a specific research study was associated with low participation and increased time to complete that observational study. Efforts to protect patient privacy may come into conflict with the ability to produce timely and valid research to safeguard and improve public health.

Effects of financial incentives on the intention to consent to organ donation: a questionnaire survey.

PubMed

Mayrhofer-Reinhartshuber, D; Fitzgerald, A; Benetka, G; Fitzgerald, R

2006-11-01

Shortage of donor organs is a serious problem for transplantation medicine. One controversial suggestion to increase the number of organ donors is financial incentives for consent. The aim of this study was to test whether different forms and amounts of financial incentives were apt to increase the consent to organ donation. Data were collected via questionnaires in urban and rural regions of Austria and randomly assigned to settings with three different amounts of financial incentives. The questionnaire was designed by using the theory of planned behaviour of Ajzen. Parents 69 mothers and 35 fathers; ages 25 to 65 years were evaluated for intention to consent to organ donation, perceived social norm, and positive/ negative aspects of organ donation without and with various financial incentives. The intention to consent to organ donation dropped highly significantly (Z = -7.556 P = .000) from the basic condition (M = 1.13; confidence interval [CIs] 0.78 to 1.51) to the condition with financial incentives (M = -1.58; CI, 1.96 to -1.15). No influence of the amount of financial incentive was observed. Highly significant differences were measured between both conditions for the social norm (Z = -5.638; P < .000) and the attitude toward organ donation (Z = -1.962; P < .05; Z = -2.104; P < .035). Financial incentives led to decreased consents and elicited strong rejections and negative reactions of the participants. Taking money for consent to organ donation seems to be a strict taboo for most people in Austrian society.

"She made up a choice for me": 22 HIV-positive women's experiences of involuntary sterilization in two South African provinces.

PubMed

Strode, Ann; Mthembu, Sethembiso; Essack, Zaynab

2012-12-01

Since 1998 South African law has provided that adults should have access to sterilization but only with their informed consent. However, the right to sterilization and other sexual and reproductive rights have not been fully realized as women struggle to access limited services, and there are allegations of discrimination and sterilization abuses. This qualitative study explores the experiences of 22 HIV-positive women in two provinces who reported being sterilized between 1996 and 2010 without their informed consent (n=18) or without their knowledge (n=4). Key issues reported by participants included failure to respect their autonomy, lack of information given about what sterilization entailed, and subtle or overt pressure to sign the consent form. Although the legal framework was intended to ensure informed decision-making regarding sterilization, these protections appear to have failed the HIV-positive women in this study. The findings suggest that some health professionals may consider a signature on a consent form as sufficient regardless of how it was obtained. Furthermore the women's perceptions that they were singled out as needing to be sterilized simply because they were HIV-positive warrants further investigation. More research is required on the nature of the problem and on other stakeholders' perceptions. Copyright © 2012 Reproductive Health Matters. Published by Elsevier Ltd. All rights reserved.

Parental attitudes towards and perceptions of their children's participation in clinical research: a developing-country perspective.

PubMed

Nabulsi, Mona; Khalil, Yvette; Makhoul, Jihad

2011-07-01

Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials. To explore such perceptions and attitudes in Lebanese parents. 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed in colloquial Arabic, and later subjected to thematic analysis. Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term 'randomisation' hindered parental approval of participation. Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation.

A qualitative study to assess school nurses' views on vaccinating 12-13 year old school girls against human papillomavirus without parental consent.

PubMed

Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

2009-07-21

In the UK, parental consent for the routine vaccination of 12-13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given, and in the UK, this includes conducting, and acting upon, an assessment of the maturity and competence of an adolescent minor. To facilitate this, policies, training and support structures for health providers should be implemented.

A qualitative study to assess school nurses' views on vaccinating 12–13 year old school girls against human papillomavirus without parental consent

PubMed Central

Stretch, Rebecca; McCann, Rosemary; Roberts, Stephen A; Elton, Peter; Baxter, David; Brabin, Loretta

2009-01-01

Background In the UK, parental consent for the routine vaccination of 12–13 year olds schoolgirls against human papillomavirus (HPV) is recommended, although legally girls may be able to consent themselves. As part of a vaccine study conducted ahead of the National HPV Vaccine Programme we sought the views of school nurses on vaccinating girls who did not have parental consent. Methods HPV vaccination was offered to all 12 year old girls attending schools in two Primary Care Trusts in Greater Manchester. At the end of the study semi-structured, tape-recorded interviews were conducted with school nurses who had delivered the vaccine (Cervarix™). The interview template was based on concepts derived from the Theory of Planned Behaviour. Transcripts were analysed thematically in order to understand school nurses' intentions to implement vaccination based on an assessment of Gillick competency. Results School nurses knew how to assess the competency of under-16s but were still unwilling to vaccinate if parents had refused permission. If parents had not returned the consent form, school nurses were willing to contact parents, and also to negotiate with parents who had refused consent. They seemed unaware that parental involvement required the child's consent to avoid breaking confidentiality. Nurses' attitudes were influenced by the young appearance and age of the school year group rather than an individual's level of maturity. They were also confused about the legal guidelines governing consent. School nurses acknowledged the child's right to vaccination and strongly supported prevention of HPV infection but ultimately believed that it was the parents' right to give consent. Most were themselves parents and shared other parents' concerns about the vaccine's novelty and unknown long-term side effects. Rather than vaccinate without parental consent, school nurses would defer vaccination. Conclusion Health providers have a duty of care to girls for whom no parental consent for HPV vaccination has been given, and in the UK, this includes conducting, and acting upon, an assessment of the maturity and competence of an adolescent minor. To facilitate this, policies, training and support structures for health providers should be implemented. PMID:19622145

Differentiating and evaluating common good and public good: making implicit assumptions explicit in the contexts of consent and duty to participate.

PubMed

Bialobrzeski, A; Ried, J; Dabrock, P

2012-01-01

The notions 'common good' and 'public good' are mostly used as synonyms in bioethical discussion of biobanks, but have different origins. As a consequence, they should be applied differently. In this article, the respective characteristics are worked out and then subsequently examined which consent models emerge from them. Distinguishing normative and descriptive traits of both concepts, it turns out that one concept is unjustly used, and that the other one fits better to the context of a plural society. A reflected use of these differing concepts may help to choose an appropriate form of consent and allows public trust in biobank research to deepen. Copyright © 2012 S. Karger AG, Basel.

A School-Located Vaccination Adolescent Pilot Initiative in Chicago: Lessons Learned.

PubMed

Caskey, Rachel N; Macario, Everly; Johnson, Daniel C; Hamlish, Tamara; Alexander, Kenneth A

2013-09-01

Many adolescents underutilize preventive services and are underimmunized. To promote medical homes and increase immunization rates, we conceptualized and implemented a 3-year, 8-school pilot school-located vaccination collaborative program. We sought community, parent, and school nurse input the year prior to implementation. We selected schools with predominantly Medicaid-enrolled or Medicaid-eligible students to receive Vaccines For Children stock vaccines. Nurses employed by a mass immunizer delivered these vaccines at participating schools 3 times a year. Over 3 years, we delivered approximately 1800 vaccines at schools. School administrators, health centers, and neighboring private physicians generally welcomed the program. Parents did not express overt concerns about school-located vaccination. School nurses were not able to participate because of multiple school assignments. Obtaining parental consent via backpack mail was an inefficient process, and classroom incentives did not increase consent form return rate. The influenza vaccine had the most prolific uptake. The optimal time for administering vaccines was during regular school hours. Although school-located vaccination for adolescents is feasible, this is a paradigm shift for community members and thus accompanies challenges in implementation. High principal or school personnel turnover led to a consequent lack of institutional memory. It was difficult to communicate directly with parents. Because we were uncertain about the proportion of parents who received consent forms, we are exploring Internet-based and back-to-school registration options for making the consent form distribution and return process more rigorous. Securing an immunization champion at each school helped the immunization processes. Identifying a financially sustainable school-located vaccination model is critical for national expansion of school-located vaccination. © The Author 2013. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Patient's autonomy of will in Polish law.

PubMed

Swiderska, Małgorzata

2012-09-01

A principle of Polish legislation is that the evidence of legality for any medical intervention is the patient's consent. The issue is directly referred to by both the Patient's Rights Act from 2008 and the Medical Profession Act from 1996. The patient's consent may be given after obtaining reliable, accessible and thorough information about all stages of medical intervention: diagnosis, therapy prospects or rehabilitation. The extent of information about the potential risk of medical treatment should include the typically foreseeable results, which usually brings the matter down to typical risk. However, there are interventions, which bear greater risk, and even though it can't be considered typical, it should also be mentioned, despite the fact that the postulate of tactfulness should be respected here. The burden of proof that appropriate information has been given lies upon the doctor. Thus default consent, especially one given on being admitted to hospital, to all medical actions isn't valid in legal terms. The role of forms including standard information for giving consent is limited. Polish law doesn't regulate this issue, and other forms of indirect communication are used as auxiliary and cannot replace direct contact between a patient and a doctor. According to the Patient's Rights Act, in case of deliberate breach of those rights, the court can grant the aggrieved party with an appropriate sum as financial compensation for the harm sustained or an appropriate sum of money for the charity chosen by the aggrieved party. It is a legal basis for claiming compensation for non-material harm in case of a breach of the patient's right to give consent. It is possible both in case of liability in tort, as well as contractual claims.

Mandating audio-video recording of informed consent: are we right in enforcing this?

PubMed

Agrawal, A R; Joshi, R P; Shah, V

2014-07-01

Medicines are the result of experimentation carried out in animals and humans. However, there are numerous instances in the history of medicine where humans were subjected to undue risks and abuses, requiring regulations for their safety. Idea of informed consent has found its presence in medical literature from the times of Hippocratic Oath propagating principles of '...never do harm to anyone' and physician directed care of patients. This was revived in post-world war II era in the form of Nuremberg code and the declaration of Helsinki in response to various debilitating experimentations done on prisoners in concentration camps and elsewhere. Complete information and voluntary participation forms the ethical tenets of these acts and the same has been reflected in various guidelines enacted worldwide, which are sufficient to make sure that patient consent is obtained in fair and just manner. Despite this, there have been undesirable lapses in the conduct of clinical trials. This situation worsens, when intentional lapses in conduct of trial hamper the ability of socially and economically disadvantaged communities in developing countries to make free and informed decision.

[The meaning of autonomy in Chinese culture: obtaining informed consent for operation].

PubMed

Lin, Mei-Ling; Wu, Jo Yung-Wei; Huang, Mei-Chih

2008-10-01

The purpose of gaining the patient's informed consent is ethical, lying in respect for his or her autonomy, and such consent forms the foundation for the performance of clinical medical treatment. In order to respect the patient's autonomy, for example, during decisions about operations, doctors have the obligation to clearly explain that patient's medical condition to him/her. A thorough briefing should be given prior to the obtaining of the patients' consent. In fulfillment of their duties as medical professionals, both doctors and nurses should be involved in clinically informing patients as well as in obtaining their signature for operation and anesthesia. Although informing patients about their physical state is not the responsibility of nurses, it remains absolutely necessary for nurses to understand how people in Asian cultures understand autonomy. This paper begins with a discussion of autonomy in ethics, and then outlines the differences between the Eastern and Western concepts of autonomy, before discussing the obtaining of the signature of consent, a process performed by the nursing staff during clinical treatment, and resulting in the provision of such signatures by patients with the legal capacity to provide them.

Consent for participating in clinical trials - Is it really informed?

PubMed

Alexa-Stratulat, Teodora; Neagu, Marius; Neagu, Anca-Iulia; Alexa, Ioana Dana; Ioan, Beatrice Gabriela

2018-06-22

The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north-eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants' decision-making is meaningful and that their interests are protected. © 2018 John Wiley & Sons Ltd.

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

29 CFR 2520.104b-1 - Disclosure.

Code of Federal Regulations, 2011 CFR

2011-07-01

... documents furnished in electronic form at any location where the participant is reasonably expected to... or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent; (B) In the case of documents to be furnished through the Internet or other electronic...

29 CFR 2520.104b-1 - Disclosure.

Code of Federal Regulations, 2014 CFR

2014-07-01

... documents furnished in electronic form at any location where the participant is reasonably expected to... or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent; (B) In the case of documents to be furnished through the Internet or other electronic...

29 CFR 2520.104b-1 - Disclosure.

Code of Federal Regulations, 2012 CFR

2012-07-01

... documents furnished in electronic form at any location where the participant is reasonably expected to... or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent; (B) In the case of documents to be furnished through the Internet or other electronic...

29 CFR 2520.104b-1 - Disclosure.

Code of Federal Regulations, 2013 CFR

2013-07-01

... documents furnished in electronic form at any location where the participant is reasonably expected to... or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent; (B) In the case of documents to be furnished through the Internet or other electronic...

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

NASA Technical Reports Server (NTRS)

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

2015-01-01

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

Reading Level and Length of Written Research Consent Forms

PubMed Central

Foe, Gabriella; Lally, Rachel

2015-01-01

Abstract In 100 Institutional Review Board approved consent forms (CFs), we assessed pages, reading levels, and whether they included essential elements. CF page numbers ranged from 3 to 28 (mean, 10.3) and readability ranged from grades 5.6 to 28.9 (mean, 11.6). The CF mean score for including essential elements was 90.8% (range: 63.5–100%). There were no significant differences by specialty in number of pages (p = 0.053), but surgical specialties had the highest readability (mean, 13.1), and pediatrics the lowest (10.5), p = 0.008. While approved CFs generally included the Office for Human Research Protections recommended essential elements, they were very long, and even pediatric forms, which had the lowest reading levels, were written on average at a tenth grade level. Researchers need guidance to resolve pressure between regulatory mandates and guidelines and “keeping it simple and clear.” PMID:25580939

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

PubMed

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

2014-05-02

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

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

PubMed Central

2014-01-01

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

29 CFR 37.74 - Are there any forms that a complainant may use to file a complaint?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Are there any forms that a complainant may use to file a... Procedures § 37.74 Are there any forms that a complainant may use to file a complaint? Yes. A complainant may file a complaint by completing and submitting CRC's Complaint Information and Privacy Act Consent Forms...

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.

Analysis of the concept of informed consent concerning the use of genetic material according to the European Convention on Bioethics and in other solutionsm - Propositions for broad consent for future genetic research from the point of view of the activity of the Biobank.

PubMed

Patryn, Rafał; Sak, Jarosław

2017-09-21

The aim of the article is a critical presentation of the typology of consents included in the European Convention on Bioethics and in other formal solutions concerning the gathering of genetic material in institutions called Biobanks. Existing types of Acts of Consent are inaccurate in their scope and possess insufficient information regarding the gathering of genetic material (application, usage, processing) and their final (future and diverse) use. Lack of precise legal regulations on the broad future use of genetic material may result in various formal problems relating both to research participants as well as those commissioning the research. Ultimately, it may lead to various complications with the appropriate legal interpretation of consent and possible claims on behalf of the donors. The presented proposition of consent with a terminal premise is to be applied eventually to legal and formal aspects of the collecting of genetic material. It is a possible solution which would clarify the issue of informed consent, and may be implemented in the regulations of the Convention as well as constitute a self-contained legislative solution to this matter. For example, Polish law in its current form, without the ratification of the Bioethical Convention, allows the collecting of material for genetic testing for determination of the risk of genetic defects in common genetic material from people who are planning to have a child.

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

PubMed

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

2017-05-01

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

77 FR 69505 - Notice of Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-19

... application forms, parental consent forms, and pre and post parent/student surveys. Surveys are designed to... programs are designed to engage underrepresented rising 5th-8th grade students in a one-on-one virtual... mentoring opportunities in science, technology, engineering, and math (STEM) disciplines for female students...

78 FR 77696 - Agency Information Collection Activities: Application for Permission To Reapply for Admission...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

...-0018] Agency Information Collection Activities: Application for Permission To Reapply for Admission... Collection. (2) Title of the Form/Collection: Application for Permission to Reapply for Admission into the... on Form I-212 is used by USCIS to adjudicate applications filed by aliens requesting consent to...

77 FR 40702 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention... Estate. Form: PD F 3565. Abstract: Used by heirs of deceased owners of Retirement Plan and/ or Individual... Being Settled Without Administration. Form: PD F 1050. Abstract: Used to obtain creditors consent to...

Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon

PubMed Central

2012-01-01

Background Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist’s potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. Method Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. Results Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77%) and informed consent in 77 (47.83%). Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01%) and was not reported in any Bachelors’ degree dissertation. Informed consent was also highly reported in MD theses (64.58%) followed by undergraduate theses (31.58%). Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. Conclusions Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE) be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance. PMID:22686445

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

PubMed

Montalvo, Wanda; Larson, Elaine

2014-11-01

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

Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon.

PubMed

Munung, Nchangwi Syntia; Tangwa, Godfrey B; Che, Chi Primus; Vidal, Laurent; Ouwe-Missi-Oukem-Boyer, Odile

2012-06-11

Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist's potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics. Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed. Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77%) and informed consent in 77 (47.83%). Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01%) and was not reported in any Bachelors' degree dissertation. Informed consent was also highly reported in MD theses (64.58%) followed by undergraduate theses (31.58%). Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned. Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE) be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance.

