February 24, 2013

HHS Issues New Guidelines for Federal Funding of High-Risk Influenza Research

The Department of Health and Human Services (HHS) has released guidelines for the federal funding of research on highly pathogenic avian influenza (HPAI) H5N1 viruses. The need to specifically address whether and how such research would be funded was made clear when two NIH-supported publications detailed the creation of modified HPAI viruses that exhibited enhanced transmissibility in mammals (i.e., highly lethal avian flu viruses had acquired the potential to transmit easily among humans) (see here and here). Much of the controversy that ensued focused on whether such research should be published (because the furor arose after the research was completed), but the background issue of funding controls on such potentially risky research remained unaddressed. Now, the HHS guidelines (which will largely target NIH-funded research) provide a sequence of review for such grant proposals: standard peer review for scientific merit, NIH review applicable to dual use research of concern (DURC), followed by a new and specific HHS department-level review which can recruit any relevant authorities to advise on the merits of funding such research. The guidelines contain seven criteria that will be used to identify projects worth funding:

1) The virus anticipated to be generated could be produced through a natural evolutionary process;
2) The research addresses a scientific question with high significance to public health;
3) There are no feasible alternative methods to address the same scientific question in a manner that poses less risk than does the proposed approach;
4) Biosafety risks to laboratory workers and the public can be sufficiently mitigated and managed;
5) Biosecurity risks can be sufficiently mitigated and managed;
6) The research information is anticipated to be broadly shared in order to realize its potential benefits to global health; and
7) The research will be supported through funding mechanisms that facilitate appropriate oversight of the conduct and communication of the research. 

It is clear that HHS will entertain funding for such projects where a near-necessity can be shown ("
no feasible alternative methods to address the same scientific question") – in addition to actual scientific merit and compliance with DURC funding standards. This elevates the standard for HPAI H5N1 virus grant proposals to meet – essentially instituting a cost-benefit analysis at the start. Publication issues are not directly addressed (the NSABB remains available to consider that eventuality); however, the guidelines do contemplate dissemination of results ("anticipated to be broadly shared") – that fact only highlighting the need to ensure that the research results that are released are demonstrably related to real public health concerns.

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