Guidance

Prisoners in Research

IRBMED
Oct 21, 2020 3:30 pm
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Convened Board review and approval of research designed to study incarcerated persons, or persons likely to become incarcerated, is a multistep process and must be conducted in accordance with the requirements in 45 CFR 46 Subparts A (Common Rule) and C (Additional Prisoner considerations) prior to any interaction or intervention with prisoners or research participants who are now classified as prisoners. The steps include:

  1. Review of the research by a convened Board that is constituted with at least one voting member of the Board in attendance who is a prisoner or prisoner representative;
    • Subpart C includes a modified definition of “no more than minimal risk”;
  2. Determinations by the Board that:
    • the seven findings for research under 45 CFR 46.305(a) are fulfilled; and
    • the research meets one of the four permissible categories of research under 45 CFR 46.306(a)(2);
  3. Federally sponsored studies: UM Institutional Official submits, according to OHRP guidance How to Prepare a Prisoner Certification Letter to OHRP, a completed Subpart C Certification Form regarding the completed IRB review, and awaits receipt of an authorization letter from OHRP with the judgment of the HHS Secretary that the research is permissible under 45 CFR 46.306(a).

    Studies without federal funding: The IRB will certify to the Institutional Official (IO) or Deputy Institutional Official (DIO) that the research meets the criteria for approval of research with prisoners. The IO or DIO assumes the role of the HHS Secretary. (Reference: HRPP Operations Manual Part 7.II.B)

  4. Obtaining permission from the warden or other equivalent leadership role at each correctional facility involved, if these are known ahead of time.
    • If not known ahead of time, submit by ORIO when each facility’s permission is received.
    • Wardens may choose to provide permission to conduct research at the facility over the course of the study, or for research activities with a specific subject (redact subject identifiers in the copy provided to the IRB).  
  5. Approval from Michigan Department of Corrections (MDOC) Research Section if the research is conducted in a state prison . This is generally required before full IRB approval.
  6. If early study activities work will not require prisoner interaction, the IRB may approve these activities and require an Amendment, including MDOC letter, before any prisoner interaction takes place.

This process may be lengthy. Contact the IRBMED office for assistance with the process.

  • Enrollment

    Prisoners at the time of enrollment

    The protocol should detail the Follow reporting requirementsexpectations 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.

    Participants may become incarcerated, and interaction/intervention during incarceration IS expected

    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.

    Participants may become incarcerated, and NO interaction/intervention will take place during incarceration

    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.

  • Participant becomes incarcerated in a study NOT approved for prisoners

    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).

    IRB submissions when a participant is incarcerated
    Situation ORIO subtype Considerations
    Research activities with this participant will continue during incarceration Subject Incarceration ALSO submit an Amendment for re-review according to Subpart C (see above).
    Research activities with this participant will be paused, resulting in missed visits, procedures and/or data collection. Participant participation will resume after incarceration. Subject Incarceration Include whether any wash-out procedures are necessary, and how the study team will re-contact after incarceration
    Participant will be withdrawn from the study Subject Withdrawal Include whether any wash-out procedures are necessary, and whether any follow-up information will be collected after withdrawal
    No research activities with this participant are scheduled during the incarceration. Participation will resume after incarceration. There is no expectation that data collection or study procedures will be affected. No ORIO necessary  

    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

  • REGULATORY REQUIREMENTS

    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.

    Definition

    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).

  • REFERENCES
Units: Institutional Review Boards (IRBMED)
Topic: Informed Consent & Assent Investigator & Study Team Responsibilities Regulations & Policies (Federal, State & Local) Subject Populations
Questions?

Contact us at [email protected] or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: [email protected]
Last Updated: March 8, 2021 2:15PM

 

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