Prisoners in Research

The protocol should detail the reporting expectations to the IRB (for instance, whether the IRB will be informed of the number of current and former prisoners active in the study) outlined in the protocol.

Participant populations in which the possibility of incarceration is expected should seek approval to conduct research with prisoners , if the principal investigator would like to continue interacting with the now-incarcerated subject. Often follow-up surveys are conducted while a participant is incarcerated. Other   intervention may be difficult to continue after incarceration since protocols are likely not able to be followed. This is very study-specific and should be clearly described in the protocol.

The IRB should be notified by ORIO when a subject becomes incarcerated, with documentation of the correctional facility approval uploaded. Note it is not necessary to notify the IRB when a subject first becomes incarcerated but the appropriate correctional facility approval has not yet been obtained.

If a participant becomes incarcerated and if the study is not approved for research with prisoners, no study activity may occur with that subject. This includes follow-up surveys, contact with the subject, or further intervention.

Depending on the anticipated length of the incarceration, the participant might miss study-related interactions, and depending on the protocol might need to be withdrawn from the study. The participant may resume study activities after incarceration, if appropriate. The principal investigator should assess data integrity and participant benefit/safety.

Withdrawal should be reported to the IRB at time of continuing review or in a separate ORIO if extenuating circumstances are present. Protocol Violation ORIOs should follow reporting guidelines according to protocol.

If a study participant becomes incarcerated during the conduct of a study that is not approved for prisoner research, and participant intervention/interaction is expected to continue during the incarceration, then promptly submit an ORIO (Other Related Information or Occurrence).

No ORIO is necessary if the study design is such that no study procedures would have taken place during the time of incarceration (e.g. the Participant is in long-term follow-up through medical record review only).

A “Subject Incarceration” ORIO is not necessary if the study team learns that a Participant was formerly incarcerated and already has been released. However, any missed visits, procedure, and/or data collection should be tracked as Protocol Violations (see ORIO guidance).

If the participant is now classified as a prisoner and will continue research participation during incarceration, the IRB must promptly re-review the research application in accordance with the requirements in 45 CFR 46 subpart C.

1. Contact IRBMED office by phone 734-763-4768 and email [email protected] immediately (the same day that notification of the incarceration is received);
2. Do not perform any study intervention or interaction (except those necessary to avoid immediate harm to the Participant, as determined by the PI) or collect any Protected Health Information (PHI). Study team may confirm incarceration by contacting the detention facility.
   If it is in the best interests of the Participant to remain in the research study while incarcerated, the PI should contact the IRB Chair on call, who may make the preliminary determination that the Participant may continue to participate in the research until IRB re-reviews according to subpart C requirements.
3. Prepare and submit both of the following eResearch applications:
   • Amendment
     In the Amendment Title include “Prisoner Research approval,” “Participant now prisoner,” or something similar.
   • ORIO
     “Subject Incarceration” sub-type

Regulations 45 CFR 46 Subpart C require that IRBs:

1. Conduct special Board review according to Subpart C requirements of prospective studies or amendments:
   1. intending to recruit prisoners; or
   2. where it is anticipated that members of the study population will become incarcerated at some point during the conduct of the study (e.g. studies of substance abuse and risky behaviors) and it is desirable that participants continue with study participation;
2. Conduct Board re-review of amendments to existing studies, not previously approved for prisoner research, to continue the research involvement of participants now classified as prisoners that become incarcerated during the study.

This review must be by Convened Board unless the study qualifies for expedited review. Guidance from the Office of Human Research Protections (OHRP) recommends Convened Board review in all cases.

According to 45 CFR 46.303(c):

“Prisoner” means 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.

For studies that may involve probationers or individuals with monitoring devices, and for any other situations where prisoner status may not be clear, consult with U-M Office of General Counsel (OGC).

• University of Michigan HRPP Operations Manual
  •  Part 7.II.B (Participant Protection)
  • Part 11.II.D.1 (State Laws, Additional Protections for Vulnerable Populations)
• Michigan Department of Corrections
  • Policy Directives: 01.04 Management Information/Documentation/Research
  • Policy Directive 01.04.120 “Research Involving Corrections Facilities or Offenders”
• Office of Human Research Protections (OHRP)
  • Regulations: 45 CFR 46 Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
  • FAQs  Topic: Prisoner Research
  • Guidance Prisoner Involvement in Research (2003)
  • Guidance Prisoner Research Certification (2020)