Reportable Events

Over the course of conducting a study, investigators may encounter situations or events that need to be reported to the IRB.

Examples of events that require IRB reporting include (not limited to):

  • New Information indicating a change to the risks or potential benefits of the research
  • Deviation from approved protocol
  • Subject complaint
  • Incarceration of a subject
  • Adverse event
  • Unanticipated problem involving risks to subjects or others

For more information regarding reporting events to the IRB, please refer to the following: