Enhanced Potential Pandemic Pathogen Oversight Framework

S3: Science Safety Security

Research involving potential pandemic pathogens (PPPs) is essential to protecting global health and security. Research that may enhance the ability of a pathogen to cause disease can help define the fundamental nature of human-pathogen interactions, thereby enabling assessment of the pandemic potential of emerging infectious agents, informing public health and preparedness efforts, and furthering medical countermeasure development. However, there are biosafety and biosecurity risks associated with undertaking such research that should be adequately considered and appropriately mitigated in order to safely realize the potential benefits. The Department of Health and Human Services (HHS) Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework) guides HHS funding decisions on proposed research that is reasonably anticipated to create, transfer, or use PPPs resulting from the enhancement of a pathogen’s transmissibility or virulence in humans (enhanced PPPs, or ePPPs). ePPPs do not include naturally occurring pathogens that are circulating in or have been recovered from nature, regardless of their pandemic potential.

The HHS P3CO Framework will remain in effect through May 6, 2025, on which date it will be replaced by the U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.

The HHS P3CO Framework describes a robust multidisciplinary, pre-funding review process that considers the potential scientific and public health benefits, biosafety and biosecurity risks, and appropriate risk mitigation strategies to help inform agency decisions. The HHS P3CO Framework is responsive to, and in accordance with, the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight issued by the White House Office of Science and Technology Policy on January 9, 2017, and supersedes the previous Framework for Guiding Department of Health and Human Services Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets. Adoption of the HHS P3CO Framework lifted the research funding pause on HHS research that was set forth by the U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses.