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. References 1. Barber B, Lally JJ, Makarushka JL, et al: Research on Human Subjects: Problems of Social Control in Medical Experimentation . New York, Brunner Mazel, 1973. 2. Cooper JD, Levy HL: Ethical Standards in Research on Humans, Fifth Conference on Philosophy and Technology of Drug Assessment. Washington, DC, Interdisciplinary Communications Associates Inc, 1976. 3. Mendelsohn E, Swazey JP, Taviss I: Human Aspects of Biomedical Innovation . Cambridge, Mass, Harvard University Press, 1971. 4. National Academy of Sciences: Experiments and Research with Humans: Values in Conflict . Washington, DC, 1975. 5. Gray BH: Human Subjects in Medical Experimentation . New York, John Wiley & Sons Inc, 1975. 6. Schoolar JC, Gaitz CM: Research and the Psychiatric Patient . New York, Brunner Mazel, 1975. 7. Bogomolny RL: Symposium on Human Experimentation . Dallas, Tex, Southern Methodist University, 1976. 8. Protection of human subjects . Federal Register 44:47688-47729 ( (Aug 14) ) 1979. 9. Cole JO: Obstacles to research , in Schoolar JC, Gaitz CM (eds): Research and the Psychiatric Patient . New York, Brunner Mazel, 1975, pp 42-49. 10. Pellegrino ED: Physicians, patients and society: Some tensions in medical ethics , in Mendelsohn E, Swazey JP, Taviss I (eds): Human Aspects of Biomedical Innovation . Cambridge, Mass, Harvard University Press, 1971, pp 77-97. 11. Crandall RG, Day H, Beckett PGS, et al: Conflict between treatment and science on a research ward investigating schizophrenia . Can Psychiatr Assoc J 11:303-313, 1966. 12. Reich LH, Weiss BL: The clinical research ward as a therapeutic community: Incompatibilities . Am J Psychiatry 132:48-51, 1975. 13. Epstein RS, Janowsky DS: Research on the psychiatric ward . Arch Gen Psychiatry 21:455-463, 1969.Crossref 14. Jacobs L, Kotkin J: Fantasies of psychiatric research . Ant J Psychiatry 32:1074-1080, 1972. 15. Sacks M, Carpenter WT, Richmond MB: Psychotherapy in hospitalized research patients . Arch Gen Psychiatry 32:581-585, 1975.Crossref 16. Braff DL, Bachman J, Glick ID, et al: Therapeutic community as a research ward . Arch Gen Psychiatry 36:355-360, 1979.Crossref 17. Bunney WE Jr: Drug therapy and psychobiological research advances in the psychoses in the past decade . Am J Psychiatry 135( (July) suppl): pp 8-13, 1978. 18. Spitzer RL, Endicott J, Robins E: Research Diagnostic Criteria (RDC) , ed 3. New York, Biometrics Research, New York State Psychiatric Institute, 1978.
Archives of General Psychiatry – American Medical Association
Published: May 1, 1981