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?

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?

• A. Notify the IRB promptly and allow the subject to remain in the study while the IRB makes the determinations required by the regulations.
• B. Remove the subject from the study immediately.
• C. Continue the study without updates.
• D. Seek permission from the prison authorities.

Answer: (A)

When a subject becomes incarcerated, research involving prisoners must meet extra protections under Subpart C and be reviewed by the IRB for those specific requirements. If the study hasn’t received that approval, the investigator should involve the IRB to determine whether and how the research can proceed with prisoners. The best action is to notify the IRB promptly and keep the subject in the study while the IRB makes the necessary determinations. This approach centers the IRB’s role in safeguarding prisoners’ rights and welfare and prevents making unilateral moves that could undermine consent, risk assessment, or appropriate safeguards. It also avoids abrupt removal or continuation without regulatory review, and it recognizes that prison authorities don’t substitute for IRB approval. Choosing to remove the subject immediately, continue without updates, or seek prison authorization alone would bypass the required protections and oversight.

When a subject becomes incarcerated, research involving prisoners must meet extra protections under Subpart C and be reviewed by the IRB for those specific requirements. If the study hasn’t received that approval, the investigator should involve the IRB to determine whether and how the research can proceed with prisoners. The best action is to notify the IRB promptly and keep the subject in the study while the IRB makes the necessary determinations.

This approach centers the IRB’s role in safeguarding prisoners’ rights and welfare and prevents making unilateral moves that could undermine consent, risk assessment, or appropriate safeguards. It also avoids abrupt removal or continuation without regulatory review, and it recognizes that prison authorities don’t substitute for IRB approval.

Choosing to remove the subject immediately, continue without updates, or seek prison authorization alone would bypass the required protections and oversight.