HRPP policies & procedures manual

504: Research with prisoners

1. Purpose

This policy describes the requirements concerning review of research that involves prisoners who could be potentially vulnerable to coercion in regard to autonomy and who present conditions that may affect risk/benefit determinations or bear unequal burden in research.

2. Policy

Prisoners may be under constraints because of their incarceration, which could affect their ability to make a truly voluntary and non-coerced decision whether or not to participate in research. To safeguard their interest and to protect them from harm, special ethical and regulatory considerations apply when reviewing research involving this population.

3. Definitions

For prisoners, “minimal risk” means the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives or in the routine medical, dental, or psychological examination of a healthy person.

4. Specific policies

4.1 IRB composition

The IRB shall meet the following requirements:

  • A majority of the board shall have no association with the prison(s) involved, apart from their membership on the IRB.
  • A least one member of the IRB shall be a prisoner or a prisoner representative with appropriate background and experience to serve in that capacity.

4.2 Additional duties of the IRB when reviewing research with prisoners

If an investigator indicates in the study submission that prisoners will participate in the research, or that subjects may reasonably be expected to be incarcerated at some time point during the study, the additional requirements will apply to IRB review of the project:

  • If the research involving prisoners is neither conducted nor supported by the Department of Health and Human Services (HHS), then the IRB will include in its minutes that the research falls into one of the four categories of research 45 CFR 46.306(2)(A)-(D).
  • If the research involving prisoners is either conducted or supported by HHS, then the IRB will certify to OHRP that the duties of the IRB have been fulfilled.

Minor modifications to research may be reviewed using the expedited procedure described below, using either of the two procedures described based on the type of modification.

Modification involving more than a minor change reviewed by the convened IRB

  • Must use the same procedures for initial review, including the responsibility of the prisoner representative to review the modification and participate in the meeting

Continuing review

  • Must use the same procedure for initial review, including the responsibility of the prisoner representative to review the continuing review materials and participate in the meeting
  • If no subjects have been enrolled, the research may receive continuing review using the expedited procedure under expedited category #8.
Local regulations

In addition to meeting federal regulations, the project must comply with local and state requirements for inclusion of prisoners as subjects.

4.3 When subjects become prisoners during a research protocol

This policy applies whenever any human subject in a research protocol becomes a prisoner at any time during the protocol, e.g., after the research has commenced.  This is necessary because it is unlikely that review of the research and the consent document contemplated the constraints imposed by the possible future incarceration of the subject.

  • If a subject becomes a prisoner after enrollment in research, the principal investigator is responsible for reporting this situation in writing to the IRB immediately.
  • At the earliest opportunity after receiving the investigator’s notice or otherwise becoming aware of the prisoner status of a subject, the IRB should review the protocol again with a prisoner representative as a member of the IRB. The IRB should take special consideration of the conditions of being a prisoner.
  • Upon this review, the IRB can either (a) approve the involvement of the prisoner-subject in the research in accordance with this policy or (b) determine that this subject must be withdrawn from the research.
  • If involvement of the prisoner subject is approved, a special addendum to the consent document must be created that informs the subject of the impact incarceration may have on his or her continued participation.

If a subject becomes a prisoner while enrolled in a research study that was not reviewed according to Subpart C:

  • Before terminating the enrollment of the incarcerated subject the IRB should consider the risks associated with terminating participation in the study.
  • If the subject cannot be terminated for health or safety reasons:
    • Keep the subject enrolled in the study and review the research under Subpart C.
    • If some requirement of Subpart C cannot be met, but it is in the best interest of the subject to remain in the study, keep the subject enrolled and inform the Office for Human Research Protections (OHRP) of the decision along with the justification.

5. Applicable regulations and guidelines

The Belmont Report

45 CFR 46: Subparts C, 45 CFR 46.305, 45 CFR 46.122

21 CFR 56.111

Office for Human Research Protections (OHRP) IRB Guidebook

6. Attachment

Addendum 3

7. Procedures employed to implement this policy & assignment of responsibility

IRB coordinatorMaintain and update checklist to conform to applicable regulations and guidelines. Secure prisoner representative for the IRB’s meeting.
Select appropriate primary, secondary and tertiary reviewers and/or obtain an expert consultant.
ORA director Certify to the OHRP that the IRB has reviewed and approved the research under CFR 46.305I.