NCJ Number
110229
Journal
Rutgers Law Review Volume: 39 Issue: 2-3 Dated: (Winter-Spring 1987) Pages: 425-441
Date Published
1987
Length
17 pages
Annotation
An overview of the rules and procedures under which psychiatric patients are currently allowed to take part in research concludes with recommendations for future research and for regulating psychiatric patients' participation in that research.
Abstract
Psychiatric research is regulated by ethical guidelines, professional codes, regulatory agencies, and, most important, by local interdisciplinary groups known as Institutional Review Boards (IRB's). Until now, case law has offered little guidance concerning mechanisms for obtaining or assessing the adequacy of informed consent. However, case law concerning biomedical and behavioral human research is scarce. Regulatory requirements of the U.S. Department of Health and Human Services have the greatest influence on the conduct of psychiatric research. Nevertheless, few empirical studies exist to confirm or deny the views of commissions, national agencies, and other commentators that the mentally disabled are 'vulnerable' and require special protections concerning consent. The two major issues related to the mentally disabled are comprehension and undue influence. A stronger empirical base is needed regarding the actual conduct of research with the mentally disabled. Studies should focus on how subjects are recruited, how consent is obtained, and the effects of the consent process on the mentally disabled. 113 footnotes.