DUAL-USE RESEARCHStrengthening U.S. Government’s Enhanced Potential Pandemic Pathogen Framework, Dual Use Research

Published 20 July 2022

Group of scientists, public health experts, policy researchers propose strengthening of U.S. government’s policies regarding enhanced potential pandemic pathogen framework and dual use research of concern.

A group of senior scientists, public health experts, and policy researchers has submitted recommendations intended to strengthen the oversight of research involving enhanced potential pandemic pathogens (ePPPs) and life sciences dual-use research of concern to the White House National Security Council and Office of Science and Technology Policy, the US National Institutes of Health (NIH), and the National Science Advisory Board on Biosecurity (NSABB). The US government is currently reviewing its policies that provide governance and guidance for this realm of research.

The COVID-19 pandemic has shown that a novel, highly transmissible virus can quickly cause significant morbidity and mortality as well as serious disruption to healthcare systems, economies, and civil society on a global scale. Experiments that create the possibility of initiating a pandemic require rigorous risk assessment. Increased technical means of genetic manipulation and broad access to materials and tools needed to create ePPPs present growing challenges for oversight.

“There are critical gaps in these guidance documents that need to be addressed as part of the current USG review process and concomitant NSABB review,” write the 34 signatories. “The USG has an extraordinary obligation to prevent USG funding or approval of work that could start an epidemic or pandemic, as well as to provide international leadership in this realm.”

The group recommends a series of actions including:

  • Modify and expand the scope of pathogens to be governed by the ePPP Framework*
  • Assess and detail risks and benefits of proposed experiments
  • Clarify and restructure processes of review, communication, biosafety and biosecurity, and transparency
  • Expand the reach of the ePPP Framework to include all USG agencies and non-federally funded research
  • Revise the USG DURC Policy to expand its scope and clarify requirements

Read the full recommendations.

*For the purpose of the recommendations, the experts refer to the “ePPP Framework” as consisting of both the White House Office of Science and Technology’s (OSTP) “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO)” and the US Department of Health and Human Services’ (HHS) “Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens.”