American Society for Microbiology critiques HHS framework on H5N1 research

The American Society for Microbiology's Public and Scientific Affairs Board recently issued a series of concerns and recommendations about a proposal to guide funding decisions concerning gain-of-function research on H5N1 highly pathogenic avian influenza.

ASM's Scientific Affairs Board made its concerns known in a letter to the National Institutes of Health about the Department of Health and Human Services "Framework for Guiding HHS Funding Decisions about HPAI H5N1 Gain-of-Function Research."

The letter said that there is value in conducting gain-of-function research on HPAI H5N1 as long as the research's benefits outweigh the risks. The letter also said, however, that there may be risks associated with not conducting gain-of-function studies.

"The information generated by such studies is intended to provide the foundation for developing effective vaccines, therapeutics, diagnostics, and other countermeasures, and enhances our surveillance capabilities," ASM said. "To not engage in this type of research could introduce its own risks by compromising the ability of the scientific and public health communities to prepare for and respond to outbreaks-both naturally-occurring and those stemming from intentional misuse-of influenza viruses with pandemic potential."

ASM's letter said that the HHS document is an important step towards the creation of a way to study H5N1 safely, but that it also needs to be more carefully crafted because it will likely become a prototype for future dual-use protocols. The letter describes concerns about departmental reviews and operations, research classification and criteria for requiring higher level reviews for proposals.

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