Regulating Research for the Decisionally Impaired: Implications for Mental Health Professionals

Mental health professionals, in fulfilling their different roles, often become involved with research protocols involving decisionally impaired current or prospective human subjects, many of whom are elderly. The opening section of this paper briefly describes the present regulatory environment regarding human subjects research, followed by an overview of the Institutional Review Board (IRB) process. There then ensues an enumeration of some of the general criticisms of the current regulatory scheme that have been enunciated recently. Particular concerns concerning decisionally impaired persons as research subjects are then addressed, referring when applicable to the recommendations made by the National Bioethics Advisory Commission (NBAC) in its 1998 report on this subject and the implications of those recommendations for mental health professionals.