You learn that one of the subjects from your study will be admitted to prison next week. You assert that it is in the best interest of the subject to remain in the study while incarcerated. However, the study was not approved by the IRB in accordance with the requirements for research involving prisoners under Subpart C. What is the best course of action?
Stop all research activities with the subject immediately.
Notify OHRP and request an exception.
Withdraw the subject from the study and delete the collected data.
Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.
What would be the right answer?
The Correct Answer and Explanation is:
Correct Answer: Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.
Explanation:
When a research participant becomes a prisoner during the course of a study, specific regulatory protections come into play under Subpart C of 45 CFR 46, which governs research involving prisoners. Prisoners are considered a vulnerable population due to the potential limitations on their autonomy and increased risk of coercion. The Office for Human Research Protections (OHRP) has issued clear guidance on how researchers should proceed in such circumstances.
According to OHRP guidelines, if a subject becomes a prisoner after enrollment in a study not previously reviewed and approved under Subpart C, the researcher must promptly notify the Institutional Review Board (IRB). The IRB is then responsible for re-reviewing the study under Subpart C to determine whether the research may ethically and legally continue with the individual as a prisoner participant.
Key points:
- The subject should not be automatically withdrawn from the study, as this may deprive them of potential benefits, especially if the research offers a therapeutic intervention.
- Stopping all activities immediately is not the correct initial step unless the IRB directs this.
- Deleting collected data is inappropriate without IRB consultation and would violate data integrity and ethical research principles.
- An exception from OHRP is generally not required; the IRB must determine compliance under Subpart C.
- The subject may remain in the study, but no further research interventions should occur until the IRB completes its review and approves the subject’s continued participation under Subpart C.
Therefore, the most ethically sound and regulatory-compliant course of action is to notify the IRB promptly and allow it to make the required determinations for research involving prisoners.