Reportable Events

Effective date: 8/1/2017

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Brief Overview

The Principal Investigator (PI) is responsible for informing the IRB of any reportable events or problems that may increase the subject’s anticipated risk or decrease the anticipated benefit by participating in the research. These events include local and external events or other problems that are unexpected and at least probably related to the research interventions, procedures, or assessments.

NOTE: PIs of protocols reviewed and approved through a non-UT System IRB must report local events to the IRB on which they are reliant.

IRB Tracking Logs and Forms

  • Events (Adverse and Non-Adverse) and Unanticipated Problems (UPIRSOs) Tracking Log
  • Unanticipated Problems (UPIRSOs) Form
  • Protocol Deviations and Violations Tracking Log
  • Protocol Deviation/Violation Form
  • How to Use the IRB Tracking Logs and Forms with Examples

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References and Additional Guidance

Food and Drug Administration (FDA)

Adverse Event Reporting to IRBs – Improving Human Subject Protection

NIH Office of Biotechnology Activities (OBA)

Reporting of Incidents Related to Research Subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acids to the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA)

Office of Human Research Protections (OHRP)

Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events

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Updated: 8/1/2017