On January 9, 2017 the White House Office of Science and Technology Policy (OSTP) released their “Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (P3CO).” Noting “[a]doption of these recommendations will satisfy the requirements for lifting the current moratorium on certain life sciences research that could enhance a pathogen’s virulence and/or transmissibility to produce a potential pandemic pathogen (an enhanced PPP).”

By the end of that year, on December 19, 2017, Francis Collins, Director of US National Institute of Health (NIH) announced it was lifting the October 16, 2014 funding moratorium [9, 10] on Gain-of-Function (GoF) research. [6]  “Dual Use” research continued because HHS adopted the pre-funding review mechanism called the Potential Pandemic Pathogen Care and Oversight (P3CO) Framework which would be used to make funding decisions for GoF-type research. [1, 20]

How this came about:

Starting late 2014,  the National Science Advisory Board for Biosecurity (NSABB) who served as the “official federal advisory body on GoF research issues and is responsible for developing recommendations for the appropriate level of Federal oversight of GoF research”. Which was infomed by Gryphon Scientific, who were “contracted by the NIH Office of Science Policy [OSTP] to conduct risk and benefit assessments (RBA) of GoF research involving the pathogens subject to the funding pause.”  NSABB worked in conjunction with the National Academies of Sciences. [18]

Following less than 3 years (2014-2016) of NSABB symposiums, together with Gryphon Scientific reports, two report were published:

  • May 2015 the NSABB recommended Framework for Conducting Risk and Benefit Assessments of Gain-of-Function Research
  • May 2016 the NSABB  final report titled Recommendations for the evaluation and oversight of proposed Gain-of-Function research  which Section 6 included “a more rigorous description of GOF research of concern (GOFROC).” [2, 14]

On January 9, 2017, just before the Inauguration of Donald Trump as President, the Obama White House OSTP released their recommended policy guidance for the Department of Health and Human Services (HHS) to develop a GoF research assessment framework based on the NSABB recommendations. [3, 4]

By December 2017 the HHS adopted the pre-funding guidance mechanism called the Potential Pandemic Pathogen Care and Oversight (P3CO).  Under the HHS P3CO Framework, the HHS P3CO Review Group [11] make funding decisions for enhanced PPP/GoF research projects. [5, 6]  The review group approved example A & B. [12]

By February 2022 at a NSABB meeting, the NIH show slides with revised definitions of GoF research; either “Dual Use Research Of Concern (DURC)” or emerging pandemic potential pathogens “ePPP‘s”. [7, 8]

Working in conjuction with NSABB, the The National Academies of Sciences held two Gain of Function Symposiums (Dec. 15-16, 2014 [17] & Mar. 10-22, 2016). Participating in these symposiums were: