Reporting Unexpected Incidents to the IBC
When unexpected events occur during the conduct of a clinical trial, research personnel may wonder if the event is reportable, and if so, to whom. This blog is intended to provide guidance and clarity on reporting such unexpected events.
Who Should I Report Unexpected Events to?
Studies involving engineered genetic materials (such as genetic vaccines, gene-modified cellular therapies, and gene therapies) require institutional review board (IRB) and institutional biosafety committee (IBC) review:
- IRB assesses the safety and welfare of the research subjects
- IBC 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
This distinction between the roles of the two committees helps explain what incidents are reportable to which committee.
Which Incidents Should I Report?
In her blog, Reporting to the IRB: What NOT to Report, Advarra’s VP of IRB Operations, Laurie Carlisle, stated:
“A key aspect of whether an event should be reported [to the IRB] is determining if it pertains directly to the safety of the participants involved in the study. Ask yourself:
- Is the event unexpected (in terms of nature, severity, or frequency) given the information provided in research-related documents and the characteristics of the participant population being studied?
- Is the event related or possibly related to participation in the research?
- Does the event suggest that the research places participants or others at a greater risk of harm than was previously known or recognized, typically requiring updates to the protocol and/or informed consent form (ICF)?”
When conducting a trial involving engineered genetic materials, incidents involving occupational safety and environmental protection are also reportable to the IBC. Such incidents include:
- Occupational exposures involving the investigational product, such as needle sticks or splashes to the eyes, nose, or mouth
- Spills of the investigational product outside of a biosafety cabinet
- Environmental releases outside of the research facility
If such an incident occurs, immediately notify the site’s principal investigator (PI) and report it to the IBC.
The incident report should include a description of the incident, how it is being addressed (e.g., spill cleanup, post-exposure medical care, etc.), and what corrective actions are being taken to avoid a recurrence (e.g., review of standard operating procedures [SOPs] and retraining, employing a new type of safety procedure or safety sharp device, etc.).
What Does the IBC do with an Unexpected Event Report?
Once the IBC receives an incident report, they may contact the site for additional information to understand more about the incident. This process is intended to ensure the safety of the research staff, community, and environment around the site and is not punitive in any way. Rather, IBCs seek to collaborate with researchers to identify gaps, develop corrective actions, and protect everyone involved.
The IBC will review the incident in a convened committee meeting to determine if any additional actions are required. Incidents involving overt exposures, spills, or environmental releases of engineered genetic material may also require reporting to the National Institutes of Health (NIH) Office of Science Policy.
The IBC will determine whether the incident merits reporting to the NIH and will copy the site’s PI on the report. The NIH reviews the reports and determines if additional safety measures or corrective actions are required. The Food and Drug Administration (FDA) does not receive any notifications from the IBC.