Publishing Scientific Papers with Potential Security Risks: Issues for Congress
Congressional research reportMar 18, 2013
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Publishing Scientific Papers with Potential
Security Risks: Issues for Congress
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Specialist in Science and Technology Policy
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Specialist in Science and Technology Policy
March 18, 2013
Congressional Research Service
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www.crs.gov
R42606
CRS Report for Congress
Prepared for Members and Committees of Congress
Publishing Scientific Papers with Potential Security Risks: Issues for Congress
Summary
The federal government generally supports the publication of federally funded research results
because wide dissemination may drive innovation, job creation, technology development, and the
advance of science. However, some research results could also be used for malicious purposes.
Congress, the Administration, and other stakeholders are considering whether current policies
concerning publishing such research results sufficiently balances the potential benefits with the
potential harms. The current issues under debate cut across traditional policy areas, involving
simultaneous consideration of security, science, health, export, and international policy. Because
of the complexity of these issues, analysis according to one set of policy priorities may adversely
affect other policy priorities. For example, maximizing security may lead to detriments in public
health and scientific advancement, while maximizing scientific advancement may lead to security
risks. Accounting for such trade-offs may allow policymakers to establish regulatory frameworks
that more effectively maximize the benefits from such “dual-use,” i.e., potentially beneficial and
also potentially harmful, research while mitigating its potential risks.
The issue of balancing scientific publication with security concerns has a long historical context,
but the current consideration began in late 2011, when two groups of U.S. government-funded
scientists submitted papers to academic journals detailing genetic modifications that increase the
transmissibility of a deadly influenza strain. Although these research results may improve
pandemic influenza preparedness and response, they may also increase the probability that a
highly contagious and deadly influenza strain will be introduced, either accidently or deliberately,
into the human population. Stakeholders, including the Department of Health and Human
Services, the World Health Organization, journal publishers, and scientists, debated whether the
possible benefits of publication outweighed the potential harms. The editors of the scientific
journals decided to publish modified versions of both papers.
The controversy surrounding the publication of these influenza experiments revealed weaknesses
in the existing federal mechanisms to identify and balance potential benefits of life science
research and security trade-offs. Responding to these cases, the Administration released new
government-wide policies to address some of these flaws. These new policies establish roles for
federal funding agencies, institutions, and scientists to regularly review life science research
portfolios and develop methods to mitigate security risks.
It is not clear whether the 113th Congress will agree with the Administration that the new policies
sufficiently address all of the dual-use issues brought to light by this recent controversy. Congress
could decide to allow the new policies to be fully implemented before evaluating them.
Alternatively, Congress could require agencies to implement new, different processes to identify
potential research of concern prior to funding; require federal prepublication review of all
potential research of concern to establish appropriate limits on the distribution of the research
results; require federal licensing of researchers permitted to conduct such experiments and access
results; and limit such research to the most safe and secure laboratories. All of these options
might, however, reduce the number and quality of research studies undertaken.
This report describes the underlying controversy, the potential benefits and harms of publishing
these manuscripts, the actions taken by domestic and international stakeholders, and options that
may improve the way research is handled to minimize security concerns.
