Ethics of Surrogate Consent for Dementia Research

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DESCRIPTION (provided by applicant): Enrolling adults with decisional incapacity in dementia research based on surrogate permission (surrogate-based research, or SBR) is increasingly practiced but without widely accepted policy guidelines, despite decades of controversy. Policy is especially vague when the research poses significant risks but holds little or no prosepect for direct benefit to the subjects. The need for clearer policy is acute, as serious adverse events increasingly occur in innovative, early phase Alzheimer's disease research studies. This project will address an important gap in our knowledge regarding SBR policy: the perspectives of a key lay stakeholder group (family surrogates) and of the older general public, regarding the appropriateness of surrogate consent for research with significant risks and little or no potential for benefit. This proposal combines two complementary projects to maximize generalizability and internal validity. First, a nationally representative survey of the older public's views regarding SBR will generate the first broadly generalizable data on this issue. It will also allow an examination of the key correlates of individuals' attitudes toward SBR in several domains (racial and ethnic background, social relational factors, volunteerism and civic mindedness, among others). Second, a series of day-long deliberative democratic (DD) consultation sessions with family members of persons with dementia and with members of the older general public will be conducted. The DD project optimizes internal validity by providing balanced education and promoting facilitated deliberations among participants and by an experimental, controlled design to measure its effect. The DD project's quantitative results will be enriched by a thorough in-depth qualitative analysis of DD sessions to provide further insights into people's attitudes towards SBR. This proposal brings together experts in dementia research, research ethics, deliberative democracy theory and practice, survey research, and mixed methods research. A multidisciplinary Advisory Panel will add objectivity and balance to the content of the DD sessions. The results of this project will inform the work of research ethics policymakers, policy-implementers (such as IRBs), researchers in their recruitment of incapacitated subjects, and family members who may act as surrogates for research consent.