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.

Retrospective access to data: the ENGAGE consent experience

PubMed Central

Tassé, Anne Marie; Budin-Ljøsne, Isabelle; Knoppers, Bartha Maria; Harris, Jennifer R

2010-01-01

The rapid emergence of large-scale genetic databases raises issues at the nexus of medical law and ethics, as well as the need, at both national and international levels, for an appropriate and effective framework for their governance. This is even more so for retrospective access to data for secondary uses, wherein the original consent did not foresee such use. The first part of this paper provides a brief historical overview of the ethical and legal frameworks governing consent issues in biobanking generally, before turning to the secondary use of retrospective data in epidemiological biobanks. Such use raises particularly complex issues when (1) the original consent provided is restricted; (2) the minor research subject reaches legal age; (3) the research subject dies; or (4) samples and data were obtained during medical care. Our analysis demonstrates the inconclusive, and even contradictory, nature of guidelines and confirms the current lack of compatible regulations. The second part of this paper uses the European Network for Genetic and Genomic Epidemiology (ENGAGE Consortium) as a case study to illustrate the challenges of research using previously collected data sets in Europe. Our study of 52 ENGAGE consent forms and information documents shows that a broad range of mechanisms were developed to enable secondary use of the data that are part of the ENGAGE Consortium. PMID:20332813

Retrospective access to data: the ENGAGE consent experience.

PubMed

Tassé, Anne Marie; Budin-Ljøsne, Isabelle; Knoppers, Bartha Maria; Harris, Jennifer R

2010-07-01

The rapid emergence of large-scale genetic databases raises issues at the nexus of medical law and ethics, as well as the need, at both national and international levels, for an appropriate and effective framework for their governance. This is even more so for retrospective access to data for secondary uses, wherein the original consent did not foresee such use. The first part of this paper provides a brief historical overview of the ethical and legal frameworks governing consent issues in biobanking generally, before turning to the secondary use of retrospective data in epidemiological biobanks. Such use raises particularly complex issues when (1) the original consent provided is restricted; (2) the minor research subject reaches legal age; (3) the research subject dies; or (4) samples and data were obtained during medical care. Our analysis demonstrates the inconclusive, and even contradictory, nature of guidelines and confirms the current lack of compatible regulations. The second part of this paper uses the European Network for Genetic and Genomic Epidemiology (ENGAGE Consortium) as a case study to illustrate the challenges of research using previously collected data sets in Europe. Our study of 52 ENGAGE consent forms and information documents shows that a broad range of mechanisms were developed to enable secondary use of the data that are part of the ENGAGE Consortium.

Decision-making capacity for research participation among addicted people: a cross-sectional study.

PubMed

Morán-Sánchez, Inés; Luna, Aurelio; Sánchez-Muñoz, Maria; Aguilera-Alcaraz, Beatriz; Pérez-Cárceles, Maria D

2016-01-13

Informed consent is a key element of ethical clinical research. Addicted population may be at risk for impaired consent capacity. However, very little research has focused on their comprehension of consent forms. The aim of this study is to assess the capacity of addicted individuals to provide consent to research. 53 subjects with DSM-5 diagnoses of a Substance Use Disorder (SUD) and 50 non psychiatric comparison subjects (NPCs) participated in the survey from December 2014 to March 2015. This cross-sectional study was carried out at a community-based Outpatient Treatment Center and at an urban-located Health Centre in Spain. A binary judgment of capacity/incapacity was made guided by the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and a clinical interview. Demographics and clinical characteristics were assessed by cases notes and the Mini-Mental State Examination, the Global Assessment Functional Scale and the Clinical Global Impression Scale. NPCs performed the best on the MacCAT-CR, and patients with SUD had the worst performance, particularly on the Understanding and Appreciation subscales. 32.7% SUD people lacked research-related decisional capacity. There were no statistically significant differences between the groups in terms of capacity to consent to research. The findings of our study provide evidence that a large proportion of individuals with SUD had decisional capacity for consent to research. It is therefore inappropriate to draw conclusions about capacity to make research decisions on the basis of a SUD diagnosis. In the absence of advanced cognitive impairment, acute withdrawal or intoxication, we should assume that addicted persons possess decision-making capacity. Thus, the view that people with SUD would ipso facto lose decision-making power for research consent is flawed and stigmatizing.

The requirement for prior consent to participate on survey response rates: a population-based survey in Grampian

PubMed Central

Angus, Val C; Entwistle, Vikki A; Emslie, Margaret J; Walker, Kim A; Andrew, Jane E

2003-01-01

Background A survey was carried out in the Grampian region of Scotland with a random sample of 10,000 adults registered with a General Practitioner in Grampian. The study complied with new legislation requiring a two-stage approach to identify and recruit participants, and examined the implications of this for response rates, non-response bias and speed of response. Methods A two-stage survey was carried out consistent with new confidentiality guidelines. Individuals were contacted by post and asked by the Director of Public Health to consent to receive a postal or electronic questionnaire about communicating their views to the NHS. Those who consented were then sent questionnaires. Response rates at both stages were measured. Results 25% of people returned signed consent forms and were invited to complete questionnaires. Respondents at the consent stage were more likely to be female (odds ratio (OR) response rate of women compared to men = 1.5, 95% CI 1.4, 1.7), less likely to live in deprived postal areas (OR = 0.59, 95% CI 0.45, 0.78) and more likely to be older (OR for people born in 1930–39 compared to people born in 1970–79 = 2.82, 95% CI 2.36, 3.37). 80% of people who were invited to complete questionnaires returned them. Response rates were higher among older age groups. The overall response rate to the survey was 20%, relative to the original number approached for consent (1951/10000). Conclusion The requirement of a separate, prior consent stage may significantly reduce overall survey response rates and necessitate the use of substantially larger initial samples for population surveys. It may also exacerbate non-response bias with respect to demographic variables. PMID:14622444

Legal aspects of the management of chronic pain.

PubMed

Mendelson, G; Mendelson, D

1991-11-04

To review the legal provisions which control the prescription of opioid analgesics in Australia, and to summarise the areas in which practitioners who treat patients with chronic pain may expect to become involved with the legal system. The relevant legislation was reviewed, and a selective review was undertaken of literature dealing with the legal aspects of pain and suffering which may form a basis for personal injury claims. Case law which deals with issues of consent to treatment was also examined. Statutory requirements which control the prescription of opioids were summarised. Leading cases on patient consent were discussed to clarify for the practitioner the principles which the Courts use in the assessment of the validity of the consent given by patients for treatment. The assessment of the pain patient involved in litigation was briefly discussed. The prescription and administration of opioid analgesics must be in accordance with the legislative provisions. Treatment options must be discussed and explained to patients so that valid consent can be obtained. Patients' questions must be answered in full, and documentation in the clinical record is required.

Strengthening protections for human subjects: proposed restrictions on the publication of transplant research involving prisoners.

PubMed

Valapour, Maryam; Paulson, Kristin M; Hilde, Alisha

2013-04-01

Publication is one of the primary rewards in the academic research community and is the first step in the dissemination of a new discovery that could lead to recognition and opportunity. Because of this, the publication of research can serve as a tacit endorsement of the methodology behind the science. This becomes a problem when vulnerable populations that are incapable of giving legitimate informed consent, such as prisoners, are used in research. The problem is especially critical in the field of transplant research, in which unverified consent can enable research that exploits the vulnerabilities of prisoners, especially those awaiting execution. Because the doctrine of informed consent is central to the protection of vulnerable populations, we have performed a historical analysis of the standards of informed consent in codes of international human subject protections to form the foundation for our limit and ban recommendations: (1) limit the publication of transplant research involving prisoners in general and (2) ban the publication of transplant research involving executed prisoners in particular. Copyright © 2013 American Association for the Study of Liver Diseases.

Coercion, competence, and consent in offenders with personality disorder

PubMed Central

Zlodre, J; Yiend, J; Burns, T

2016-01-01

Competence to consent to treatment has not previously been examined in a personality disorder cohort without comorbid mental disorder. We examined competence and coercion in 174 individuals diagnosed with severe personality disorder using two validated tools (the MacArthur Competence Assessment Tool for Treatment and the MacArthur Coercion Assessment Scale – Short Form). Competence was not categorically impaired, but there were variations within the sample on dimensional competence measures. Further, there were significant negative correlations between experienced coercion and competence. Higher coercion scores were associated with two components of competence: lower understanding and reasoning. Patients who consented to treatment had higher scores on competence measures and experienced less coercion. These findings suggest that therapeutic approaches that decrease experienced coercion and increase competence may increase the engagement of individuals diagnosed with severe personality disorders in treatment. PMID:27284235

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.…

76 FR 9579 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-18

... Enrollment, Chain and Ownership System (PECOS) Security Consent Form; Use: The primary function of the... proposed information collection for the proper performance of the Agency's function; (2) the accuracy of.... Form CMS-37 is the primary document used by CMS in developing the national Medicaid budget estimates...

76 FR 51472 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-18

... CUBES. Form: PD F 1832 E. Abstract: Used to certify assignments of U.S. registered definitive securities. Affected Public: Individuals or Households. Estimated Total Burden Hours: 1,250. OMB Number: 1535-0113... Consent with Respect to United States Savings Bond/Notes. Form: PD F 1849 E. Abstract: Used to obtain a...

Targeting Autophagy for the Treatment of TSC and LAM

DTIC Science & Technology

2013-10-01

UU 5 19b. TELEPHONE NUMBER (include area code) Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std. Z39.18 Page 3 of 5 Table...and consent form.  Summary of Amendment 04  A spirometry measurement was added to visit 6  Urinalysis was included in visit 6  Urine pregnancy

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.

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.

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.

Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial.

PubMed

Ellett, Lenore; Villegas, Rocio; Beischer, Andrew; Ong, Nicole; Maher, Peter

2014-01-01

To determine whether providing additional information to the standard consent process, in the form of a multimedia module (MM), improves patient knowledge about operative laparoscopy without increasing anxiety. Randomized controlled trial (Canadian Task Force classification I). Two outpatient gynecologic clinics, one in a private hospital and the other in a public teaching hospital. Forty-one women aged 19 to 51 years (median, 35.6 years) requiring operative laparoscopy for investigation and treatment of pelvic pain. Following the standard informed consent process, patients were randomized to watch the MM (intervention group, n = 21) or not (control group, n = 20). The surgeon was blinded to the group assignments. All patients completed a knowledge questionnaire and the Spielberger short-form State-Trait Anxiety Inventory. Six weeks after recruitment, patients completed the knowledge questionnaire and the State-Trait Anxiety Inventory a second time to assess knowledge retention and anxiety scores. Patient knowledge of operative laparoscopy, anxiety level, and acceptance of the MM were recorded. The MM intervention group demonstrated superior knowledge scores. Mean (SE) score in the MM group was 11.3 (0.49), and in the control group was 7.9 (0.50) (p <.001) (maximum score, 14). This did not translate into improved knowledge scores 6 weeks later; the score in the MM group was 8.4 (0.53) vs. 7.8 (0.50) in the control group (p = .44). There was no difference in anxiety levels between the groups at intervention or after 6 weeks. Overall, patients found the MM acceptable, and 18 women (86%) in the intervention group and 12 (60%) in the control group stated they would prefer this style of informed consent in the future. Use of an MM enhances the informed consent process by improving patient knowledge, in the short term, without increasing anxiety. Copyright © 2014 AAGL. Published by Elsevier Inc. All rights reserved.

Challenges in recruiting African-American women for a breast cancer genetics study.

PubMed

Compadre, Amanda J; Simonson, Melinda E; Gray, Katy; Runnells, Gail; Kadlubar, Susan; Zorn, Kristin K

2018-01-01

African-American women, especially in the southern United States, are underrepresented in cancer genetics research. A study was designed to address this issue by investigating the germline mutation rate in African-American women in Arkansas with a personal and/or family history of breast cancer. Women were tested for these mutations using a large panel of breast cancer susceptibility genes. In this analysis, we discuss the challenges encountered in recruiting African-American women from an existing biorepository to participate in this study. We attempted to contact 965 African-American women with a personal and/or family history of breast cancer who participated in Spit for the Cure (SFTC) between 2007 and 2013 and provided consent to be recontacted. The SFTC participants were invited by telephone and email to participate in the genetic study. Enrollment required completion of a phone interview to obtain a family and medical history and return of a signed consent form. Among eligible SFTC participants, 39.6% (382/965) were able to be contacted with the phone numbers and email addresses they provided. Of these, 174 (45.5%) completed a phone interview and returned a signed consent form. Others were not able to be contacted ( n  = 583), declined to participate ( n  = 57), did not keep phone interview appointments ( n  = 82), completed the phone interview but never returned a signed consent ( n  = 54), were deceased ( n  = 13), or were too confused to consent to participate ( n  = 2). Recruiting African-American women into our breast cancer genetics study proved challenging primarily due to difficulty establishing contact with potential participants. Given their prior participation in breast cancer research, we anticipated that this would be a highly motivated population. Indeed, when we were able to contact SFTC participants, only 14.9% declined to participate in our study. Innovative communication, retention, and recruitment strategies are needed in future studies to address the recruitment challenges we faced.

The Christchurch Tissue Bank to support cancer research.

PubMed

Morrin, Helen; Gunningham, Sarah; Currie, Margaret; Dachs, Gabi; Fox, Stephen; Robinson, Bridget

2005-11-11

To report on the development of a central resource of consented cancer tissues for researchers to use for ethically approved projects, and to describe the banking process. The development of tissue banking in Christchurch, New Zealand is described, including the number and main types of samples collected. The consent forms have evolved with several new donor options added between 1996 and 2004. Since June 2004, disposal of tissues by a karakia (blessing) has been offered. Characteristics of each tissue including amount, location in the bank, and relevant clinicopathological data have been recorded prospectively in a detailed secure relational database. The changes in the consent form and donor options are described. Most donors (99.6%) consented to allow access to medical records (since May 2002); 98.3% to tissue being sent overseas (since May 2003), 97.4% to commercial research (since May 2003), and 35.6% requested disposal with a karakia. Since May 2003, 87% of donors have been Caucasian, 5.1% Maori, and the remainder composed of other categories as stated on the 2001 New Zealand census format. By March 2005, samples have been banked from more than 2000 donors. For each of the last 4 years, samples have been collected from more than 300 donors, including fresh-frozen tissue, DNA preparations, serum, plasma, and paraffin blocks. The predominant tissues are from donors with cancers of the breast, colon, urological, and gynaecological sites. The Christchurch Tissue Bank is a successful model for potential New Zealand-wide application, providing quality tissue samples for cancer research whilst appropriately addressing ethical, legal, and cultural aspects of their collection.

78 FR 42591 - Proposed Collection; Comment Request for Regulation Project

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... consent of taxpayers before representing conflicting interests; (3) practitioners do not use e-commerce to... through the use of automated collection techniques or other forms of information technology; and (e...

Social Anxiety Disorders and Alcohol Abuse

MedlinePlus

... was self-destructive, and that compounded my low self-esteem. About 20 percent of people with social anxiety ... submitting this form, I am consenting to receive communications from ADAA. I have read and understand ADAA's ...

24 CFR 236.710 - Qualified tenant.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., the income of the individual or family must be determined to be too low to permit the individual or... consent forms for the obtaining of wage and claim information from State Wage Information Collection...

[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.

Patient representatives' views on patient information in clinical cancer trials.

PubMed

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-02-01

Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines.

PubMed

Symonds, R P; Lord, K; Mitchell, A J; Raghavan, D

2012-09-25

Throughout the world there are problems recruiting ethnic minority patients into cancer clinical trials. A major barrier to trial entry may be distrust of research and the medical system. This may be compounded by the regulatory framework governing research with an emphasis on written consent, closed questions and consent documentation, as well as fiscal issues. The Leicester UK experience is that trial accrual is better if British South Asian patients are approached by a senior doctor rather than someone of perceived lesser hierarchical status and a greater partnership between the hospital and General Practitioner may increase trial participation of this particular ethnic minority. In Los Angeles, USA, trial recruitment was improved by a greater utilisation of Hispanic staff and a Spanish language-based education programme. Involvement of community leaders is essential. While adhering to national, legal and ethnical standards, information sheets and consent, it helps if forms can be tailored towards the local ethnic minority population. Written translations are often of limited value in the recruitment of patients with no or limited knowledge of English. In some cultural settings, tape-recorded verbal consent (following approval presentations) may be an acceptable substitute for written consent, and appropriate legislative changes should be considered to facilitate this option. Approaches should be tailored to specific minority populations, taking consideration of their unique characteristics and with input from their community leadership.

The reactions of patients to a video camera in the consulting room

PubMed Central

Martin, Edwin; Martin, P. M. L.

