What should researchers do upon encountering unexpected adverse events during a study?

Reporting unexpected adverse events to the Institutional Review Board (IRB) and following established protocols is essential for several reasons. The primary focus of ethical research is the safety and well-being of participants. When an adverse event occurs, even if it seems minor, it’s important to promptly inform the IRB to ensure that the study continues to adhere to ethical standards and regulatory requirements.

The IRB is responsible for overseeing research studies involving human participants, and they evaluate the potential risks and benefits. By reporting adverse events, researchers provide the IRB with the necessary information to assess whether the study protocol needs adjustments to enhance participant safety. Furthermore, this transparency helps maintain the integrity of the research process and ensures that appropriate measures can be taken to mitigate risks.

Adverse events can sometimes indicate unanticipated risks that weren't previously identified, making it imperative for researchers to address them proactively rather than overlooking them. Following established protocols ensures that the response to the event is systematic and aligned with ethical guidelines, maintaining the trust of participants and the broader research community. This process upholds the principles of respect, beneficence, and justice essential to conducting ethical research.