34 - Institutional Biosafety Committee Oversight of Clinical Trial Research: Data and Best Practices from a Central IBC Provider

Background: Nearly 80% of institutional biosafety committees (IBCs) in the United States are administered by central providers to review human subject research. However, lack of accepted standards leads to variable practices across IBCs. Here, we sought to develop best practices for the review of clinical trials by centrally-administered IBCs.

Program

Description: As a central IBC provider, WCG administers IBCs on behalf of institutions conducting clinical trial research subject to the NIH Guidelines in the United States. Using example-based prompts and pre-defined categories, we trained Microsoft Copilot to categorize meeting discussion points from all study reviews conducted in 2024. For each review, we characterized the product being tested and classified over 4,000 unique IBC discussions from these reviews into 11 distinct categories to assess rigor and scope of the reviews. We also surveyed more than 500 biosafety and clinical consultants serving on these IBCs for an independent perspective to inform best practices.

Program

Assessment: In 2024, our IBCs conducted more than 800 reviews of clinical research conducted by 475 unique investigators across 265 institutions. 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%).

Survey 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, survey respondents identified institutional participation in review meetings as beneficial to the IBC review process (91%), and rated the quality of biosafety-specific discussions during IBC review meetings as above average or excellent (93%). Taken together, our data highlight the rigor of reviews conducted by these IBCs and inform the development of best practices by which centrally-administered IBCs may operate.

Limitations: Our analysis is limited by several factors. First, meeting discussions may have been misclassified by the AI tool we developed, even with implementation of a manual quality assurance accuracy check using subsets of data. Second, the IBC member survey was anonymous, with a response rate of 66%, which may introduce sampling bias. Lastly, compared to the commonly tested products noted above, our IBCs reviewed fewer studies involving novel emerging genetic engineering technologies, potentially limiting the conclusions that can be drawn from our analysis.

Discussion: Based on our data and experience, we recommend the following as best practices for centrally-administered IBCs reviewing clinical trial research:

• IBC discussions 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, community members should be present during IBC deliberations to advise on local norms and regulations.

Such an approach will be critical to ensure ongoing confidence in federal biosafety oversight systems and the clinical research enterprise more broadly.