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 related to a study in ARROW, click the “Reportable Event” button in the study workspace. See Presenting Noncompliance Reports to the IRB.

Occasionally, a reportable event unrelated to a study in ARROW needs to be submitted. This typically occurs when research activities have taken place without IRB approval or when a study has been closed/archived, and there is no ARROW application under which to submit a reportable event. In these cases, studies teams should complete HRP-214 – FORM – Reportable New Information and email it to IRBDirector@hsirb.wisc.edu.

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.