A Pause in Funding Certain Types of Gain-of-Function Research

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The White House announced today that U.S. government agencies will institute a pause in the funding of new “gain-of-function” research on influenza, SARS, and MERS viruses that could increase the pathogenicity or transmissibility to mammals (also see NIH Guide Notice NOT-OD-15-011). During this funding pause, the government will carry out a deliberative process to assess the risks and benefits of such studies and will develop a new Federal policy regarding the funding of this research.

For those of you who may not be familiar with this topic, gain-of-function research refers to any modification of a biological agent — like viruses or bacteria — that gives it new or enhanced activity, such as the ability to infect a host. While research on factors that could increase transmission or infection can be important for informing prevention strategies, some information from these studies might also be misused for harmful purposes.

Over the past several years, there has been much debate in the scientific community over the risks and benefits of gain-of-function research. The most notable source of discussion in recent years involved two studies on H5N1 — commonly known as “bird flu” — that sought to identify genetic factors that could enhance its ability to infect mammals. Many questioned whether the research findings from these two studies should be made public, and whether this type of research should even be conducted in the first place. After a review by the National Science Advisory Board for Biosecurity (NSABB) — an independent expert committee that advises the U.S. Government on matters of biosecurity — the findings related to these two studies were eventually published. Following this controversy, the Department of Health and Human Services (HHS) developed a framework to guide funding decisions about research with highly pathogenic avian influenza H5N1 viruses.

Since the publication of the framework, gain-of-function studies have continued, as has the debate surrounding them. To address ongoing concerns in the community, the U.S. government will further assess the risks and benefits of such studies and will develop a new Federal policy regarding the funding of this research. While these deliberations are underway, NIH will not fund any new or continuing gain-of-function research on influenza, SARS, and MERS, and we encourage investigators who are currently conducting this type of work – whether federally funded or not – to pause their research voluntarily while the government determines how to proceed. We will keep you informed of new policy developments.

We also encourage you to view the NIH Director’s statement regarding this issue.

Amy Patterson, M.D., is NIH’s Associate Director for Biosecurity and Biosafety Policy.

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