1984-01-01

In a general practice survey of reactions to the presence of a video camera in the consulting room 13 per cent of patients refused to be filmed, and 11 per cent of those who did consent disapproved of recording. Patients were more willing to express their reservations about video recording if asked to fill in a questionnaire later at home rather than immediately at the surgery. Patients with anxiety, depression, or problems relating to the breasts or reproductive system were more likely to withhold consent. Patients were less likely to refuse video recording of their consultation if they were asked by the doctor for their verbal permission as they entered the consulting room rather then if they were asked to sign a consent form. Only a small minority of the patients who refused to be filmed felt that this refusal had affected their consultation with the doctor. PMID:6502570

26 CFR 1.9101-1 - Permission to submit information required by certain returns and statements on magnetic tape.

Code of Federal Regulations, 2014 CFR

2014-04-01

... satisfied by submitting the information required by such form on magnetic tape or by other media, provided... submitting the information required by such form on magnetic tape or other approved media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or employee thereof...

26 CFR 1.9101-1 - Permission to submit information required by certain returns and statements on magnetic tape.

Code of Federal Regulations, 2013 CFR

2013-04-01

... satisfied by submitting the information required by such form on magnetic tape or by other media, provided... submitting the information required by such form on magnetic tape or other approved media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or employee thereof...

26 CFR 1.9101-1 - Permission to submit information required by certain returns and statements on magnetic tape.

Code of Federal Regulations, 2011 CFR

2011-04-01

... satisfied by submitting the information required by such form on magnetic tape or by other media, provided... submitting the information required by such form on magnetic tape or other approved media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or employee thereof...

26 CFR 1.9101-1 - Permission to submit information required by certain returns and statements on magnetic tape.

Code of Federal Regulations, 2012 CFR

2012-04-01

... satisfied by submitting the information required by such form on magnetic tape or by other media, provided... submitting the information required by such form on magnetic tape or other approved media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or employee thereof...

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

PubMed

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

2014-05-09

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

Patient information, consents and privacy protection scheme for an information system dedicated to pervasive developmental disorders.

PubMed

Ben Said, Mohamed; Robel, Laurence; Messiaen, Claude; Craus, Yann; Jais, Jean Philippe; Golse, Bernard; Landais, Paul

2014-01-01

Patients explicit and unambiguous information, patients consents and privacy protection are reviewed in this article, in the frame of the deployment of the information system TEDIS dedicated to autism spectrum disorders. The role of the Delegate to the Protection of Data is essential at this stage. We developed a privacy protection scheme based on storing encrypted patients personal data on the server database and decrypting it on the Web browser. It tries to respond to the end-users request to manage nominative data in a human readable form and to meet with privacy protection framework.

26 CFR 31.6011(a)-7 - Execution of returns.

Code of Federal Regulations, 2011 CFR

2011-04-01

... be satisfied by submitting the information required by such form on magnetic tape or by other media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or...

26 CFR 31.6011(a)-7 - Execution of returns.

Code of Federal Regulations, 2014 CFR

2014-04-01

... be satisfied by submitting the information required by such form on magnetic tape or by other media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or...

26 CFR 31.6011(a)-7 - Execution of returns.

Code of Federal Regulations, 2013 CFR

2013-04-01

... be satisfied by submitting the information required by such form on magnetic tape or by other media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or...

26 CFR 31.6011(a)-7 - Execution of returns.

Code of Federal Regulations, 2010 CFR

2010-04-01

... be satisfied by submitting the information required by such form on magnetic tape or by other media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or...

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.

Prevalence of Multiple Forms of Sexting Behavior Among Youth: A Systematic Review and Meta-analysis.

PubMed

Madigan, Sheri; Ly, Anh; Rash, Christina L; Van Ouytsel, Joris; Temple, Jeff R

2018-04-01

The existing literature on sexting among youth shows that sexting is a predictor of sexual behavior and may be associated with other health outcomes and risky behaviors. However, there remains a lack of consensus on the prevalence of sexting, which is needed to inform future research, intervention, and policy development. To provide a meta-analytic synthesis of studies examining the prevalence of multiple forms of sexting behavior, analyzed by age, sex, geography, and method of sexting. In an academic setting, electronic searches in MEDLINE, PsycINFO, EMBASE, and Web of Science were conducted for the period January 1990 to June 2016, yielding 1147 nonduplicate records. Studies were included if participants were younger than 18 years and the prevalence of sexting explicit images, videos, or messages was reported. Literature review and data extraction followed established PRISMA guidelines. Two independent reviewers extracted all relevant data. Random-effects meta-analyses were used to derive the mean prevalence rates. Thirty-nine studies met final inclusion criteria. Meta-analyses of the prevalence of sending, receiving, and forwarding without consent, as well as having one's sext forwarded without consent. Among 39 included studies, there were 110 380 participants; the mean age was 15.16 years (age range, 11.9-17.0 years), and on average 47.2% were male. Studies were available for sending (n = 34), receiving (n = 20), forwarding without consent (n = 5), and having a sext forwarded without consent (n = 4). The mean prevalences for sending and receiving sexts were 14.8% (95% CI, 12.8%-16.8%) and 27.4% (95% CI, 23.1%-31.7%), respectively. Moderator analyses revealed that effect sizes varied as a function of child age (prevalence increased with age), year of data collection (prevalence increased over time), and sexting method (higher prevalence on mobile devices compared with computers). The prevalence of forwarding a sext without consent was 12.0% (95% CI, 8.4%-15.6%), and the prevalence of having a sext forwarded without consent was 8.4% (95% CI, 4.7%-12.0%). The prevalence of sexting has increased in recent years and increases as youth age. Further research focusing on nonconsensual sexting is necessary to appropriately target and inform intervention, education, and policy efforts.

Legal and ethical aspects of deliberate G-induced loss of consciousness experiments.

PubMed

Euretig, J G

1991-07-01

Informed consent is both a legal and accepted ethical prerequisite to nontherapeutic human experimentation. The informed consent obtained from the subject in G-LOC experimentation is in the same form as the risk disclosures used in high-G acceleration experiments. However, in high acceleration protocols G-LOC is a potential risk while in G-LOC experiments it is the result. The case law embodies three modern evidentiary standards (the "professional," "material fact," and "possible risks" tests) employed by common law courts when deciding whether the risk disclosures are sufficient to elicit the informed consent of the subject. Each standard is applied against the disclosures in the G-LOC protocol to determine if the elements of the requirement are met. The risk disclosures are wanting in specific identification under the three tests. The deficiency is the failure to inform the subject that G-LOC may result in a pathologic state of unconsciousness about which little is known. Without complete disclosure of this lacking state of medical knowledge, it is questionable whether informed consent can be given. If subjected to judicial scrutiny, the disclosures stated in the G-LOC protocol used in government sponsored research will probably be found deficient.

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.

38 CFR 1.475 - Form of written consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... or title of the individual or the name of the organization to which disclosure is to be made. (3) The... abuse, alcoholism or alcohol abuse, HIV, or sickle cell anemia program or activity. Where a person or...

48 CFR 1352.235-70 - Protection of human subjects.

Code of Federal Regulations, 2012 CFR

2012-10-01

... investigation, including research development, testing and evaluation, designed to develop or contribute to... subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms... addition, if the contractor modifies a human subjects research protocol, questionnaire, survey...

48 CFR 1352.235-70 - Protection of human subjects.

Code of Federal Regulations, 2011 CFR

2011-10-01

... investigation, including research development, testing and evaluation, designed to develop or contribute to... subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms... addition, if the contractor modifies a human subjects research protocol, questionnaire, survey...

48 CFR 1352.235-70 - Protection of human subjects.

Code of Federal Regulations, 2013 CFR

2013-10-01

... investigation, including research development, testing and evaluation, designed to develop or contribute to... subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms... addition, if the contractor modifies a human subjects research protocol, questionnaire, survey...

48 CFR 1352.235-70 - Protection of human subjects.

Code of Federal Regulations, 2014 CFR

2014-10-01

... investigation, including research development, testing and evaluation, designed to develop or contribute to... subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms... addition, if the contractor modifies a human subjects research protocol, questionnaire, survey...

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.

Development and progress of Ireland's biobank network: Ethical, legal, and social implications (ELSI), standardized documentation, sample and data release, and international perspective.

PubMed

Mee, Blanaid; Gaffney, Eoin; Glynn, Sharon A; Donatello, Simona; Carroll, Paul; Connolly, Elizabeth; Garrigle, Sarah Mc; Boyle, Terry; Flannery, Delia; Sullivan, Francis J; McCormick, Paul; Griffin, Mairead; Muldoon, Cian; Fay, Joanna; O'Grady, Tony; Kay, Elaine; Eustace, Joe; Burke, Louise; Sheikh, Asim A; Finn, Stephen; Flavin, Richard; Giles, Francis J

2013-02-01

Biobank Ireland Trust (BIT) was established in 2004 to promote and develop an Irish biobank network to benefit patients, researchers, industry, and the economy. The network commenced in 2008 with two hospital biobanks and currently consists of biobanks in the four main cancer hospitals in Ireland. The St. James's Hospital (SJH) Biobank coordinates the network. Procedures, based on ISBER and NCI guidelines, are standardized across the network. Policies and documents-Patient Consent Policy, Patient Information Sheet, Biobank Consent Form, Sample and Data Access Policy (SAP), and Sample Application Form have been agreed upon (after robust discussion) for use in each hospital. An optimum sequence for document preparation and submission for review is outlined. Once consensus is reached among the participating biobanks, the SJH biobank liaises with the Research and Ethics Committees, the Office of the Data Protection Commissioner, The National Cancer Registry (NCR), patient advocate groups, researchers, and other stakeholders. The NCR provides de-identified data from its database for researchers via unique biobank codes. ELSI issues discussed include the introduction of prospective consent across the network and the return of significant research results to patients. Only 4 of 363 patients opted to be re-contacted and re-consented on each occasion that their samples are included in a new project. It was decided, after multidisciplinary discussion, that results will not be returned to patients. The SAP is modeled on those of several international networks. Biobank Ireland is affiliated with international biobanking groups-Marble Arch International Working Group, ISBER, and ESBB. The Irish government continues to deliberate on how to fund and implement biobanking nationally. Meanwhile BIT uses every opportunity to promote awareness of the benefits of biobanking in events and in the media.

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.

26 CFR 1.9101-1 - Permission to submit information required by certain returns and statements on magnetic tape.

Code of Federal Regulations, 2010 CFR

2010-04-01

... submitting the information required by such form on magnetic tape or by other media, provided that the prior... required by such form on magnetic tape or other approved media, provided that the prior consent of the Commissioner of Social Security (or other authorized officer or employee thereof) has been obtained. [T.D. 6883...

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

PubMed Central

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

2015-01-01

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

[Data protection and data access (I): federal data protection law and the social welfare code with reference to carrying out occupational medicine epidemiologic studies in Germany].

PubMed

Weigelt, E; Scherb, H

1992-11-01

The regulations applicable to research in occupational epidemiology are the federal data protection (confidentiality) law (BDSG), the social welfare code (SGB), medical professional secrecy regulations and the federal statistics law (BStatG). The SGB, medical professional secrecy, and BStatG codes take precedence over BDSG rulings. This paper discusses BDSG and SGB. Medical professional secrecy and BStatG will be the topic of another publication (Datenschutz and Datenzugang II). The BDSG permits processing and utilization of personal data only if 1. this is permitted by BDSG or a law with higher priority, or 2. if the individual concerned has given her or his informed consent. According to the BDSG private research institutes can have access to personal data collected within non-public institutions only via section 28 (2) without consent of the individual. The "research paragraph" section 40 governs the processing and utilisation of personal data by research institutions. As a rule, the SGB permits access to epidemiological data sources only with the informed consent of the individuals concerned. The exception is section 75 SGBX. This paragraph permits disclosure of personal data without the individual's consent by the relevant public institution only if public interest considerably outweighs the private concerns. To our knowledge, however, this clause has had no practical significance. The concept of "informed consent" is discussed in detail, including the requirements for a legal form for informed consent. The legal codes of the BDSG, professional secrecy, and BStatG permit the transfer of personal data if the individuals concerned remain anonymous. This paper deals in detail with the concept of "anonymity".(ABSTRACT TRUNCATED AT 250 WORDS)

75 FR 22786 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-30

..., avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address... comment. Use of the http://www.regulations.gov website to submit comments to EPA electronically is EPA's...

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

[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.

Informed consent should be obtained from patients to use products (skin substitutes) and dressings containing biological material.

PubMed

Enoch, S; Shaaban, H; Dunn, K W

2005-01-01

Biological products (tissue engineered skin, allograft and xenograft, and biological dressings) are widely used in the treatment of burns, chronic wounds, and other forms of acute injury. However, the religious and ethical issues, including consent, arising from their use have never been addressed in the medical literature. This study was aimed to ascertain the views of religious leaders about the acceptability of biological products and to evaluate awareness among healthcare professionals about their constituents. The religious groups that make up about 75% of the United Kingdom population were identified and a questionnaire on 11 biological products was sent to its leaders. Another questionnaire concerning 17 products (11 biological and 6 synthetic dressings) was sent to 100 healthcare professionals working in seven specialist units in the UK. All religious leaders (100% response rate) replied, some after consultation with international bodies. Among them, 77% said that patients should be informed of the constituents of the biological products and consent obtained. Some leaders expressed concerns about particular products including the transmission of viral and prion diseases, cruelty to animals, and material derived from neonates. None of the healthcare professionals (73% response rate) surveyed knew the constituents of all the products correctly. Ignoring religious sensitivities and neglecting consent in the usage of biological products could have very serious implications, including litigation. Hospitals and manufacturers should take immediate measures to enlighten healthcare professionals of the constituents of these products so that they can obtain informed consent from patients.

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

PubMed Central

Broder, Sherri; Ponsaran, Roselle; Goldenberg, Aaron

2012-01-01

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

US public cord blood banking practices: recruitment, donation, and the timing of consent.

PubMed

Broder, Sherri M; Ponsaran, Roselle S; Goldenberg, Aaron J

2013-03-01

Cord blood has moved rapidly from an experimental stem cell source to an accepted and important source of hematopoietic stem cells. There has been no comprehensive assessment of US public cord blood banking practices since the Institute of Medicine study in 2005. Of 34 US public cord blood banks identified, 16 participated in our qualitative survey of public cord blood banking practices. Participants took part in in-depth telephone interviews in which they were asked structured and open-ended questions regarding recruitment, donation, and the informed consent process at these banks. Thirteen of 16 participants reported a variably high percentage of women who consented to public cord blood donation. Fifteen banks offered donor registration at the time of hospital admission for labor and delivery. Seven obtained full informed consent and medical history during early labor and eight conducted some form of phased consent and/or phased medical screening and history. Nine participants identified initial selection of the collection site location as the chief mode by which they recruited minority donors. Since 2005, more public banks offer cord blood donor registration at the time of admission for labor and delivery. That and the targeted location of cord blood collection sites are the main methods used to increase access to donation and HLA diversity of banked units. Currently, the ability to collect and process donations, rather than donor willingness, is the major barrier to public cord blood banking. © 2012 American Association of Blood Banks.

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.

Minors' capacity to refuse treatment: a reply to Gilmore and Herring.

PubMed

Cave, Emma; Wallbank, Julie

2012-01-01

Re R and Re W allow a parent to consent to treatment a competent minor refuses, but the cases have not been tested post-Human Rights Act 1998. Gilmore and Herring offer a means by which they might be distinguished or sidelined. They interpret Gillick to say that in order to consent a minor need only have a full understanding of the particular treatment. They argue that the minors in Re R and Re W were refusing all treatment which requires a separate assessment of capacity-an assessment which was not made. We fear that this distinction would not be workable in clinical practice and argue that their interpretation of Gillick is flawed. From a clinician's point of view, competence cannot always be judged in relation to a specific treatment, but instead must relate to the decision. We show that a decision can incorporate more than one treatment, and more than one decision might be made about one treatment. A minor's understanding of a specific treatment is not always sufficient to demonstrate competence to make a decision. The result is that whilst there might be situations when a parent and a minor both have the power to consent to a particular treatment, they will not share concurrent powers in relation to the same decision. Consequently, a challenge to Re R and Re W, if forthcoming, would need to take a different form. We emphasise the necessity to minimise the dichotomy between legal consent and how consent works in medical practice.

How US institutional review boards decide when researchers need to translate studies

PubMed Central

Klitzman, Robert

2013-01-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees’ (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions. PMID:23475805

How US institutional review boards decide when researchers need to translate studies.

PubMed

Klitzman, Robert

2014-03-01

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards (IRBs) and research ethics committees' (RECs) about the need for researchers to translate consent forms and other study materials. Sixty US IRBs (every fourth one in the list of the top 240 institutions by The National Institutes of Health funding) were contacted, and leaders (eg, chairs) from 34 (response rate=57%) and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals-what, when and how to translate (eg, for how many or what proportion of potential subjects), why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy (through informed consent) and justice (to ensure fair distribution of benefits and burdens of research) against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions.

