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
|Research activities with this participant will continue during 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.
||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|Participant will be withdrawn from the study
||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.
- Contact IRBMED office by phone 734-763-4768 and email firstname.lastname@example.org immediately (the same day that notification of the incarceration is received);
- 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.
- Prepare and submit both of the following eResearch applications:
In the Amendment Title include “Prisoner Research approval,” “Participant now prisoner,” or something similar.
“Subject Incarceration” sub-type