Reportable Events

Definitions

• Reportable events include events that must be reported to UMMC IRB in addition to other agencies or oversight affiliates.
• Reportable events may include unanticipated problems involving risk to participant or others.

Policies/guidelines

• Investigators are required to report all unanticipated problems involving risk to participants or others (including serious protocol deviations) to the Institutional Review Board within 10 business days of discovery.
  • Only exception: Death of a study participant at UMMC. The study-related death of a UMMC research participant must be reported within 48 hours of notice.
  • Adverse events in clinical trials must be reported to the sponsor in compliance with FDA regulations and sponsor requirements.
• In addition to reporting to the IRB, as applicable, federal regulations require prompt reporting to regulatory authorities  (e.g. FDA) of 
  • Any unanticipated problems involving risk to participants or others;
  • Any serious or continuting non-complicance with the applicable federal regulations or the requirements or determinations or the IRB; and
  • Any suspensions or termination of IRB approval.

• Events that do not meet the definition of an unanticipated problem involving risk to participants or others, including research related injury occurring at a UMMC performance site or to a UMMC study participant, participant complaints, continuing problems, minor protocol deviations and non-compliance with the IRB’s requirements for protecting human research participants should be reported as follows:
  • Minor deviations and problems should be submitted at the time of continuing review, as instructed on the form.
  • All other events should be reported in writing via letter or e-mail to the IRB with sufficient detail to allow the reviewer to understand the problem and any actions taken to prevent it from happening again.

• An adverse event is considered an unanticipated problem that should be reported if it is:
  • Serious
  • Unexpected
  • Related or possibly related to participation in the research; and/or
  • Suggests that the research places participants or others at greater risk of harm than previously expected.

Templates/forms

• To submit an unanticipated problem to the UMMC IRB, use the Unanticipated Problem form in the IRB electronic system.
• To submit an adverse events to a sponsor or regulatory agency (such as FDA), follow its specific reporting procedure.

Training

• See the Unanticipated Problems Reporting Policy
• See Section 16 Unanticipated Problems Involving Risks to Participants or Others in the University of Mississippi Medical Center Standard Operating Procedures Human Research Protection Program (HRPP), October 2, 2023 - PDF (Intranet)