IRB Guidance: Research Involving Prisoners as Participants

This page addresses Additional Considerations when research includes prisoners as participants. A ‘prisoner’ is defined as any individual involuntarily confined in a penal institution or who are being detained in other facilities which provide alternatives to incarceration in a penal institution (such as commitment to a mental health or rehabilitation facility).

Research involving prisoners is never exempt from IRB review.

Requirements to review research involving prisoners
When reviewing proposed research that includes prisoners as participants the IRB membership must include at least one member who is a prisoner representative/advocate. The prisoner advocate serves as a voting member of the IRB when protocols that include prisoners as participants are reviewed.

Research involving prisoners that is permissible under federal regulations (45 CFR 46.306(a)(2))
Under federal regulations, research may involve prisoners as subjects only if the IRB confirms the determination that it falls into one of the following categories:
i.    Study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;
ii.    Study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;

Though not typically applicable to research reviewed by the ED/SBS IRB, 46.306 also permits:

iii.    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) provided that the study may proceed only after the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research; or
iv.    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 cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which 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 published notice, in the Federal Register, of the intent to approve such research.

Requirements for Approval to enroll prisoners (per 45 CFR 46 SubPart C)
Per federal regulation 45 CFR 46.305, in order to approve the enrollment of prisoners, the IRB must document that it has considered all of the following criteria, and may approve the research only if it finds that:

  1. The research under review represents one of the categories of research listed above as permissible under 46.306(a)(2).
  2. Any possible advantages to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired
  3. The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers
  4. Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. (NOTE:  Unless the PI provides justification in writing for following other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project)
  5. The information is presented in language which is understandable to the subject population.  (NOTE:  Reading level for prison populations is typically lower than for non-incarcerated individuals and all participant documents/scripts should be presented at the appropriate level for the majority of the targeted prisoner population.)
  6. Adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole
  7. Where the IRB finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and participants must be informed of this fact.

Criteria 4-7 should be outlined as part of the consent process and/or document, if applicable.




Keywords:prisoners, SubPart C, 46.305, 46.306   Doc ID:69369
Owner:Casey P.Group:Education and Social/Behavioral Science IRB
Created:2016-12-12 14:13 CDTUpdated:2018-10-16 14:45 CDT
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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