(BJS, 2004). The environments to which prisoners are consigned have expanded to include work-release programs, halfway houses, electronic monitoring programs, and other alternatives to incarceration (BJS, 2004).

  • Overrepresentation of communicable diseases, such as HIV/AIDS, hepatitis B and C, and tuberculosis, in prisons (Hammett et al., 2002; Khan et al., 2005; MacNeil et al., 2005; National Commission on Correctional Health Care [NCCHC], 2002). In addition, among an aging prison population, chronic diseases such as diabetes and hypertension are critical management issues (NCCHC, 2002).

  • Increasing admissions of mentally ill prisoners with the closing of the large state mental institutions (HRW, 2003). Mental illness and violence take a heavy toll on the prisoner population (BJS, 1999; New Freedom Commission on Mental Health [NFCMH], 2004).

At the same time that prison populations have been expanding, there has been a considerable amount of confusion and disagreement in the research community regarding the interpretation and application of Subpart C of 45 C.F.R. Part 46 (“Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects” [DHHS, 2005a]) to current issues of research involving prisoners. The OHRP’s responsibilities include implementation of the DHHS Regulations for the Protection of Human Subjects (DHHS, 2005a) and the provision of guidance on ethical issues in biomedical and behavioral research. OHRP has oversight and educational responsibilities wherever DHHS funds are used to conduct research involving human participants. The Secretary’s Advisory Committee for Human Research Protections(SACHRP), the advisory committee to OHRP, has asked OHRP to rewrite Subpart C, taking into consideration the current prison environment (see Appendix C).

OHRP recommended that, before such an effort is undertaken, there should be a thorough review of the ethical considerations in research involving prisoners, which could serve as the basis for developing new regulations. Beyond its importance regarding revisions to Subpart C, such a review would be instructive for developing ethical bases for making future changes to the DHHS Regulations for the Protection of Human Subjects and the Common Rule.


This report addresses ethical considerations for the protection of prisoners involved in research. The overall purpose of the committee was to examine whether the conclusions reached by the national commission in 1976 remain appropriate today. This examination considered the impact of developments in correctional systems since that time and societal percep-

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