The Council on Governmental Relations (COGR), representing over 200 U.S. research universities and related institutions, submitted detailed comments to the Office of Science and Technology Policy (OSTP) regarding proposed changes to the oversight policies for Dual Use Research of Concern (DURC) and Potential Pandemic Pathogen Care and Oversight (P3CO). While COGR emphasizes its strong commitment to biosafety and supports periodic policy review, it expresses substantial concern about shifting from the current list-based regulatory framework to a broad risk-based model as suggested in the recent Request for Information (RFI). COGR argues that such a change would impose significant administrative, technical, and resource burdens on principal investigators and institutional review entities, potentially leading to regulatory inconsistency, delays in research, and in some cases, the curtailment of vital scientific work, particularly among institutions with fewer resources.
Specifically, COGR highlights that consolidating federal policies and transferring more risk assessment responsibilities to institutions could overwhelm existing biosafety structures, especially given the vast number of potential agents and the nuanced risks they present. The response calls for clear, detailed federal guidance, extensive training, and readily accessible support if broader definitions are adopted. COGR also voices strong support for maintaining policy clarity through specific agent lists or well-defined risk group criteria and urges exclusion of certain essential activities, such as clinical diagnostics and vaccine development, from heightened oversight to prevent impeding pandemic response. Regarding in silico research, COGR cautions against overexpansion of regulatory scope, warning this may hinder open scientific collaboration crucial during public health emergencies. Ultimately, COGR recommends that any policy revisions prioritize clarity, feasibility, and minimization of unintended negative consequences for research institutions and the broader scientific enterprise.
