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

The correct response is to report the adverse drug experience in a timely manner using IRB protocols. This is essential because the Institutional Review Board (IRB) is responsible for ensuring the safety and welfare of research participants. When an adverse event occurs, it's vital to promptly inform the IRB so they can assess the implications for participant safety, consider necessary actions, and ensure that the study complies with ethical standards and regulatory requirements.

Timely reporting allows the IRB to evaluate the severity and frequency of the event, which can impact ongoing participant safety and the integrity of the study. This proactive approach demonstrates the investigator's commitment to ethical conduct and participant welfare. Moreover, timely communication can help in the potential modification of study protocols or inform participants about any new risks that could affect their involvement in the research.

This approach is critical in maintaining transparency and trust in the research process and ensures that any necessary changes to the study design or participant monitoring are executed without delay. Ignoring the event or waiting until the next scheduled report would compromise participant safety and violate ethical research standards. Additionally, conducting a new trial simply to assess the adverse effect does not address the immediate need for reporting and managing the incident appropriately.