You are here

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).  NIH OBA reporting requirements can be found in Appendix M-I-C-4 of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules

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:

The reporting requirements for adverse events that occur on U-M human gene transfer clinical trials 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).  See the AE process information on the IBC Human Gene Transfer Clinical Trials web page for more information.

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.