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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH075023-04
Application #
7489849
Study Section
Special Emphasis Panel (ZRG1-HOP-E (50))
Program Officer
Niederehe, George T
Project Start
2005-09-01
Project End
2010-08-31
Budget Start
2008-09-01
Budget End
2009-08-31
Support Year
4
Fiscal Year
2008
Total Cost
$282,225
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Psychiatry
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Palmer, Barton W; Ryan, Kerry A; Kim, H Myra et al. (2012) Neuropsychological Correlates of Capacity Determinations in Alzheimer Disease: Implications for Assessment. Am J Geriatr Psychiatry :
Kim, Scott Y H; Appelbaum, Paul S; Kim, H Myra et al. (2011) Variability of judgments of capacity: experience of capacity evaluators in a study of research consent capacity. Psychosomatics 52:346-53
Kim, Scott Y H (2011) The ethics of informed consent in Alzheimer disease research. Nat Rev Neurol 7:410-4
Kim, Scott Y H; Karlawish, Jason H; Kim, H Myra et al. (2011) Preservation of the capacity to appoint a proxy decision maker: implications for dementia research. Arch Gen Psychiatry 68:214-20
Kim, Scott Y H; Holloway, Robert G (2010) Is it research?: an increasingly common question. Neurology 75:102-4