for 45 C.F.R. Part 46, which contains four subparts. Subpart A, also known as the Common Rule, is “Basic U.S. DHHS Policy for Protection of Human Research Subjects” (DHHS, 2005a). Subparts B, C, and D of 45 C.F.R. Part 46 provide further and more specific protection for certain particularly vulnerable populations: pregnant women, fetuses, and neonates; prisoners; and children, respectively (DHHS, 2005a). Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects,” the focus of this project, was first finalized in 1978 (DHHS, 2005a).

This examination will consider the impact of developments in correctional systems since that time (1976) as well as societal perceptions of the balance between burdens and potential benefits of research.

Many changes have occurred within the U.S. correctional system since the late 1970s, and these changes have important ramifications for research involving prisoners. They include the following:

  • An escalating prisoner population. For example, persons under prison supervision grew from 216,000 in 1974 to 1.4 million in 2004, largely as a result of the war on drugs, harsher sentencing laws, and high recidivism rates (Bureau of Justice Statistics [BJS], 2003, 2005a; Human Rights Watch [HRW], 2003; Jacobson, 2005). The overall correctional population, including persons in prison, jail, and on parole and probation, has jumped from 1.5 million in 1978 to nearly 7 million in 2004 (BJS, 2005a,b,c,d).

  • The overrepresentation of men and women of color in prisoner populations (BJS, 2003). One out of eight black men in their late 20s is under the jurisdiction of the criminal justice system, including, jail, prison, probation, and parole (Lotke, 1997; Mauer and King, 2004).

  • Increased overcrowding in correctional facilities, resulting in diminished availability of and access to programs and services. Construction has not kept pace with the increasing number of inmates (Jacobson, 2005).

  • Inadequate health-care services is a reality of some correctional settings, notwithstanding Eighth Amendment proscriptions against “deliberate indifference to the serious medical needs” of prisoners (Braithwaite et al., 2005; HRW, 2003; Metzner, 2002; Restum, 2005; Sturm, 1993).

  • Increasing population of female inmates—growing at a faster rate than that of male inmates—who face unique challenges (BJS, 1999). As with male prisoners, female inmates are more likely to be a minority, poor, and undereducated, but as women they are more likely to be the primary caregiver for children, and they suffer disproportionate victimization from sexual and physical abuse (BJS, 1999).

  • Increased number of prisoners serving their sentences in alternative programs, outside the traditional “bricks and mortar” prisons and jails

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