By Daniel Eisenman, Executive Director, Biosafety Services and Scott Swindle, Assistant Director, Biosafety Services
During a clinical trial, when unforeseen events arise, research personnel may question whether these events are reportable and, if they are, to whom they should be reported. According to Advarra’s VP of IRB Operations, Laurie Carlisle, deciding whether an event should be reported hinges on its direct relevance to the safety of the study participants.
From there, researchers will have to determine if their event should be reported to the institutional review board (IRB)—which assesses the safety and welfare of the research subjects—and/or the institutional biosafety committee (IBC), which assesses the risks associated with engineered genetic materials, ensuring they are properly mitigated for the research staff, the community, and the environment around the research site.
To better understand the differences and when an unexpected incident should be reported to the IBC, utilize this comprehensive guide for reference and clarity.