Reportable New Information

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

Use the following resources to submit reportable new information:

• Reportable New Information: Quick Guide
  High-level, step-by-step guide on how to submit a reportable event for a study.

• Submit Monitoring Reports
  Form for submitting written reports of study monitors to the Quality Assurance program of the HRPP. Monitoring reports no longer require mandatory submission to the IRB. However, investigators are required to submit promptly reportable events to the IRB within five business days of discovery of the event. Occasionally, such events are identified during clinical monitoring and, as such, must be reported to the IRB accordingly.

• How to Withdraw or Discard a Submission: Quick Guide
  High-level, step-by-step guide on how to withdraw or discard a submission.

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

• Investigator Manual
  Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Minnesota.

• 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 - download)
  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.