History of Research Oversight Policies
S3: Science Safety Security
Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. Research oversight policies have evolved over time, taking into account advancing technological developments and
biological incidents.
On March 29, 2012, the U.S. government released the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (2012 Federal DURC Policy). This action established a U.S. government policy for the identification and oversight of Dual Use Research of Concern (DURC). The policy applies to a well-defined subset of life sciences research that involves 15 agents and toxins and seven categories of experiments and established regular review of U.S. government-funded or conducted research for its potential to be DURC. On September 24, 2014, the U.S. government released the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (2014 Institutional DURC Policy). This policy addresses institutional oversight of DURC, including policies, practices, and procedures to identify DURC and implement risk mitigation measures, where applicable. Institutional oversight of DURC was a critical step in developing a comprehensive oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen responsible conduct and communication. The
2014 Institutional DURC Policy and the
2012 Federal DURC Policy are complementary and emphasize a culture of responsibility by outlining roles and responsibilities of all involved parties in the shared duty to uphold the integrity of science and prevent its misuse.
In 2013, HHS released an additional oversight framework on a particular subset of potential DURC, known as “gain of function” studies. For several decades, highly pathogenic avian influenza (HPAI) H5N1 virus had been recognized as a threat to agriculture and human health. Research on this virus was acknowledged as important for understanding potential shifts in transmissibility (including transmissibility to and among humans) and for developing countermeasures to prepare for a potential human HPAI H5N1 virus. Because a subset of this research posed potential risks to humans or animal health and safety, in February 2013 HHS issued the Framework for Guiding Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets (HHS HPAI H5N1 Framework) to guide funding decisions on proposals for “gain of function” research anticipated to generate HPAI H5N1 viruses that are transmissible among mammals by respiratory droplets. This framework outlined a robust review process that took into account scientific and public health benefits, the biosafety and biosecurity risks, and the appropriate risk mitigation measures for the proposed research.
So called “gain-of-function” studies 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. Such studies may entail enhanced biosafety and biosecurity risks; therefore, their risks and benefits must be evaluated, both in the context of recent U.S. biosafety incidents and to keep pace with new technological developments, in order to determine which types of studies should go forward and under what conditions.
In October 2014, 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 was issued, and a deliberative period began during which funding for research expected to confer attributes to influenza, MERS, or SARS viruses, such that the viruses would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route, was paused. During this funding pause, the National Science Advisory Board for Biosecurity (NSABB) was tasked to conduct a deliberative process to draft a set of recommendations for the oversight of gain-of-function research funding that would be reviewed by the broader life sciences community. NSABB meetings and meetings hosted by the National Academies of Sciences, Engineering, and Medicine facilitated broad public discussions and inputs.
In 2017, informed by the NSABB recommendations and other inputs, the White House issued the Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (OSTP P3CO Policy Guidance). Departments and agencies that adopt review mechanisms consistent with the provisions in the OSTP P3CO Policy Guidance would satisfy the requirements for lifting that department or agency’s funding pause instituted by the U.S. government in 2014. on certain gain-of-function research under the U.S. Government Gain-of-Function Deliberative Process Later in 2017, HHS issued the 2017
HHS P3CO Framework, in accordance with the OSTP P3CO Policy Guidance, lifting the funding pause at HHS and superseding the 2013
HHS HPAI H5N1 Framework. The 2017 HHS P3CO Framework is broader than the 2013 HHS HPAI H5N1 Framework, addressing a wider range of pathogens.
The 2017 HHS P3CO Framework and the 2012 and 2014 DURC policies will be replaced in May 2025 with the
U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.
