P325: Institutional Biosafety Committee Oversight of Clinical Trial Research: Data and Best Practices from a Central IBC Provider
Poster Presenter
Sarah Roberge
IBC Chair, IBC Services
WCG Clinical United States
Objectives
Nearly 80% of institutional biosafety committees (IBCs) in the US are administered by central providers. However, lack of accepted standards leads to variable practices across IBCs. We sought to identify best practices for the review of clinical trials by centrally-administered IBCs.
Method
We used an artificial intelligence tool to analyze data from all reviews conducted by our IBCs in 2024 and surveyed more than 500 voting members serving on these IBCs. For each IBC review, we characterized the product being tested and classified IBC discussions into 11 distinct categories.
Results
In 2024, our IBCs conducted more than 800 meetings to review clinical trial research conducted by 475 unique investigators across 265 institutions. Reflective of general trends in clinical research with investigational products subject to IBC oversight, we found that our IBCs predominantly reviewed trials involving genetically engineered viruses or viral vectors (45%), engineered cell therapies (32%), and nucleic acid-based products (23%). Committee discussions during IBC reviews were diverse, focusing primarily on biohazardous waste handling (18%); spill and exposure prevention/response (15%); biohazard signage (15%); and containment (12%).
To gain further insight into the rigor and processes by which our IBCs operate, we conducted a survey of 525 independent consultants serving on our IBCs that focused on their experiences participating in IBC reviews. Respondents highlighted the importance of implementing SOPs tailored to the institution and the research being reviewed; involving institutional staff in IBC reviews; and requiring community IBC member attendance in review meetings. Further, 91% of survey respondents indicated that institutional participation in review meetings is beneficial to the IBC review process. Respondents also emphasized the utility of community member participation in IBC review meetings to provide input on relevant local and state regulations that may differ from one institution to another. Lastly, 93% of survey respondents rated the quality of biosafety-specific discussions during IBC review meetings as above average or excellent, reflective of their overall satisfaction with the rigor of reviews conducted by these centrally-administered IBCs.
Conclusion
Nearly 80% of IBCs registered with the National Institutes of Health (NIH) exist solely to review clinical trial research subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Despite this, current biosafety regulations and guidance documents primarily focus on bench research conducted in laboratories, not clinical trials, and are predominantly unbinding in nature. This can present problems for clinical investigators and their staff and underscores the importance of rigorous IBC review of such research.
Our organization administers IBCs for institutions conducting clinical trials subject to IBC oversight requirements outlined in the NIH Guidelines. We sought to gain insight into the conduct and rigor of these IBCs by examining meeting minutes from more than 800 reviews conducted in 2024. We found that IBC discussions were primarily focused on biohazardous waste handling, spill and exposure prevention/response, biohazard signage, and containment. Data from IBC member surveys indicate satisfaction with how these IBC reviews were conducted, with members specifically noting the utility of including institutional study staff and community IBC members in review meetings to inform IBC discussions.
Based on this experience, we recommend the following best practices:
• IBC reviews should be tailored to the research in question and focus on substantive biosafety concerns;
• Institutional staff should be present during IBC deliberations to answer site-specific questions posed by the IBC;
• In addition to their inclusion on the IBC roster, community members should be present during IBC deliberations to advise on local regulations.
Such an approach will be critical to ensure confidence in federal biosafety oversight systems and the clinical research enterprise more broadly. This will be particularly important as new advanced genetic therapies move from the laboratory to the clinic.
