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Arch Gen Psychiatry. 1999;56:701-702.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

IN ITS RECENTLY issued report and recommendations, the National Bioethics Advisory Commission (NBAC) has endeavored to promote enhanced federal regulatory safeguards and protections for "Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity."¹ The article by Oldham et al² offers a detailed summary and critique of these recommendations. Their comments center on 2 perceived deficiencies: a dichotomy between minimal risk and more than minimal risk, which might lead to undue restriction on current and future psychiatric research that exceeds minimal risk; and an unjustified and "stigmatizing" focus on research concerning mental disorders rather than on the entire range of clinical research with patient-volunteers who are vulnerable because of impaired decision-making capacity.

In place of the NBAC's classification of research as either minimal risk or more than minimal risk, the authors advocate a tripartite classification including an intervening category of research with "a minor increase over minimal risk." This . . . [Full Text of this Article]

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