U.S. Requires New Dual-Use Biological Research Reviews

The U.S. government today released a new policy that will require federal agencies to systematically review the potential risks associated with federally funded studies involving 15 "high consequence" pathogens and toxins, including the H5N1 avian influenza virus. The reviews are designed to reduce the risks associated with "dual use research of concern" (DURC) that could be used for good or evil.

The new DURC policy—months in the making, and in part a reaction to the ongoing controversy over research involving the H5N1 avian flu viruses—will expand current reviews already conducted by two major biomedical research funding agencies, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). Both agencies already review intramural studies proposed by staff scientists for dual-use potential; now, they will extend those reviews to extramural projects conducted by scientists at universities and other institutions. The new rules would also apply to any other federal agency funding unclassified biological research, such as the U.S. Department of Agriculture and the Department of Defense.

The new policy requires all agencies to review both proposed projects and those already funded. If a review identifies DURC potential, the funding agency, the institution, and the lead scientist are supposed to develop a "risk mitigation plan." It could include efforts to modify how the research is conducted, move it to a more secure laboratory, and communicate it to the public and other scientists responsibly. For especially problematic studies, agencies will determine whether to "request voluntary redaction of the research publications or communications," or to classify the findings.

The policy, which appears to go into effect immediately, requires agencies to report to the White House within 60 days on how many proposed or ongoing studies involve the 15 targeted agents, and within 90 days on how many DURC projects their reviews have identified.