A framework for considering the ethical aspects of psychiatric research protocols

The ethics of psychiatric research has emerged as a topic of national impor tance. Attention to this topic has been stimulated by a number of factors, including heightened awareness of the distinct moral problems arising in th e care of mental illness, the rapid development of new psychopharmaceutical agents, the emergence of evidence-based approaches in psychiatry, the expa nsion of clinical trials within the private mental health sector, and recen t recommendations offered by the President's National Bioethics Advisory Co mmission (NBAC). Consequently, clinical practitioners and investigators ali ke will increasingly be called upon to evaluate the ethical acceptability o f psychiatric research protocols encountered in their professional work. In light of this, we present a framework for considering ethical aspects of p sychiatric research protocols. This framework gives emphasis to nine elemen ts: (1) scientific issues; (2) research team issues; (3) risk and benefit i n protocol design; (4) confidentiality; (5) selection, exclusion, and recru itment considerations; (6) informed consent and decisional capacity; (7) in centives; (8) institutional and peer/professional review issues; and (9) da ta presentation issues. Case illustrations are provided. It is hoped that e nhanced knowledge of the considerations presented in this framework will ul timately improve our ability to help people with mental illness. Copyright (C) 2001 by W.B. Saunders Company.