The document provides an overview and institutional discussion on the recent U.S. government policy overhaul regarding Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP), as detailed in the May 2024 Office of Science and Technology Policy (OSTP) report. This new federal policy aims to unify and broaden oversight of federally funded biological research that could threaten public health or national security, replacing the prior DURC policies from 2012, 2014, and 2017. The new framework significantly expands the scope of regulated research, encompassing a wider array of biological agents and experiments, and introduces more complex review and risk assessment processes involving principal investigators, institutional review entities (IREs), and federal agencies. Notably, it requires federal agencies to update their guidance by May 2025 and establishes new requirements for appeals and multi-level federal review, especially for PEPP-related research.
Institutions anticipate considerable operational challenges stemming from the policy’s broader scope, which is expected to increase the number of research protocols requiring intensive review from hundreds to potentially thousands. Concerns center on unclear communication channels, shared authority for risk assessment between institutions and federal agencies, and ambiguity regarding appeals processes and final determination of research categorization. The policy’s open-ended definitions for the types of research falling under its purview could impose significant administrative burdens and potentially affect institutional willingness to conduct certain types of research. Institutions are calling for additional federal guidance and tools to assist in compliance and risk assessment, while also expressing apprehension over increased review timelines, institutional capacity constraints, and the possibility of divergent agency requirements or the extension of oversight to non-federally funded research. Overall, the new policy marks a substantial shift in the governance of high-risk biological research, with far-reaching implications for institutional compliance, risk management, and national research agendas.
