- Recommendation: Consider expanding the role of the HHS P3CO or its successor entity to include making determinations about whether a research project should be subject to its review framework. If HHS P3CO cannot or will not appropriately accomplish this charged duty, Congress should consider alternative entities. Such review authority must be wholly independent of the NIH/NIAID and should be empowered and charged with making a final determination as to whether a proposed experiment involving GOFROC/DURC in a grant that NIAID has selected for funding should be approved, modified, or rejected. Such entity should issue regular, detailed reports of its determination decisions. Any such leadership or board members should be free of conflicts of interest, and member composition and identity should be made publicly available. Congress could consider whether Senate confirmation of leadership or members is desirable. Congress should also examine what, if any, additional biosecurity or biosafety functions or policy responsibilities should be relocated to such reviewing entity or committee.
- Recommendation: Require institutions conducting NIAID-funded research involving potentially dangerous agents to establish community oversight boards, similar to those currently required for high-containment biosafety level four laboratories.
in a human population and would likely cause moderate to severe disease in humans.” See Section 3.K. Thus, many of the most likely pandemic pathogens such as Ebola, Mpox, SARS-like viruses that bind to hACE2, MERS-like viruses that bind to the DPP-4 receptor, Nipah, Hendra, and highly pathogenic avian influenza, among other, do not qualify as potential pandemic pathogens simply because they have yet to spillover and cause widespread human to human transmission even though scientific consensus is that these viruses pose a serious pandemic threat. As written, the definition is too backwards looking and inappropriately exempts viral discovery and characterization work (like that performed at the Wuhan Institute of Virology) from additional biosafety review.
Moreover, Category 2 Research – which is subject to department level review – is limited to experimental outcomes that are reasonably anticipated to enhance transmissibility, virulence, or immune evasion in humans. The publicly stated positions of NIH and NIAID leadership would exempt almost all gain-of-function experiments from Category 2 review. NIH and NIAID leadership take the position that experimentally infecting animal models, including those animal models used as a stand-in for humans such as humanized mice and ferrets, with PPP or enhanced PPP is irrelevant to determining whether it a pathogen is reasonably anticipated to be transmissible or cause disease in humans.
Committee staff believe a sounder approach would be to define potential pandemic pathogens as “a pathogen that is likely capable of wide and uncontrollable spread in mammals and would likely cause moderate to severe disease and or mortality in mammals.” Similarly, Category II Research Experimental Outcomes or Actions (Section 4.2.2) should also be defined in the context of mammals instead of limited to humans. This would result in experiments involving potentially dangerous emerging viruses with pandemic potential, such as those listed above, receiving appropriate, additional biosafety and biosecurity reviews.
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