Debate grows over HHS funding policy

Debate is growing over the U.S. Department of Health and Human Services' new policy framework for determining funding for dual-use, gain-of-function research.

At the end of 2012, HHS responded to the controversy started by two gain-of-function studies showing how H5N1 avian influenza can be modified to become transmissible between ferrets, a common stand in for humans in flu studies. The new rules have yet to be accepted by scientific experts, according to Scientific American.

A year earlier, the National Science Advisory Board for Biosecurity first recommended that neither H5N1 study be published without redaction. The NSABB later recanted, but not until after influenza scientists worldwide instituted their own moratorium on gain-of-function studies in order to highlight their seriousness.

The new HHS policy says, among several rules, that gain-of-function studies must address a scientific question with high significance to public health, that biosecurity risks can be sufficiently managed and mitigated, and that the research is supported through funding mechanisms that facilitate the appropriate oversight.

If the research meets all seven total qualifications it can be funded, but HHS reserves the right to monitor its outcomes, transfer it to a different agency so it can by conducted as classified research or later deny funding all together.

"There is always likely to be room for disagreement about the extent to which gain-of-function studies are significant, or viruses emergent, but at present the ambiguity is stark enough to be worrying," Nicholas Evans said, according to Scientific American. "With no guidance, researchers may be pressed upon to provide assurances they simply can't make given evidence possessed before research is conducted."

Evans said that the international community has yet to fully weigh in on the new U.S. policy. In the absence of agreement, it is entirely possible that such research could move offshore to places with limited oversight or entirely different ideas as to what constitutes value to public safety.

"Ultimately, the reasons for creating policy need to be the right reasons, and generate the right kinds of outcome-in this case, funding research that really is in the public interest," Evans said, Scientific American reports. "After all, when regulation succeeds in its aims, no one notices; when it fails, science is derailed, corruption occurs, and people get hurt."