The National Bioethics Advisory Commission (NBAC), charged with providing advice to the President on the protection of human research subjects, has proposed additional safeguards for “research involving persons with mental disorders that may affect decision making capacity” (5). Several branches of the National Institutes of Health (NIH) developed Points to Consider for research on “individuals who are, may be, or may become decisionally impaired” (8). At the state level, the Maryland Attorney General's office developed regulations for “decisionally incapacitated subjects” (7) and, in response to T.D. v. New York State Office of Mental Health, a New York Department of Health advisory group endorsed guidelines on “research involving those unable to consent” (6). Internationally, the Canadian Tri-Council regulations represent a consensus of the Medical Research, Natural Sciences and Engineering, and Social Sciences and Humanities Councils (9); the Council of Europe's recommendations have been signed by 24 members (10). Although the Canadian and European policies cover all clinical research, they include safeguards for patients who are unable to consent.