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Are the rules for research with subjects with dementia changing?

Views from the field

From the Section of Geriatrics (Drs. Stocking and Sachs, G.W. Hougham and A.R. Baron) and MacLean Center for Clinical Medical Ethics (Dr. Stocking), Department of Medicine, University of Chicago, IL.

Address correspondence and reprint requests to Dr. C.B. Stocking, MacLean Center for Clinical Medical Ethics, Department of Medicine, University of Chicago, 5841 S. Maryland Ave. (MC 6098), Chicago, IL 60637; e-mail: cstockin{at}medicine.bsd.uchicago.edu

Deliberative bodies have recommended additional protections for persons with dementia included in clinical trials. This survey of experienced dementia researchers revealed that 45 to 64% considered that specific ones of these recommendations would increase subject protection, and 40 to 86% considered they would make research less feasible. The real tradeoff between protection and difficulty in conducting research on devastating illnesses needs to be confronted when new regulations in this area are debated.

Received April 18, 2003. Accepted in final form September 11, 2003.

See also pages 1645 and 1662

Presented in part at the November 2002 meeting of the Gerontological Society of America.

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				S. Y.H. Kim and J. H.T. Karlawish Ethics and politics of research involving subjects with impaired decision-making abilities Neurology, December 23, 2003; 61(12): 1645 - 1646. [Full Text] [PDF]