Required Reporting During Conduct of Study

During the conduct of human subject research, investigators sometimes receive information that has a direct impact on the research study, and/or certain types of incidents/events/problems may occur that require prompt review by the IRB. The Reportable Problems or Events Policy provides detailed information about the types of incidents/events/problems that must be submitted to the Wright State IRB within 10 business days (see below for examples of events that require prompt reporting). The policy also defines incidents/events/problems that do not require immediate reporting to the Wright State IRB but must be reported at time of renewal/continuing review.  

Please consult the policy (page 3) to determine whether an incident/event that occurred during your study must be reported to the IRB and if needed, add, complete, and submit a form in Cayuse Human Ethics. If the study also requires changes based on the event reported, an modification can be submitted concurrently in Cayuse.

Examples of incidents, problems or events that must be promptly reported to IRB:

  • A subject event during the research that is serious (death or hospitalization), unexpected (not listed as risk in consent) and related or possibly related to the study
  • Subject death in a “greater than minimal risk” study even if expected if it occurs within 30 days of study-related research procedure
  • Major deviation from the approved IRB protocol, such as:
    • Failure to obtain written consent prior to a subject’s study participation
    • Recruiting subjects under the age of 18 when not previously approved by IRB
    • Subject received a dose of a study drug that is not consistent with the protocol
  • Breach of confidentiality for research involving protected health information (PHI), such as loss of a laptop containing identifiable study data
  • Incarceration of an active study subject for a study that is not approved to involve prisoners
  • Subject complaint that cannot be fully resolved by the study team
  • FDA or sponsor audit (does not include regular sponsor monitoring)

 

How do I submit an Incident or Reportable Event?

For a step-by-step guide for creating and submitting a reportable event submission in Cayuse, refer to the How to Submit Post-Approval Forms Guide (Coming Soon).