75 FR 35033 - U-Haul International, Inc. and AMERCO; Analysis of Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-21

... comments electronically or in paper form. Comments should refer to``U-Haul AMERCO, File No. 081 0157'' to... paper form, must be clearly labeled ``Confidential,'' and must comply with FTC Rule 4.9(c), 16 CFR 4.9(c...). Because paper mail addressed to the FTC is subject to delay due to heightened security screening, please...

47 CFR 73.3500 - Application and report forms.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Wireless Telecommunications Bureau Application for Assignments of Authorization and Transfers of Control... Station Construction Permit or License. 315 Application for Consent to Transfer of Control of Corporation... Broadcast Station Construction Permit or License or Transfer of Control of Corporation Holding Broadcast...

24 CFR 235.1208 - Eligible mortgagors.

Code of Federal Regulations, 2010 CFR

2010-04-01

... submitting of consent forms by mortgagors and cooperative members for the obtaining of wage and claim information from State Wage Information Collection Agencies, see part 200, subpart V, of this chapter... MORTGAGE INSURANCE AND ASSISTANCE PAYMENTS FOR HOME OWNERSHIP AND PROJECT REHABILITATION Eligibility...

Constructing an ethical framework for embryo donation to research: is it time for a restricted consent policy?

PubMed

Ehrich, Kathryn; Farsides, Bobbie; Williams, Clare; Scott, Rosamund

2011-06-01

An Ethics & Policy Workshop was held with 20 invited UK stakeholders to consider whether embryo donors should be able to restrict the future use of human embryonic stem cells (hESCs) created from their embryos. Participants cited tensions between pure altruism and a more reciprocal basis for donation; and between basic research (in which genetic material would never form part of another living being) and treatment applications. Two restriction models were suggested to acknowledge specific ethical issues raised by hESCs' use in research and treatments: (1) a two tier system: hESCs with unrestricted consent could go to the UK Stem Cell Bank; those with restricted consent could be used in individual labs which could guarantee to honour the restrictions, and Bank deposit would not be required. (2) a three category system: restrictions could include (i) basic hESC research; (ii) hESC research and treatment; no gamete derivation (iii) 'unrestricted' hESC research and treatment.

A new informed consent form model for cancer patients: preliminary results of a prospective study by the Italian Association of Medical Oncology (AIOM).

PubMed

Gori, Stefania; Greco, Maria Teresa; Catania, Chiara; Colombo, Cinzia; Apolone, Giovanni; Zagonel, Vittorina

2012-05-01

To document the preliminary validity of a new informed consent form (ICF) model in terms of face/content validity and feasibility, to collect patients' and oncologists' opinions on it, and to explore physicians' and patients' "knowledge", "opinions" about "the information exchanged". The working group for informed consent promoted by the Italian Association of Medical Oncology developed a new ICF model which was tested in ten Italian cancer centers. Patients and physicians received questionnaires on the new ICF model. Twenty-six independent oncologists were interviewed to collect their opinions. Seventy eight cancer patients were enrolled: about 90% reported having received information about diagnosis and therapy and 80% about prognosis. About 63% of oncologists had no difficulty in administering the ICF. Oncologists used "correct terms" about diagnosis in 92% of patients with localized disease and in 90% with metastasis and about therapy in respectively 75.7% and 80%. About prognosis, oncologists used "vague" and "no information-no pertinent terms" in 79% of patients with localized disease and 92.5% of patients with metastasis. The ICF seemed to have sufficient validity and feasibility. This ICF model could mean that patients require oncologists to spend more time explaining the diagnosis, prognosis and treatment, increasing patient's opportunities to participate actively in the care process. Crown Copyright © 2011. Published by Elsevier Ireland Ltd. All rights reserved.

[Surgery without blood transfusion for pheocromocytoma in a Jehovah's Witness patient: a case report].

PubMed

Ito, Toshiki; Kurita, Yutaka; Shinbo, Hitoshi; Yasumi, Yasuhiro; Ushiyama, Tomomi

2013-05-01

A 59-year-old woman who identified as a Jehovah's Witness was diagnosed with pheochromocytoma in the left adrenal gland, measuring 11 cm in diameter, during treatment for hypertension. Given her desire to undergo transfusion-less surgery for religious reasons, we obtained fully informed consent and had the patient sign both a transfusion refusal and exemption-from-responsibility certificate and received consent to instead use plasma derivatives, preoperative diluted autologous transfusion and intraoperative salvaged autologous transfusion. To manage anemia and maintain total blood volume, we preoperatively administered erythropoiesis-stimulating agents and alpha 1 blocker, respectively. During the left adrenalectomy, the patient underwent a transfusion of 400 mL of preoperative diluted autologous blood, ultimately receiving no intraoperative salvaged autologous blood. The operation took 4 hours 42 minutes, and the total volume of blood lost was 335 mL. In conclusion, to complete transfusion-less surgery for pheochromocytoma, it is necessary to have the patient sign a generic refusal form for transfusion and exemption-from-responsibility certificate as well as outline via another consent form exactly what sort of transfusion is permitted on a more specific basis. And doctors should become skilled in perioperative management and operative technique for pheochromocytoma and make the best effort by all alternative medical treatment in order to build trust confidence with a patient.

Informed Consent, Body Property, and Self-Sovereignty.

PubMed

Rao, Radhika

2016-09-01

Recent cases involving biosamples taken from indigenous tribes and newborn babies reveal the emptiness of informed consent. This venerable doctrine often functions as a charade, a collective fiction which thinly masks the uncomfortable fact that the subjects of human research are not actually afforded full information regarding the types of research that may be contemplated, nor do they provide meaningful consent. But if informed consent fails to provide adequate protection to the donors of biological materials, why not turn to principles of property law? Property is power, yet current law permits everyone except for those who donate biological materials to possess property rights. The reluctance to invoke property probably stems from fears of resurrecting slavery and the commodification of human beings. But ironically, avoidance of property transforms the subjects of human research into objects that can be owned only by others, resulting in new forms of oppression and exploitation. Human research subjects are autonomous individuals who should not only possess the power to contribute their biological materials, but also the right to help control the course of research, and to share in the resulting benefits or profits. Conferring body property might enable research subjects to regain power and a measure of self-sovereignty. © 2016 American Society of Law, Medicine & Ethics.

Delegating Informed Consent.

PubMed

Koch, Valerie Gutmann

2017-11-01

Ten years ago, Megan Shinal sought the care of neurosurgeon Steven Toms for the surgical treatment of a recurrent nonmalignant tumor in the pituitary region of her brain. In their twenty-minute meeting, Shinal did not make a final decision about which surgical approach she wished to pursue. Subsequently, she spoke with Tom's physician assistant once by phone and once in person, when she signed the consent form, which did not appear to designate which surgical approach she had chosen. During the operation-a total resection-Toms perforated Shinal's carotid artery, resulting in hemorrhage, stroke, brain injury, and partial blindness. The jury found that Toms had fulfilled his informed-consent obligations prior to performing the resection; however, in June 2017, the Supreme Court of Pennsylvania overturned the decision, relying on the Pennsylvania Medical Care Availability and Reduction of Error Act. The court found that the language of the act is unambiguous in its requirement that "a physician's duty to provide information to a patient sufficient to obtain her informed consent is non-delegable." Presumably, this rule of nondelegation applies beyond the surgical theater to other major treatment decisions. And it is unclear whether it applies to other professionals in a subordinate position to the treating physician, such as residents and fellows. © 2017 The Hastings Center.

77 FR 8874 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

... through the use of automated collection techniques or other forms of information technology. Written...,000 2 30/60 3,000 Health Assessment 4,000 2 30/60 4,000 Success Story Consent and 400 1 10/60 67...

40 CFR 57.403 - Written consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PRIMARY... following form: As a condition of receiving a Primary Nonferrous Smelter Order (NSO) under Section 119 of... of, and obtain data from ambient air quality monitors operated by the company under the requirements...

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

PubMed

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

2015-04-01

The development of Electronic Health Records (EHRs) forms an integral part of the information strategy for the National Health Service (NHS) in the UK, with the aim of facilitating health information exchange for patient care and secondary use, including research and healthcare planning. Implementing EHR systems requires an understanding of patient expectations for consent mechanisms and consideration of public awareness towards information sharing as might be made possible through integrated EHRs across primary and secondary health providers. To explore levels of public awareness about EHRs and to examine attitudes towards different consent models with respect to sharing identifiable and de-identified records for healthcare provision, research and planning. A cross-sectional questionnaire survey was administered to adult patients and members of the public in primary and secondary care clinics in West London, UK in 2011. In total, 5331 individuals participated in the survey, and 3157 were included in the final analysis. The majority (91%) of respondents expected to be explicitly asked for consent for their identifiable records to be accessed for health provision, research or planning. Half the respondents (49%) did not expect to be asked for consent before their de-identified records were accessed. Compared with White British respondents, those from all other ethnic groups were more likely to anticipate their permission would be obtained before their de-identified records were used. Of the study population, 59% reported already being aware of EHRs before the survey. Older respondents and individuals with complex patterns of interaction with healthcare services were more likely to report prior awareness of EHRs. Individuals self-identifying as belonging to ethnic groups other than White British, and those with lower educational qualifications were less likely to report being aware of EHRs than White British respondents and respondents with degree-level education, respectively. Those who reported being aware of EHRs were less likely to say they expected explicit consent to be sought before use of their de-identified record. A large number of patients remain unaware of EHRs, while preference for implicit consent is stronger among those who report previous awareness. Differences in awareness levels and consent expectations between groups with different socio-demographic characteristics suggest that public education and information campaigns should target specific groups to increase public awareness and ensure meaningful informed consent mechanisms. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

[Global analysis of the readability of the informed consent forms used in public hospitals of Spain].

PubMed

Mariscal-Crespo, M I; Coronado-Vázquez, M V; Ramirez-Durán, M V

To analyse the readability of informed consent forms (ICF) used in Public Hospitals throughout Spain, with the aim of checking their function of providing comprehensive information to people who are making any health decision no matter where they are in Spain. A descriptive study was performed on a total of 11,339 ICF received from all over Spanish territory, of which 1617 ICF were collected from 4 web pages of Health Portal and the rest (9722) were received through email and/or telephone contact from March 2012 to February 2013. The readability level was studied using the Inflesz tool. A total of 372 ICF were selected and analysed using simple random sampling. The Inflesz scale and the Flesch-Szigriszt index were used to analyse the readability. The readability results showed that 62.4% of the ICF were rated as a "little difficult", the 23.4% as "normal", and the 13.4% were rated as "very difficult". The highest readability means using the Flesch index were scored in Andalusia with a mean of 56.99 (95% CI; 55.42-58.57) and Valencia with a mean of 51.93 (95% CI; 48.4-55.52). The lowest readability means were in Galicia with a mean of 40.77 (95% CI; 9.83-71.71) and Melilla, mean=41.82 (95% CI; 35.5-48.14). The readability level of Spanish informed consent forms must be improved because their scores using readability tools could not be classified in normal scales. Furthermore, there was very wide variability among Spanish ICF, which showed a lack of equity in information access among Spanish citizens. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Consents or waivers of responsibility? Parents' information in NICU.

PubMed

Bellieni, Carlo V; Coradeschi, Caterina; Curcio, Maria R; Grande, Elisa; Buonocore, Giuseppe

2018-05-14

Informing the patient is a base of modern medicine; nonetheless, a great discrepancy exists between hospitals on the way this information should be administered. This is particularly important when the patient are babies: the information should be given to their parents who should approve or disapprove the treatment. Aim of this study is to assess the adequacy of the information administered to the parents of babies admitted into the Neonatal Intensive Care Units. We analyzed the consent forms of center-north Italy NICUs. To this aim, we assessed if the forms had acceptable length and other features; we then asked some volunteers to simulate an information process and to score the forms for their easiness, comprehensibility and explicability to others. Twenty-one NICUs accepted to participate. Only 7 out of 21 had an adequate information form; the other 14 could be described as "waiver of responsibility " (WOR), because they were too prolix and contained too many hypothetical procedures. The overall level of easiness, comprehensibility and explicability to others was suboptimal, being lower in those forms we defined WOR. The results are far to be optimal. More care should be devoted to the process of informing parents at the admission into the NICU: an information overload should be avoided and information should be tailored on the baby's state. Further analysis should be devoted to whether the use of WOR is routine in other countries.

Informed consent for clinical trials of deep brain stimulation in psychiatric disease: challenges and implications for trial design.

PubMed

Lipsman, Nir; Giacobbe, Peter; Bernstein, Mark; Lozano, Andres M

2012-02-01

Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population.

Factors influencing participation of psychiatry inpatients in clinical trials.

PubMed

Mopuru, Nandeeshwar Reddy; Jose, Sam Padamadan; Viswanath, Biju; Kumar, C Naveen; Math, Suresh Bada; Thirthalli, Jagadisha

2018-02-01

Serious concerns have arisen in recent years regarding the unethical and illegal practices resorted to during clinical trials. Clinical trials in psychiatry are further complicated by issues such as 'validity of consent' and 'decision making capacity' of patients. This study was planned to explore the factors determining patient participation in clinical trials. A random sample of 123 consenting psychiatry inpatients were provided the information and consent-form of a hypothetical clinical drug trial. They were interviewed regarding their decision, the decision maker and factors that led to the decision. Family members tended to be the decision makers when patients were females, had low-income, were from rural background or had severe illnesses. Anticipated side effects and not wanting to interfere with existing treatment were the common reasons for refusal to participate while hope of betterment of the patient and benefit to humanity were cited for consent. The educated, urban, affluent class had more awareness regarding unethical trials and tended to be mistrustful of the medical community leading to higher rates of non-participation. Those who were adherent with ongoing treatment were also unwilling to participate. The lesser educated, low-income patients and rural domicile patients on the other hand had lesser awareness regarding clinical trials, trusted doctors and were more likely to participate. A good doctor-patient relationship, detailed explanations and clarification regarding the study and its conduct, and building awareness regarding clinical trials among vulnerable groups is necessary to ensure a valid consent involving no coercion, removal of prejudices, and ethical conduct of trials. Copyright © 2017 Elsevier B.V. All rights reserved.

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...

48 CFR 1352.235-73 - Research involving human subjects-after initial contract award.

Code of Federal Regulations, 2012 CFR

2012-10-01

... the United States Department of Health and Human Services' Office for Human Research Protections... documentation may include: (1) Copies of the human subjects research protocol, advertisements, recruitment... human subjects research protocol, advertisements, recruitment material, and informed consent forms by...

Reexamining issues of conceptualization and willing consent: the hidden role of coercion in experiences of sexual acquiescence.

PubMed

Conroy, Nicole E; Krishnakumar, Ambika; Leone, Janel M

2015-07-01

This study problematizes the literature's conceptualization of sexual compliance, predominantly defined as willing participation in, and consent to, unwanted sexual activity in the absence of immediate partner pressure. Using a feminist theoretical framework, we argue that covert forms of social coercion, including normalized expectations for heterosexual women to participate in sexual activity and maintain relationship satisfaction, ultimately pressure women into participating in unwanted sexual activity. In other words, immediate partner pressure is not necessary for a sexually coercive experience to occur. Results of the current study indicate that relationship control and media influence significantly predict sexual acquiescence, and women acquiesce to unwanted sexual activity in an effort to maintain relationships and partner satisfaction as well as to avoid negative outcomes. Women cite various forms of social coercion, such as fulfilling sexual scripts and relationship obligations, as primary reasons for participating in unwanted sexual activity without resisting their partners. © The Author(s) 2014.

The radiology informed consent form: recommendations from the European Society of Cardiology position paper.

PubMed

Carpeggiani, Clara; Picano, Eugenio

2016-06-01

Every radiological and nuclear medicine examination confers a definite long-term risk of cancer, but most patients undergoing such examinations receive no or inaccurate information about radiation dose and corresponding risk related to the dose received. Informed consent is a procedure to support (not substitute) the physician/patient dialogue and relationship, facilitating a free, informed and aware expression of the patient's will in the principle of patient autonomy. Physicians are responsible for providing patients with all the information on risks, benefits and alternatives useful to the patient to make the decision. In current radiological practice the information on the radiation dose and long-term cancer risks is difficult to find and not easy to understand. The form using plain language should spell-out the type of examination, the effective dose (mSv), the effective dose expressed in number of chest radiographs and the risk of cancer. The current practice clashes against the guidelines and the law.

18 CFR 3b.225 - Written consent for disclosure.

Code of Federal Regulations, 2010 CFR

2010-04-01

... as a statistical research or reporting record, and the record is to be transferred in a form that is... for statistical purposes. In addition to stripping personally identifying information from records released for statistical purposes, the system manager will ensure that the identity of the individual...

Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies

PubMed Central

2015-01-01

Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications – US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved. PMID:26225759

Linguistic and Cultural Challenges in Communication and Translation in US-Sponsored HIV Prevention Research in Emerging Economies.

