Reportable Events

Report any of the events below through the Click Research Compliance System as a "Report New Information" (RNI) submission. For any urgent events, please contact the MSU HRPP by phone (517-355-2180).

Select the item below for more information, including a timeline for reporting.

• Any Activities or Circumstances that Affect the Rights and/or Welfare of Research Subjects
  • Report promptly
  • For more information, see HRPP Manual 4-6, Responsibilities of Investigators
• Change Made to Eliminate Immediate Hazard to Subjects
  • Report immediately to the IRB thereafter
  • For more information, see HRPP Manual 9-5, Unapproved Changes in Protocol and 8-6, Revisions to an Approved Study
• Emergency Use of Investigational Drugs or Devices
  • Report prior to emergency use and within 5 working days of emergency use, even if investigator notified the IRB prior to use
  • For more information, see HRPP Manual 7-3, Emergency Use of Investigational Drugs and Devices
• New Potential Conflict of Interest
  • Report promptly
  • For more information, see HRPP Manual 10-1, Conflict of Interest
• Protocol Deviations/Violations
  • Report promptly to the MSU IRB
  • For more information, see HRPP Manual 9-8, Protocol Deviations or Violations
• Subject Complaints
  • Report promptly
  • For more information, see HRPP Manual 9-4, Subject Complaints
• Suspected or Confirmed Noncompliance
  • Report immediately
  • For more information, see HRPP Manual 9-2, Noncompliance
• Unanticipated Problems Involving Risks to Subjects or Others
  • Report within 24 hours of knowledge of the event, or earlier if the unanticipated problem resulted in subject death, was potentially life threatening, or risked serious harm to the subject.
  • Report within 72 hours for all other potentially unanticipated problems involving risks to subjects or others.
  • For more information, see HRPP Manual 9-1, Unanticipated Problems Involving Risks to Subjects or Others