Congressional Research Service
Publishing Scientific Papers with Potential Security Risks: Issues for Congress
Contents
Introduction...................................................................................................................................... 1
Case Study: H5N1 Influenza Research ............................................................................................ 2
H5N1 Influenza in Nature ......................................................................................................... 2
H5N1 Influenza Experiments Under Debate ............................................................................. 3
Dual-Use Results ....................................................................................................................... 4
Balancing Potential Benefits and Harms ............................................................................. 4
Possible Benefits ................................................................................................................. 5
Possible Harms .......................................................................................................................... 5
Stakeholder Recommendations ................................................................................................. 6
National Science Advisory Board for Biosecurity (NSABB) ............................................. 7
World Health Organization.................................................................................................. 9
Department of Health and Human Services ........................................................................ 9
Scholarly Publishers .......................................................................................................... 11
Scientific Community ....................................................................................................... 11
Issues for Congress ........................................................................................................................ 12
Overseeing Dual-Use Life Science Research .......................................................................... 13
Publishing Dual-Use Research Results ................................................................................... 15
Prepublication Review and Export Control....................................................................... 15
Limited Access to Research Results.................................................................................. 16
Funding Dual-Use Research .................................................................................................... 17
Scope ....................................................................................................................................... 18
Options for Congress ..................................................................................................................... 19
Allow Current Policy Framework to Develop ......................................................................... 20
Change Current Policy Framework ......................................................................................... 20
Early Identification of Dual-Use Research of Concern..................................................... 20
Prepublication Review of Dual-Use Results ..................................................................... 21
Federal Licensing of Research .......................................................................................... 22
Increase Biosafety Level ................................................................................................... 23
Conclusion ..................................................................................................................................... 24
Contacts
Author Contact Information........................................................................................................... 24
Congressional Research Service
Publishing Scientific Papers with Potential Security Risks: Issues for Congress
Introduction
The federal government generally supports the open publication of unclassified, federally funded
research results. It does so because wide dissemination may drive innovation, job creation,
technology development, and the advance of science. Many federal grants and contracts
supporting scientific research urge the publication of research results. Only in cases where
security concerns rise to the level of classification does the federal government bar publication of
fundamental research. This current federal policy, established in National Security Decision
Directive 189, is that fundamental research results should be widely available, and that in the rare
case where it is necessary to restrict access, classification is the appropriate mechanism.1
Advances in technology that have lowered technical barriers in modern biological sciences,
making it easier for people, including potential adversaries, to reproduce biological experiments
raise questions whether the use of classification as the standard for determining the tradeoff
between dissemination and security.
Recent events regarding influenza research serve as a case study of the challenges the federal
government faces in balancing funding scientific discovery with limiting security concerns. In
late 2011, two groups of researchers receiving federal funding separately sought to publish
manuscripts in scientific journals describing their successful attempts to increase the
transmissibility of a highly pathogenic strain of influenza. This strain of influenza, H5N1, is
sometimes referred to as avian or bird flu in the popular press. It causes severe disease in humans,
but is not highly contagious between humans. The federal government moved first to restrict
publication of the manuscripts. Following additional discussions and deliberations, the federal
government recommended publishing modified versions of the manuscripts. Some stakeholders
believe the research results should not have been published. They assert that broad dissemination
of such research results increases the likelihood that a highly contagious form of the virus will be
introduced, either accidently or deliberately, into the human population. Others state that the
public health benefits from such research outweigh concerns regarding malicious use.
The H5N1 influenza research case study highlights the general tensions among stakeholders and
the ramifications of various federal actions and policies. The controversy surrounding the
decisions to publish these manuscripts highlights deficiencies in the federal decision-making
processes related to dual-use life science research.2 In addition, the debate about the publication
of scientific research with potential security implications cuts across multiple policy issues. These
include federal support of research, maintenance of homeland security, and the flow of research
information, and may require simultaneous consideration of security, science, health, export, and
international policy. Because of the complexity of these issues, analysis according to one set of
policy priorities may adversely affect other policy priorities. In addition, the controversy
surrounding the decision to publish these experiments has demonstrated flaws in the existing
mechanisms to identify and balance the potential public benefits and security trade-offs.
1
White House, Executive Office of the President, “National Policy on the Transfer of Scientific, Technical, and
Engineering Information,” National Security Decision Directive-189, 1985. For non-fundamental research, additional
mechanisms may be used to restrict dissemination, such as contract clauses related to release of information and export
controls.
2
For a historical perspective on the development of current policy framework, see Gerald L. Epstein, “Preventing
Biological Weapon Development Through the Governance of Life Science Research,” Biosecurity and Bioterrorism:
Biodefense Strategy, Practice, and Science, vol. 10, no. 1 (2012).
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Congress has acted in the past to restrict access to pathogens where it deemed the potential risk of
their misuse posed a greater threat than the benefits arising from unrestricted access.
Congressional policymakers may decide that research results in some areas pose similar risks and
may move to impose similar limits through a variety of mechanisms. Conversely, congressional
policymakers may determine the risks of information exchange insufficient to warrant additional
regulation.
