Capacity to Appoint a Proxy for Research Consent

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DESCRIPTION (provided by applicant): Alzheimer's disease (AD) research is probably the most common type of research that enrolls incapacitated adults. Research with such participants continues to be an unsettled area of research ethics policy. One shortcoming of empirical and conceptual work in this area has been the neglect of the actual strengths of persons with progressive neurodegenerative disorders. This project examines whether persons with AD who are incapable of providing independent informed consent to enroll in research still retain other important ethically relevant abilities. Specifically, it is hypothesized that a significant proportion of persons with AD who are incapable of independent consent to research may still retain the capacity to appoint a proxy for research decision-making. Using a well-validated measure of capacity for informed consent to research and a novel instrument for assessing abilities relevant to appointing a research proxy, the project will interview 180 persons with Alzheimer's disease, recruited from clinics at the University of Michigan and the University of Pennsylvania. Since the capacity to give informed consent is specific to particular protocols, two protocols of varying risk-benefit profiles will be used to assess the capacity for informed consent. Thus, this project will include an innovative assessment of the effect of research risk-benefit profiles on capacity determinations. The subjects' categorical capacity status (for informed consent and for appointing a proxy) will be determined by a 5 expert judge panel who will each independently review videos of subjects undergoing semi-structured capacity interviews. This project will answer whether subjects in AD research can provide more than assent or lack of dissent when asked to participate in research by assessing whether they can capably appoint proxies for research consent, even after they have developed significant cognitive deficits that impair their capacity for independent consent.