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Abstract
Background: This paper reviews the past 25 years of empirical research funded by the National Institutes of Health (NIH) on matters of ethics in psychiatric research. Methods: Using the NIH RePORTER and Medline databases, we identified 43 grants and 77 publications that involved the empirical study of a matter of ethics in research involving mental health service users. Results: These articles provide original and useful information on important topics, most especially the capacity to consent and the voluntariness of consent. For example, participants who share a diagnosis vary widely in levels of cognitive impairment that correlate with decisional capacity, and capacity to consent can be enhanced easily using iterative consent processes. Few articles address matters of justice or benefits in research, particularly from the perspectives of participants. No articles address matters of privacy, confidentiality, or researcher professionalism. Conclusions: Despite the usefulness of data from the studies conducted to date, current research on research ethics in psychiatry does not adequately address the concerns of service users as expressed in recent publications.
Acknowledgments
The research for this paper was funded by a grant from the National Institute of Mental Health (5R13MH079690) and the National Center for Research Resources (UL1RR024992).
Notes
RePORTER replaces CRISP (Computer Retrieval of Information on Scientific Projects), which was initiated in 1998 and contained records dating from 1972. The CRISP database was taken offline December 30, 2009.
We have published tables listing studies on assessing capacity to consent, risk factors for incapacity to consent, and enhancing capacity to consent at www.emhr.net. These tables include many foundation-funded studies.