This report describes the underlying controversy, the potential benefits and harms of publishing
these manuscripts, the actions taken by domestic and international stakeholders, and options to
improve the way research is handled to minimize security concerns.
Case Study: H5N1 Influenza Research
The ongoing controversy regarding the appropriateness of funding research on (and publishing
the results of) H5N1 influenza transmissibility serves as a case study for the broader challenges of
balancing the potential benefits and potential harms from such research. This section outlines the
presence of H5N1 influenza in nature; describes and discusses the transmissibility experiments
that led to the current policy debate; outlines the potential benefits and harms arising from the
conduct and publication of such research; and outlines the various recommendations and actions
from various governmental and non-governmental stakeholders.
H5N1 Influenza in Nature
Influenza is a virus that circulates through both human and animal populations. The form of the
influenza virus changes frequently. These changes produce various strains with differing
properties, including host species, levels of contagiousness, and severity of disease. Strains
harmless in one host may be deadly in another. Scientists and public health officials often refer to
different influenza virus strains through abbreviation. Influenza viruses have two specific diseaserelated proteins (H for hemagglutinin and N for neuraminidase), each of which have several
varieties denoted by different numbers. For example, the H1N1 influenza virus caused the 2007
“swine flu” human pandemic.
A different strain, the H5N1 influenza virus, commonly known as avian or bird flu, began
infecting people in China in 1997. This highly pathogenic strain had previously infected only
birds. In the initial outbreak, the virus infected 18 people, 6 of whom died.3 Since then, the virus
has spread internationally, infecting humans in at least 15 countries. As of February 2013, the
World Health Organization (WHO) has confirmed 615 human cases and 364 deaths from this H
5N1 influenza strain.4
Although highly contagious among birds, the H5N1 influenza virus does not pass easily between
people. Nearly all of the known human infections resulted from close contact with infected
poultry. However, because viruses constantly change, future versions of H5N1 influenza virus
3
World Health Organization, H5N1 Avian Influenza: Timeline of Major Events, December 17, 2012;
http://www.who.int/influenza/H5N1_avian_influenza_update_20121217b.pdf.
4
World Health Organization, Cumulative Number of Confirmed Human Cases for Avian Influenza A (H5N1) Reported
to WHO, 2003-2013, February 1, 2013. For the most current data available, see http://www.who.int/influenza/
human_animal_interface/H5N1_cumulative_table_archives/en/index.html.
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might be more contagious among humans. If the virus did become more contagious among
humans and also kept its disease-causing characteristics, a human pandemic with serious
disruptions in services and social order might occur. These potential consequences drive federal
investments in influenza pandemic preparedness activities, including research on various
influenza strains.
H5N1 Influenza Experiments Under Debate
While scientists know that H5N1 influenza strains naturally change over time, they do not yet
understand in detail how these specific changes lead to new viral properties. Gaps in our current
scientific understanding limit our ability to determine the likelihood of increased human-tohuman transmission.5 This likelihood could have important public health policy ramifications. For
instance, if these changes are likely to occur, then policymakers might increase H5N1 influenzarelated countermeasure development efforts. Conversely, if such changes are unlikely or
impossible, then policymakers might decrease such efforts or divert federal efforts into more
pressing threats.
The National Institute for Allergy and Infectious Disease (NIAID) funded multiple researchers to
determine the genetic changes that would cause H5N1 strains to become more transmissible
among humans. Dr. Yoshihiro Kawaoka, based at the University of Wisconsin-Madison, and Dr.
Ron Fouchier, based at the Erasmus Medical Center in Rotterdam, the Netherlands, each led
research groups that successfully determined such changes. Both groups used ferret-to-ferret
transmission to model human-to-human transmission.6 Independently, and using different
methods, each group found specific genetic changes to the H5N1 influenza virus that make it
transmissible through the air between ferrets in separate cages.
