If a subject in your study is about to be admitted to prison, and your study was not originally approved by the IRB under the special requirements for prisoner research (Subpart C), the best course of action is to promptly notify the IRB of the subject’s change in status. The subject may remain in the study temporarily while the IRB reviews the situation and determines whether the study can be amended and approved to include prisoners under the regulatory requirements
. Key steps include:
- Notify the IRB immediately about the subject’s incarceration and submit a modification request to include prisoners in the study protocol for IRB review
- Suspend all research interactions and interventions with the prisoner-subject until the IRB re-approves the study for prisoner involvement, except in cases where the investigator asserts it is in the best interest of the subject to continue participation during the review period
- The IRB must then assess whether the research meets the specific regulatory criteria for prisoner research, including permissible categories of research, additional protections against coercion, and appropriate IRB membership including a prisoner representative
- If the study is federally funded, after IRB approval, certification must be submitted to the Office for Human Research Protections (OHRP) and authorization obtained before continuing research with the prisoner-subject
- If the IRB does not approve the inclusion of prisoners, the subject must be withdrawn from the study
This process ensures compliance with federal regulations protecting prisoners as a vulnerable population and maintains ethical standards for research
