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 human gene transfer clinical trials are outline on the U-M IBC Adverse Event Reporting Requirements for Human Gene Transfer Clinical Trials. Reporting adverse events to the IBC occurs through the IRB AE/ORIO reporting function. If the IBC served as an ancillary committee for the original review, then the IBC is alerted automatically to the submission of an AE/ORIO. IBC reviewers are looking at AEs for unexpected potential relatedness to the study agent.