When new information arises that could affect participant safety, what is required?

• A. Inform participants only.
• B. Report to IRB/IEC and follow procedures.
• C. Wait until trial end.
• D. Notify sponsor only.

Answer: (B)

When new information emerges that could affect participant safety, the investigator must promptly report it to the IRB/IEC and follow the established procedures. This ensures an independent review of the new data and timely decisions about protections for participants, such as whether protocol or consent changes are needed, whether participants should be informed or re-consented, and whether additional monitoring or actions are required. The sponsor may also need to be informed as part of the oversight process, and the trial may need modifications, pauses, or even early termination depending on the risk. Simply informing participants or waiting until the trial ends does not provide the necessary ethical review or protection.