High Consequence Research Oversight
Update: In compliance with the Executive Order on Improving the Safety and Security of Biological Research issued on May 5, 2025, federal departments and agencies will revise or replace the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential. This page will be updated once the revised policy is available.
Research involving biological agents and toxins is essential to the scientific advances that underpin improvements in national and global health and safety. However, there are biosafety and biosecurity risks associated with undertaking such research that are carefully considered and appropriately mitigated in order to safely realize these benefits. The U.S. government has existing statutes, regulations, policies, and guidelines that address potential biosafety and biosecurity risks, including those associated with research oversight and management. Together, these authorities, policies, and guidelines provide a foundation for ensuring that scientific research is conducted safely and securely.
Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. The intent of research oversight programs is to increase the awareness of researchers, research institutions, and federal funding agencies about the biosafety and biosecurity concerns associated with certain types of research and to ensure that appropriate risk mitigation measures are in place to prevent biosafety incidents (e.g., unintended personal exposure or release of an agent outside of containment) or biosecurity incidents (e.g., theft or intentional misuse of information, knowledge, products, or technology). Several past policies and frameworks have been key components of the federal oversight framework for research involving biological agents and toxins and have provided scientists, institutions, and federal funding agencies with valuable insight.
A new policy and implementation guidance for research involving Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) was released in May 2024.
Dual Use Research of Concern Oversight Policy Framework
Enhanced Potential Pandemic Pathogen Oversight Framework
Research Reviewed Under the HHS P3CO Framework
History of Research Oversight Policies