PubMed

Hanrahan, Donna; Sexton, Patrina; Hui, Katrina; Teitcher, Jennifer; Sugarman, Jeremy; London, Alex John; Barnes, Mark; Purpura, James; Klitzman, Robert

2015-01-01

Linguistic and cultural differences can impede comprehension among potential research participants during the informed consent process, but how researchers and IRBs respond to these challenges in practice is unclear. We conducted in-depth interviews with 15 researchers, research ethics committee (REC) chairs and members from 8 different countries with emerging economies, involved in HIV-related research sponsored by HIV Prevention Trials Network (HPTN), regarding the ethical and regulatory challenges they face in this regard. In the interviews, problems with translating study materials often arose as major concerns. Four sets of challenges were identified concerning linguistic and cultural translations of informed consent documents and other study materials, related to the: (1) context, (2) process, (3) content and (4) translation of these documents. Host country contextual issues included low literacy rates, education (e.g., documents may need to be written below 5th grade reading level), and experiences with research, and different views of written documentation. Certain terms and concepts may not exist in other languages, or have additional connotations that back translations do not always reveal. Challenges arise because of not only the content of word-for-word, literal translation, but the linguistic form of the language, such as tone (e.g., appropriate forms of politeness vs. legalese, seen as harsh), syntax, manner of questions posed, and the concept of the consent); and the contexts of use affect meaning. Problems also emerged in bilateral communications--US IRBs may misunderstand local practices, or communicate insufficiently the reasons for their decisions to foreign RECs. In sum, these data highlight several challenges that have received little, if any, attention in past literature on translation of informed consent and study materials, and have crucial implications for improving practice, education, research and policy, suggesting several strategies, including needs for broader open-source multilingual lexicons, and more awareness of the complexities involved.

Patient consent to publication and data sharing in industry and NIH-funded clinical trials.

PubMed

Spence, O'Mareen; Onwuchekwa Uba, Richie; Shin, Seongbin; Doshi, Peter

2018-05-03

Participants are recruited into clinical trials under the assumption that the research will contribute to medical knowledge. Therefore, non-publication trials-and, more recently, lack of data sharing-are widely considered to violate the trust of trial participants. Existing practices regarding patient consent to publication and data sharing have not been evaluated. Analyzing informed consent forms (ICFs), we studied what trial participants were told regarding investigators' intention to contribute to medical knowledge, publish trial results, and share de-identified trial data. We obtained 98 ICFs of industry-funded pre-marketing trials for all (17) antibiotics approved by the European Medicines Agency and 46 ICFs of publicly funded trials from the National Heart, Lung and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) data repository. Three authors independently reviewed ICFs to identify and extract what was stated or implied regarding: (1) publication of results; (2) sharing de-identified data; (3) data ownership; (4) confidentiality of identifiable data; and (5) whether the trial will produce knowledge that offers public benefit. Consensus was obtained from the two reviewers with the greatest overall agreement on all five measures. Disagreements were resolved through discussion among all authors. Four (3%) trials indicated a commitment to publish trial results; 140 (97%) did not commit to publishing trial results; six (4%) indicated a commitment to share de-identified data with third party researchers. Commitments to share were more common in publicly funded trials than industry-funded trials (7% vs 3%). A total of 103 (72%) ICFs indicated the trials will or may produce knowledge that offers public benefits, while 131 (91%) ICFs left unstated who "owned" trial data; of those with statements, the sponsor always claimed ownership. Patient confidentiality was guaranteed in 137 (95%) trials. Our results suggest that consent forms rarely disclose investigators' intentions regarding the sharing of de-identified data or publication of trial results.

Participants with schizophrenia retain the information necessary for informed consent during clinical trials

PubMed Central

Fischer, Bernard A.; McMahon, Robert P.; Meyer, Walter A.; Slack, Daniel J.; Appelbaum, Paul S.; Carpenter, William T.

2015-01-01

Objective Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge--including assessment of therapeutic misconception--in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks. Method Individuals enrolling in one of seven clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not re-reviewed at any follow-up visit. Results Fifty-nine participants were enrolled; analysis included 52 participants with at least one follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44= 3.43, p= 0.001). Retention of study knowledge was not related to symptoms, but had a weak correlation with cognitive capacity (R= 0.28, p= 0.07). Performance did not differ between participants from research clinics and those from community mental health centers. Conclusions Clinically-stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely re-evaluate participants during this type of clinical trial. PMID:23842013

Informed consent in human research: what to say and how to say it.

PubMed

Reiman, Robert E

2013-02-01

To ensure that the possibility of harm to human research subjects is minimized, clinical trials and other research protocols are subject to oversight by Institutional Review Boards (IRBs). IRBs require that subjects be fully informed about the real or potential risks of participation in a research study. The use of radiological examinations in research protocols subjects the participants to exposure to ionizing radiation, which in theory carries a risk of stochastic effects such as radiation-induced cancer, and in practice may lead to deterministic effects such as skin injury. Because IRB members and clinical study coordinators may have little knowledge of radiation effects or how best to communicate the risk to the research subjects, they will consult with institutional Radiation Safety Committees and radiation protection professionals regarding how to integrate radiation risk information into the informed consent process. Elements of radiation informed consent include: (1) comparison of the radiation dose to some benchmark that enables the study subjects to make a value judgment regarding the acceptability of the risk; (2) a quantitative expression of the absolute risk of stochastic effects; (3) an expression of uncertainty in the risk; and (4) understandability. Standardized risk statement templates may be created for specific radiological examinations. These standardized risk statements may be deployed as paper forms or electronically in the form of internet-based applications. The technical nature of creating useful radiation risk statements represents an opportunity for radiation protection professionals to participate productively in the clinical research process.

Autonomy, privacy and informed consent 3: elderly care perspective.

PubMed

Scott, P A; Välimäki, M; Leino-Kilpi, H; Dassen, T; Gasull, M; Lemonidou, C; Arndt, M

Despite the growing interest in clinical healthcare ethics, there is a dearth of empirical studies investigating the ethical elements of day-to-day clinical practice from the perspective of either patients or staff. This article, the third in a four-part series, reports the results of a Scottish Study that formed part of a multi-site comparative study funded by the European Commission. It explores patient autonomy, privacy and informed consent in the care of elderly people in long-stay care facilities (i.e. nursing homes and continuing care units). A convenience sample of 101 elderly residents and their nurses (n = 160) participated in the study. Data were collected by means of a self-completion questionnaire for staff and a structured interview schedule for elderly residents. Results indicate marked differences between staff's and residents' responses on three of the four dimensions explored: information-giving, and opportunity to participate in decision-making about care and consent. There was much closer agreement between staff's and residents' responses regarding protection of patient privacy. From the results of this study there is indication of a clear need for further empirical studies exploring issues of patient autonomy, privacy and informed consent in the day-to-day nursing care of older people. Findings to date suggest there is still a significant need to educate staff concerning ethical awareness and sensitivity to the dignity and rights of patients.

Researchers’ Perceptions of the Ethical Implications of Pharmacogenomics Research with Children

PubMed Central

Avard, D.; Silverstein, T.; Sillon, G.; Joly, Y.

2009-01-01

Background This paper presents the results of an exploratory qualitative study that assesses Canadian pediatric researchers’ perceptions of a pre-selected group of ethical issues raised by pharmacogenomics research with children. Methods As a pilot study, we conducted semi-structured telephone interviews with Canadian pediatric pharmacogenomic researchers. The interviews were guided by the following themes: (1) benefits and risks of inclusion, (2) the consent/assent process, and (3) the return of research results. Results Issues about assent, consent, risks and benefits, as well as the communication of results were addressed by the respondents. Some issues, such as the unique vulnerability of children, the long term privacy concerns associated with biobanking, additional core elements that need to be discussed and included in the consent/assent forms, as well as the challenges of communicating research results in a pediatric research were not explicitly identified by the respondents. Conclusion Further consideration should be given to address the ethical challenges of including children in pharmacogenomics research. This exploratory study indicates that further guidance is needed if children are to be protected and yet benefit from such research. PMID:19204423

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

PubMed

Kongsholm, Nana Cecilie Halmsted; Kappel, Klemens

2017-07-01

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

Physician perspectives on legal processes for resolving end-of-life disputes.

PubMed

Chidwick, Paula; Sibbald, Robert

2011-01-01

In order to understand how to effectively approach end-of-life disputes, this study surveyed physicians' attitudes towards one process for resolving end-of-life disputes, namely, the Consent and Capacity Board of Ontario. In this case, the process involved examining interpretation of best interests between substitute decision-makers and medical teams. Physicians who made "Form G" applications to the Consent and Capacity Board of Ontario that resulted in a decision posted on the open-access database, Canadian Legal Information Institute (CanLii), were identified and surveyed. This purposive sample led to 13 invitations to participate and 12 interviews (92% response rate). Interviews were conducted using a prescribed interview guide. No barriers to the Consent and Capacity Board process were reported. Applications were made when physicians reached an impasse with the family and further treatment was perceived to be "unethical." The most significant challenge reported was the delay when appeals were launched. Appeals extended the process for an indefinite period of time making it so lengthy it negated any perceived benefits of the process. Benefits included that a neutral third party, namely the Consent and Capacity Board, was able to assess best interests. Also, when decisions were timely, further harm to the patient was minimized. Physicians reported this particular approach, namely the Consent and Capacity Board has a mechanism that is worthwhile, patient centred, process oriented, orderly and efficient for resolving end-of-life disputes and, in particular, determining best interests. However, unless the appeal process can be adjusted to respond to the ICU context there is a risk of not serving the best interest of patients. Physicians would recommend framing end-of-life treatment plans in the positive instead of negative, for example, propose palliative care and no escalation of treatment as opposed to withdrawal.

From actors to authors: a first account about the involvement of patients in the informed consent governance of a major Italian translational research hospital.

PubMed

Casati, Sara; Monti, Paolo; Bonino, Ferruccio

2010-01-01

From 2007 to 2009 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, one of the major public research hospitals in Italy, has invested on a participatory action to promote a good practice of informed consent. The project focused on the improvement and innovation of informed consent considered as a participated act through the involvement of all the actors at stake. The main purpose was to improve the informative practices through the participatory innovation of institutional and organizational elements as conditions of possibility. Therefore the project has pursued the involvement of managers, healthcare professionals, patients and their associations in the institutional governance of informed consent. The involvement of citizens and patients within the whole process meant to put them in charge not just as actors or final evaluators of a good practice, but as co-authors in defining standards, tools and conditions for a good practice. Several actions were taken, including a phase of analysis which involved 20 patients from 8 Associations, a phase of innovation and education where 113 patients and citizens worked together with clinicians from 53 Units in deliberative laboratories, the institution of a multidisciplinary committee inclusive of representatives from 6 associations of patients.The project has produced different outcomes: new institutional guidelines adopted by the hospital; the renewal of consent forms and procedures as part of an explicit shared informative process; an increased implementation of institutional standards of good informative practice; the measure and communication of the outcomes of care and their bench-marking; bottom-up building of paths of validation; the creation of participatory electronic tools; an innovative education on the field for patients and clinicians.

An Examination of the Relationship between Self-Perceived Physical Attractiveness and Social Competence.

ERIC Educational Resources Information Center

Steward, Robbie J.; Sobczak, Joan

This study investigated the relationship between self-perceived physical attractiveness and self-perceived social competence. Subjects were 157 male and 215 female college students who completed a consent form, demographic questionnaire, the Texas Social Behavior Inventory, and the Body Parts/Physical Attractiveness Scale. Significant correlations…

A Mindfulness-Based Cognitive Psychoeducational Group Manual for Problem Gambling

ERIC Educational Resources Information Center

Cormier, Abigail; McBride, Dawn Lorraine

2012-01-01

This project provides a comprehensive overview of the research literature on problem gambling in adults and includes a detailed mindfulness-based psychoeducational group manual for problem gambling, complete with an extensive group counselling consent form, assessment and screening protocols, 10 user-friendly lesson plans, templates for a…

12 CFR 213.3 - General disclosure requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... consumer consent and other applicable provisions of the Electronic Signatures in Global and National... model form in appendix A of this part. (3) Timing of disclosures. A lessor shall provide the disclosures... scheduled payments may be different because a scheduled date is not a business day; (3) That months have...

12 CFR 213.3 - General disclosure requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... consumer consent and other applicable provisions of the Electronic Signatures in Global and National... model form in appendix A of this part. (3) Timing of disclosures. A lessor shall provide the disclosures... scheduled payments may be different because a scheduled date is not a business day; (3) That months have...

78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-09

... public comment on proposed data collection projects, the National Institute Heart, Lung, and Blood... projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written... other technological collection techniques or other forms of information technology. To Submit Comments...

75 FR 76988 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-10

... Enrollment, Chain and Ownership System (PECOS) Security Consent Form; Use: The primary function of the... for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3... the primary document used by CMS in developing the national Medicaid budget estimates that are...

78 FR 62645 - Agency Information Collection Activities: Application for Permission to Reapply for Admission...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-22

...-0018] Agency Information Collection Activities: Application for Permission to Reapply for Admission.... (2) Title of the Form/Collection: Application for Permission To Reapply for Admission Into the United... I-212 is used by USCIS to adjudicate applications filed by aliens requesting consent to reapply for...

A Student Experiment in Pharmaceutics: Saliva Concentrations of Acetaminophen.

ERIC Educational Resources Information Center

Gwilt, Peter R.; And Others

1979-01-01

It is desirable that the undergraduate pharmacy student gain some experience in the collection and mathematical treatment of pharmacokinetic data. An experiment to provide the student with data for obtaining pharmacokinetic parameters is described, including lists of materials and equipment, with a student consent form appended. (MLW)

27 CFR 24.145 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the business or operation have been approved by the appropriate TTB officer. (Sec. 201, Pub. L. 85-859..., DEPARTMENT OF THE TREASURY LIQUORS WINE Establishment and Operations Bonds and Consents of Surety § 24.145... part and the instructions printed on the form. A person may not commence or continue any business or...

24 CFR 235.375 - Termination, suspension, or reinstatement of the assistance payments contract.

Code of Federal Regulations, 2010 CFR

2010-04-01

... obtaining of wage and claim information from State Wage Information Collection Agencies, as provided by part... HOME OWNERSHIP AND PROJECT REHABILITATION Assistance Payments-Homes for Lower Income Families § 235.375... consent forms for the obtaining of wage and claim information from State Wage Information Collection...

Ultrasound and the IRB

ERIC Educational Resources Information Center

Epstein, Melissa A.

2005-01-01

The purpose of this paper is to assist researchers in writing their research protocols and subject consent forms so that both the Institutional Review Board (IRB) and subjects are assured of the minimal risk associated with diagnostic B-scan ultrasound as it is used in speech research. There have been numerous epidemiological studies on fetal…

48 CFR 52.227-18 - Rights in Data-Existing Works.

Code of Federal Regulations, 2014 CFR

2014-10-01

... (CONTINUED) CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 52... practicable of any claim or suit, affords the Contractor an opportunity under applicable laws, rules, or regulations to participate in the defense of the claim or suit, and obtains the Contractor's consent to the...

48 CFR 52.227-18 - Rights in Data-Existing Works.

Code of Federal Regulations, 2012 CFR

2012-10-01

... (CONTINUED) CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 52... practicable of any claim or suit, affords the Contractor an opportunity under applicable laws, rules, or regulations to participate in the defense of the claim or suit, and obtains the Contractor's consent to the...

48 CFR 52.227-18 - Rights in Data-Existing Works.

Code of Federal Regulations, 2013 CFR

2013-10-01

... (CONTINUED) CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 52... practicable of any claim or suit, affords the Contractor an opportunity under applicable laws, rules, or regulations to participate in the defense of the claim or suit, and obtains the Contractor's consent to the...

48 CFR 52.227-18 - Rights in Data-Existing Works.

Code of Federal Regulations, 2011 CFR

2011-10-01

... (CONTINUED) CLAUSES AND FORMS SOLICITATION PROVISIONS AND CONTRACT CLAUSES Text of Provisions and Clauses 52... practicable of any claim or suit, affords the Contractor an opportunity under applicable laws, rules, or regulations to participate in the defense of the claim or suit, and obtains the Contractor's consent to the...

Acute cardiomyopathy with MCAT abuse.

PubMed

Redfern, Andrew; Sampson, Caroline; Giovannelli, Marco

2015-02-01

Consent This article has been accepted for publication as a letter rather than a case report due to an inability to contact the patient to gain written or verbal consent for publication. The letter has been anonymised, and the author affiliations are available by request to the Editor-in-Chief. The manuscript has undergone extensive review by JICS editors and the Editor-in-Chief of another medical journal in order to ensure that the principles behind its publication strictly adhere to the guidance of the Committee on Publication Ethics. Caldicott Guardian approval for its publication has been given by the Executive Medical Director of the Trust in which the patient was treated. All reviewers believe that the message being imparted justifies its publication albeit in an anonymised form.

