Assessing the Importance of Institutional Biosafety Committee Oversight of Clinical Research

Abstract

Institutional Biosafety Committees (IBCs) play a critical role in overseeing biosafety risks associated with clinical research involving human gene transfer, a field that has expanded rapidly in scale and complexity. As part of the National Institutes of Health (NIH) Biosafety Modernization Initiative, proposals have been advanced to modify biosafety oversight frameworks in the United States, including the potential reduction or elimination of IBC review for clinical research conducted under the purview of the Food and Drug Administration (FDA). To inform these discussions, we conducted an anonymous survey of voting members serving on IBCs administered by our organization in 2025 to assess perceptions of the value and importance of IBC oversight. Survey responses demonstrated strong support for maintaining IBC review of clinical research, with nearly all respondents indicating that IBC oversight increases confidence in the safe conduct of studies at participating institutions. Only a small minority supported eliminating IBC oversight for FDA-regulated clinical trials. Respondents also emphasized the importance of IBC-provided guidance for safe investigational product handling, staff training and education, and prevention of needlesticks and other exposure incidents. These findings highlight the unique, site-specific role of IBCs in addressing biosafety considerations that are not fully encompassed by FDA regulatory oversight. Reducing or eliminating IBC oversight of clinical research could create significant biosafety gaps, particularly at smaller or non-academic institutions, and may undermine confidence in biosafety practices as emerging biomedical technologies continue to advance.