CorrectCare

Legalities
Take Care When Using Prisoners as Research Subjects
by T. Howard Stone, JD, LLM

Clinical health research unquestionably is important; without it, our understanding of human disease will not progress. And critical to this progress is the participation of patients and other volunteers as research subjects. Yet whether the same may be said of prisoner participation is far more tentative.

Research involving prisoners not only provides insight into the many perplexing problems that particularly affect prisoners as a social substrate, but also may help us to shape responses suitable to the unique but confounding prison environment.

Yet a strong note of caution must be sounded. First, we must not forget the lessons about past abuses involving prisoners as “guinea pigs.” Second, existing guidelines and rules intended to protect prisoners from research risks must be more clearly interpreted, more widely disseminated and more completely applied. Finally, correctional facilities must adopt appropriate mechanisms to help ensure that prisoners are adequately protected from research risks.

PAST LESSONS
The past use of prisoners in human subject research is characterized by an utter disregard for their well-being. This includes the horrific Nazi experiments of World War II, as well as the use of prisoners in this country in, for example, postwar radiation experiments and malaria research.

However disparate these events may seem, they are the origin of ethical codes and federal regulations that restrict the use of prisoners in modern-day human subject research. At the heart of these codes and regulations are concerns about the voluntariness of consent and the risks to which prisoners are exposed.

For instance, the Nuremberg Code—which arose in 1946 from the prosecution of Nazi physicians and scientists for their barbaric experiments—provides that “[t]he voluntary consent of the human subject is absolutely essential . . . . this means that the person involved should . . . be so situated as to be able to exercise free power of choice, without . . . constraint or coercion . . . .”

The Nuremberg Code rests upon the premise that prisons are coercive milieus whose inhabitants’ free power of choice regarding almost any matter is inherently suspect. This perspective resonates among those who argue that truly informed consent about participating in research simply cannot be had when prison conditions and prisoners’ health status are so deficient. Thus, the Nuremberg Code is interpreted by many as forbidding the use of any prisoner in research.

Similar concerns are central to federal research regulations, which note that the constraints of incarceration could affect prisoners’ “ability to make a truly voluntary and uncoerced decision . . . .” Intended as a more practical response than the Nuremberg Code to past abuses, these regulations have provisions designed to protect prisoners from research risks, and a few that appear to emphasize the voluntariness of consent.

Proposed research must first be reviewed and approved by a specially constituted committee, one of whose members must be a prisoner or a “prisoner representative.” Prisoners may be involved in only certain categories of research, such as research into conditions specifically involving a prisoner or relating to prisoners as a group. The committee may approve only of research in which the advantages accruing to prisoners do not unduly influence their ability to make a truly voluntary choice about participating. Information about the research must be in language that prisoners can understand. Finally, researchers must ensure that parole boards do not take into account prisoners’ participation in research, and that prisoners are so informed.

REGULATORY IMPERFECTIONS
Not everyone is convinced that the federal regulations or their underlying ethical principles provide prisoners with meaningful protection. One concern, not often voiced, is that researchers, institutions and sponsors may unreasonably or arbitrarily restrict the use of prisoners as human subjects, thereby depriving them of the benefits of research. The ethical problem is that categorical exclusion is paternalism in the guise of overprotection. Such paternalism implies that prisoners are implicitly unable to decide for themselves, and denies the presumption of autonomy. It also conflicts with our notions of justice and the fair distribution of benefits as well as risks. 
Another concern is that the federal regulations apply only to research involving human subjects that is “conducted, supported or otherwise subject to regulation by any Federal Department of Agency which takes appropriate administrative action to make the policy applicable to such research.” For the regulations to have any legal effect, then, the research in question must be federally supported or regulated, such as research funded by the National Institutes of Health or research involving drugs regulated by the Food and Drug Administration. Research conducted without federal support or regulation, including research conducted by state, local or private entities, need not conform to these regulations.

A subtler but no less critical interpretation is that the regulations are not legally binding upon federal agencies other than Health and Human Services unless those agencies affirmatively adopt the regulations. In fact, many agencies have not adopted the regulations. And significantly, no agency apart from HHS has adopted the provisions that specifically apply to prisoners as human subjects.

RECENT NONCOMPLIANCE
Even when the federal regulations plainly apply, many provisions are so deceptively simple or inordinately ambiguous that researchers are almost certain to run afoul of otherwise well-intended guidelines. For example, some researchers were cited for failing to provide the HHS Office for Human Research Protections with notice that each protocol involving prisoners had been reviewed and approved in accordance with federal regulations. Apparently, since they had already executed a Project Assurance agreement stating that the review of all protocols involving prisoners would conform to federal law, they assumed there was no need to provide notice later for each approved protocol.

The OHRP also found institutions that didn’t include a prisoner representative with “appropriate background and experience” on review committees that approved of research involving prisoners. In most cases, corrective action involved little more than procedural changes, such as filing more timely notice of approved protocols or appointing to review committees prisoner representatives with acceptable credentials.

Whether researchers and institutions can comply with the regulations’ more substantive provisions is less clear. This is especially the case when the advantages that may accrue to prisoners might impair their ability to make a truly voluntary choice about participating, or where information about research is not presented in language that they can understand. For example, there is no evidence that researchers or reviewers actually consider prisoners’ health status or their access to health services in determining whether a research project with a treatment arm might compel prisoners to participate simply as a way to obtain needed health services.

Unfortunately, little guidance exists to help researchers or reviewers determine how regulators will evaluate research in the context of these concerns. Still, these practice pointers will help those who conduct or oversee research to ensure that prisoners are adequately protected.

— About the author: T. Howard Stone, JD, LLM, is an associate professor at the University of Louisville’s Institute for Bioethics, Health Policy & Law. Reach him at thston01@louisville.edu. Support for this work was provided in part by the NIH National Institute on Drug Abuse.

[This article first appeared in the Winter 2002 issue of CorrectCare.]