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U.S. Announces More New Rules for Potentially Risky Research

Greater scrutiny. U.S.-funded researchers working with 15 especially dangerous agents, such as the Ebola virus (above), face new regulatory hurdles.

Centers for Disease Control and Prevention

Researchers interested in conducting studies with 15 potentially dangerous agents and toxins—including the H5N1 avian influenza virus—face some new hurdles in getting funding from the U.S. government. Federal officials today released two policy documents that lay out stricter requirements for institutional and government oversight of studies that pose especially problematic safety concerns.

One policy, released by the U.S. Department of Health and Human Services (HHS), applies only to scientists seeking funds for experiments that might create new strains of the H5N1 virus that can move between mammals in respiratory droplets. (The virus normally infects birds.) Experts fear that such mammal-transmissible H5N1 viruses could spark a deadly human pandemic if they escape from a laboratory or are intentionally released by terrorists. U.S. officials outline the new policy today in Science.

The other document, released by the White House's Office of Science and Technology Policy (OSTP), asks for public comment on proposed new rules for scientists, universities, and other institutions working with a broader set of 15 especially dangerous agents and toxins—including H5N1—that could be used to cause harm. Existing U.S. rules, released in March 2012, require federal agencies to review funding proposals that involve the 15 agents for "dual use research of concern," or DURC. The draft policy would require additional reviews by scientists and their institutions. Universities would also need to establish procedures for developing plans for mitigating risks associated with such dual-use studies.

Both policies are direct responses to a global controversy that emerged in late 2011 after two laboratories, one in the United States and one in the Netherlands, announced they had engineered mammal-transmissible H5N1 viruses. The research sparked disagreement over whether the results should be published and whether scientists should be conducting such research at all. H5N1 researchers imposed a yearlong voluntary moratorium on their work, which ended last month, while governments worked out new oversight rules.

Both of the policies announced today are expected to apply to a relatively small slice of biological research. Officials have said that just a handful of U.S.-funded researchers are engaged in H5N1 research that would fall under the new policy. The new DURC policy would have a broader impact, officials say, covering perhaps several hundred laboratories known to work with the 15 agents. All but one of the agents are already regulated under a separate set of safety and security rules governing "select agents."

Under the proposed rules, scientists would be asked to determine whether a proposed study met the definition of DURC—for example, whether the experiment might make a toxin more deadly or confer resistance to treatments, and whether the results "could be directly misapplied to pose a significant threat" to the public. Universities would also be required to establish a new committee—or use an existing one—to do DURC reviews, and appoint an "Institutional Contact for Dual Use Research," or ICDUR, to oversee potentially problematic projects. Universities would have 30 days to inform a funding agency that they were reviewing a proposal and 90 days to submit a draft plan for mitigating any risks.

The plan also calls on institutions to make its DURC review procedures "accessible to the public." But the government doesn't want institutions to publish "details of particular cases or the minutes of the DURC review entity's proceedings."

That might be a hard rule to enforce in states with expansive freedom of information laws covering publicly funded institutions, said Franca Jones, OSTP's assistant director for chemical and biological countermeasures, in a teleconference with reporters today. It is just one of the difficult issues in the draft policy that officials are hoping the public will comment on, she said. Comments are due by 23 April.

The draft policy is drawing mixed reactions from university groups. "At first blush, there is a need for biosecurity regulation of select agents," says Carrie Wolinetz of the Association of American Universities in Washington, D.C. But existing select agent rules are fairly strict, she noted, and "imposing a second review system [for DURC] on agents that are already heavily regulated may be of marginal benefit."

H5N1 researchers are likely to be happier with the new HHS rules, which were revised following a December 2012 meeting on the topic. The new language removes any mention of classifying problematic studies or results, for instance, instead clarifying that HHS will support only research that can be shared publicly. The final rule also drops language that called on researchers to show that the virus they wanted to create could evolve in nature "in the foreseeable future." Instead, researchers need only to provide evidence that the virus could "be produced through a natural evolutionary process."

Officials say they will regularly review and revise both new policies as needed.

*Update 4:32 p.m., 21 February: This item has been updated to clarify the definition of DURC.