Assessing the Importance of Institutional Biosafety Committee Oversight of Clinical Research

Since 1976, Institutional Biosafety Committees (IBCs) have worked to safeguard researchers, their communities, and the environment from risks posed by research with infectious agents and other biohazardous materials. Initially conceived in response to the advent of recombinant DNA technology, the role of IBCs has evolved as science has advanced. In 1990, IBCs began overseeing clinical research involving human gene transfer (HGT), which is defined by the National Institutes of Health (NIH) as the deliberate transfer of recombinant or synthetic nucleic acids into human research participants.

Since the first HGT clinical trial began more than 30 years ago, the field has grown significantly. Since 2016, the number of new HGT trials initiated in the United States has increased every year, and there were over 800 active HGT trials in the United States as of 2024. ¹ This growth has led to a concurrent increase in the number of IBCs registered with the NIH. Since 2019, the number of NIH-registered IBCs has grown from approximately 1,400 to over 4,000.^2,3 Today, nearly 80% of these IBCs are administered by external providers to specifically oversee clinical trial research involving HGT. ³ The types of investigational agents reviewed by IBCs overseeing HGT research vary widely, from lower-risk products, like nonreplicating DNA- and mRNA-based vaccines for infectious diseases, to higher-risk products, like genome editors and replicating oncolytic viruses.

In September 2025, the NIH announced a Biosafety Modernization Initiative, aimed at modernizing and strengthening biosafety oversight in the United States and ensuring gold-standard science is conducted under gold-standard biosafety conditions. ⁴ As part of the initiative, the NIH has sought input from the biosafety community on several proposals to expand, modify, or eliminate certain IBC oversight requirements. One proposal under consideration is to reduce oversight of clinical research conducted under the purview of the Food and Drug Administration (FDA). ⁵

As an external IBC provider, our organization administers IBCs for hospitals and clinics conducting clinical trial research involving HGT in the United States. We provide a chair for each IBC we administer and work with a diverse network of independent consultants to fill the remaining roles on each IBC. In 2025, our IBCs reviewed 255 unique clinical trials at 279 institutions. These reviews collectively covered nearly every type of HGT research, including trials testing investigational vaccines, gene and cell therapies, xenotransplants, and in vivo-acting genome editors.

We sought to inform discussions surrounding the NIH proposal to reduce oversight of clinical research by conducting a survey of voting members serving on the IBCs we administer. The survey was conducted over a 3-week period in November and December 2025 using a commercial web-based platform (SurveyMonkey) and prompts delivered via email. All respondents remained anonymous, all questions were optional, and responses are reported exactly as they were received herein. Our data show that an overwhelming 98% of survey respondents (183/186) indicated that IBC oversight enhances their confidence that clinical research is conducted safely at the institutions for which they are an IBC member (Figure 1A). Furthermore, only 3% of respondents (6/190) were supportive of the proposal to eliminate IBC oversight of clinical trial research conducted under the purview of the FDA (Figure 1B).

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Figure 1.

Opinions of IBC members on IBC oversight of clinical research. Voting IBC members were surveyed for their opinions on whether IBC oversight enhances their confidence that research is being conducted safely at the institutions for which they are IBC members (A), and whether they would support elimination of IBC oversight for research conducted under the purview of the FDA (B). Members were also asked to rate the importance of guidance provided by IBCs to clinical staff regarding investigational product handling procedures (C), training and education (D), and prevention of needlesticks and other exposures (E). The survey was conducted November 17–December 12, 2025. Responses to any question were provided by 225 of 562 members surveyed (40%); responses for individual questions were as follows: 186 (A); 190 (B and C); 191 (D and E). Percentages above each bar were calculated based on the number of responses provided to the indicated question.

We also asked IBC members to assess their perceptions of the importance of guidance provided by IBCs to clinical research staff related to several key areas: product handling, training and education, and the prevention of needlesticks and other exposures. Respondents emphasized the value of the guidance IBCs provide to clinical staff, with 97% rating the guidance for safe product handling procedures as important or very important, 95% for training and education, and 93% for the prevention of needlesticks and other exposures (Figure 1C–E).

