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First published online January 21, 2026
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Distribution of Biosafety Violations in Laboratories: Implications for Measuring Biosafety Culture

Kelly Kim, Henry Wyneken, […], Christian H. Garnier, Noah Gunther, Karl Nubbe, Adam E.J. Fleming, Sa-Lin Bernstein, Jay Schroeder, John Crocker, IV, Diann R. Stedman, Scott J. Patlovich, and Rocco Casagrande [email protected]+9View all authors and affiliations
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https://doi.org/10.1177/15356760251412440

Abstract

Introduction:

Effectively managing biological risk in a research setting requires a strong organizational commitment to promoting safe practices and adhering to established protocols, a concept known as a “culture of biosafety.” Although a sound culture of biosafety is critical for responsible conduct of research, its assessment remains challenging, relying on self-reporting and qualitative and subjective evaluations.

Methods:

To determine if a laboratory’s culture of biosafety could be evaluated objectively, we examined historical biosafety violation data at three U.S. universities, including biosafety cabinet recertification violations at one university and a range of violations at two other universities. These data were analyzed to determine the distribution of violations among investigators.

Results:

At all three institutions, we found that a majority of investigators operate laboratories with low rates of biosafety violations and few repeat violations; however, a minority of investigators operate laboratories that are repeatedly in violation of established biosafety guidelines and standards. Repeat violations were unequally distributed amongst laboratories, with only 20% of laboratories accounting for 70–90% of total repeat violations.

Discussion:

We found that a vast majority of investigators operate laboratories with commendable cultures of biosafety that manifest as low rates of violations and repeat violations.

Conclusion:

This research establishes metrics for evaluating a laboratory’s culture of biosafety with an objective evidence basis and transparent approach, laying the foundation for future research to understand the drivers of biosafety culture, create interventions to improve biosafety culture, and creating a near-term mechanism to promote biosafety culture at institutions via data-driven retention and recruitment strategies.

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