Bridging Biosafety and Biosecurity Gaps: DURC and EPPP Policy Insights from U.S. Institutions

Overview

Journal Front Bioeng Biotechnol

Date 2024 Oct 14

PMID 39398640

Authors

David R Gillum

An Tran

Jennifer Fletcher

Kathleen M Vogel

Affiliations

Soon will be listed here.

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.

References

Lipsitch M, Bloom B . Rethinking biosafety in research on potential pandemic pathogens. mBio. 2012; 3(5). PMC: 3484391. DOI: 10.1128/mBio.00360-12. View

Selgelid M . Governance of dual-use research: an ethical dilemma. Bull World Health Organ. 2009; 87(9):720-3. PMC: 2739909. DOI: 10.2471/blt.08.051383. View

Klotz L, Sylvester E . The consequences of a lab escape of a potential pandemic pathogen. Front Public Health. 2014; 2:116. PMC: 4128296. DOI: 10.3389/fpubh.2014.00116. View

Epstein G . Controlling biological warfare threats: resolving potential tensions among the research community, industry, and the national security community. Crit Rev Microbiol. 2002; 27(4):321-54. View

Lowen A, Casadevall A, Alwine J, Enquist L, Goodrum F, Imperiale M . Oversight of Pathogen Research Must Be Carefully Calibrated and Clearly Defined. J Virol. 2023; 97(3):e0017623. PMC: 10062122. DOI: 10.1128/jvi.00176-23. View

Nixdorff K, Bender W . Ethics of university research, biotechnology and potential military spin-off. Minerva. 2004; 40(1):15-35. DOI: 10.1023/a:1015045127363. View

Casadevall A, Imperiale M . Risks and benefits of gain-of-function experiments with pathogens of pandemic potential, such as influenza virus: a call for a science-based discussion. mBio. 2014; 5(4):e01730-14. PMC: 4128368. DOI: 10.1128/mBio.01730-14. View

Merler S, Ajelli M, Fumanelli L, Vespignani A . Containing the accidental laboratory escape of potential pandemic influenza viruses. BMC Med. 2013; 11:252. PMC: 4220800. DOI: 10.1186/1741-7015-11-252. View

Trump B, Cummings C, Klasa K, Galaitsi S, Linkov I . Governing biotechnology to provide safety and security and address ethical, legal, and social implications. Front Genet. 2023; 13:1052371. PMC: 9873990. DOI: 10.3389/fgene.2022.1052371. View

10.

Imperiale M, Casadevall A . A New Approach to Evaluating the Risk-Benefit Equation for Dual-Use and Gain-of-Function Research of Concern. Front Bioeng Biotechnol. 2018; 6:21. PMC: 5853790. DOI: 10.3389/fbioe.2018.00021. View

11.

Kanabrocki J . Interactions between biocontainment laboratories and their communities: a successful work in progress. Trends Microbiol. 2011; 19(5):209-10. DOI: 10.1016/j.tim.2011.01.008. View

12.

Fletcher J, Gillum D, Moritz R, Schwartz A . Demographic and Salary Trends of the 2020 Biosafety Workforce. Appl Biosaf. 2022; 26(3):164-174. PMC: 9134334. DOI: 10.1089/apb.20.0066. View

13.

Sandbrink J, Alley E, Watson M, Koblentz G, Esvelt K . Insidious Insights: Implications of viral vector engineering for pathogen enhancement. Gene Ther. 2022; 30(5):407-410. PMC: 10191845. DOI: 10.1038/s41434-021-00312-3. View

14.

Inglesby T, Lipsitch M . Proposed Changes to U.S. Policy on Potential Pandemic Pathogen Oversight and Implementation. mSphere. 2020; 5(1). PMC: 6977183. DOI: 10.1128/mSphere.00990-19. View

15.

Evans N, Lipsitch M, Levinson M . The ethics of biosafety considerations in gain-of-function research resulting in the creation of potential pandemic pathogens. J Med Ethics. 2015; 41(11):901-8. PMC: 4623968. DOI: 10.1136/medethics-2014-102619. View

16.

Sarwar S, Ilyas S, Khan B, Lohman D, Haffez S, Rafique M . Awareness and Attitudes of Research Students Toward Dual-use Research of Concern in Pakistan: A Cross-sectional Questionnaire. Health Secur. 2019; 17(3):229-239. DOI: 10.1089/hs.2019.0002. View

17.

Nowak R . Disaster in the making. New Sci. 2003; 169(2273):4-5. View

18.

Koblentz G . Dual-use research as a wicked problem. Front Public Health. 2014; 2:113. PMC: 4121526. DOI: 10.3389/fpubh.2014.00113. View

19.

Kellman B . Regulation of biological research in the terrorism era. Health Matrix Clevel. 2003; 13(1):159-80. View

20.

Pannu J, Palmer M, Cicero A, Relman D, Lipsitch M, Inglesby T . Strengthen oversight of risky research on pathogens. Science. 2022; 378(6625):1170-1172. DOI: 10.1126/science.adf6020. View