Which statement best describes the investigator's obligation to communicate with the IRB/IEC?

• A. Communication with the IRB/IEC is optional for investigators.
• B. The investigator should only communicate with IRB/IEC if requested by the sponsor.
• C. The investigator should communicate with IRB/IEC only at the start of the trial.
• D. The investigator should maintain ongoing communication with the IRB/IEC as required.

Answer: (D)

Maintaining ongoing communication with the IRB/IEC is essential for protecting participants and ensuring regulatory compliance throughout the study. The IRB/IEC provides continuous oversight, so investigators must keep them informed as changes occur and as new information arises. This includes promptly reporting serious adverse events and other safety updates, submitting protocol amendments for review and approval, and informing the IRB of any information that could affect risk–benefit or the consent process. Ongoing communication also encompasses continuing review at the intervals required by the protocol and regulatory rules, with progress reports as needed. Communication isn’t optional, nor is it limited to the study start or to sponsor requests; it must happen throughout the trial whenever changes, safety concerns, or new information emerge.