High Consequence Research Oversight
S3: Science Safety Security
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). The
2012 Federal DURC Policy, the
2014 Institutional DURC Policy, and the 2017 Office of Science and Technology Policy Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (OSTP P3CO Policy Guidance) and the
2017 HHS P3CO Framework have been key components of the federal oversight framework for research involving biological agents and toxins. Scientists, institutions, and federal funding agencies have gained valuable insight from implementing these policies over the past decade.
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. This new U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential will supersede the
2012 and
2014 DURC Policies and the
2017 HHS P3CO Framework, beginning on May 6, 2025.
The email address
ASPRBIO@hhs.gov is available to collect feedback from stakeholders on interpreting and/or implementing this policy. Feedback will be used for policy evaluation purposes and may result in FAQs. Not all emails will receive a response.
