Research Involving Vulnerable Populations: Prisoners
Categories of Permitted Research
Subpart C only allows prisoners to be included as subjects when the research involves one of the following four categories (46.306(a)(2)):
- A study of criminal behavior and of the possible causes, effects, and processes of incarceration that presents no more than minimal risk and no more than inconvenience to the subjects
- A study of prisons as institutional structures or of prisoners as incarcerated persons that presents no more than minimal risk and no more than inconvenience to the subjects
- Research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults). The study may proceed only after the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and has published notice of the intent to approve such research in the Federal Register
- Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In studies which require the assignment of prisoners to control groups that may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and has published notice of the intent to approve such research in the Federal Register
The Secretary of DHHS has the authority to waive the applicability of some or all of the provisions of 45 CFR 46 to research activities otherwise covered by the regulations (46.101(i)). This authority was used to adopt a waiver of 46.305(1) and 46.306(2) for important and necessary epidemiologic research on prisoners that meets the following criteria:
- Studies in which the sole purposes are
- To describe the prevalence or incidence of a disease by identifying all cases, or
- To study potential risk factor associations for a disease, and
- Studies where the institution responsible for the conduct of the research certifies to OHRP that the IRB approved the research and fulfilled its duties under 46.305(a)(2)-(7) and determined and documented that
- The research presents no more than minimal risk and no more than inconvenience to the prisoner-subjects, and
- Prisoners are not a particular focus of the research
Additional information and an example of research that meets these criteria are found in the Federal Register announcement of June 20, 2003.
NOTE: No exemptions found in 46.101(b) apply to research under Subpart C (research involving prisoners).