To ensure the protection of research participants, the IRB requires investigators to report situations where participants experience unanticipated or anticipated problems during the course of the research promptly or at the time of continuing review.

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.