Review HRP 415-CHECKLIST-Prisoners to ensure that you provide sufficient information in your protocol or application to justify enrollment of prisoners in your study.

Following IRB review and approval of DHHS-supported research involving prisoners, the IRB will provide a certification letter to the Office of Human Research Protections (OHRP) as required in 45CFR46.306.

Once the research has commenced, similar considerations apply when a participant becomes a prisoner at any time during the conduct of the study, regardless of study funding. In this event:

• Report this to the IRB as a reportable event; and
• Review HRP 415-CHECKLIST-Prisoners to ensure you have provided sufficient information.