Severe adverse events must be reported to the IRB within what time frame?

Severe adverse events, often referred to as serious adverse events (SAEs), must be reported to the Institutional Review Board (IRB) within a specific time frame to ensure the safety and well-being of research participants. Reporting within 24 hours is critical for several reasons:

1. Timeliness: Immediate reporting allows the IRB to quickly assess the situation, determine if there is a need to modify the study protocol, and protect the welfare of the participants. This is crucial especially in cases where the adverse event may indicate potential risks associated with the study intervention.

2. Compliance: Regulations set forth by the FDA and other regulatory bodies require that serious adverse events be reported promptly to ensure ongoing oversight and monitoring of the research environment. Adhering to this 24-hour reporting window is essential for compliance with these regulations.

3. Participant Safety: Rapid identification and reporting of SAEs help the research team take necessary actions, such as informing subjects or initiating follow-ups, which can be vital in ensuring the health and safety of all participants enrolled in a study.

The other options suggest longer time frames for reporting, which could compromise participant safety and the integrity of the research study. Therefore, the requirement to report severe adverse events within 24 hours is