US debuts life sciences dual-use research policy

Mar 29, 2012 (CIDRAP News) – Federal health officials today unveiled a new policy for overseeing life sciences dual-use research, such as two recent H5N1 transmission studies that have sparked bioterror concerns as well as cries of censorship.

The launch of the new policy, first reported by ScienceInsider, comes while a US biosecurity advisory group is meeting to discuss the latest version of two H5N1 transmission papers, one by a group from Erasmus University in the Netherlands and one by a team from the University of Wisconsin, Madison.

The move also follows a demand from a US congressman that President Obama's science office explain why the National Science Advisory Board for Biosecurity (NSABB) didn't consider the dual-use implications until after the studies were completed and what safeguards are in place to protect Americans against biological attacks. The congressman, Rep Jim Sensenbrenner, R-Wisc., asked John Holdren, who leads the White House Office of Science and Technology Policy, to report back by Mar 31.

The NSABB is meeting today and tomorrow to weigh further data presented by the two research groups on their studies.

The 4-page policy, which came from the National Institutes of Health (NIH) Office of Biotechnology Activities, requires federal agencies to routinely review potential risks of federally funded studies that involve 15 "high consequence" pathogens and toxins, including H5N1 avian flu, Bacillus anthracis, and Ebola virus.

According to the NIH's Web site, "The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research."

The policy expands reviews that the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), the government's two largest biomedical agencies, already conduct on staff-run studies and extends oversight to federally funded studies at universities and other facilities. The new requirements also apply to other federal agencies that conduct unclassified life sciences research, such as the Department of Defense.

It applies to research studies that are on the horizon and ones that have already been funded. Reviews that find dual-use potential require the funding agencies and scientists to develop a risk mitigation plan.

According to the new policy, if the risks can't be mitigated with several suggested measures, federal agencies are required to determine whether to request voluntary redaction of the resulting research publications or communications, to classify the research, or to withhold or terminate funding for the study.

Actions to restrict publication may have implications for export control laws and regulations, the new policy states. Earlier this month, the Dutch government said it was considering using export controls to prevent full publication by the Erasmus group.

Within 60 days federal agencies are required to report to the White House the number of proposed or ongoing studies related to the 15 high-consequence agents, and in 90 days to report how many have dual-use potential.

The NIH has already completed its own dual-use biosecurity assessment and found fewer than 10 studies that warrant further risk management, the Washington Post reported today.

See also:

Mar 29 ScienceInsider story

US government dual-use oversight policy

NIH Web site on dual use

Mar 12 CIDRAP News story "Dutch export rules could block publication of Fouchier H5N1 study"

Mar 5 CIDRAP News story "Details of H5N1 study sparks queries from congressman, experts"

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