Vasomotor Symptoms Monitoring with a Commercial Activity Tracking Watch

DTIC Science & Technology

2017-12-31

volunteers wearing physiological monitors. The study protocol and written consent form were...available, but similar devices with EDA/GSR sensors are available. Vasomotor symptoms started disrupting the sleep of a woman volunteer on...November 23, 2015, calling attention to their occurrence. After November 23, 2015, the volunteer started personally logging the occurrence of

76 FR 21945 - Proposed Collection; Comment Request for Form 8848

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-19

... proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995... 8848, Consent to Extend the Time To Assess the Branch Profits Tax Under Regulations Sections 1.884-2(a... To Extend the Time To Assess the Branch Profits Tax Under Regulations Sections 1.884-2(a) and (c...

75 FR 44259 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-28

... general public and other Federal agencies to take this opportunity to comment on the renewal of existing... to Exercise Trust Powers (3064-0025), and Insurance Sales Consumer Protections (3064- 0140). No...: 1. Title: Application for Consent to Exercise Trust Powers. OMB Number: 3064-0025. Form Number: FDIC...

75 FR 76762 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-09

... financial condition, as disclosed in its most recent balance sheet, available for inspection by any bona... delivering their balance sheet, in paper or electronic form, to customers who request it. Additionally, if the delivery is electronic, the requesting customer must provide consent to receive the balance sheet...

The Effectiveness of Mandatory-Random Student Drug Testing

ERIC Educational Resources Information Center

James-Burdumy, Susanne; Goesling, Brian; Deke, John; Einspruch, Eric

2011-01-01

One approach some U.S. schools now use to combat high rates of adolescent substance use is school-based mandatory-random student drug testing (MRSDT). Under MRSDT, students and their parents sign consent forms agreeing to the students' participation in random drug testing as a condition of participating in athletics and other school-sponsored…

75 FR 48686 - Tops Markets LLC; Analysis of Agreement Containing Consent Orders to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... FEDERAL TRADE COMMISSION [File No. 101 0074] Tops Markets LLC; Analysis of Agreement Containing... electronically or in paper form. Comments should refer to``Tops-Penn Traffic, File No. 101 0074'' to facilitate... identifiable health information. In addition, comments should not include any ``[t]rade secret or any...

Mediation in the Schools. ERIC Digest.

ERIC Educational Resources Information Center

Trevaskis, David Keller

This digest discusses mediation as a form of conflict management that is receiving widespread attention in schools. Mediation involves a neutral third person, called a mediator, who assists the disputants in resolving their problem with the consent of all parties. It offers a risk-free way to settle disputes for the parties involved. Unresolved…

75 FR 42749 - Fidelity National Financial, Inc.; Analysis of the Agreement Containing Consent Order to Aid...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-22

... FEDERAL TRADE COMMISSION [File No. 091 0032] Fidelity National Financial, Inc.; Analysis of the... prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to... comments electronically or in paper form. Comments should refer to ``Fidelity National Financial, File No...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2012 CFR

2012-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2014 CFR

2014-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

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...

Protocol Information Office (PIO) | Division of Cancer Prevention

Cancer.gov

PIO Instructions and Tools Find instructions, forms, and templates for the management of all types of Division of Cancer Prevention clinical trials.Read more about PIO Instructions and Tools Clinical Trials Reference Materials Model clinical agreements, human subject protection and informed consent models, gender and minority inclusion information, and monitoring policy and

Educational Behavior Apps and Wearable Devices: Current Research and Prospects

ERIC Educational Resources Information Center

Lowe, Heather

2016-01-01

Dartmouth and MIT have developed educational behavior apps and wearable devices that collect contiguous streams of data from student users. Given the consent of the user, the app collects information about a student's physical activity, sleep patterns, and location to form conjectures about social and academic behavior. These apps have the…

Women and cosmetic breast surgery: weighing the medical, social, and lifestyle risks.

PubMed

Boulton, Tiffany N; Malacrida, Claudia

2012-04-01

In this article we provide a comparative analysis of qualitative, semistructured interviews with 24 women who had undergone different forms of cosmetic breast surgery (CBS). We argue that women must negotiate three types of risk: potential medical risks, lifestyle risks connected with choosing "frivolous" self-enhancements, and countervailing social risks affiliated with pressures to maximize one's feminine beauty. In addition, we highlight the challenges faced in negotiating these risks by examining the limits to traditional forms of medical informed consent provided to the women, who received little information on the medical risks associated with CBS, or who were given uncertain and contradictory risk information. Even respondents who felt that they were well informed expressed difficulties in making "wise" choices because the risks were distant or unlikely, and hence easily minimized. Given this, it is fairly understandable that the known social risks of "failed" beauty faced by the women often outweighed the ambiguous or understated risks outlined by medicine. We argue that traditional notions of informed consent and risk awareness might not be adequate for women choosing CBS.

'Many people know the law, but also many people violate it': discrimination experienced by people living with HIV/AIDS in Vietnam--results of a national study.

PubMed

Messersmith, Lisa J; Semrau, Katherine; Hammett, Theodore M; Phong, Nguyen Tuan; Tung, Nguyen Duy; Nguyen, Ha; Glandon, Douglas; Huong, Nguyen Mai; Anh, Hoang Tu

2013-01-01

In Vietnam, discrimination against people living with HIV/AIDS (PLHIV) is defined within and prohibited by the 2007 national HIV/AIDS law. Despite the law, PLHIV face discrimination in health care, employment, education and other spheres. This study presents the first national estimates of the levels and types of discrimination that are defined in Vietnamese law and experienced by PLHIV in Vietnam. A nationally representative sample of 1200 PLHIV was surveyed, and 129 PLHIV participated in focus group discussions (FGDs). In the last 12 months, nearly half of the survey population experienced at least one form of discrimination and many experienced up to six different types of discrimination. The most common forms of discrimination included disclosure of HIV status without consent; denial of access to education for children; loss of employment; advice, primarily from health care providers, to abstain from sex; and physical and emotional harm. In logistic regression analysis, the experience of discrimination differed by gender, region of residence and membership status in a PLHIV support group. The logistic regression and FGD results indicate that disclosure of HIV status without consent was associated with experiencing other forms of discrimination. Key programme and policy recommendations are discussed.

Does my older cancer patient have cognitive impairment?

PubMed

Snaedal, Jon

2018-05-01

Cancer and impaired cognition are both frequent conditions in old age and consequently coexist to certain degree. The prevalence of impaired cognition increases sharply after the age of 65 and the more advanced form of cognitive impairment; dementia, is exceeding 30% by the age of 85years. Adequate cognition is crucial for understanding important facts and for giving consent for intervention. There are many different stages of cognitive impairment, ranging from subjective cognitive impairment to severe dementia. The mildest stages of cognitive impairment are sometimes reversible but in more severe stages, there is brain damage of some kind, most frequently caused by neurodegenerative disorder such as Alzheimer's disease. Therefore, some kind of evaluation of cognition should be offered to all older individuals with cancer and in need for intervention. In this evaluation, information should also be sought from a close relative. In the earlier stages of cognitive impairment, the individual usually retains ability to give consent and understands information given but in later stages of dementia, a surrogate decision maker is needed. In milder stages of dementia, an individual evaluation is needed for decision of capability for consent. A specific diagnosis of a disorder such as Alzheimer's disease does not in itself preclude the individual from giving consent, the degree of cognitive impairment, impaired judgement and poor insight are more decisive in this regard. It is also important to know the difference of delirium, most often a time limited condition and dementia that usually is progressive. Copyright © 2017 Elsevier Inc. All rights reserved.

[Psychiatric medication as restraint: between autonomy and protection, is there place for a legal framework?].

PubMed

Bernheim, Emmanuelle

2010-01-01

The use of chemical restraint has been regulated for the past ten years in Quebec. However, clinical, ethical and legal issues, sometimes contradictory, have not really been considered during the legislative process leading to consolidation in its current form. The author supports that, because of the absence of consent and the effects of medication, a specific legal framework to the use of medication is necessary in a context of unplanned intervention to protect both patients and medical staff. This framework would prescribe good practice, take into account the non-medical aspects of consent to care and formalize the practice as an exception to the rule. In addition, the symbolism of law, through which social solidarity can be expressed, must not be underestimated.

[Tubal sterilization in mentally handicapped women].

PubMed

Barjot, P; Hervé, C

2001-09-22

When performed for contraception purposes, tubular sterilization for mentally handicapped women poses important ethical issues, including patient's rights, body integrity, and the notion of informed consent. French law guarantees the respect and safety of all patients, but in everyday practice, patient's rights must be upheld by family and healthcare workers searching for the most adapted solutions for each individual situation. We present here our proposals for everyday practice. Our conclusions are based on an analysis of the notion of handicap as defined by the WHO and on the observed sexual activities of this type of patient. In this context, informed consent involves a number of subjective factors pointing out the difficulty encountered in providing dear comprehensible information. Finally we discuss the ethical issue of tubular sterilization which many consider to be a masked form of eugenism.

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2014 CFR

2014-04-01

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

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2012 CFR

2012-04-01

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

21 CFR 50.25 - Elements of informed consent.

Code of Federal Regulations, 2013 CFR

2013-04-01

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

Should consent be required for organ procurement?

PubMed

Zambrano, Alexander

2018-06-08

Must we obtain a patient's consent before posthumously removing her organs? According to the consent requirement, in order to permissibly remove organs from a deceased person, it is necessary that her prior consent be obtained. If the consent requirement is true, then this seems to rule out policies that do not seek and obtain a patient's prior consent to organ donation, while at the same time vindicating policies that do seek and obtain patient consent. In this paper, however, I argue that once we recognize the difference between consent, on the one hand, and wishing or desiring, on the other, we will see that obtaining consent before organ removal is neither necessary nor sufficient to respect patient autonomy in organ procurement. © 2018 John Wiley & Sons Ltd.

Routine recovery: an ethical plan for greatly increasing the supply of transplantable organs.

PubMed

Spital, Aaron; Taylor, James S

2008-04-01

All current organ procurement policies require some form of consent. Many families refuse to permit organ recovery from a recently deceased relative; therefore, the major cost of requiring consent is the loss of some lives that could have been saved through transplantation. Here, we argue for a much more efficient approach to organ procurement from brain dead individuals - routine recovery of all transplantable organs without consent. Careful analysis of the relevant literature shows that, compared with its competitors, routine recovery has the greatest potential to increase cadaveric organ procurement and save lives while causing very little harm. Furthermore, a recent survey suggests that 30% of the US public would already accept routine recovery even though the respondents were not educated regarding the value of this approach. Patients on the transplant waiting list are dying while organs that could have saved them are being buried or burned because of family refusal to allow posthumous organ procurement. Routine recovery would eliminate this tragic loss of life-saving organs without violating ethical principles. Indeed, we argue that of all the proposals designed to increase the supply of transplantable cadaveric organs, routine recovery is the best.

Why female sex workers participate in HIV research: the illusion of voluntariness.

PubMed

Reed, Elizabeth; Fisher, Celia B; Blankenship, Kim M; West, Brooke S; Khoshnood, Kaveh

2017-07-01

The purpose of this study was to examine factors influencing the motivation for and perceived voluntariness of participation in non-intervention HIV research among female sex workers (FSW) in India. FSW (n = 30) who participated in non-intervention HIV studies in the previous three years were recruited from a local community-based organization. Semi-structured qualitative interviews focused on women's personal and economic motivations for participation and their perceptions of the informed consent process. Interviews were audio-recorded, translated, transcribed, and reviewed for common themes. Content analysis indicated that while many women reported willing participation, reports of obligatory participation were also a common theme. Obligations included money-related pressures and coercion by other FSW, social pressures, not wanting to disappoint the researchers, and perceiving that they had a contractual agreement to complete participation as a result of signing the consent form. Findings suggest a need for additional efforts during and following informed consent to prevent obligatory participation in HIV research studies among FSW. Findings emphasize the importance of integrating ongoing participant feedback into research ethics practices to identify issues not well addressed via standard ethics protocols when conducting HIV research among vulnerable populations.

Interventions to improve patient understanding of cancer clinical trial participation: a systematic review.

PubMed

Kao, C Y; Aranda, S; Krishnasamy, M; Hamilton, B

2017-03-01

Patient misunderstanding of cancer clinical trial participation is identified as a critical issue and researchers have developed and tested a variety of interventions to improve patient understanding. This systematic review identified nine papers published between 2000 and 2013, to evaluate the effects of interventions to improve patient understanding of cancer clinical trial participation. Types of interventions included audio-visual information, revised written information and a communication training workshop. Interventions were conducted alone or in combination with other forms of information provision. The nine papers, all with methodological limitations, reported mixed effects on a small range of outcomes regarding improved patient understanding of cancer clinical trial participation. The methodological limitations included: (1) the intervention development process was poorly described; (2) only a small element of the communication process was addressed; (3) studies lacked evidence regarding what information is essential and critical to enable informed consent; (4) studies lacked reliable and valid outcome measures to show that patients are sufficiently informed to provide consent; and (5) the intervention development process lacked a theoretical framework. Future research needs to consider these factors when developing interventions to improve communication and patient understanding during the informed consent process. © 2016 John Wiley & Sons Ltd.

Informed consent in human subject research: a comparison of current international and Nigerian guidelines.

PubMed

Fadare, Joseph O; Porteri, Corinna

2010-03-01

Informed consent is a basic requirement for the conduct of ethical research involving human subjects. Currently, the Helsinki Declaration of the World Medical Association and the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences (CIOMS) are widely accepted as international codes regulating human subject research and the informed consent sections of these documents are quite important. Debates on the applicability of these guidelines in different socio-cultural settings are ongoing and many workers have advocated the need for national or regional guidelines. Nigeria, a developing country, has recently adopted its national guideline regulating human subject research: the National Health Research Ethics Committee (NHREC) code. A content analysis of the three guidelines was done to see if the Nigerian guidelines confer any additional protection for research subjects. The concept of a Community Advisory Committee in the Nigerian guideline is a novel one that emphasizes research as a community burden and should promote a form of "research friendship" to foster the welfare of research participants. There is also the need for a regular update of the NHREC code so as to address some issues that were not considered in its current version.

Mothers' perceptions of their child's enrollment in a randomized clinical trial: poor understanding, vulnerability and contradictory feelings.

PubMed

Carvalho, Adriana Assis; Costa, Luciane Rezende

2013-12-10

Little is known about the views of mothers when their children are invited to participate in randomized clinical trials (RCTs) investigating medicines and/or invasive procedures. Our goal was to understand mothers' perceptions of the processes of informed consent and randomization in a RCT that divided uncooperative children into three intervention groups (physical restraint, sedation, and general anesthesia) for dental rehabilitation. This is a qualitative study based on semi-structured interviews with mothers accompanying children under 3 years old presenting severe early childhood caries. Their responses were analyzed using content analysis. We identified one major theme from 15 mothers' responses - "Understanding of, attitudes toward, and feelings about consenting to participate in a RCT involving advanced behavior guidance techniques and about randomization" - that was derived from the following subcategories: confusion in defining techniques, questions after signing the consent form, lack of knowledge about the techniques, acceptance or questioning of the drawing, sharing responsibility with the child during the drawing, and feelings of faith in God, fear, powerlessness to choose, and relief from or an increase in pressure. Despite mothers' misunderstanding, vulnerability, and contradictory feelings, they were willing to overlook their thoughts in order to complete their children's dental treatment.

Factors affecting consent in pediatric critical care research.

PubMed

Menon, Kusum; Ward, Roxanne E; Gaboury, Isabelle; Thomas, Margot; Joffe, Ari; Burns, Karen; Cook, Deborah

2012-01-01

Consent for research is a difficult and unpredictable process in pediatric critical care populations. The objectives of this study were to describe consent rates in pediatric critical care research and their association with patient, legal guardian, consent process, and study design-related factors. A prospective, cohort study was conducted from 2009 to 2010 in six tertiary care pediatric intensive care units (PICU) in Canada with legal guardians of patients who were approached for consent for any ongoing PICU research study. Data were recorded on details of the consent process for all consent encounters. We recorded 271 consent encounters. The overall consent rate was 80.1% (217/271). We observed higher consent rates when the research assistant was introduced by a member of the clinical team prior to approaching the family (89.7 vs. 77.7%; P = 0.04). Legal guardians of cardiac surgery patients were less likely to provide consent than those of all other patients (75.3 vs. 86.0%; P = 0.03). There was no difference in consent rates between therapeutic (117/145, 80.7%) versus non-therapeutic studies (100/126, 79.4%; P = 0.88). This study provides future researchers with consent data for determination of recruitment rates, sample sizes, budget estimations, and study timelines. Future pediatric critical care studies should consider incorporating the lower consent rates in cardiac surgery patients and routine introduction of the research assistant to the family by a member of the patient's care team into their study designs. The potential influence of parental factors on consent rates in pediatric critical care studies requires further research.

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.

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

PubMed Central

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

2014-01-01

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

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

PubMed

Allmark, P; Mason, S

2006-08-01

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

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

PubMed

Lad, Pramod M; Dahl, Rebecca

2014-06-01

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

Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial.

