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Research involving persons with cognitive impairments: results of a survey of Alzheimer disease research centers in the United States

, : Research involving persons with cognitive impairments: results of a survey of Alzheimer disease research centers in the United States. Alzheimer Disease and Associated Disorders 14(1): 20-27

Research involving persons with cognitive impairments presents ethical and practical challenges, including how to obtain valid informed consent. We asked the directors of the 29 U.S. research centers funded by the National Institute on Aging as "Alzheimer Disease Centers" to provide us with policies or guidelines used in their centers or associated institutions with regard to research involving cognitively impaired subjects. Twenty-four of the 29 centers (83%) responded. Five institutions (21%) had authored their own institutional policies, seven (29%) used guidelines issued by the Department of Health and Human Service's Office for Protection from Research Risks, and 12 (50%) had no policy or guidelines. The five institutional policies addressed a variety of issues, including obtaining consent from cognitively impaired subjects or their authorized representatives, subjects' assent to research participation, and guidance concerning determination of subjects' intellectual capacity. A well-written policy on the protection of cognitively impaired research subjects is one way a research institution demonstrates that it gives serious attention to the rights and welfare of these vulnerable persons. We recommend that all institutions conducting such research author written policies articulating appropriate safeguards for these vulnerable subjects. To promote the protection of cognitively impaired subjects, federal agencies and other funding groups may want to consider requiring written institutional policies as one condition of receiving funds to conduct such research.


PMID: 10718201

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