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A Controlled Study

James H. Kocsis, MD; Allen Frances, MD; Thomas P. Kalman, MD; M. Katherine Shear, MD

Arch Gen Psychiatry. 1981;38(5):511-515.

Abstract
• Recent advances in psychiatric research methodology promise major progress. Simultaneously, however, mounting concerns about ethics of human experimentation have resulted in increased scrutiny and regulation that threaten scientific productivity. Virtually no systematic data have been gathered about the effects of research participation on treatment outcome or patient satisfaction. In this study 56 hospitalized depressed patients, who had agreed to participate in psychobiological research protocols, were then randomly assigned to treatment on a research unit or on standard adult inpatient (nonresearch) units. Research participants received more diagnosis-related somatic treatments, had a longer mean length of stay, and experienced trends toward greater symptom reduction and better consumer satisfaction. We conclude that research participation may be helpful to patients but that more systematic study is needed to help to resolve ethical questions and to assist risk-benefit evaluations.

Author Affiliations
From the Department of Psychiatry, Payne Whitney Clinic, New York Hospital-Cornell Medical Center, New York.

Footnotes
Accepted for publication Feb 8, 1980.

Read before the 132nd annual meeting of the American Psychiatric Association, Chicago, May 16, 1979.

Reprint requests to Department of Psychiatry, Payne Whitney Clinic, New York Hospital-Cornell Medical Center, 525 E 68th St, New York, NY 10021 (Dr Kocsis).

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