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Reporting Safety Incidents Involving Potentially Hazardous Biologics

IMPORTANT!

For immediate response procedures refer to the Spill & Exposure Response Procedures for Etiologic Agents & Recombinant DNA.

Reporting Spills and Exposures Involving Potentially Hazardous Biologics (Including Near-Misses)

ALL spills and exposures, including near-misses, involving potentially hazardous biologics — even if the spill only involves exempt rDNA work — must be reported to the following:

  • Principal Investigator or Director of Lab (immediately)
  • Biosafety Officer (Janet Follo), 734-647-3133 (immediately)
  • Work Connections (within 24 hours)
  • IBC (may be reported through the Biosafety Officer)

Once notified, the IBC will coordinate preparation of any report(s) required to be submitted to the NIH Office of Biotechnology Activities (NIH OBA).

For after hours emergencies, contact the U-M Division of Public Safety & Security at 734-763-1131 or, from a campus phone, 911.

Reporting Adverse Events (AEs) on Human Gene Transfer Research Clinical Trials

This information is for Principal Investigators (and their study teams) who are conducting human gene transfer clinical trials at U-M:

There are special reporting requirements for adverse events that occur on human gene transfer clinical trials at U-M. These requirements differ from those described in the Standard IRBMED Adverse Event Reporting Timetable. Principal Investigators at U-M involved in this type of clinical trial must follow the U-M IBC Adverse Event Reporting Requirements for Human Gene Transfer Clinical Trialswhich explains the criteria, the timing, and the process for reporting human gene transfer AEs to the U-M IBC and, when required, to the NIH Office of Biotechnology Activities (NIH OBA).

Key points:

  • Adverse events meeting certain criteria on human gene transfer clinical trials at U-M must be reported to the U-M IBC.
  • Reporting adverse events to the U-M IBC occurs through the IRB AE/ORIO reporting function.
  • In some instances these adverse events must also be reported by the Principal Investigator to the NIH Office of Biotechnology Activities (NIH OBA) within specific timeframes.
  • These requirements are in addition to any reporting requirements imposed by the study sponsor or other regulatory bodies.
  • Your IRB application should indicate at Section 32-1 that you will be following a Study-Specific AE Reporting Plan (U-M IBC Adverse Event Reporting Requirements for Human Gene Transfer Clinical Trials).

Full information on NIH OBA reporting requirements is at Appendix M-I-C-4 of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid MoleculesQuestions about the U-M IBC Adverse Event Reporting Requirements for Human Gene Transfer Clinical Trials, or other matters regarding IBC oversight of human gene transfer clinical trials, can be directed to the IBC at 734-615-3960 or IBCstaff@umich.edu.

 

Questions?

See the Environment, Health & Safety (EHS) Contact website for additional contact information.  

For after hours emergency, contact the U-M Division of Public Safety & Security at (734) 763-1131 or from a campus phone, 911.