To ensure the protection of research participants, federal regulations and IRB policy require study teams to submit reportable events to the IRB for review. Reportable events include noncompliance, new information, and potential unanticipated problems. Depending on the nature of the event, reporting timelines can vary (see Investigator Manual linked below).

To submit a reportable event, click the “Reportable Event” button in the study workspace. See Presenting Noncompliance Reports to the IRB.

Resources

We recommend reviewing the following documents from the HRPP Toolkit Library:

• Investigator Manual (HRP-103)
  Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Wisconsin-Madison.
  
• New Information (HRP-024)
  Establishes the process to manage information reported to the IRB to ensure that the rights and welfare of human participants are protected. Specific to issues of: Noncompliance, unanticipated problems involving risks to subjects or others, suspensions of IRB approval, and termination of IRB approval.
  
• Review of Information Items (HRP-321, Worksheet)
  Used by the convened IRB when reviewing issues of: Serious noncompliance, continuing noncompliance, unanticipated problems involving risks to subjects or others, suspensions of IRB approval, and termination of IRB approval.
  
• Unanticipated Problems/Adverse Event Reporting Decision Guide
  Provides information on when unanticipated problems require reporting to the IRB.
  
• COVID Questions Answered
  Answers to COVID questions related to human subjects research.