The general stance of Subpart C is that only research that fits within four or five categories is permitted in prisoner populations.

The committee’s review of current research revealed that most research involving prisoners is taking place outside the purview of Subpart C, and many prisoner studies are being conducted without IRB review. There is no ethically defensible reason to exclude certain prisoners from most, if not all, human subject protections afforded by federal regulation. All of these factors point to a population that is more vulnerable and requires stronger protections than those inspired by the national commission in the 1970s.

With these concerns in mind, the OHRP of the DHHS commissioned the IOM to review the ethical considerations in research involving prisoners as a basis for updating DHHS regulations to protect prisoners as research subjects.

The committee was charged with the following tasks:1

  • Consider whether the ethical bases for research with prisoners differ from those for research with nonprisoners.

  • Develop an ethical framework for the conduct of research with prisoners.

  • Identify considerations or safeguards necessary to ensure that research with prisoners is conducted ethically.

  • Identify issues and needs for future consideration and study.


The committee developed each recommendation in this report with the interests of prisoners in mind. Throughout its deliberations, the committee was well aware of the dark history of research involving prisoners (Hornblum, 1998; Jones, 1993; Murphy, 2005) and was determined not to permit the exposure of prisoners to the kind of research abuses that oc-


The committee decided to exclude children (unless treated as adults), military personnel, persons under restricted liberty due to mental illness, and persons outside the criminal justice system, such as those detained under the U.S. Patriot Act. By excluding these groups, the committee emphasizes that these groups face very similar circumstances and that very strong ethical safeguards are required. However, the committee lacks the expertise to address the needs of these special populations and such an inquiry exceeds the committee’s charge. Parallel studies, such as the one undertaken by this committee, may be needed to explore ethical issues of research involving these groups. If, however, juveniles are transferred from the original jurisdiction of the family court (or the equivalent, such as a juvenile court) to the jurisdiction of a state or federal criminal court, then they would fall under the provisions of this report.

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