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Public's approach to surrogate consent for dementia research: cautious pragmatism.

ABSTRACT: OBJECTIVES:To describe how members of the older general public deliberate with one another in finding solutions to the dilemma of involving persons with decisional incapacity in dementia research. DESIGN, SETTING, AND PARTICIPANTS:One hundred sixty persons age 50 years and older who participated in an all-day deliberative democracy session on the ethics of surrogate consent for dementia research. The deliberative democracy day consisted of both extensive, interactive education with experts in clinical research and ethics, as well as small group deliberations. MEASUREMENTS:Audiotaped small group deliberations were transcribed and analyzed and the main thematic elements were coded. RESULTS:During deliberation, participants acknowledged the limitations of advanced research directives and discussed ways to improve their use. Although there was consensus about the necessity of surrogate consent, the participants recognized potential pitfalls and looked for ways to safeguard the process. Participants supporting surrogate consent for research emphasized societal and individual benefits, the importance of assent, and trust in surrogates and the oversight system. Other participants felt that the high risk of some research scenarios was not sufficiently offset by benefits to patients or society. CONCLUSIONS:Members of the older general public are able to make use of in-depth education and peer deliberation to provide reasoned and informed opinions on the ethical use of surrogate consent for dementia research. The public's approach to surrogate consent is one of cautious pragmatism: an overall trust in science and future surrogates with awareness of the potential pitfalls, suggesting that their trust cannot be taken for granted.

SUBMITTER: De Vries R

PROVIDER: S-EPMC3357450 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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Public's approach to surrogate consent for dementia research: cautious pragmatism.

De Vries Raymond R Ryan Kerry A KA Stanczyk Aimee A Appelbaum Paul S PS Damschroder Laura L Knopman David S DS Kim Scott Y H SY

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry 20130112 4

<h4>Objectives</h4>To describe how members of the older general public deliberate with one another in finding solutions to the dilemma of involving persons with decisional incapacity in dementia research.<h4>Design, setting, and participants</h4>One hundred sixty persons age 50 years and older who participated in an all-day deliberative democracy session on the ethics of surrogate consent for dementia research. The deliberative democracy day consisted of both extensive, interactive education wit ...[more]

PMID: 23498383

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Project description:ObjectiveA mixed-methods study exploring the UK general public's views towards consent for the use of biosamples for biomedical research.SettingCross-sectional population-based focus groups followed by an online survey.Participants12 focus groups (81 participants) selectively sampled to reflect a range of demographic groups; 1110 survey responders recruited through a stratified sampling method with quotas set on sex, age, geographical location, socioeconomic group and ethnicity.Main outcome measures(1) Views on the importance of consent when donating residual biosamples for medical research; (2) preferences for opt-in or opt-out consent approaches and (3) preferences for different consent models.ResultsParticipants believed obtaining consent for use of residual biosamples was important as it was 'morally correct' to ask, and enabled people to make an active choice and retain control over their biosamples. Survey responders preferred opt-in consent (55%); the strongest predictor was being from a low socioeconomic group (OR 2.22, 95% CI 1.41 to 3.57, p=0.001) and having a religious affiliation (OR 1.36, 95% CI 1.01 to 1.81, p=0.04). Focus group participants had a slight preference for opt-out consent because by using this approach more biosamples would be available and facilitate research. Concerning preferred models of consent for research use of biosamples, survey responders preferred specific consent with recontact for each study for which their biosamples are eligible. Focus group participants preferred generic consent as it provided 'flexibility for researchers' and reduced the likelihood that biosamples would be wasted. The strongest predictor for preferring specific consent was preferring opt-in consent (OR 4.58, 95% CI 3.30 to 6.35, p=0.015) followed by non-'White' ethnicity (OR 2.94, 95% CI 1.23 to 7.14, p<0.001).ConclusionsThere is a preference among the UK public for ongoing choice and control over donated biosamples; however, increased knowledge and opportunity for discussion is associated with acceptance of less restrictive consent models for some people.

Project description:Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research.A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.None.Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults.Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives.Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.

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

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Public's approach to surrogate consent for dementia research: cautious pragmatism.

Publications

Public's approach to surrogate consent for dementia research: cautious pragmatism.

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