The document outlines the forthcoming implementation and implications of the United States Government’s new policy for the Oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP), set to replace previous guidance in May 2025. The policy establishes comprehensive, unified oversight for research that could be reasonably anticipated to generate pathogens or knowledge with significant potential for misuse, encompassing both federally and non-federally funded work. Novel definitions and categories clarify the scope of DURC (Category 1) and PEPP (Category 2) research, greatly expanding oversight to all Risk Group 3 and 4 agents and encouraging inclusion of Risk Group 2, with substantial procedural and administrative changes required at institutional levels. The policy mandates rigorous pre-award and ongoing review, risk-benefit analyses, risk mitigation planning, and annual/semi-annual assessments led by Institutional Review Entities (IRE), as well as detailed reporting and training obligations for principal investigators and compliance officers.
Presentations from academic institutions, including Cornell University, Penn State, and Texas A&M, detail early efforts to align local oversight, processes, and staff training with the new policy’s demands. Common themes include the establishment of PI self-assessment tools, cross-functional working groups, integration of DURC/PEPP considerations into grant and protocol review processes, and a strong emphasis on education, communication, and record-keeping. Significant logistical, financial, and operational challenges are highlighted, including uncertainty regarding federal guidance, potential strain on compliance infrastructure, difficulties with training prior to rollout, possible disruptions to research progress, and potential barriers to recruitment and retention in critical fields. Institutional and professional organizations, such as ABSA International, are positioned to provide support through resource sharing, advocacy, technical feedback, and development of training materials to facilitate collective adaptation to the new regulatory landscape. Overall, the shift to the new DURC/PEPP framework represents a substantial evolution in biosafety oversight, demanding coordinated, transparent, and well-resourced implementation by all research stakeholders.
