Current U.S.

Government Policy on
Gain-of-Function Research
Andrew M. Hebbeler, Ph.D.
Assistant Director for Biological and Chemical Threats
Office of Science and Technology Policy
The White House

The Overarching Challenge

How can we reliably identify, and where
necessary, mitigate risks while protecting
scientific autonomy, discovery and
innovation, public health, national
security, and other critical interests
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U.S. Laboratory Incidents

June 13: Exposure of CDC employees
to potentially live anthrax

July 1: Smallpox discovery

at FDA/NIH campus

July 9: Contamination by
CDC of low-path H9N2
with high-path H5N1

June

July
2014

August

Federal Response to Lab Incidents

Several investigations to identify causes and contributing
factors
Activities by departments and agencies to strengthen
pathogen control and handling, biosafety, and laboratory
biosecurity
John Holdren and Lisa Monaco urged departments and
agencies to take specific steps to strengthen safety and
security in their memorandum entitled Enhancing Biosafety
and Biosecurity in the United States (August 18, 2014)
HHS asks the U.S. Government to consider re-evaluating the
risk/benefit ratio for conducting gain-of-function research
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Reassessing Gain-of-Function
Research
The recent laboratory incidents prompted a

reassessment of the risk/benefit calculus that underpins

funding for certain types of gain-of-function studies

Recent calls from multiple stakeholders for science-

based deliberation

Cambridge Working Group

Scientists for Science
European and other efforts

Highest concern for respiratory pathogens with

pandemic potential (MERS, SARS, and influenza)

U.S. Frameworks that Address GOF

HHS Framework for Highly Pathogenic Avian Influenza Research (2012)
USG Policy for Oversight of Life Sciences Dual Use Research of Concern
(March 29, 2012)
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic
Acid Molecules (November 2013)
USG Policy for Institutional Oversight of Life Sciences Dual Use Research
of Concern (September 24, 2014)

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Frameworks are available at www.phe.gov/s3

GOF Deliberative Process

On October 17th, the U.S.
Government announced the
launch of a deliberative process
to assess the potential risks
and benefits associated with
gain-of-function studies.
During the deliberative
process, the U.S. Government
instituted a pause on funding
for certain kinds of gain-offunction experiments involving
influenza, SARS, and MERS
viruses.

Key Voices in the U.S. Gain-ofFunction Deliberative Process

National Science Advisory Board for Biosecurity (NSABB)
Draft a set of recommendations on a conceptual approach to
the evaluation of proposed gain of function studies that will
be reviewed by the broader life sciences community
Serve as the official federal advisory body for providing advice
on oversight of this area of research to the HHS Secretary
National Academies
Convene two public conferences to facilitate broad discussion
of the issues associated with gain of function research, to
include discussion of the NSABB draft recommendations.
Provide summary of public discussions and feedback on the
forthcoming NSABB draft recommendations

Estimated Timeline*
Mid 2015 Late 2015

Late 2014 Early 2015

NSABB
deliberates
key features
of study
design

NSABB considers
National Academies
input & advises on
draft study design

NSABB periodically
assesses progress &
reviews preliminary
results

NSABB
reviews final
results

NSABB analyzes &

discusses results
Develops draft
recommendations

Conduct of Study
Study Design

National
Academies host
Public
Symposium to
discuss
assessment of
GOF research

National
Academies
provide
Symposium
Summary

Risk Assessment +
Benefit Assessment

Results of Study

NSABB delivers
final
recommendations
to USG

Weighing of Risks &

Benefits +
Development of
Recommendations

National Academies
host Public Symposium
to discuss NSABB draft
recommendations &
provide Symposium
Summary

USG GOF
Policy

*The USG intends for these efforts to occur as expeditiously as possible, and dates are subjects to change based on the deliberative process.

For More Information

Holdren/Monaco memorandum on Enhancing Biosafety and
Biosecurity in the United States (August 2014)

http://www.whitehouse.gov/sites/default/files/microsites/ostp/enhancing_biosafety_
and_biosecurity_19aug2014_final.pdf

U.S. Government Deliberative Process and Funding Pause on

Certain Types of Gain-of-Function Research (October 2014)
http://www.phe.gov/s3/dualuse/Pages/default.aspx

USG Policy for Oversight of Life Sciences Dual Use Research of

Concern (March 2012)
http://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf

USG Policy for Institutional Oversight of Life Sciences Dual Use

Research of Concern (September 2014)
http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf

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Charge to the Academies

Mary Groesch, PhD
Program on Biosecurity and Biosafety Policy
National Institutes of Health

Charge to the NRC

Provide a forum for broad public debate, which
will inform the NSABBs deliberations and the
development of USG policy on GOF research

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NRC Symposia
First Symposium (early in the deliberative process):
Examine the underlying scientific and technical
questions that are the source of current discussion
and debate over GOF research involving pathogens
with pandemic potential
Second Symposium (later in the deliberative process):
Discuss the NSABB draft recommendations regarding
GOF research
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Goals of the Symposia

The symposia will engage invited participants that represent a
diverse range of perspectives and expertise, including but not
limited to:

Public health & public health surveillance

Biosafety and biosecurity
Infectious disease research
Drug and vaccine development
International perspectives

The NRC will provide a summary within one month of each

symposium summarizing the salient points made during the
symposia. These summaries will inform NSABB and USG
deliberations

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First NRC Symposium

Topics to be addressed include principles and key
considerations in the design of risk and benefit
assessments of GOF research.
This will be informed by discussion of the following topics:
Potential benefits of the research
Potential risks associated with the research
Alternative methods that may be employed to yield similar
scientific insights and/or potential benefits, while reducing
potential risks

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