The document outlines the implications and implementation procedures stemming from the newly issued NIH policy (NOT-OD-25-061) on oversight of Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP). Effective May 6, 2025, this policy consolidates and supersedes previous federal regulations, broadening the range of biological agents and experimental categories requiring oversight. It establishes two regulated categories—Category 1 (DURC) and Category 2 (PEPP)—and prohibits federal funding for such research in select countries. Institutions must now navigate an expanded compliance burden, including extensive initial and ongoing protocol evaluations, mandatory risk-benefit assessments, and the development and approval of risk mitigation plans. These procedural requirements also increase reporting obligations and the responsibilities of institutional review entities and designated contacts.
The policy specifically tasks research institutions with implementing comprehensive processes to ensure compliance, including collaboration among biosafety committees, research administrators, and designated institutional contacts. Prompt action is required to identify active and future NIH-funded projects falling within the policy’s broadened scope, even those previously exempt due to low quantities of select agents. The policy introduces stricter federal documentation, review, and approval thresholds for covered research, alongside encouragement (though not a mandate) to extend similar oversight to non-federally funded projects. Coordination within institutions and clear communication with federal agencies are stressed as vital, given the magnitude of the changes and tight implementation timelines. Ongoing advocacy and educational efforts by professional organizations such as ABSA and COGR aim to support the research community during this transition.
