reasonable for the Committee to infer that assertions that the experiment was never conducted are inaccurate in light of HHS’s past misrepresentation that the risky experiment[1] was never formally proposed or approved.
The Committee needs additional evidence from HHS, the NIH, or NIAID to have confidence that the experiment did not occur. While it could have been by inadvertence or mistake, the deceptive conduct suggests that HHS, the NIH, and particularly NIAID, may have knowingly and deliberately misled the Committee regarding potentially dangerous intramural GOFROC/DURC research.[2] The obstruction and misrepresentations by the agencies involved is also concerning if the experiment, in fact, never occurred because it illustrates the lengths to which NIAID will go to evade outside oversight just for the sake of evasion.
Despite the obstructive behavior by HHS and the NIH, Committee staff believe that NIAID is the agency that bears the most responsibility for misleading the Committee. The NIH has a decentralized structure where the research institutes have a large degree of autonomy in setting research priorities and managing grants, including approval and oversight of biosafety measures.[3] Further, NIAID has the personnel with first-hand knowledge of events, subject matter expertise, and control of the documents related to the experiment.
- ↑ The bidirectional gene transfer experiment raises the possibility of making the more transmissible clade gain the lethality of clade I. Under the 2017 HHS Potential Pandemic Pathogens Care and Oversight (P3CO) framework, there are legitimate concerns that this experiment could enhance a pathogen with pandemic potential by making the more transmissible mpox clade I more transmissible.
- ↑ “Gain-of-function (GOF) research is a broad area of scientific inquiry where an organism gains a new property or an existing property is altered.” Congressional Research Service, supra note 5.
Gain-of-function research of concern is defined as “experiments that enhance a pathogen’s transmissibility or virulence, or disrupt the effectiveness of pre-existing immunity, regardless of its progenitor agent, such that it may pose a significant threat to public health, the capacity of health systems to function, or national security.” See The White House Office of Science and Technology Policy, U.S. Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential, Section3.J (May 6, 2024), https://www.whitehouse.gov/ostp/news-updates/2024/05/06/united-states-government-policy-for-oversight-of-dual-use-research-of-concern-and-pathogens-with-enhanced-pandemic-potential/.
“Dual use research of concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.” U.S. Health & Human Serv., supra note 6.
- ↑ Judith A. Johnson & Kavya Sekar, Cong. Research Service, R41705, The National Institutes of Health (NIH): Background and Congressional Issues (2019), https://www.crs.gov/Reports/R41705?source=search#ifn21.
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