Evaluating Safety and Security in Biological Research

The May 5, 2025, Executive Order (EO) 14292, “Improving the Safety and Security of Biological Research,” will shape the future of dual-use research of concern (DURC) and research involving pathogens with enhanced pandemic potential (PEPPs). Building on its definition of “dangerous gain-of-function research,” the authors recommend that the Office of Science and Technology Policy and relevant agencies develop a decision-making tool that includes well-defined criteria for “dangerous gain-of-function research.” This tool could be used to score future proposed research and ongoing DURC/PEPP projects on their risks and benefits. In combination with other tools and assessment methods, it could also be implemented into a standardized decisionmaking framework to help provide oversight for high-consequence biological research. Clearly defining the scope of what research is covered under EO 14292 through an objective and reproducible scoring tool could improve public transparency and may facilitate more-consistent implementation without hampering U.S. innovation in biotechnology.

The tool is intended to be applied consistently and reproducibly by all entities involved in proposing, reviewing, approving, and overseeing high-consequence biological research. Through the application of this scoring mechanism throughout the research cycle, principal investigators, institutional review entities, subject-matter experts, the DURC/PEPP committee within the U.S. Department of Health and Human Services, funding agencies, or a bioresponsibility agency can come to the same conclusions about the appropriateness of specific research proposals for oversight, the appropriateness of experimental designs, and the need for additional safety and security mitigations—including when new experimental results require reassessment through ongoing research.