Informed Consent in Early Psychosis Research: National Institute of Mental Health workshop, November 15, 2000.

Recent research on the early detection and treatment of schizophrenia has generated significant scientific interest along with considerable controversy and debate. Because our ability to alleviate fully the symptoms and deficits of established schizophrenia is limited, the prospect of interrupting disease progression early is compelling. At the same time, in the absence of an infallible marker of disease risk, there are serious questions about the safety, feasibility, and ethics of intervention research on "at-risk" or putatively prodromal individuals. A workshop, Informed Consent in Early Psychosis Research, was convened by the National Institute of Mental Health (NIMH) on November 15, 2000, to review the results of recent research on early detection and intervention in schizophrenia. Beginning with the assumptions that (1) treatment of asymptomatic individuals with antipsychotic medication is not appropriate in research or clinical care, and (2) neither data nor clinical consensus defines optimal intervention for symptomatic at-risk individuals, workshop participants-including clinical researchers, mental health consumers and family members, bioethicists, community health care providers, and NIMH staff-systematically reviewed available data on the potential risks and benefits of alternate approaches to the management of prodromal states. Ethical issues involved in early detection and intervention studies were discussed. Workshop participants summarized information presented during the meeting into informed consent "bullets" that must be communicated to, and understood and appreciated by, potential research participants.