August 1999

Protecting Vulnerable Research Subjects Without Unduly Constraining Neuropsychiatric Research

Author Affiliations

Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999

Arch Gen Psychiatry. 1999;56(8):701-702. doi:10.1001/archpsyc.56.8.701

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.

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