Funding Pause for Certain Types of Gain-of-Function Research Projects


Notice Number:

NOT-OD-15-011

Key Dates

Release Date:  October 17, 2014

Related Announcements

None

Issued by

National Institutes of Health (NIH)

Purpose

The purpose of this Guide Notice is to notify applicants that in accordance with the October 17 White House announcement, the National Institutes of Health is instituting a funding pause on the provision of new funding for certain gain-of-function research projects, Federal-wide, so that a deliberative process can be undertaken to assess the potential benefits and risks associated with these types of studies.

Background

The recent series of laboratory biosafety incidents at U.S. Government research facilities has caused the federal government to re-assess the risk/benefit calculus underpinning funding decisions for a certain subset of gain-of-function research involving agents that pose a significant risk to public health.

On October 17, 2014, the U.S. Government announced that it would be instituting a funding pause on gain-of-function research projects that reasonably may be anticipated to confer attributes to influenza, MERS, or SARS viruses such that the resulting virus has enhanced pathogenicity and/or transmissibility (via the respiratory route) in mammals.  In addition to the funding pause, the U.S. Government will undertake a deliberative process to assess the potential benefits and risks associated with these types of studies.  The results of the deliberative process will assist the U.S. Government in developing a framework that will guide future funding decisions. 

The funding pause does not apply to characterization or testing of naturally occurring influenza, MERS, and SARS viruses, unless these tests reasonably are anticipated to increase transmissibility or pathogenicity.  An exception to the funding pause may also be granted by the head of a federal funding agency if that official determines that the research is urgently necessary to protect public health or national security.  Lastly, the U.S. Government encourages the currently-funded research community to join in adopting a voluntary pause as well. 

Impact

NIH will continue to accept new applications for research projects involving gain-of-function studies, including those that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the resulting virus has enhanced pathogenicity and/or transmissibility (via the respiratory route) in mammals.  However, as described in the background section of this Guide Notice, NIH will not provide any new or continuation funding for research subject to the pause while the funding pause is in effect.   In cases where reviewers identify possible gain-of-function research as described above, this will be recorded as an administrative note, but the presence of such research in the application will not affect the impact scores. Program officials will then review the proposed research to determine if the research meets the above criteria, and work with the grantee and grants management officials, as appropriate, to determine how best to proceed, e.g., if the proposed research may be redirected to experiments that are not covered by the pause, etc. Ongoing NIH awards will be addressed with the grantees on a case-by-case basis. 

Inquiries

Please direct all inquiries to the Program Official that is listed in the Notice of Award under the Contacts Section.