“Restricted Community Members”: Research Protections and Opportunities for Individuals Committed to Assisted Outpatient Treatment

Institutionalized persons with mental illness and prisoners represent two particularly vulnerable populations. For individuals residing in inpatient psychiatric settings, research protections remain fragmented across state laws and federal regulations, a situation that has led some to call for a moratorium on the recruitment of this extremely vulnerable population (1). Meanwhile, in recent years, mechanisms of jail diversion—such as drug and mental health courts—for offenders with mental illness have been developed that challenge our understanding of the concept of “prisoner.”

There now exists a large population of individuals treated in the community as a result of a diverse array of structured mandated community treatment programs, which span the social welfare and criminal justice systems (2). For example, individuals with serious mental illness who are at risk of deteriorating and being committed to a psychiatric hospital or incarcerated may now live in the community with close court supervision under a regimen commonly referred to as assisted outpatient treatment (AOT). Many individuals on AOT have a serious psychosis spectrum disorder, such as schizophrenia, and without treatment they may decompensate. A subpopulation of this group also has substance use disorders.

We should note that other ways to enhance treatment compliance exist. These range from voluntary treatment contracts to social service providers that use housing opportunities or financial incentives as leverage for compliance. These cases are distinct from AOT—which requires a court mandate—although the range of coercion within specific AOT regimens may vary.

The ethical principles promulgated by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the Belmont Report (3) have guided research involving vulnerable populations for the past 35 years. These principles were adapted in regulations for federally funded research in the Common Rule (4). Subpart C of the Common Rule pertains to the protection of prisoners, a class defined as “any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing” (4).

In 2007, a committee of the Institute of Medicine (IOM)—now the National Academy of Medicine—issued a report, Ethical Considerations for Research Involving Prisoners (5). Recognizing that the concept of prisoner goes beyond custodial confinement, the report recommended expanding the term “to include all settings, whether a correctional institution or a community setting, in which a person’s liberty is restricted by the criminal justice system.” This includes persons on parole, probation, or work release programs. The IOM report excluded those whose liberty has been restricted because of mental illness—ostensibly this would include persons on AOT. Likewise, the committee suggested that individuals who have been through mental health courts should count as prisoners and concluded the opposite for individuals who have been ordered to adhere to mandated treatment by way of juvenile, probate, and civil courts. However, because these individuals often traverse both the criminal and civil court systems and the juridical mechanisms for placing individuals into AOT programs vary from state to state, such fine-grained distinctions may create untenable challenges for researchers in developing compliant recruitment strategies and protocols.

For example, investigators leading a multicenter study (CTN-0051) funded by the National Institute on Drug Abuse confronted the dilemma of how to appropriately recruit individuals from a generalizable sample that likely included individuals on AOT (6). They consulted the Office of Human Research Protections, which applied 45 CFR 46 §306 (iv); this section states, in part, that “biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects only if in the judgment of the Secretary the proposed research involves solely the following: research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject (7).”

There are several advantages to application of this rule for a population that likely includes individuals involved in court-mandated treatment. It simplifies matters, obviating the need for study personnel to determine and monitor an individual participant’s involvement in the civil courts or the criminal justice system—a potentially complex and costly endeavor. However, such a designation may come at a greater cost, because without a clear designation, all potential research participants are to be treated as prisoners, which increases the time and cost of protocol development, oversight, and execution of the study and shifts the standard by which minimal risk is determined.

The case of CTN-0051 should prompt a question for mental health and addiction researchers, institutional review boards (IRBs), and policy makers: Should individuals committed to AOT be considered institutionalized patients, prisoners, community members, or something else? As far as we can tell, very little has been written to answer this question. Although research has been and continues to be conducted with this population, as CTN-0051 illustrates, there remains no obvious consensus on how to treat these individuals. The lack of both consensus and careful analysis may engender confusion among researchers and IRBs about the proper way to categorize these individuals.

A lack of policy consensus places individuals on AOT into a conceptual limbo bounded by the concepts of psychiatric inpatient and community member. To bring clarity to this situation, we propose that a new designation—“restricted community member” (RCM)—be created that more accurately reflects the uniquely vulnerable position of individuals on AOT while also offering these individuals a broader range of opportunities to participate, if they wish, in research than is afforded to an incarcerated prisoner or a patient in a psychiatric hospital or recovery center.