Ethics of Genetic and Biomarker Test Disclosures in Neurodegenerative Disease Prevention Trials

Neurology, 2015; 84:1488–1494

8 Pages Posted: 4 Dec 2015

See all articles by Scott Y. Kim

Scott Y. Kim

National Institutes of Health; University of Michigan at Ann Arbor

Jason Karlawish

University of Pennsylvania

Benjamin Berkman

University of North Carolina (UNC) at Chapel Hill - National Institute of Health

Date Written: 2015

Abstract

Prevention trials for neurodegenerative diseases use genetic or other risk marker tests to select participants but there is concern that this could involve coercive disclosure of unwanted information. This has led some trials to use blinded enrollment (participants are tested but not told of their risk marker status). We examined the ethics of blinded vs transparent enrollment using well-established criteria for assessing the ethics of clinical research. Normative analysis applying 4 key ethical criteria-favorable risk-benefit ratio, informed consent, fair subject selection, and scientific validity-to blinded vs transparent enrollment, using current evidence and state of Alzheimer disease (AD) and other prevention trials. Current evidence on the psychosocial impact of risk marker disclosure and considerations of scientific benefit do not support an obligation to use blinded enrollment in prevention trials. Nor does transparent enrollment coerce or involve undue influence of potential participants. Transparent enrollment does not unfairly exploit vulnerable participants or limit generalizability of scientific findings of prevention trials. However, if the preferences of a community of potential participants would affect the rigor or feasibility of a prevention trial using transparent enrollment, then investigators are required by considerations of scientific validity to use blinded enrollment. Considerations of risks and benefits, informed consent, and fair subject selection do not require the use of blinded enrollment for AD prevention trials. Blinded enrollment in AD prevention trials may sometimes be necessary because of the need for scientific validity, not because it prevents coercion or undue influence.

Suggested Citation

Kim, Scott Y. and Karlawish, Jason and Berkman, Benjamin, Ethics of Genetic and Biomarker Test Disclosures in Neurodegenerative Disease Prevention Trials (2015). Neurology, 2015; 84:1488–1494. Available at SSRN: https://ssrn.com/abstract=2698772

Scott Y. Kim (Contact Author)

National Institutes of Health ( email )

Warren G. Magnuson Clinical Center
Bethesda, MD 20895-1156
United States

University of Michigan at Ann Arbor ( email )

500 S. State Street
Ann Arbor, MI 48109
United States

Jason Karlawish

University of Pennsylvania ( email )

Philadelphia, PA 19104
United States

Benjamin Berkman

University of North Carolina (UNC) at Chapel Hill - National Institute of Health ( email )

Chapel Hill, NC
United States

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