HRPP Policy - prisoners in research

The IRB shall approve research involving prisoners only if it finds all of the following:

• Any possible advantages accruing to the prisoner through his/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
• The risks involved in the research are commensurate with risks that would be accepted by non-prisoner volunteers
• Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the Principal Investigator (PI) provides to the IRB justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project.
• The information is presented in language understandable to the subject population
• 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/her parole
• Where the IRB finds there may be a need for follow-up examination or care of subjects 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 for informing subjects of this fact
• Research personnel are appropriately qualified to work and interact with prisoners, based on previous research experience, academic preparation, and/or relevant training and oversight by the PI
• For federally-funded research, the research represents one of the categories of research or waiver permissible under section 2.2 below

Pursuant to 45 CFR 46.306(a)(2), federally-funded biomedical or behavioral research may involve prisoners as subjects only if the IRB determines the research falls under one or more of the following categories:

• 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;
• 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;
• 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 DHHS 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; or
• Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subjects. In cases in which those studies require the assignment of prisoners in a manner consistent with studies approved by the IRB to control groups that may not benefit from the research, the study may proceed only after the DHHS 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.

Per notice in the federal register, the requirement that the research represent one of the categories of research listed above may be waived when DHHS conducts or supports certain important and necessary epidemiologic research on prisoners that meet all of the following criteria:

• The sole purposes are (i) to describe the prevalence or incidence of a disease by identifying all cases, or (ii) to study the potential risk factor associations for a disease
• Where the institution responsible for the conduct of research certifies to the Office of Human Research Protections, DHHS, acting on behalf of the DHHS Secretary, that the IRB approved the research and fulfilled its duties under 45 CFR 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

Research involving prisoners cannot be conducted by VA research personnel while on official duty, at VA facilities, or at VA-approved off-site facilities unless a waiver has been granted by the Chief Research and Development Officer. If the waiver is granted, the research must be conducted in accordance with 45 CFR 46, Subpart C.

The use of prisoners for medical, pharmaceutical, or cosmetic experiments is prohibited, per DOC Policy and Administrative Procedures 01-02-101 and 00-04-201.

Research involving a detainee or prisoner of war as a human subject is prohibited.  This prohibition does not apply to research involving investigational drugs and devices and informed consent is obtained when the same products would be offered to DOD-affiliated personnel consistent with established medical practices.

For research conducted with the Bureau of Prisons (BOP), the requirements of 28 CFR 512 must be followed, including, but not limited to:

• The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing
• The research design must be compatible with both the operation of prison facilities and protection of human participants. The researcher must observe the rules of the institution or office in which the research is conducted
• Any researcher who is a non-employee of the Bu­reau must sign a statement in which the researcher agrees to adhere to the requirements of 28 CFR 512
• All research proposals will be reviewed by the Bureau Research Review Board.

For studies proposing to enroll prisoners, the study team completes the IRB application and provides protocol-specific information related to research with this population. The IRB considers the information in the IRB application and documents its determinations as appropriate.

When research is conducted in detention or correctional facilities, research personnel must obtain approval or permission to conduct the research from the facilities involved in the research and provide documentation to the IRB.

When a human subject involved in ongoing research becomes a prisoner during the course of the study, and the relevant research study was not previously approved by the IRB for the inclusion of prisoners:

• All research procedures with the now-incarcerated prisoner-subject, including interactions and interventions and collection of identifiable private information, must immediately cease.
• If research personnel wish to have the prisoner-subject continue to participate in the research, the study team must submit an amendment to the IRB requesting inclusion of prisoners and the IRB must approve the inclusion in accordance with this policy. The prisoner-subject may continue to participate in research procedures once the amendment is approved.
• If research personnel believe it is in the best interest of the prisoner-subject to continue to receive research procedures before such an amendment can be reviewed, the IRB Chair may determine that the prisoner-subject may continue to participate in the research until the above requirements are met.
• IRB approval for inclusion of prisoners is not required if research procedures will not occur during the incarceration period.

When a prisoner is also a child (e.g., an adolescent detained in a juvenile detention facility), appropriate additional requirements must be satisfied for the inclusion of children in research as outlined in the IU HRPP Policy on Children in Research.