Accordingly, HHS and NIH leadership would initially be reliant on NIAID to relay to them accurate information about the MPXV experiments. The documents reviewed by Committee staff, except for the Federal Select Agent Program documents held by the Centers for Disease Control and Prevention (CDC), belonged to NIAID. Such reliance does not excuse HHS and the NIH’s conduct, but principal responsibility for misleading the Committee most likely lies within NIAID.
The primary conclusion drawn at this point in the investigation is that NIAID cannot be trusted to oversee its own research of pathogens responsibly. It cannot be trusted to determine whether an experiment on a potential pandemic pathogen or enhanced potential pandemic pathogen poses unacceptable biosafety risk or a serious public health threat. Lastly, NIAID cannot be trusted to honestly communicate with Congress and the public about controversial GOFROC experiments.[1]
This interim finding is particularly relevant given that the White House Office of Science and Technology Policy (OSTP) recently issued updated policy and related guidance on DURC and Gain-of-Function (GOF) research. This updated policy replaced the earlier OSTP Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight and the HHS Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (collectively hereinafter referred to as “P3CO”) imposed in 2017.[2]
The new OSTP policy continues to give funding agencies, like NIAID, primary responsibility for oversight of GOFROC and DURC experiments involving potentially dangerous pathogens.[3] Under both the 2017 policy and the new 2024 policy, for the vast majority of experiments involving potentially dangerous pathogens—like MPXV, the agency conducting the experiment is also tasked with regulating and overseeing the experiment. In almost any other scientific field or industry, this arrangement would be immediately recognized as a conflict of interest, necessitating independent review and oversight.
- ↑ U.S. HHS Office of Inspector General, A-05-21-00025, The National Institutes of Health and EcoHealth Alliance Did Not Effectively Monitor Awards and Subawards, Resulting in Missed Opportunities to Oversee Research and Other Deficiencies (2023)); U.S. Gov’t Accountability Office, GAO-23-106119, NIH Could Take Additional Actions to Manage Risks Involving Foreign Subrecipients (2023).
- ↑ The White House Office of Science and Technology Policy, Recommended Policy Guidance for Potential Pandemic Pathogen Care and Oversight (Jan. 9, 2017), https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/p3co-finalguidancestatement.pdf.
- ↑ 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 (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/.
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