• Donald L Rosenstein and Franklin G Miller.
• National Institute of Mental Health, Building 10, Room 3N242, 10 Center Drive MSC 1276, MD 20892-1276, Bethesda, USA. rosensteind@intra.nimh.nih.gov
• Psychopharmacology (Berl.). 2003 Dec 1;171(1):92-7.

RationaleResearch subjects who are unable to provide informed consent must be protected from exploitation. The federal regulations governing human subjects research mandate additional protections for "mentally disabled" subjects but include neither a definition of this "vulnerable" population nor any guidance on what safeguards should be employed or how they should be implemented.ObjectivesThis article begins with a definition of vulnerability due to a mental disorder in the context of the clinical research setting. It is organized along the following sequential phases of psychopharmacological research: study design and methodology; protocol review; subject recruitment and enrollment; conduct and monitoring of the study; and manuscript preparation and publication. Practical recommendations are then offered to clinical researchers and Institutional Review Boards (IRBs) for implementing additional protections for decisionally impaired subjects at each phase of the psychopharmacological research process.MethodsA computer-assisted literature review was performed to identify descriptions of safeguards for decisionally impaired subjects. Recommendations for additional protections were also drawn from the authors' experiences with the IRB review process and the conduct and monitoring of clinical research with decisionally impaired subjects.ResultsThe use of informed consent monitoring and the independent assessment of decision-making capacity are two feasible safeguards that IRBs can mandate for research with decisionally impaired subjects. There has been little systematic implementation of other safeguards such as research advance directives or prospective authorization for research participation.ConclusionsClinical investigators and IRBs are under considerable scrutiny with respect to the protection of decisionally impaired research subjects. There is a pressing need for data-driven strategies for the optimal protection of decisionally impaired research subjects.

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