A new resource manual from the APA Office of Research should help investigators safely navigate the sometimes hazardous shoals of psychiatric research on human subjects.
The manual, "Ethics in Psychiatric Research: A Resource Manual for Human Subjects Research," is scheduled for release this fall. It was approved by the Board of Trustees as an APA resource document. The editors were Harold Pincus, M.D., an APA deputy medical director and director of APA's Office of Research; Jeffrey Lieberman, M.D., an associate editor of the American Journal of Psychiatry; and Sandy Ferris, staff liaison to the APA Council on Research.
"This manual represents the contribution of a wide array of leading bioethics, psychiatric, and other researchers," Pincus told Psychiatric News. "It also represents an important effort to assure that young investigators learn how to conduct research in an ethical and appropriate way and that all researchers across the career-development span have access to information needed to guarantee that the array of issues involved in protecting human subjects have been thought through."
The manual includes a discussion of the history of human research controversies and ethics, approaches to research design and the provision of quality care within the research setting, and a wide range of information relating to informed consent. In particular, the manual devotes considerable attention to the challenging issues raised by research on cognitively impaired subjects, including an entire chapter on surrogate decision-making and advance directives with the cognitively impaired.
The manual is but one aspect of APA's response to widely publicized reports of controversial psychiatric research on humans (Psychiatric News, August 7). Those reports led to congressional hearings about the adequacy of the existing system of institutional review boards designed to balance the needs of scientists against the safety of human research subjects. At the most recent hearing in June, APA was represented by Paul Appelbaum, M.D., chair of APA's Ethics Appeals Board.
Appelbaum helped draft APA's new "Guidelines for Assessing the Decision-Making Capacities of Potential Research Subjects With Cognitive Impairment," which were approved by the Board at its July meeting in San Diego.
The manual will be available through the American Psychiatric Press Inc., which may be reached by calling (800) 368-5777. Although the manual will not be posted on the APA Web site, those interested in other information on research resources should go to www.psych.org and click on "Research Resources."