Research Risk for Persons With Psychiatric Disorders: A Decisional Framework to Meet the Ethical Challenge

Objective: There is a lack of consensus on how to evaluate the risk of research studies conducted with persons who have psychiatric disorders. The authors reviewed research on vulnerability, risk, and procedures to mitigate risk in studies with this population to help inform evaluation of such research. Methods: Searches of MEDLINE (1966-2006), PsycINFO (1967-2006), and Google Scholar used combinations of the terms mental illness, vulnerable, psychiatric, schizophrenia, and depression combined with terms such as research risk, vulnerability, research harm, capacity, risk, and mitigation of risk. Articles were identified from reference lists, and additional searches used terms from identified articles. Results: Evidence for two types of vulnerability-capacity based and power based-is presented, which supports the notion of vulnerability as a state, rather than a trait, among persons with psychiatric disorders. Three categories of risk are described - minimal risk, minor increment over minimal risk, and greater than minor increment. Evidence shows that many common types of studies pose risk in the first two categories when conducted with this population. The literature also describes procedures for reducing vulnerability and mitigating risk that should be considered in study evaluations. The authors offer a framework for evaluating the category of risk posed by a study. Conclusions: Although more research is needed, there is sufficient evidence that many common types of research present minimal risk or only a minor increment over minimal risk for large segments of the population of persons with psychiatric disorders, as they do for persons in the general population. (Psychiatric Services 60: 374-383, 2009)