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

Overview:

This study gathered empirical data on the knowledge and expertise of biosafety and biosecurity personnel, and researchers overseeing research with enhanced Potential Pandemic Pathogens (ePPPs) and Dual Use Research of Concern (DURC) across various U.S. sectors. The data aims to improve public health measures and oversight for DURC and ePPP, offering insights for future policies. A relationship was found between the size of biosafety/biosecurity teams and the likelihood of conducting ePPP research, with larger teams being more likely to engage in such research.

Methods:

A survey of 541 biosafety and biosecurity professionals was conducted between March 8 and April 10, 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 institutions were found to be more likely to conduct DURC experiments compared to other Organizational Categories (i.e., Academic, Commercial, Consulting, Government, Other). Public institutions reviewed a higher number of experiments beyond the U.S. DURC Policy compared to Private for-Profit institutions. Institutions with larger biosafety/biosecurity teams were associated with increased research activities and more effective non-compliance reporting mechanisms (e.g., anonymous hotlines, anonymous reporting forms). Financial support and implementation challenges varied significantly across organizational categories.

Discussion:

The findings highlight the need for adequate staffing and resources for high-risk biosafety and biosecurity research activities. The survey results call for a tailored regulatory approach and equitable resource distribution for managing such research. Additionally, establishing effective non-compliance reporting mechanisms is essential for mitigating risks.

Methods
Data were collected through surveys administered to individuals affiliated with the American Biological Safety Association International (ABSA International) and those listed as Institutional Biosafety Committee contacts with the National Institutes of Health Office of Science Policy in 2024 in alignment with prior research of this profession (Fletcher et al., 2021; Gillum et al., 2013, 2014, 2016). 1096 individuals received the survey, and 541 respondents completed the survey in full or partial response, representing approximately 49.4% of the total recipients. Of these respondents, 21 were from countries outside of the United States and were eliminated from the study, as our grant was specific to only those located inside the United States. Participation in the survey was optional and voluntary. Because respondents were not required to complete every question, and respondents could skip or select “Prefer not to say” for certain questions, the total number of responses for each question varied.