If the IRB/IEC terminates or suspends its approval, what should the investigator do?

• A. Inform the institution and promptly notify the sponsor; provide the sponsor with a detailed written explanation
• B. Continue the trial as if nothing happened
• C. Inform only the site staff
• D. Notify regulatory authorities before informing the sponsor

Answer: (A)

When an IRB/IEC suspends or terminates approval, immediate and documented communication is required. The investigator must inform the institution and promptly notify the sponsor, providing a detailed written explanation. This ensures the sponsor can assess participant safety, halt enrollment and treatment at the site, and coordinate any necessary regulatory reporting or corrective actions. It also preserves accountability and helps protect current participants and data integrity. Informing only site staff is insufficient, continuing the trial ignores the IRB decision, and notifying regulators before the sponsor bypasses the established reporting chain.