If the IRB/IEC withdraws or suspends approval, what should be done?

• A. Terminate the trial immediately and notify regulatory authorities
• B. Continue the trial as if nothing happened
• C. Document and address the reason for withdrawal or suspension and seek re-evaluation if possible
• D. Suspend the trial without documentation

Answer: (C)

When the ethics committee withdraws or suspends approval, the priority is to protect participants and maintain regulatory compliance. The investigator should document the exact reason given by the IRB/IEC, halt activities that require IRB approval, and work to address the concerns so that re-evaluation or re-approval can be sought if feasible. This creates a clear, auditable record of what happened, what issues were identified, and what corrective actions are needed—whether that means revising the protocol, consent form, safety measures, or monitoring plan before attempting to resume the study. Continuing without addressing the IRB’s concerns would undermine participant safety and GCP obligations, and suspending without documentation would fail to meet regulatory record-keeping requirements. Terminating immediately isn’t the only path; addressing the IRB’s concerns and seeking re-approval is the appropriate next step when possible.