If an adverse event occurs during a study, what should be the investigator's priority regarding the IRB?

The priority for an investigator in the event of an adverse event occurring during a study is to report it immediately based on IRB guidelines. Adverse events can have significant implications for the safety of participants and the integrity of the study. By promptly notifying the Institutional Review Board (IRB), the investigator ensures that appropriate actions can be taken to assess the risk to participants and to maintain compliance with ethical and regulatory standards.

Timely reporting allows the IRB to evaluate the severity of the event and determine whether any modifications to the study protocol are necessary to protect participants’ safety and well-being. It also ensures that the study remains compliant with federal regulations, which require immediate reporting of significant adverse events. This approach underscores the commitment to participant safety and the ethical conduct of research, maintaining trust between researchers, participants, and regulatory bodies.