New pathogen research rules: Gain of function, loss of clarity

Lynn Klotz and Greg Koblentz, two members of our Scientists Working Group, wrote an article in the Bulletin of the Atomic Scientists on new pathogen research rules.

In December 2017, after six years of debate and discussion, the United States government closed a chapter—though perhaps not the book—on one of the most controversial experiments in the annals of dual-use research: the creation of an H5N1 avian influenza virus that was transmissible through the air between mammals. That is, the Health and Human Services Department has finally issued new rules governing how it will decide whether to fund similar experiments in the future. While these new rules embody a reasonable set of principles for assessing the risks and benefits of such research, the review process could also be strengthened in several ways to ensure that it is comprehensive and rigorous.

The rise of “gain of function.” In 2011, Dutch researcher Ron Fouchier and American virologist Yoshihiro Kawaoka sparked a major controversy when, separately, they submitted manuscripts to Science and Nature in which they described how to generate strains of H5N1 avian influenza that were transmissible between mammals. This research on mammalian airborne transmissible H5N1, or matH5N1, was published only after the National Science Advisory Board on Biosecurity and the World Health Organization engaged in lengthy and contentious review processes that focused on whether the research should be made public. Read more