PubMed

Hall, Eric William; Sanchez, Travis H; Stein, Aryeh D; Stephenson, Rob; Zlotorzynska, Maria; Sineath, Robert Craig; Sullivan, Patrick S

2017-03-06

Web-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants. The aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM). From July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension. Of the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score increase=1.79; 95% CI 1.02-2.55) and participants who received the staff video consent (score increase=1.79; 95% CI 0.99-2.59). There was no significant difference in comprehension for those who received the FAQ consent. Participants spent more time on the 2 video consents (staff video median time=117 seconds; professional video median time=115 seconds) than the FAQ (median=21 seconds) and standard consents (median=37 seconds). Mediation analysis showed that though time spent on the consent page was partially responsible for some of the differences in comprehension, the direct effects of the professional video (score increase=0.93; 95% CI 0.39-1.48) and the staff-produced video (score increase=0.99; 95% CI 0.42-1.56) were still significant. Video-based consent methods improve consent comprehension of MSM participating in a Web-based HIV behavioral survey. This effect may be partially mediated through increased time spent reviewing the consent material; however, the video consent may still be superior to standard consent in improving participant comprehension of key study facts. Clinicaltrials.gov NCT02139566; https://clinicaltrials.gov/ct2/show/NCT02139566 (Archived by WebCite at http://www.webcitation.org/6oRnL261N). ©Eric William Hall, Travis H Sanchez, Aryeh D Stein, Rob Stephenson, Maria Zlotorzynska, Robert Craig Sineath, Patrick S Sullivan. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 06.03.2017.

Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial

PubMed Central

Sanchez, Travis H; Stein, Aryeh D; Stephenson, Rob; Zlotorzynska, Maria; Sineath, Robert Craig; Sullivan, Patrick S

2017-01-01

Background Web-based surveys are increasingly used to capture data essential for human immunodeficiency virus (HIV) prevention research. However, there are challenges in ensuring the informed consent of Web-based research participants. Objective The aim of our study was to develop and assess the efficacy of alternative methods of administering informed consent in Web-based HIV research with men who have sex with men (MSM). Methods From July to September 2014, paid advertisements on Facebook were used to recruit adult MSM living in the United States for a Web-based survey about risk and preventive behaviors. Participants were randomized to one of the 4 methods of delivering informed consent: a professionally produced video, a study staff-produced video, a frequently asked questions (FAQs) text page, and a standard informed consent text page. Following the behavior survey, participants answered 15 questions about comprehension of consent information. Correct responses to each question were given a score of 1, for a total possible scale score of 15. General linear regression and post-hoc Tukey comparisons were used to assess difference (P<.001) in mean consent comprehension scores. A mediation analysis was used to examine the relationship between time spent on consent page and consent comprehension. Results Of the 665 MSM participants who completed the comprehension questions, 24.2% (161/665) received the standard consent, 27.1% (180/665) received the FAQ consent, 26.8% (178/665) received the professional consent video, and 22.0% (146/665) received the staff video. The overall average consent comprehension score was 6.28 (SD=2.89). The average consent comprehension score differed significantly across consent type (P<.001), age (P=.04), race or ethnicity (P<.001), and highest level of education (P=.001). Compared with those who received the standard consent, comprehension was significantly higher for participants who received the professional video consent (score increase=1.79; 95% CI 1.02-2.55) and participants who received the staff video consent (score increase=1.79; 95% CI 0.99-2.59). There was no significant difference in comprehension for those who received the FAQ consent. Participants spent more time on the 2 video consents (staff video median time=117 seconds; professional video median time=115 seconds) than the FAQ (median=21 seconds) and standard consents (median=37 seconds). Mediation analysis showed that though time spent on the consent page was partially responsible for some of the differences in comprehension, the direct effects of the professional video (score increase=0.93; 95% CI 0.39-1.48) and the staff-produced video (score increase=0.99; 95% CI 0.42-1.56) were still significant. Conclusions Video-based consent methods improve consent comprehension of MSM participating in a Web-based HIV behavioral survey. This effect may be partially mediated through increased time spent reviewing the consent material; however, the video consent may still be superior to standard consent in improving participant comprehension of key study facts. Trail Registration Clinicaltrials.gov NCT02139566; https://clinicaltrials.gov/ct2/show/NCT02139566 (Archived by WebCite at http://www.webcitation.org/6oRnL261N). PMID:28264794

Supreme Court to Hear Case on Union Fees

ERIC Educational Resources Information Center

Honawar, Vaishali

2006-01-01

The U.S. Supreme Court agreed last September 2006 to take up the issue of when a teachers' union may spend the money it collects in the form of "agency fees" from nonmembers on political causes. The justices said they would review a Washington state law that requires nonmembers to "affirmatively consent," or opt in, before a…

A resolution honoring the legacy of A. Philip Randolph and saluting his efforts on behalf of the people of the United States to form "a more perfect union".

THOMAS, 113th Congress

Sen. Nelson, Bill [D-FL

2013-09-09

Senate - 06/04/2014 Resolution agreed to in Senate without amendment and with a preamble by Unanimous Consent. (All Actions) Tracker: This bill has the status Agreed to in SenateHere are the steps for Status of Legislation:

75 FR 38104 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-01

... 2 1.5 Guide (participation in focus group). Parents of boys and girls, ages 11 to Online Survey E... respondents respondent (in hours) Youths ages 11 to 18 and parents of Focus Group Screening 576 2 5/60 boys and girls, ages 11 to 18. Instrument for Youth and Script for Obtaining Verbal Consent from Parent...

47 CFR 73.3540 - Application for voluntary assignment or transfer of control.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Application for voluntary assignment or transfer of control. (a) Prior consent of the FCC must be obtained for a voluntary assignment or transfer of control. (b) Application should be filed with the FCC at least... “Assignment of license” or FCC Form 316 “Short form” (See paragraph (f) of this section). (d) Application for...

47 CFR 73.3540 - Application for voluntary assignment or transfer of control.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Application for voluntary assignment or transfer of control. (a) Prior consent of the FCC must be obtained for a voluntary assignment or transfer of control. (b) Application should be filed with the FCC at least... “Assignment of license” or FCC Form 316 “Short form” (See paragraph (f) of this section). (d) Application for...

47 CFR 73.3540 - Application for voluntary assignment or transfer of control.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Application for voluntary assignment or transfer of control. (a) Prior consent of the FCC must be obtained for a voluntary assignment or transfer of control. (b) Application should be filed with the FCC at least... “Assignment of license” or FCC Form 316 “Short form” (See paragraph (f) of this section). (d) Application for...

47 CFR 73.3540 - Application for voluntary assignment or transfer of control.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Application for voluntary assignment or transfer of control. (a) Prior consent of the FCC must be obtained for a voluntary assignment or transfer of control. (b) Application should be filed with the FCC at least... “Assignment of license” or FCC Form 316 “Short form” (See paragraph (f) of this section). (d) Application for...

78 FR 64423 - Children's Online Privacy Protection Rule Applications for Approval of Proposed Parental Consent...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

..., Inc.; Application for Approval of Safe Harbor Program by kidSAFE Seal Program AGENCY: Federal Trade... kidSAFE Seal Program (``kidSAFE''), owned and operated by Samet Privacy, LLC, under the safe harbor... following the instructions on the web-based form. For comments concerning kidSAFE, write ``kidSAFE...

Manufacturing Consent for Privatization in Public Education: The Rise of a Social Finance Network in Canada

ERIC Educational Resources Information Center

Poole, Wendy; Sen, Vicheth; Fallon, Gerald

2016-01-01

Multiple forms of privatization are emerging in the Canadian public sector, including public-private partnerships. This article focuses on one approach to public-private partnerships called "social finance," and a network of public, private, and not-for-profit organizations that promotes social finance as a means of funding public…

75 FR 62913 - 30-Day Notice of Proposed Information Collection: Form DS-3053, Statement of Consent or Special...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-13

... properly perform our functions. Evaluate the accuracy of our estimate of the burden of the proposed... issuance of passports to U.S. citizens and nationals under the age of 16. The primary purpose of soliciting... family circumstances. Methodology: Passport Services collects information from U.S. citizens and non...

17 CFR 260.10a-4 - Consent of trustee to service of process.

Code of Federal Regulations, 2014 CFR

2014-04-01

... business under the laws of a foreign government shall furnish to the Commission on Form F-X (§ 249.250 of... papers in any Commission investigation or administrative proceeding and any civil suit or action brought... such suit, action or proceeding may be commenced by the service of process upon said agent for service...

17 CFR 260.10a-4 - Consent of trustee to service of process.

Code of Federal Regulations, 2013 CFR

2013-04-01

... business under the laws of a foreign government shall furnish to the Commission on Form F-X (§ 249.250 of... papers in any Commission investigation or administrative proceeding and any civil suit or action brought... such suit, action or proceeding may be commenced by the service of process upon said agent for service...

17 CFR 260.10a-4 - Consent of trustee to service of process.

Code of Federal Regulations, 2012 CFR

2012-04-01

... business under the laws of a foreign government shall furnish to the Commission on Form F-X (§ 249.250 of... papers in any Commission investigation or administrative proceeding and any civil suit or action brought... such suit, action or proceeding may be commenced by the service of process upon said agent for service...

17 CFR 260.10a-4 - Consent of trustee to service of process.

Code of Federal Regulations, 2011 CFR

2011-04-01

... business under the laws of a foreign government shall furnish to the Commission on Form F-X (§ 249.250 of... papers in any Commission investigation or administrative proceeding and any civil suit or action brought... such suit, action or proceeding may be commenced by the service of process upon said agent for service...

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

PubMed

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

2008-01-23

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

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.

Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk.

PubMed

Rogers, C G; Tyson, J E; Kennedy, K A; Broyles, R S; Hickman, J F

1998-04-01

The objective of this study was to assess a modified consent procedure allowed under federal regulations and developed for studies, particularly clinical trials, that are judged by the Institutional Review Board to reduce or have no effect on patient risk. This was a randomized trial of a conventional consent procedure that required parental signature to give consent (opting in) after a comprehensive disclosure of the rights of participants in research versus a modified consent procedure that required parental signature to refuse consent (opting out) after specific disclosures appropriate when risk is not increased. Consent was sought for a trial of primary follow-up care for disadvantaged infants at high risk, a trial judged by our Institutional Review Board to increase access to care for both groups. A blinded assessor interviewed mothers within 24 hours of the consent decision. Among the 44 mothers interviewed, the modified consent group scored higher than the conventional consent group in recall and understanding of study purpose and methods (47% vs 30%; p < 0.02). Other comparisons provided no evidence that the modified consent procedure was less desirable. Virtually all mothers reported satisfaction. The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing. Further evaluation of a modified consent procedure for such studies is warranted.

The Effects of Requiring Parental Consent for Research on Adolescents' Risk Behaviors: A Meta-analysis.

PubMed

Liu, Chao; Cox, Ronald B; Washburn, Isaac J; Croff, Julie M; Crethar, Hugh C

2017-07-01

Requiring parental consent may result in sampling biases that confound scientific conclusions and stifle the representation of children most at risk for adverse outcomes. This study aims to investigate whether active parental consent, compared with passive parental consent, creates a bias in response rate, demographic makeup, and adverse outcomes in adolescent samples. A meta-analysis was performed on peer-reviewed articles and unpublished dissertations from 1975 to 2016 in five computerized databases ERIC, PsycINFO, MEDLINE, PubMed and ProQuest. Quantitative studies were retained if they included the following keywords: active consent (or informed consent or parental consent), passive consent (or waiver of consent), risk behavior, adolescen*. Fifteen studies were identified with a total number of 104,074 children. Results showed (1) response rates were significantly lower for studies using active consent procedure than those using passive consent procedure (Z = 3.05, p = .002); (2) more females, younger participants, and less African-Americans were included in studies using active consent procedures than studies using passive procedures (Z = -2.73, p = .006; Z = -12.06, p < .00001; Z = 2.19, p = .03, respectively); (3) studies with passive consent procedures showed higher rates of self-reported substance use than studies using active consent procedures (Z = 3.07, p = .002). Requiring active parental consent can lead to a systematic bias in the sample where the population under study is misrepresented. Institutional review board committees should collaborate with researchers to find solutions that protect minors without silencing the voice of high-risk youth in the literature. Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

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

PubMed Central

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

2012-01-01

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

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

PubMed

Hwang, Min-A; Kwak, In Ja

2015-01-01

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

Impact of Institutional Review Board Practice Variation on Observational Health Services Research

PubMed Central

Green, Lee A; Lowery, Julie C; Kowalski, Christine P; Wyszewianski, Leon

2006-01-01

Objective To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. Data Source and Setting Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. Design Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. Data Collection and Abstraction Methods Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. Principal Findings Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites.Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document.Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. Conclusions Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects. PMID:16430608

Why is it hard to make progress in assessing children's decision-making competence?

PubMed

Hein, Irma M; Troost, Pieter W; Broersma, Alice; de Vries, Martine C; Daams, Joost G; Lindauer, Ramón J L

2015-01-10

For decades, the discussion on children's competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children's interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children's competence to consent, however, is currently not assessed in a standardized way. Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children's competence.This article aims at identifying these gaps in knowledge and suggests options for dealing with the obstacles in empirical research in order to advance policies and practices regarding children's medical decision-making competence. Understanding children's competency is hampered by the law. Legislative regulations concerning competency are established on a strong presumption that persons older than a certain age are competent, whereas younger persons are not. Furthermore, a number of contextual factors are believed to be of influence on a child's decision-making competence: the developmental stage of children, the influence of parents and peers, the quality of information provision, life experience, the type of medical decision, and so on. Ostensibly, these diverse and extensive barriers hinder any form of advancement in this conflicted area. Addressing these obstacles encourages the discussion on children's competency, in which the most prominent question concerns the lack of a clear operationalization of children's competence to consent. Empirical data are needed to substantiate the discussion. The empirical approach offers an opportunity to give direction to the debate. Recommendations for future research include: studying a standardized assessment instrument covering all four relevant dimensions of competence (understanding, reasoning, appreciation, expressing a choice), including a study population of children covering the full age range of 7 to 18 years, improving information provision, and assessing relevant contextual data.

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

PubMed Central

2017-01-01

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

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.

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.

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

PubMed

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

2014-01-01

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

Patients' experiences towards the donation of their residual biological samples and the impact of these experiences on the type of consent given for secondary use: A systematic review.

PubMed

Wai, Chan Tuck; Mackey, Sandra Jane; Hegney, Desley Gail

Background Residual or leftover clinical tissues are valuable resources for biomedical research. There is on-going discussion about the methodological, legal, and ethical issues on the collection, storage and use of these tissues for future research. This systematic review will consider qualitative studies previously conducted, which report on patients' preferences, experiences and willingness to donate their tissues.Objectives The aim of this review was to critically appraise, synthesize and present the best available evidence related to the experiences of patients toward consent when donating their leftover tissue for research.Search strategy The search strategy aimed to find both published and unpublished studies. A three-step search strategy was utilized. An initial limited search of MEDLINE and CINAHL was undertaken, followed by analysis of text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all identified keywords and index terms was then undertaken across all included databases. Thirdly, the reference lists of all identified reports and articles were searched for additional studies.Data collection & analysis The standardised data extraction tool from the Joanna Briggs Institute Qualitative Assessment and Review Instrument (JBI-QARI) was used to extract data from each paper. The qualitative research findings were presented as thematic pooling using the JBI-QARI approach in a narrative form. During the analysis, 131 study findings from 18 publications were aggregated into 19 categories to form four synthesized findings.Main results The synthesized findings generated were: (1) Healthcare professionals should be aware that patients' consent to the use of their left-over tissues are influenced by many and varied factors. Primarily these factors included: benefits to self and other and trust in research and researchers; (2) Healthcare institutions and regulatory authorities must provide strict safeguards and controls in order to maintain privacy and confidentiality of the patients; (3) Healthcare professionals should be aware that the views on ownership and rights to the tissues will vary between individual patients; (4) Healthcare professionals, institutions and regulatory authorities should be aware that patients have different views on the commercial use of their tissues.Discussion Patients would prefer that institutions requesting donation of leftover tissues establish a good governance system for the collection and storage of tissues, as well as a system for protecting the rights and confidentiality of patients. Most patients prefer to have an ethical and effective system, which decides the future use of their tissues, especially when a full informed consent is not obtained from the patients at time of donation and subsequent use.Implications for Practice The results from this review can assist researchers and policy makers to understand the experiences of patients and their attitudes and preferences on the collection, storage, distribution and use of their leftover tissue for research. This is especially so when designing a prospective model of consent regimen, to respect patients' needs and make recommendations for the use of existing and previously collected biological samples with no consent taken.Implications for Research Further qualitative research can be undertaken to ascertain patients' expectations when they donate their tissues; the type of consent model to be used; the perceived risks of genetic and stem cells research; and the effects of culture, religion and age on patients' willingness to donate their leftover tissues for future research.

Downsizing genomic medicine: approaching the ethical complexity of whole-genome sequencing by starting small.

