Accountability in research using persons with mental illness

Although medical research involving the use of persons with mental illness is critically important, in order for the research to be ethical and legal there are certain considerations and restrictions which should be immediately readdressed in order to insure that the welfare of these vulnerable research subjects is protected, and their best interests are assured. A brief historical examination of medical research codes, guidelines, recommendations and Federal Regulations reveals the various considerations and restrictions on informed consent and accountability applicable to the use of persons with mental illness in medical research. Several concerns are raised about how these considerations and restrictions have been interpreted, and specific recommendations are offered to improve them immediately by means of representation from consumers and/or their families, and organizations, e.g., NAMI members.