It is important to note that these findings align with published literature emphasizing the importance of strong biosafety programs for staff training, education, and the prevention of needlestick injuries. For example, extensive research has shown that a well-trained and safety-conscious staff is key to preventing research-related infections and accidents, underscoring the need for initial and ongoing biosafety training for clinical researchers.^6,7 In addition, the Centers for Disease Control and Prevention (CDC) estimates that approximately 385,000 sharps-related injuries occur annually among healthcare workers in the United States, highlighting the critical need for rigorous programs and guidance to prevent needlesticks in clinical settings. ⁸

Our survey findings also align with an analysis of meeting minutes from more than 700 reviews conducted in 2024 by IBCs that our organization administers. In that analysis, biohazardous waste handling and disposal at clinical sites conducting HGT research was the most often-discussed topic. ⁹ While those data may not be representative of a more heterogenous group of IBCs, when combined with IBC member survey responses, they underscore the importance of IBC oversight for minimizing exposure risks and preventing the unintended release of biohazards into the environment or patient-facing clinical areas.

All survey responses were provided anonymously, questions were optional, and the survey was conducted over a short period, with only 40% of voting IBC members providing feedback, all of which are limitations of our analysis. We also acknowledge that all survey respondents serve on IBCs administered by our organization, which are primarily established for small clinics and community hospitals, and follow similar procedures. This could impact the generalizability of our findings to individuals serving on locally-administered IBCs, and those established for larger academic medical centers. However, when examining demographic information provided with the survey, we found that respondents included at least 52 individuals with leadership or equivalent roles in biosafety, environmental health and safety, or infection control. Similarly, at least 26 respondents hold ABSA biosafety professional credentials (RBP, CBSP, or both). We believe our survey data therefore provide an accurate snapshot of the clinical biosafety community that can help inform public policy moving forward.

In addition to changes pertaining to IBC oversight of clinical research, the NIH’s ongoing Biosafety Modernization Initiative proposes to modify IBC oversight requirements for certain types of basic research based on risk. We agree that some low-risk research may benefit from streamlined or reduced IBC oversight. However, any exemptions must be considered carefully, particularly in the context of clinical research. Relying solely on the Risk Group (RG) of a product, for example, would be insufficient. Instead, the vector type, transgenes, and mechanism of action must be evaluated independently for each product; low-risk vector types should not be exempted if they carry high-risk transgenes. As an example, lipid nanoparticles do not meet criteria for inclusion in any RG but are often used to deliver high-risk transgenes, such as those encoding targeted endonucleases and guide RNAs designed to permanently modify cellular genomes. ¹⁰ The same is true for products based on adeno-associated virus, a RG1 agent commonly used in gene therapy and gene editing trials.

Oversight of clinical research by the FDA is an integral and necessary part of the regulatory process. However, the FDA’s focus is centered on protecting research participants and ensuring regulatory compliance, not biosafety at individual trial sites. In contrast, IBCs provide site-specific oversight focused on the adequacy of facilities, maintenance of engineering controls and other safety equipment, spill and exposure response plans, and staff training for safe work practices. In this regard, IBCs are uniquely positioned to conduct risk assessments and make determinations that holistically take the product, facility, and clinical staff into account. Elimination or reduction of IBC oversight for clinical trial research would therefore leave a significant biosafety gap, in which existing differences between laboratory biosafety training and that provided to clinical researchers are exacerbated, and could lead to an increase in exposures and other biosafety incidents.^11,12

Such a biosafety gap would be especially evident at smaller institutions that are not affiliated with academic medical centers, which make up approximately 75% of the IBCs registered with the NIH. ³ These institutions often lack biosafety infrastructure beyond that required to conduct HGT trials, as evidenced by the fact that less than 2% (59/3165) of externally administered IBCs are accompanied by a local IBC that is separately administered by the corresponding institution. ³ If IBC oversight requirements for clinical research were eliminated, larger institutions with self-administered IBCs could continue to review HGT research through institutional policy. However, institutions that lack a self-administered IBC may opt to eliminate their externally administered IBCs to conserve resources and be left without an entity to evaluate biosafety altogether.

Lastly, it is worth noting that reducing or eliminating IBC oversight of clinical research may impact biomedical research more broadly at a time when public trust in science has already been declining. ¹³ In this regard, eliminating IBC oversight of clinical trial research would be a step backward, with the potential to further undermine public confidence in biosafety and clinical research at large as emerging technologies continue to advance from bench to bedside.

Ethical Approval and Informed Consent Statement

This article does not contain any studies with human or animal participants.

Authors’ Disclosure Statement

All authors are employees of WCG Clinical, Inc.