Reporting To The IRB: What Does And Does Not Need To Be Reported

An institutional review board’s (IRB’s) role in clinical research is to protect the rights and welfare of human subjects enrolled in a study. They have the responsibility of approving, requiring modifications to, or disapproving research as necessary. The IRB often obtains reports from sponsors and/or research teams that provide information on how the study is progressing following initial review. However, it may be challenging for researchers to understand exactly what to report to the IRB when they are managing multiple reporting requirements for different entities. 

Ultimately, the IRB is in place to protect the rights and welfare of human subjects enrolled in research. It is important for investigators, sponsors, and CROs to remember this mission and act accordingly. Understanding your reporting responsibilities helps those you are reporting to perform their duties, keeping the participants safe. As investigators and sponsors, you are uniquely positioned to assess events that occur in a study and determine if it’s necessary to report.