Research with Prisoners
Research that proposes to involve prisoners as subjects requires special protections under the federal regulations because these individuals may not be free to make voluntary decisions about participation and may be subject to coercion or undue influence. Under the Common Rule (45 CFR 46, Subpart C), prisoner is defined as
any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
Because the ethical requirements for a study that targets or includes prisoners as subjects can involve additional protections or safeguards, the IRB review process is often more stringent and lengthy. In addition, if IRB approval is granted, this approval may need to be certified at the federal level by the Office for Human Research Protections (OHRP). OHRP guidance on research with prisoners can be found here.
One very important note: The regulations and standards for research involving prisoners are not limited only to those studies that target prisoners, but can apply whenever any human subject in a research protocol becomes a prisoner at any time during the study. OHRP provides the following guidance:
What should be done when a subject becomes a prisoner after enrollment in a study which was not reviewed and approved by the IRB in accordance with the requirements of subpart C (research involving prisoners)?
When a previously enrolled research subject becomes a prisoner and the relevant research protocol was NOT reviewed and approved by the institutional review board (IRB) in accordance with the requirements of HHS regulations at 45 CFR part 46, subpart C, the principal investigator should promptly notify the IRB of this event. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must cease until the requirements of subpart C have been satisfied with respect to the relevant protocol. (source)
If a participant becomes incarcerated (or otherwise meets the definition of prisoner noted above) during the course of your research study, STOP all research-related interactions and data collection with that subject and contact the HSPP immediately for guidance. OHRP allows for only one exception to this rule and that exception must be determined by the IRB Chair.
If you are developing a study that relates to prisoners or prison settings or involves participants that may become prisoners during the course of your research, please contact the HSPP for guidance. To allow sufficient time for the IRB review process and, if needed, federal certification, these kinds of studies should be subitted at least six months prior to your planned start date for the research.