What must be reported to the IRB in case of a serious adverse event?

In clinical research, it's crucial to adhere to ethical standards and regulatory requirements for participant safety. A serious adverse event (SAE) is an event that results in significant harm to a participant, such as hospitalization, disability, or even death, and it may have implications for the ongoing study or future studies.

The rationale for reporting any serious adverse event related to the study promptly to the Institutional Review Board (IRB) stems from the IRB's role in protecting the rights and welfare of research participants. It is responsible for overseeing the ethical conduct of research and ensuring that any risks are appropriately managed. Prompt reporting enables the IRB to evaluate the event and take necessary actions to safeguard participants, which may include modifying the study protocol, altering the informed consent process, or even suspending the study if necessary.

Reporting only events that happen during final analysis, not reporting any events, or limiting the reporting to events linked directly to medication fails to consider the comprehensive nature of participant safety and the IRB’s oversight responsibilities. All serious adverse events, regardless of timing or direct causation, should be reported to ensure a thorough risk assessment and proper ethical oversight.