PubMed

Sharp, Richard R

2011-03-01

As we look to a time when whole-genome sequencing is integrated into patient care, it is possible to anticipate a number of ethical challenges that will need to be addressed. The most intractable of these concern informed consent and the responsible management of very large amounts of genetic information. Given the range of possible findings, it remains unclear to what extent it will be possible to obtain meaningful patient consent to genomic testing. Equally unclear is how clinicians will disseminate the enormous volume of genetic information produced by whole-genome sequencing. Toward developing practical strategies for managing these ethical challenges, we propose a research agenda that approaches multiplexed forms of clinical genetic testing as natural laboratories in which to develop best practices for managing the ethical complexities of genomic medicine.

Ethical issues in treating gay and lesbian patients.

PubMed

Drescher, Jack

2002-09-01

Since the 1973 decision to remove homosexuality from the list of mental disorders, most mental health practitioners have shifted their clinical focus from "the cure" of homosexuality to treating the concerns of gay and lesbian patients. Some clinicians, however, reject the mental health mainstream's view and continue to conceptualize homosexuality as a mental disorder. Their clinical theories have been incorporated into wider societal debates regarding the status of gay and lesbian people. The sexual conversion or reparative therapies they practice, however, may include routine ethical violations in the realm of improper pressure, confidentiality, informed consent, and fiduciary responsibility to the patient's best interest. On the other hand, a normal/identity approach to treatment, particularly in its most reductionistic forms, may involve ethical lapses in the areas of informed consent and fiduciary responsibility to the patient's best interests as well.

Participation of Adolescent Girls in a Study of Sexual Behaviors: Balancing Autonomy and Parental Involvement

PubMed Central

Short, Mary B.; Wiemann, Constance; Rosenthal, Susan L.

2009-01-01

Study Objective The process of research with adolescents should balance parental involvement and adolescent autonomy. The attendance of parents and peers at research study visits of girls participating in a 6-month study of topical microbicide acceptability is described, as well as the participants’ conversations with their parents. Methods Girls, 14 through 21 years, were recruited from previous studies (3%), advertisements (14%), clinics (17%), and recommendations by friends (66%) to participate. Girls under 18 years were required to have parental consent, but parents could provide verbal phone consent as long as a signed consent form was returned before participation. Results The 208 participants were 41% African-American, 30% Hispanic, and 29% Caucasian. Girls averaged 18 years of age, and 95 (46%) were under 18. Seventeen percent of parents attended the first visit; all but one was with a daughter of less than 18 years. The mothers of older adolescents were less likely to attend the appointment with them. More Caucasian than African-American girls came with a mother. Parental attendance decreased at follow-up visits. Thirty-seven percent of girls brought a peer to the first visit; there were no age or race/ethnic differences. There was no relationship between attending with a parent or peer and talking to a parent about the study. Some adolescents obtained parental consent to participate in the study while keeping their sexual behaviors private. Conclusions Parental attendance at study visits may not be marker of parental involvement with the study. Creative ways for balancing concerns about confidentiality, promotion of autonomy, and adult involvement should be considered. PMID:19345916

Informing the Uninformed: Optimizing the Consent Message Using a Fractional Factorial Design

PubMed Central

Tait, Alan R.; Voepel-Lewis, Terri; Nair, Vijayan N.; Narisetty, Naveen N.; Fagerlin, Angela

2013-01-01

Objective Research information should be presented in a manner that promotes understanding. However, many parents and research subjects have difficulty understanding and making informed decisions. This study was designed to examine the effect of different communication strategies on parental understanding of research information. Participants 640 parents of children scheduled for elective surgery Design Observational study using a fractional factorial design Setting Large tertiary care children's hospital Interventions Parents were randomized to receive information about a hypothetical pain trial presented in one of 16 consent documents containing different combinations of 5 selected communication strategies (i.e., length, readability, processability [formatting], graphical display, and supplemental verbal disclosure). Main outcome measures Parents were interviewed to determine their understanding of the study elements (e.g., protocol, alternatives etc.) and their gist (main point) and verbatim (actual) understanding of the risks and benefits. Results Main effects for understanding were found for processability, readability, message length, use of graphics, and verbal discussion. Consent documents with high processability, 8th grade reading level, and graphics resulted in significantly greater gist and verbatim understanding compared with forms without these attributes (mean difference, 95% CI = 0.57, 0.26–0.88, correct responses out of 7 and 0.54, 0.20–0.88 correct responses out of 4 for gist and verbatim, respectively). Conclusions Results identified several communication strategy combinations that improved parents' understanding of research information. Adoption of these active strategies by investigators, clinicians, IRBs, and study sponsors represents a simple, practical, and inexpensive means to optimize the consent message and enhance parental, participant, and patient understanding. PMID:23700028

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

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

[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.

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

PubMed Central

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

2016-01-01

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

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

PubMed Central

2014-01-01

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

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

PubMed

Masaki, Sakiko; Ishimoto, Hiroko; Asai, Atsushi

2014-02-04

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

Patients' acceptance of medical photography in a French adult and paediatric dermatology department: a questionnaire survey.

PubMed

Hacard, F; Maruani, A; Delaplace, M; Caille, A; Machet, L; Lorette, G; Samimi, M

2013-08-01

Despite the increasing use of medical photography by dermatologists, no study on patients' perceptions of photography in dermatology has been performed to date. Firstly, to evaluate patients' perceptions of medical photography. Secondly, to assess whether perceptions differed between patients in our adult department and parents accompanying a child in our paediatric department. An opinion survey was conducted at the Hospital of Tours (France) among adult patients (adult department) and accompanying parents (paediatric department) by completion of a questionnaire after any medical photography had been performed. We collected 272 questionnaires regarding 158 adults and 114 children. A camera used only in the department, and storage of the images in the department's records were the most accepted modalities (> 90%), especially in the paediatric survey. Respondents agreed with the sharing of the images with other practitioners and in medical meetings (> 85%) rather than distribution via publications (58·3%), e-mails (45·5%), health magazines (44·3%) and websites (32·0%). Most (78·8%) considered that the consent form should list all the possible uses of the images. Need for renewed consent for each use of the images was significantly more often expressed in the paediatric than the adult survey (44·5% vs. 24·5%, P = 0·001). More than 95% of respondents considered medical photography to be useful for improving diagnosis, monitoring of skin disease and aiding teaching. These findings could be used to improve practice, to increase the acceptability of medical photography and for devising a standardized consent form for medical practitioners performing medical photography. © 2013 The Authors BJD © 2013 British Association of Dermatologists.

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PubMed

Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

2017-02-01

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Petty v. United States.

PubMed

1980-12-31

Under a ruling of the U.S. District Court for the Northern District of Iowa, the registration form which individuals were required to sign before receiving a swine flu vaccination did not meet the statutory requirement of an "informed consent" form. Moreover, the federal government was negligent in failing to establish adequate procedures for assuring that the risks and benefits of the swine flu vaccine were fully explained to each individual. This case was appealed before the U.S. Court of Appeals, Eighth Circuit, as found in Petty v. United States, Federal Reporter, 2d Series, 740: 1428-1442.

Exercise to Counteract Loss of Bone and Muscle During Androgen Deprivation Therapy in Men with Prostate Cancer

DTIC Science & Technology

2009-08-01

finishers in the current study on age and body mass index . This will enable us to evaluate BMD and body composition changes in response to exercise in men...support from the Clinical Nutrition Research Unit (CNRU) • prepare data forms • prepare data base • train research staff Final approval of the protocol...the local IRB on 19 Feb 2008. In the past year, the consent form underwent minor changes to update standard language used by the local IRB (approved

Predictors of adolescents' consent to use health records for research and results from data collection in a Swedish twin cohort.

PubMed

Ullemar, Vilhelmina; Lundholm, Cecilia; Örtqvist, Anne K; Gumpert, Clara Hellner; Anckarsäter, Henrik; Lundström, Sebastian; Almqvist, Catarina

2015-06-01

Non-random selection into a study population due to differences between consenters and non-consenters may introduce participation bias. Past investigations of factors predicting consent to collection of medical health records for research imply that age, sex, health status, and education are of importance for participation, but disagree on the direction of effects. Very little is known about influences on consent from adolescents. Two cohorts of Swedish 15-year-old twins (total n = 4,611) previously invited to the Child and Adolescent Twin Study in Sweden (CATSS) responded to a questionnaire with information on sex, individual's health, height, weight, and parental factors. The questionnaire included a question for consent to collection of medical health records. Predictors for consent were analyzed using logistic regression. Additionally, regional differences in the collection of health records of consenters were evaluated. Males were significantly less likely to consent compared to females (OR 0.74, 95% CI 0.64-0.85). The twin siblings' decision to consent was strongly associated with consent (OR 10.9, 95% CI 8.76-13.5), and individuals whose parents had responded to the original CATSS study were more likely to consent to record collection at age 15 (OR 2.2, 95% CI 1.81-2.75). Results of the subsequent collection of consenters' medical health records varied between geographical regions of Sweden. We identified several predictors for adolescents' consent to collection of their medical health records. Further selection was introduced through the subsequent record collection. Whether this will induce participation bias in future studies depends on the research questions' relationship to the identified predictors.

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

PubMed Central

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

2013-01-01

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

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

PubMed Central

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

2013-01-01

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

77 FR 39493 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

... Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file... question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree... Justice determines, based on any comment submitted, that consent to this consent decree should be...

75 FR 38519 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-02

.... and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be... question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree... Justice determines, based on any comment submitted, that consent to this consent decree should be...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

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

34 CFR 300.300 - Parental consent.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 2 2013-07-01 2013-07-01 false Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

34 CFR 300.300 - Parental consent.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 2 2011-07-01 2010-07-01 true Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

34 CFR 300.300 - Parental consent.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 2 2012-07-01 2012-07-01 false Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

34 CFR 300.300 - Parental consent.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 2 2014-07-01 2013-07-01 true Parental consent. 300.300 Section 300.300 Education... Placements Parental Consent § 300.300 Parental consent. (a) Parental consent for initial evaluation. (1)(i... child with a disability under § 300.8 must, after providing notice consistent with §§ 300.503 and 300...

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.

Can Broad Consent be Informed Consent?

PubMed Central

Sheehan, Mark

2011-01-01

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

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

PubMed Central

Gupta, Umesh Chandra; Kharawala, Saifuddin

2012-01-01

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

75 FR 59718 - US Search, Inc. And US Search, LLC; Analysis of Proposed Consent Order to Aid Public Comment

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... FEDERAL TRADE COMMISSION [File No. 102 3131] US Search, Inc. And US Search, LLC; Analysis of... written comments electronically or in paper form. Comments should refer to``US Search, Inc., File No. 101... this Notice appears at ( http://www.regulations.gov/search/index.jsp ), you may also file an electronic...

12 CFR 303.182 - Establishing, moving or closing a foreign branch of an insured state nonmember bank.

Code of Federal Regulations, 2010 CFR

2010-01-01

... general consent. Notice in the form of a letter from an eligible depository institution establishing or... Preservation Act Amendments of 1980 (NHPA Amendments Act) (16 U.S.C. 470a-2). The FDIC will provide written... shall submit an application to the appropriate FDIC office. (2) Content of filing. A complete letter...

Providing for the Establishment of the Select Committee on the Events Surrounding the 2012 Terrorist Attack in Benghazi.

THOMAS, 113th Congress

Rep. Sessions, Pete [R-TX-32

2014-05-06

House - 05/08/2014 Mr. Sessions asked unanimous consent to modify H. Res. 567 in the form he had placed at the desk. Without objection, the modification was agreed to. (All Actions) Tracker: This bill has the status Agreed to in HouseHere are the steps for Status of Legislation:

26 CFR 12.9 - Election to postpone determination with respect to the presumption described in section 183(d).

Code of Federal Regulations, 2013 CFR

2013-04-01

...) and (2) of this section, if no election has been made before a suit or proceeding described in section... the suit or proceeding will be caused. (d) Manner of making election. (1) The election shall be made... to the statement properly executed consents, in the form prescribed by the Commissioner, extending...

26 CFR 12.9 - Election to postpone determination with respect to the presumption described in section 183(d).

Code of Federal Regulations, 2011 CFR

2011-04-01

...) and (2) of this section, if no election has been made before a suit or proceeding described in section... the suit or proceeding will be caused. (d) Manner of making election. (1) The election shall be made... to the statement properly executed consents, in the form prescribed by the Commissioner, extending...

26 CFR 12.9 - Election to postpone determination with respect to the presumption described in section 183(d).

Code of Federal Regulations, 2012 CFR

2012-04-01

...) and (2) of this section, if no election has been made before a suit or proceeding described in section... the suit or proceeding will be caused. (d) Manner of making election. (1) The election shall be made... to the statement properly executed consents, in the form prescribed by the Commissioner, extending...

Waiver of consent in noninterventional, observational emergency research: the PROMMTT experience.

PubMed

Fox, Erin E; Bulger, Eileen M; Dickerson, Aisha S; del Junco, Deborah J; Klotz, Patricia; Podbielski, Jeanette; Matijevic, Nena; Brasel, Karen J; Holcomb, John B; Schreiber, Martin A; Cotton, Bryan A; Phelan, Herb A; Cohen, Mitchell J; Myers, John G; Alarcon, Louis H; Muskat, Peter; Wade, Charles E; Rahbar, Mohammad H

2013-07-01

In the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, waiver of consent was used because previous literature reported low response rates and subsequent bias. The goal of this article was to examine the rationale and tradeoffs of using waiver of consent in PROMMTT. PROMMTT enrolled trauma patients receiving at least 1 U of red blood cells within 6 hours after admission at 10 US Level 1 trauma centers. Local institutional review boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent but was allowed to retain data on patients unable to be consented. Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%), and no patient or legally authorized representative refused to give consent. Of the patients, 36 (30%) died, and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, 6 of the local IRBs approved collection of residual blood samples, 1 had previous approval to collect timed blood samples under a separate protocol, and 3 reported that their local IRBs would not approve collection of residual blood under a waiver of consent. Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If the IRB for Site 8 had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Noninterventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study.

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

PubMed

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

2016-07-12

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

Waiver of consent in non-interventional, observational emergency research: the PROMMTT experience

PubMed Central

Fox, Erin E.; Bulger, Eileen M.; Dickerson, Aisha S.; del Junco, Deborah J.; Klotz, Patricia; Podbielski, Jeanette; Matijevic, Nena; Brasel, Karen J.; Holcomb, John B.; Schreiber, Martin A.; Cotton, Bryan A.; Phelan, Herb A.; Cohen, Mitchell J.; Myers, John G.; Alarcon, Louis H.; Muskat, Peter; Wade, Charles E.; Rahbar, Mohammad H.

2013-01-01

Background In the PRospective Observational Multi-center Major Trauma Transfusion (PROMMTT) study, waiver of consent was utilized because previous literature reported low response rates and subsequent bias. The goal of this manuscript is to examine the rationale and tradeoffs of using waiver of consent in PROMMTT. Methods PROMMTT enrolled trauma patients receiving at least one unit of red blood cells within 6 hours after admission at ten US Level 1 Trauma Centers. Local Institutional Review Boards (IRBs) from all sites approved the study. Site 8 was required by their IRB to attempt consent, but was allowed to retain data on patients unable to be consented. Results Of 121 subjects enrolled at Site 8, 55 consents were obtained (46%) and no patient or legally-authorized representative refused to give consent. Thirty-six (30%) patients died and 6 (5%) were discharged before consent could be attempted. Consent was attempted but not possible among 24 patients (20%). Of the 10 clinical sites, six of the local IRBs approved collection of residual blood samples, one had prior approval to collect timed blood samples under a separate protocol, and three reported that their local IRBs would not approve collection of residual blood under a waiver of consent. Conclusions Waiver of consent was used in PROMMTT because of the potential adverse impact of consent refusals; however, there were no refusals. If Site 8’s IRB had required withdrawal of patients unable to consent and destruction of their data, a serious bias would likely have been introduced. Other tradeoffs included a reduction in sites participating in residual blood collection, and a smaller than expected amount of residual blood collected among sites operating under a waiver of consent. Non-interventional emergency research studies should consider these potential tradeoffs carefully before deciding whether waiver of consent would best achieve the goals of a study. Level of Evidence Prospective, Level II PMID:23778508

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

PubMed Central

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

2014-01-01

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

32 CFR 634.8 - Implied consent.

Code of Federal Regulations, 2010 CFR

2010-07-01

... INVESTIGATIONS MOTOR VEHICLE TRAFFIC SUPERVISION Driving Privileges § 634.8 Implied consent. (a) Implied consent... their consent to evidential tests for alcohol or other drug content of their blood, breath, or urine...

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

PubMed Central

2011-01-01

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

78 FR 26028 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-03

... Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file... question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree... Justice determines that consent to this consent decree should be withdrawn, the terms of the decree will...

78 FR 23562 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-19

.... and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be... question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree... Justice determines that consent to this consent decree should be withdrawn, the terms of the decree will...

76 FR 56756 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-14

...:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be... Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or... requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree...

75 FR 71126 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-22

.... and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be.... EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if... Justice determines that consent to this consent decree should be withdrawn, the terms of the decree will...

76 FR 45564 - Proposed Consent Decree, Clean Air Act Citizen Suit

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

... Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal... Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or... requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree...