When an unexpected adverse drug experience occurs, what is the investigator's responsibility to the IRB?

The investigator's responsibility to the Institutional Review Board (IRB) when an unexpected adverse drug experience occurs includes the requirement to report this experience in a timely manner. Timely reporting is essential because it enables the IRB to assess the potential impact of the adverse event on the ongoing research and participant safety. The IRB plays a critical role in overseeing the ethical conduct of research and ensuring that participants' wellbeing is a priority. Notifying the IRB promptly allows for appropriate measures to be taken, such as revising the study protocol, informing participants about potential risks, or even suspending the study if necessary.

In contrast, waiting for the study to conclude before reporting is inappropriate as it could expose participants to unnecessary risks without the IRB's oversight. Conducting a follow-up study to ascertain reasons for the adverse experience may be important but should not delay the immediate reporting to the IRB. Lastly, while documentation and confidentiality are important components of good research practices, they do not replace the need for timely communication with the IRB about adverse events.