Feds unveil new policies for 'dual-use' H5N1 research

Feb 21, 2013 (CIDRAP News) – Federal officials announced two new policy steps today designed to guide how they and US labs address dual-use research on dangerous pathogens, especially experiments involving aerosol H5N1 avian flu transmission.

The National Institutes of Health (NIH) released a framework to guide its funding decisions for projects expected to generate respiratory-transmissible H5N1 viruses in mammals, and the White House Office of Science and Technology Policy (OSTP) published a draft for public comment of a policy that outlines the roles and responsibilities of institutions and researchers who conduct certain types of work on pathogens.

Both of these steps were prompted by controversy that erupted in late 2011 over two studies involving lab-engineered H5N1 strains. Debate over the studies flared over whether publishing the full details of the studies in scientific journals could pose a bioterror risk and what could happen in the event of an intentional or accidental lab release.

One study was by a team led by Ron Fouchier, PhD, from Erasmus University in the Netherlands, and the other was headed by Yoshihiro Kawaoka, DVM, PhD, from the University of Wisconsin at Madison. Both studies were eventually published last year.

The discussions, however, led to a voluntary research moratorium last February that was originally planned for 60 days, but went on for nearly a year for many of the world's researchers who work with lab-transmissible H5N1 strains. The researchers say their findings could help scientists better monitor the virus and understand what it would take for the potential pandemic strain to spread more easily in humans.

Most of the scientists who had signed onto the moratorium ended their pause in January, but H5N1 research projects funded by the US government are still sidelined as researchers await final guidance and policies. Both of the Fouchier and Kawaoka groups receive funding from the NIH.

The proposed OSTP policy, which is open for public comment for the next 60 days, is related to a new policy on the oversight of life-sciences dual-use research of concern (DURC) that the NIH released in March. ("Dual use" refers to research that can be used for either good or bad ends.)

The OSTP policy requires federal agencies to routinely review possible risks of studies they fund involving 15 "high consequence" pathogens and toxins. Over the following months NIH officials had hinted that they were working on guidance to help local institutions implement the government's new policy.

Franca Jones, PhD, the OSTP's assistant director for chemical and biological countermeasures, wrote in an OSTP blog post today that the proposed policy establishes certain oversight responsibilities for universities and other facilities that receive federal funding. It would require institutions to review their current DURC pathogen or toxin research and work with funding agencies to develop risk-mitigation plans.

"Together, the two policies can help the United States manage the risks of potential misuse throughout the research lifecycle—from the initial filing of a grant application to the conclusion of research and communication of results," she wrote.

At a media telebriefing today, Jones said labs are key partners in mitigating risks and are best poised to help develop the strategies.

Amy Patterson, MD, assistant director for science policy at the NIH, signaled today during the briefing that labs still observing the moratorium would likely resume their work after the government clears the risk-mitigation documentation, a step required by the new OSTP policy.

She said the NIH narrowed the focus of the funding framework after receiving feedback during a 2-day workshop in December that brought researchers, biosafety experts, and others together to discuss the proposed version of the framework and to air a host of issues related to H5N1 studies. Patterson said the NIH also took into account input it received during a public comment period.

She said two themes stood out in the feedback: (1) a desire to see the framework focus on just a subset of H5N1 studies—the aerosol ones involving mammals—and (2) the need to provide more details about the more rigorous review of aerosol H5N1 studies.

Patterson said that although the new framework document clarifies the issues, scientists will still find some gray areas. "I don't think we can really remove that element of judgment," she said.

The framework document describes a robust review process that weighs the scientific and public health benefits, the biosafety and biosecurity risks, and risk-mitigation measures. Patterson said some studies involving aerosol H5N1 transmission in mammals will trigger a more detailed department review, which would likely add about 3 or 4 weeks to the funding consideration process.

Patterson and other NIH officials described the new funding framework today in a policy forum in the journal Science. They emphasized that science is unpredictable and that not all research results can be anticipated, but the framework's goal is to ensure early consideration that allows officials to make the most informed decisions possible about supporting the work.

The Fouchier and Kawaoka studies would have likely cleared the funding framework if it had been in place at the time, but they would have likely triggered more up-front consideration, Patterson said at today's briefing.

See also:

Feb 21 US government proposed policy for institutional oversight of life sciences DURC

Feb 21 NIH framework for guiding aerosol-transmissible H5N1 studies

Feb 21 OSTP blog post

Feb 21 Science policy forum report on H5N1 research funding

Dec 17, 2012, CIDRAP News story "H5N1 researchers question proposed HHS funding framework"

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