What best describes the investigator's obligation to IRB/IEC communication?

• A. Communication with the IRB/IEC is optional for investigators.
• B. The investigator should maintain ongoing communication with the IRB/IEC as required.
• C. Investigators may contact IRB/IEC only if there is a safety event.
• D. Investigators need not communicate with IRB/IEC beyond initial approval.

Answer: (B)

Maintaining ongoing communication with the IRB/IEC is essential to protect participants and ensure ethical and regulatory compliance throughout the study. The IRB/IEC relies on the investigator to provide timely updates, report changes, and seek approval for significant amendments, as well as to disclose adverse events, unanticipated problems, and any protocol or consent changes. This ongoing dialogue includes continuing review, submission of safety reports, and adhering to specified reporting timelines and documentation requirements. By staying in regular contact as required, the investigator ensures that oversight bodies can monitor risk, approve modifications, and keep the study aligned with current ethical and regulatory standards. Options that describe communication as optional, limited to safety events, or only needed beyond initial approval do not reflect this continuous oversight and are not appropriate.