Prisoner Research

 

This means individuals under electronic monitoring, house arrest, on “probation,” or under other similar judicial restrictions likely also meet the definition of a prisoner as far as regulatory protections are concerned. Consult with the IRO and OGC if there are questions about whether an individual may meet the definition of a prisoner requiring additional IRB review.

Fred Hutch does not routinely review research with a targeted prison population; therefore, investigators must consult with the IRO prior to submission of such a study.

Fred Hutch generally only reviews research involving prisoners when the incarceration of an individual is incidental to the research. Therefore, most research involving prisoners at Fred Hutch falls under 46.306(a)(2)(iv), “Research on practices that have the intent and reasonable probability of improving the health or wellbeing of the subject” (for example, clinical trials of cancer therapies that do not involve assignment to placebo).

NOTES:  

• Transplant studies:  The involvement of healthy donors in a transplant-related research study generally will not meet the requirements for involvement of prisoners, so prisoners may only be enrolled in the treatment arm of such a study. If a healthy donor meets the definition of a human research participant in the study, and they subsequently become incarcerated, they would generally need to leave the study. However, sometimes healthy donors on a transplant study do not meet the definition of a human research participant, so this may not be an issue. Consult with the IRO.
• Retrospective data/specimen studies:  Investigators do not need to address a purely theoretical prisoner population, only a known prisoner population. For example, a PI submitting a “No Contact” study (e.g., data/specimens study using retrospective materials) should consider whether the information obtained about the subjects would provide sufficient information to know whether specimens and/or information came from a prisoner population.

Process

HRP-265 - FORM - Prisoner Certification Checklist for Investigator is used to request that the Fred Hutch IRB consider a prisoner population.

All requests to newly include a prisoner population will undergo Full Review at a convened IRB meeting that includes a prisoner representative. The requirement for the IRB to include a prisoner representative reviewer could impact the timing of review.

For New Studies

Consult with the IRO first if it is known there will be a prisoner population (which is rare at Fred Hutch). 

For Existing Studies

Generally, the PI or study team will have an ongoing study and need to address a prisoner population for one of two reasons:

• Context 1:  A potential participant who may qualify for the study who would like to enroll, but incidentally they meet the definition of a prisoner.

For this context, the individual may not be enrolled in advance of the IRB’s formal determination (and if necessary, OHRP’s concurrence) about the request to enroll the potential participant. See Modification instructions below.

• Context 2:  An existing, enrolled participant becomes incarcerated or otherwise now meets the definition of a prisoner.  

If a previously enrolled research participant becomes a prisoner (and the study was not previously reviewed and approved by the IRB for a prisoner population), the PI must immediately notify the IRB of this event. You must stop all research interactions and interventions with, and stop obtaining any new identifiable private information about, this participant until the IRB has confirmed whether the regulatory requirements under 45 CFR 46, Subpart C requirements can be met. If the Principal Investigator asserts that it is in the best interests of the research participant to remain in the research study while meeting the definition of a prisoner, the PI must provide rationale to the IRB to continue with the treatment/intervention for the prisoner.

To request the IRB’s formal determination, turn in a Modification (see instructions below).

If the Principal Investigator does not seek or obtain IRB approval to include prisoners in the study, the now incarcerated participant can no longer be involved in the study until such time as the participant is released from their status as a prisoner. When the participant is no longer considered a prisoner, 45 CFR 46.303(c) is no longer invoked and the participant may be reintegrated into the research project and resume participation consistent with the IRB-approved research. If during the participant's period of incarceration, the IRB approved an unrelated modification to the research that required re-consent of currently enrolled participants, the following steps should be taken:  Upon release, if the participant will resume participation, they must be re-consented using the most current consent form(s) before resuming participation.

 

Modification Instructions

1. Prepare and submit a Modification in Hutch IRB explaining the desire to enroll/continue including a participant who incidentally meets the definition of a prisoner. Complete and attach the Modification Supplement as well as HRP-265 - FORM - Prisoner Certification Checklist for Investigator. 
   
2. The IRB will consider the Modification (including consultation with a prisoner representative as required) at a fully convened meeting and issue a determination about whether the enrollment of a prisoner population meets the regulatory requirements under 45 CFR 45, Subpart C.
3. If the study has federal funding, you will also need to wait for confirmation from OHRP that a prisoner population can be enrolled.  IRO sends them a formal letter requesting this confirmation.

Consult with IRO@fredhutch.org with questions about this information.