The National Security Council is moving to exert greater federal control over scientific studies of highly lethal diseases and toxins in the face of mounting fears that the research could be used by terrorists and rogue states, according to people with knowledge of the process.
Under the NSC's guidance, the government plans to issue guidelines for research grants that would give agencies the authority to delay or restrict publication of findings they considered susceptible to "dual use" by terrorists or enemy states. The new guidelines are expected to be issued in the coming weeks.
But the possibility of stricter guidelines is also raising concerns about scientific openness and increased red tape that could slow the release of findings that would save lives.
"From our standpoint, it seems unreasonable for there to be approval of our research at every step of the way … and then, once we have completed critically important experiments, to have an outside group conclude we should not publish," said Dr. Yoshihiro Kawaoka, professor of virology at the University of Wisconsin in Madison, who helped touch off the controversy with his work on the H5N1 bird flu.
"If infectious disease research in this country becomes regulated beyond what is appropriate, the U.S. will not be able to provide the breakthroughs the rest of the world relies on, and public health will suffer," he said.
Last year Ron Fouchier of Erasmus Medical Center in Rotterdam, the Netherlands, created a stir when he announced at a scientific meeting that he had created a strain of avian flu that was both deadly and easily transmissible. The Kawaoka and Fouchier research projects, both funded by the National Institutes of Health, raised widespread alarm that if the studies' methodology and results were published in full, they could become how-to manuals for making biological weapons.
Security experts at the NIH stepped in to delay publication and remove certain details of studies that showed how Fouchier and Kawaoka altered the deadly H5N1 avian flu virus to make it easily contagious among mammals.
Until now, nearly all people who had contracted H5N1 got it through contact with a sick bird. The new research opened the possibility that a sick person could infect other people directly, stirring concerns about lethal pandemics.
Accepted for publication in the prestigious journals Science and Nature, the papers were sent to the NIH's National Science Advisory Board for Biosecurity, which urged that the studies not be issued intact. An expert panel of the World Health Organization decided Friday that the papers would not be published any time soon.
Despite the H5N1 scientists' compliance with the delay, the NIH and National Science Advisory Board for Biosecurity can only make recommendations to researchers, not compel action. The new guidelines would give federal agencies the legal authority to limit disclosure of research. Among the entities whose grant making could be affected are the Pentagon, Department of Homeland Security, Department of Agriculture and the NIH.
The guidelines would apply to research involving so-called Tier 1 select agents, a list of pathogens and toxins the government has determined pose the most severe threats to public health. H5N1 influenza is on the Agriculture Department's Tier 1 list.
In January, Fouchier, Kawaoka and more than 30 other top scientists in the field issued a public letter saying they had agreed to a 60-day moratorium on research to give the international scientific community a chance to find ways to gauge the benefits and reduce the risks of such work.
The WHO also decided at a recent Geneva meeting to extend the moratorium, but declined to specify the duration.