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February 1997

Protecting Subjects and Fostering ResearchStriking the Proper Balance

Author Affiliations

Department of Psychiatry and Behavioral Sciences University of Texas Medical Branch at Galveston Room 1.200, Graves Building Galveston, TX 77555-0429; Institute for the Medical Humanities Department of Psychiatry and Behavioral Sciences University of Texas Medical Branch at Galveston; University of Houston Law Center

Arch Gen Psychiatry. 1997;54(2):121-123. doi:10.1001/archpsyc.1997.01830140031005

SHOULD institutional review boards (IRBs) provide greater oversight and guidance for researchers and research subjects with regard to informed consent for participation in research studies, especially if the subjects' cognitive or affective decisionmaking capacities are diminished? Bonnie1 and Elliott2 each raise this significant question in this issue of the Archives. Bonnie addresses cognitively impaired subjects in general. He advocates a reconsideration of the role of IRBs in assessing the decision-making capacity of all cognitively impaired research subjects. Elliott raises a more specific issue—that of the influence of mood on judgment and on informed consent. The 2 articles may be considered in terms of 4 important issues with regard to medical research: (1) the context of obtaining informed consent, (2) the question of who should make medical decisions regarding clinical care or participation in research, (3) the stigmatization of psychiatric disorders, and (4) the degree of risk to the

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