How must adverse events be reported to the IRB?

Adverse events must be reported to the Institutional Review Board (IRB) in a timely manner, following the specific requirements established by the board. This practice is crucial because timely reporting allows the IRB to assess the risks to participants and make informed decisions regarding the continuation of the research. The IRB's established requirements typically outline detailed procedures and timelines for reporting such events, ensuring that any potential risks are addressed promptly.

Timeliness in reporting is not only a regulatory requirement in many cases but also reflects a commitment to participant safety and ethical research practices. Reporting adverse events that could impact participant welfare helps safeguard against prolonged exposure to harmful situations and allows for adjustments to study protocols if necessary. Therefore, adhering to these established requirements ensures that the IRB can fulfill its role in protecting participants and maintaining the integrity of the research process.