After an adverse drug experience in a clinical trial, how should the investigator respond to the IRB?

The investigator should report the adverse drug experience to the Institutional Review Board (IRB) in a timely manner using the established protocols. This response is critical because it ensures the safety and welfare of the participants involved in the clinical trial. Timely reporting allows the IRB to assess the risks associated with the study and make informed decisions about how to proceed, which may include additional safety measures or modifications to the study protocol.

Prompt communication of adverse events also aligns with ethical research practices and regulatory requirements, demonstrating a commitment to participant safety and transparency. This action supports the overall integrity of the research by allowing the IRB to monitor the ongoing risk of harm to participants and to ensure that the study remains compliant with established ethical standards and legal obligations.

Those considerations underscore the importance of adhering to the IRB protocols in response to any adverse events, reinforcing the necessity for vigilance in the conduct of clinical research.