Reportable New Information

The following types of events require reporting to the IRB.

  • Change made to eliminate an immediate hazard to subjects
  • Emergency use of investigational drug or device
  • New potential conflict of interest
  • Protocol deviations and/or violations
  • Subject complaints
  • Suspected or confirmed noncompliance
  • Unanticipated problems that involve risks to subjects or others
  • Any activities or circumstances that affect the rights and/or welfare of research subjects
  • Enrollment of a prisoner in a research study that is not approved to enroll prisoners

Visit the Reportable Event page for more information, including timelines.

Reports of Reportable New Information are made through the ClickTM Research Compliance System. However, for urgent situations, please contact the IRB office by phone: 517-355-2180.

How to Submit

  1. In Click, select "Report New Information."
  2. Complete the required fields.
  3. Complete and upload templates as appropriate.
    1. HRP-531- Template - Unanticipated Problem Involving Risk to Subjects or Others
      1. Complete when reporting a potential unanticipated problem that may involve risks to subjects or others.
      2. Upload HRP-531 (RNI SmartForm page).
    2. HRP-532 - Template - Protocol Deviation or Violation
      1. Complete when reporting a protocol deviation / violation.
      2. Upload HRP-532 (RNI SmartForm page).
    3. HRP-533 - Template - Subject Complaint
      1. Complete when reporting a subject complaint.
      2. Upload HRP-533 (RNI SmartForm page).
    4. HRP-534 - Template - Emergency Use of Investigational Drugs or Devices
      1. Complete when providing notification of emergency use.
      2. Upload HRP-534 (RNI SmartForm page).
  4. Submit the RNI.

Click Templates

  • As Appropriate:
    • HRP-531- Template - Unanticipated Problem Involving Risk to Subjects or Others (use when reporting a potential unanticipated problem that may involve risks to subjects or others)
    • HRP-532 - Template - Protocol Deviation or Violation (use when reporting a protocol deviation / violation)
    • HRP-533 - Template - Subject Complaint (use to report a subject complaint)
    • HRP-534 - Template - Emergency Use of Investigational Drugs or Devices (use for notification of emergency use)

Available at the Click Templates page.

Click Quick Guides

  • How to Report New Information

Available at the Click Quick Guides & Videos page.

More Information

For more information, visit the following HRPP Manual sections:

How to Submit