- Finding: Dr. Moss and his team at NIH formally proposed to IBC MPXV research involving gene transfers from clade I to clade II, and IBC approved this research.
- Finding: Mpox continues to evolve into a more significant public health threat. For the U.S. to be properly prepared, research is essential.
- Finding: Experiments involving pandemic or potential pandemic pathogens, including MPXV, pose a non-trivial risk to public health in the event of an accident leading to a breach of containment.
- Finding: NIAID has a culture of secrecy and obfuscation regarding experiments involving pandemic and potential pandemic pathogens. HHS and the NIH are complicit in enabling NIAID’s culture of secrecy and obfuscation. This is incompatible with accountable, democratic governance and further erodes the public’s trust in government health agencies.
- Finding: Congress and the American people must have a working relationship with the NIH and federal biomedical research enterprise that is built on trust and transparency.
- Finding: Principal investigators, research institutes, and funding agencies are poorly positioned to, and perhaps incapable of, conducting adequate risk/benefit analysis and oversight of experiments that—by virtue of having proposed them and approved their funding—they want to see conducted. This is an inescapable conflict of interest and misalignment of incentives that results in experiments being approved and conducted without sufficient scrutiny or ongoing oversight.
- Recommendation: Remove final review and approval for experiments involving GOFROC/DURC from the NIH/NIAID. Under the recently released United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential, this would remove final approval for Category 1 Research from NIAID. Committee staff should evaluate whether removal of final review and approval authority should be limited to the NIH/NIAID or applied to all federal departments and agencies funding such research.[1]
- ↑ While outside the scope of this interim report, committee staff believe several of the definitions in the policy are too narrow to effectively achieve the policy’s stated purpose. For example, the definition of pathogen with pandemic potential (PPP) is limited to those “likely capable of wide and uncontrollable spread
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