Bridging biosafety and biosecurity gaps: DURC and ePPP policy insights from U.S. institutions

David R Gillum; An Tran; Jennifer Fletcher; Kathleen M Vogel

doi:10.3389/fbioe.2024.1476527

Bridging biosafety and biosecurity gaps: DURC and ePPP policy insights from U.S. institutions

Front Bioeng Biotechnol. 2024 Sep 25:12:1476527. doi: 10.3389/fbioe.2024.1476527. eCollection 2024.

Authors

David R Gillum^{1

2}, An Tran³, Jennifer Fletcher⁴, Kathleen M Vogel¹

Affiliations

¹ School for the Future of Innovation and Society, Arizona State University, Tempe, AZ, United States.
² Research and Innovation, University of Nevada, Reno, NV, United States.
³ Environmental Science and Health, University of Nevada, Reno, NV, United States.
⁴ Accountability, Assessment and Research, Chandler Unified School District, Chandler, AZ, United States.

Abstract

Overview: This study provides empirical data on the knowledge and practices of biosafety and biosecurity professionals and researchers involved in research on enhanced Potential Pandemic Pathogens (ePPPs) and Dual Use Research of Concern (DURC) within various U.S. sectors. The goal is to improve public health interventions and oversight for DURC and ePPP, contributing valuable insights for policy development. A notable finding was the association between larger biosafety/biosecurity teams and a higher likelihood of conducting high-risk biological research.

Methods: A survey of 541 biosafety and biosecurity professionals was conducted between March 8 and 10 April 2024, with results analyzed using SAS at a significance level of 0.05. The study received approval from the Institutional Review Boards (IRBs) at Arizona State University and the University of Nevada, Reno.

Results: Government organizations were more likely to conduct DURC compared to other sectors (e.g., Academic, Commercial, Consulting). Public institutions reviewed more experiments outside the scope of the U.S. DURC Policy than private for-profit institutions. Institutions with larger biosafety/biosecurity teams reported greater research activity and more effective non-compliance reporting mechanisms (e.g., anonymous hotlines, reporting forms). Additionally, financial support and the challenges of policy implementation varied significantly across sectors.

Discussion: The findings emphasize the need for appropriate staffing and resource allocation for high-risk biosafety and biosecurity research. A differentiated regulatory approach and equitable distribution of resources are essential for effective oversight. Moreover, robust non-compliance reporting systems are critical to mitigating the risks associated with DURC and ePPP research.

Keywords: biosafety; biosafety survey; biosecurity; dual use research of concern (DURC); enhanced potential pandemic pathogens (ePPP); non-compliance reporting; organizational safety; risk management.

Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This research was partially funded by the National Institutes of Health’s (NIH) National Institute of General Medical Sciences (NIGMS) award #1R01GM155913-01.