In many important ways, the U.S. correctional system is different than it was in the 1970s, when current regulations regarding prisoners as research subjects were promulgated. The total correctional population (persons in prisons, jails, probation, and parole) increased to nearly 7 million individuals between 1978 and 2004 (Bureau of Justice Statistics [BJS], 2000a, 2005a,b,c; U.S. Census, 1994, 1998). Correctional facilities are increasingly overcrowded (BJS, 2005a), and access to programs, services, and health care has not kept pace with the rising tide of prisoners (Metzner, 2002; Sturm, 1993). More of our country’s disadvantaged populations are under correctional supervision: racial minorities, women, persons with mental illness, and persons with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis (BJS, 2005b; National Commission on Correctional Health Care [NCCHC], 2002).

Prisoners have been exploited in the past, carrying a heavier burden of the risks of research than the general population (Hornblum, 1998; Jones, 1993; Murphy, 2005). Although the level of severity varies depending on the correctional setting, prisoners face restrictions on liberty and autonomy, limited privacy, and potentially inadequate health-care services. These factors can be barriers to the prerequisites of ethical research, namely the acquisition of voluntary informed consent, protection of privacy, and access to adequate health care such that a choice between research participation and nonparticipation is not simply a desperate action to obtain treatment.

However, research can impart benefits. Responsible research has the potential of improving the health and well-being of prisoners as well as improving the conditions in which they live. Adherence to the highest ethical values, however, is critically important in designing and conducting human research involving prisoners.

Title 45 Part 46 of the Code of Federal Regulations (45 C.F.R. Part 46) contains Subpart A, the basic DHHS regulations for the protection of human research subjects, also known as the Common Rule. The Common Rule provides requirements and guidance on issues such as review by an institutional review board (IRB), informed consent by subjects, analysis of risks and benefits, protecting privacy, plus further requirements for approval of proposed research. Additional subparts of 45 C.F.R. Part 46 provide more specific protections for certain particularly vulnerable populations: pregnant women, fetuses, and neonates (Subpart B); prisoners (Subpart C); and children (Subpart D). Subpart C (Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects), the principal focus of this report, was first finalized in 1978 and was developed in response to the Report and Recommendations: Research Involving Prisoners by the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research (NCPHSBBR, 1976).



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