Views of Potential Subjects Toward Proposed Regulations for Clinical Research With Adults Unable to Consent

Wendler, Dave; Martínez, Rick A.; Fairclough, Diane L.; Sunderland, Trey; Emanuel, Ezekiel

doi:10.1176/appi.ajp.159.4.585

Cited by 69 publications

(74 citation statements)

References 17 publications

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“…Several factors contributed to emotional distress: observing a loved one in a critically ill state, grappling with uncertainty regarding which institutional review boards (IRBs) apply such protections, explored the views of individuals regard ing substituted judgment for research of chronic diseases, and looked at the emotional impact of functioning as an SDM in the ICU setting. 7,10,[13][14][15][16][17][18][19] We undertook the current investigation to further study how the pressures and concerns of serving as SDM for an acutely ill family member might infl uence attitudes regarding clinical research and how this information might be used to enhance the consent process.…”

Section: Focus Group Findingsmentioning

confidence: 99%

Real-time Perspectives of Surrogate Decision-Makers Regarding Critical Illness Research

Iverson

Celious

Kennedy

et al. 2012

Chest

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Objective : We undertook the current investigation to explore how the pressures of serving as a surrogate decision-maker (SDM) for an acutely ill family member infl uence attitudes regarding clinical investigation. Methods: We conducted a prospective study involving SDMs for critically ill patients cared for in the ICUs of two urban hospitals. Measurements included participation in focus groups designed to explore perceptions of ICU care and clinical research. Audiotapes were transcribed and analyzed to identify common patterns and themes using grounded theory. Demographic and clinical data were summarized using standard statistical methods. Results: Seventy-four SDMs (corresponding to 24% of eligible patients) participated. Most SDMs were women and described long-term relationships with the patients represented. SDMs described their role as "overwhelming," their emotions were accentuated by the fatigue of the ICU experience, and they relied on family members, social contacts, and religion as sources of support. Altruism was reported as a common motivation for potential study participation, a sentiment often strengthened by the critical illness episode. Although research was viewed as optional, some SDMs perceived invitation for research participation as tacit acknowledgment of therapeutic failure. SDMs expressed a preference for observational studies (perceived as low risk) over interventional designs (perceived as higher risk). Trust in the ICU team and the research enterprise seemed tightly linked. Conclusions: Despite signifi cant emotional duress, SDMs expressed interest in investigation and described multiple factors motivating participation. Consent processes that minimize the effects of anxiety may be one strategy to enhance recruitment.

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Section: Focus Group Findingsmentioning

confidence: 99%

Real-time Perspectives of Surrogate Decision-Makers Regarding Critical Illness Research

Iverson

Celious

Kennedy

et al. 2012

Chest

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“…(12–14, 26) Among our participants, we found that the older general public strongly supports a policy of surrogate consent for dementia research and that this support increased after in-depth education and peer deliberation; for example, at baseline, support for a policy of surrogate consent for a dementia research protocol involving gene transfer neurosurgery increased from 56% to 68% after deliberation. (22) Our thematic analysis of participants’ deliberations provides important insights into what this overall support means.…”

Section: Discussionmentioning

confidence: 85%

“…(12–15) But most of these studies have been traditional cross-sectional surveys and do not provide insights into the underlying basis for these opinions. Given the historical, ethical, and scientific complexities of the topic, understanding the underlying reasons for such opinions would provide insights into their validity.…”

mentioning

confidence: 99%

Public's Approach to Surrogate Consent for Dementia Research: Cautious Pragmatism

Vries¹,

Ryan²,

Stanczyk³

et al. 2013

The American Journal of Geriatric Psychiatry

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Objectives To describe how members of the older general public deliberate with one another in finding solutions to the dilemma of involving decisionally incapable persons in dementia research. Design, Setting, and Participants 160 persons aged 50+ who participated in an all-day deliberative democracy (DD) session on the ethics of surrogate consent for dementia research. The DD 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 benefit, 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.

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“…Surveys of potential research participants can give useful data that is distinct from any conclusions that can be drawn from the fact that patients do in fact enroll in research studies. 49 Surveys of IRB members or scientists and scientific administrators regarding how they apply the risk-benefit analysis regulations can also illuminate how policies may in fact get applied. 50 Surveys of the general public on the appropriateness of certain implied tradeoffs in research protocols can also inform the debate.…”

Section: Favorable Risk-benefit Ratiomentioning

confidence: 99%

Evidence-based ethics for neurology and psychiatry research

Kim

2004

Neurotherapeutics

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Summary: American bioethics, historically arising out of theology and philosophy, has been dominated by the method of normative analysis. Ethics as policy, however, requires in addition a solid evidence base. This paper discusses the background conditions that make neurotherapeutics research particularly challenging. Three key ethical issues are discussed within an evidence-based ethics framework: the ethical challenges arising from changes in the financial incentive structures for academic researchers and their institutions, the challenges of risk-benefit analysis for neurotherapeutics protocols testing innovative interventions, and the evolving issues surrounding impaired decision-making capacity and surrogate consent for research. For each of these issues, selected empirical data are reviewed, areas for further inquiry are noted, and the need for development of novel methods for bioethics policy research is discussed.

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Views of Potential Subjects Toward Proposed Regulations for Clinical Research With Adults Unable to Consent

Cited by 69 publications

References 17 publications

Real-time Perspectives of Surrogate Decision-Makers Regarding Critical Illness Research

Real-time Perspectives of Surrogate Decision-Makers Regarding Critical Illness Research

Public's Approach to Surrogate Consent for Dementia Research: Cautious Pragmatism

Evidence-based ethics for neurology and psychiatry research

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