Protecting mental health research subjects without prohibiting progress.

Abstract

Federal regulations governing the protection of human research subjects fail to specifically address research involving persons with mental illness. In 1990 the New York State Office of Mental Health issued regulations covering such research. The regulations are designed to respect the autonomy of psychiatric patients to make decisions about participation in research while protecting patients whose capacity to consent may be impaired. Patients who lack sufficient capacity may be included in research with the consent of a specified legally authorized surrogate if the facility's institutional review board determines that the research cannot be done without the participation of incapable subjects and it is considered likely to produce knowledge of overriding therapeutic importance for persons with the patients's condition or it has the possibility of directly benefiting the patient. In all cases involving more than minimal risk, the consent of the patient's treatment team must be obtained.