Doing Diligence to Assess the Risks and Benefits of Life Sciences Gain-of-Function Research

Following recent biosafety incidents at Federal research facilities, the U.S. Government has taken a number of steps to promote and enhance the Nation’s biosafety and biosecurity, including immediate and longer term measures to review activities specifically related to the storage and handling of infectious agents. 

As part of this review, the White House Office of Science and Technology Policy and Department of Health and Human Services today announced that the U.S. Government is launching a deliberative process to assess the potential risks and benefits associated with a subset of life sciences research known as “gain-of-function” studies. With an ultimate goal of better understanding disease pathways, gain-of-function studies aim to increase the ability of infectious agents to cause disease by enhancing its pathogenicity or by increasing its transmissibility.

Because the deliberative process launching today will aim to address key questions about the risks and benefits of gain-of-function studies, during the period of deliberation, the U.S. Government will institute a pause on funding for any new studies that include certain gain-of-function experiments involving influenza, SARS, and MERS viruses. Specifically, the funding pause will apply to gain-of-function research projects that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route.

During this pause, the U.S. Government will not fund any new projects involving these experiments and encourages those currently conducting this type of work – whether federally funded or not – to voluntarily pause their research while risks and benefits are being reassessed. The funding pause will not apply to the characterization or testing of naturally occurring influenza, MERS, and SARS viruses unless there is a reasonable expectation that these tests would increase transmissibility or pathogenicity. 

The deliberative process will involve two distinct but complementary entities: the National Science Advisory Board for Biosecurity (NSABB) and the National Research Council (NRC) of the National Academies.

The NSABB will serve as the official Federal advisory body for providing advice on oversight of this area of dual-use research, in keeping with Federal rules and regulations. The NSABB will meet on October 22, 2014, to debate the issues and begin the process of developing recommendations.

Early-on in the deliberative process, the NRC will be asked to convene a scientific symposium focused on the issues associated with gain-of-function research. The NRC will also hold a second symposium later in the deliberative process, which will include a discussion of the NSABB’s draft recommendations regarding gain-of-function research. 

The NSABB, informed by discussion at the NRC public consultations, will provide recommendations to the heads of all federal entities that conduct, support, or have an interest in life sciences research.  The final NSABB recommendations as well as the outcomes of the NRC conferences will inform the development and adoption of a new U.S. Government policy regarding gain-of-function research. 

The broader life-sciences community will be encouraged to provide input through both the NRC and NSABB deliberative processes. The funding pause will end when the U.S. government has adopted a Federal policy regarding gain-of-function studies on the basis of the deliberative process described above, which is expected to occur 2015. 

• Read a statement by Francis Collins, Director of the National Institutes of Health (NIH) here.
• For additional information on the funding pause and the deliberative process, please see the U.S. Government is launching a deliberative process;
• For additional information on dual use research and gain of function studies, please visit: http://www.phe.gov/s3/dualuse.