How should adverse events be reported to the IRB?

Reporting adverse events to the IRB promptly in writing with details of the event is critical for maintaining participant safety and ensuring compliance with ethical research standards. This procedure allows the IRB to assess the nature and seriousness of the events, enabling them to determine if any modifications to the study protocol are necessary or if additional safety measures should be implemented. Timely and detailed reporting ensures that researchers can respond effectively to any potential risks or issues arising from the study.

In contrast, waiting to report only at the end of the study does not provide the IRB with the timely information needed to protect participants. A phone call, while it may facilitate immediate communication, does not allow for a comprehensive account of the event and might lack critical documentation needed for formal review. Reporting only severe adverse events neglects the importance of understanding all types of adverse events, as even minor events can provide valuable information for evaluating the overall safety and ethical conduct of the research.