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Updated June 7, 2024

It may happen that an individual becomes incarcerated while enrolled in a University research study that was not designed to include prisoners.

Reporting Requirements for Unexpected Incarceration of a Research Participant

Upon discovery of a participant's incarceration, the principal investigator (PI) will notify the IRB in writing of the incarceration and effects of discontinuation of research intervention or treatment. If the participant were enrolled in a clinical trial involving therapeutic treatment, or investigational drugs or devices, and immediate cessation of the research intervention could imperil the imprisoned participant's health, the PI must also promptly notify the ÁùºÏ±¦µä Department of Corrections.

The report/notification should include a written assessment of whether it is in the best interest of the prisoner-participant to continue in the study, and the PI's plans for continuation or cessation of the intervention during the participant's incarceration.

Considerations for Temporary Incarceration

If a participant is incarcerated temporarily while enrolled in a study and the temporary incarceration has no effect on the study, the PI may keep the participant enrolled if research activities, including the collection of identifiable information from the incarcerated participant, are curtailed during the participant's incarceration.

If a participant is incarcerated temporarily while enrolled in a study and the temporary incarceration may affect the prisoner-participant's health or safety, the PI must assess risks to the prisoner-participant resulting from cessation of the research intervention during the temporary incarceration. The PI may consider requesting temporary continuation of the intervention.

Immediate Cessation of the Intervention

Where a prisoner-participant may be safely withdrawn from research interventions, or for research that does not involve interventions, the PI must immediately cease all research activities involving the prisoner-participant under one of the two conditions listed below.

Condition 1: The PI does not request IRB approval for continuation of the prisoner's participation in the research.

• The prisoner-participant will be immediately withdrawn from the study.
• The PI may retain and use data collected from or about the participant up to the point of incarceration.

Condition 2: The PI requests IRB approval for an amendment to allow continuation of the prisoner's participation in the study.

• All research interactions and interventions involving the prisoner-participant, including the collection of identifiable information from or about them, will temporarily cease.
• Research activities involving the prisoner-participant will resume following IRB review and approval of a project amendment to allow the research to involve prisoners.

Temporary Continuation of the Intervention

If the PI determines that immediate cessation of a study intervention may harm a prisoner-participant such that continuation of the intervention is advisable, the PI must provide the following information to the IRB:

• Determination of the minimum intervention necessary to protect the prisoner-participant;
• Plan for monitoring the prisoner-participant's health and safety during discontinuation of the medication (including tapering if warranted) or removal of the device; or for continued dosing or placement of the device;
• Description of standard care the participant was receiving while in the research study (if applicable);
• Timeline for safely withdrawing the prisoner-participant from the intervention;
• Specification of one of three outcomes for the situation:
  • following safe cessation of the intervention, the prisoner-participant will be permanently withdrawn from the study;
  • via an IRB-approved project amendment, the prisoner-participant will be kept on the study intervention under an alternate mechanism such as emergency or compassionate (devices only) use;
  • following IRB approval of a project amendment to allow the involvement of prisoners in the research, the prisoner-participant will continue participation in the research.

In preparing the request for temporary continuation, the PI may wish to consult with the IRB, a qualified representative of the ÁùºÏ±¦µä Department of Corrections Medical Division, or both to confirm the plan for continuation is compliant and feasible.

NOTE: The IRB must inform DHHS OHRP of the decision to allow the temporary continuation of an intervention for the health and safety of an individual prisoner-participant.

Continued Participation of Prisoners in the Research

In cases of unexpected incarceration of a participant where the PI wishes to amend the study to allow the continued involvement of the prisoner-participant and may wish to enroll other prisoners in the research, the PI must complete the following:

• confirm that the incarcerated participant meets the definition of a prisoner;
• submit a project amendment to allow the involvement of the individual prisoner-participant and/or other prisoners in the research;
• confirm the research meets the requirements for research involving prisoners
• revise the application to include prisoners among the study populations and modify the procedures to accommodate incarcerated persons;
• complete and submit the researcher form Population: Prisoners; and
• provide documentation of permission from the penal institutions where the prisoner-participant is incarcerated and where other prisoners may be recruited.