Reporting Safety Incidents Involving Potentially Hazardous Biologics

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 and process information can be found in the NIH OBA Incident Reporting Policy FAQs.

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 Trials, which 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.