Protecting Subjects and Fostering Research

Authors:
  • WWWilliam Winslade
    William Winslade
  • TKTodd L. Krause
    Todd L. Krause
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Abstract
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? Bonnie1and Elliott2each raise this significant question in this issue of theArchives. 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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