A framework for considering the ethical aspects of psychiatric research protocols.

The ethics of psychiatric research has emerged as a topic of national importance. Attention to this topic has been stimulated by a number of factors, including heightened awareness of the distinct moral problems arising in the care of mental illness, the rapid development of new psychopharmaceutical agents, the emergence of evidence-based approaches in psychiatry, the expansion of clinical trials within the private mental health sector, and recent recommendations offered by the President's National Bioethics Advisory Commission (NBAC). Consequently, clinical practitioners and investigators alike will increasingly be called upon to evaluate the ethical acceptability of psychiatric research protocols encountered in their professional work. In light of this, we present a framework for considering ethical aspects of psychiatric research protocols. This framework gives emphasis to nine elements: (1) scientific issues; (2) research team issues; (3) risk and benefit in protocol design; (4) confidentiality; (5) selection, exclusion, and recruitment considerations; (6) informed consent and decisional capacity; (7) incentives; (8) institutional and peer/professional review issues; and (9) data presentation issues. Case illustrations are provided. It is hoped that enhanced knowledge of the considerations presented in this framework will ultimately improve our ability to help people with mental illness.