Dr. Kawaoka’s group used standard molecular biological techniques to create a ferret-to-ferret
transmissible H5N1 virus. The scientists took the H1N1 virus that caused the 2009 human
pandemic and replaced the H1 portion with a genetically modified version of the H5 portion from
an H5N1 strain. This hybrid version passed between ferrets housed in separate cages. However,
this new virus, unlike the naturally occurring H5N1 virus, did not kill the ferrets. Additionally, his
group found that current vaccines and antiviral medications are effective against this new hybrid
strain.7
Dr. Fouchier’s group directly infected ferrets with a genetically modified H5N1 virus. After the
ferret became sick, virus from the sick ferret was used to directly infect another ferret. After
multiple iterations, the H5N1 virus had changed sufficiently to become transmissible between
5
Li-Mei Chen, Ola Blixt, and James Stevens et al., “In Vitro Evolution of H5N1 Avian Influenza Virus Toward
Human-Type Receptor Specificity,” Virology, vol. 422 (November 5, 2011), pp. 105-113; and Martin Enserink,
“Controversial Studies Give Deadly Flu Virus Wings,” Science, vol. 334 (December 2, 2011), p. 1192.
6
Most scientists agree that ferrets are an appropriate animal model for such studies; however, the new viruses may act
differently in humans. They may have different transmissibility or disease severity in humans than they do in ferrets.
See Anthony S. Fauci and Francis S. Collins, “Benefits and Risks of Influenza Research: Lessons Learned,” Science,
vol. 336 (June 22, 2012), pp. 1522-1523.
7
Yoshihiro Kawaoka, “Flu Transmission Work Is Urgent,” Nature, published online January 25, 2012,
http://www.nature.com/nature/journal/vaop/ncurrent/full/nature10884.html; and Masaki Imai, Tokiko Watanabe,
Masato Hatta et al., “Experimental Adaptation of an Influenza H5 HA Confers Respiratory Droplet Transmission to a
Reassortant H5 HA/H1N1 Virus in Ferrets,” Nature, published online May 2, 2012, http://www.nature.com/nature/
journal/vaop/ncurrent/full/nature10831.html.
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ferrets in separate cages.8 The scientists determined five specific genetic changes were sufficient
to convey airborne transmissibility among ferrets. They found that this new strain of H5N1 virus
was less transmissible and caused a less severe disease than naturally occurring seasonal
influenza. Additionally, ferrets previously exposed to seasonal flu were immune to infection with
the new H5N1 virus.9
The two groups submitted manuscripts to different scholarly journals. In both cases, the
submission was to a publisher not based in the country where the experiments were performed.
Dr. Kawaoka submitted his research conducted in the United States to the United Kingdom
journal, Nature. Dr. Fouchier submitted his research conducted in the Netherlands to the U.S.
journal, Science.
Dual-Use Results
The Department of Health and Human Services (HHS) deemed the manuscripts from these two
groups as the results of “dual-use” research. In this context, this term describes information or
technologies that have the potential to both help and harm society.10 The HHS defines dual-use
biological research as “biological research with legitimate scientific purpose that may be misused
to pose a biologic threat to public health and/or national security.”11
Balancing Potential Benefits and Harms
Policymakers and stakeholders face difficult calculations when trying to balance the potential
benefits of this research against potential harms. Most public health experts agree that an
influenza pandemic, of some nature, will occur at some indeterminate time in the future. Research
on the influenza virus may provide ways to mitigate the effects of such a pandemic. However,
most experts also agree that such research also increases the risk that an influenza pandemic
could occur through accidental or deliberate release of a modified virus.12 The disagreement
among experts largely lies in the relative probabilities of these events. No universally accepted
method exists to precisely determine these probabilities, and analysts may arrive at different, but
equally valid, conclusions.
8
Sander Herfst, Eefje J.A. Schrauwen, and Martin Linster et al., “Airborne Transmission of Influenza A/H5N1 Virus
between Ferrets,” Science, vol. 336 (June 22, 2012), pp. 1534-1541.
9
Ron Fouchier, “H5N1 Research Discussion,” Panel discussion at the American Society for Microbiology Biodefense
and Emerging Infectious Disease Research Meeting, Washington, DC, February 29, 2012,
http://www.asmbiodefense.org/index.php/program-information/nsabbs-recommendations-for-h5n1-research; and
Sander Herfst, Eefje J.A. Schrauwen, and Martin Linster et al., “Airborne Transmission of Influenza A/H5N1 Virus
Between Ferrets,” Science, vol. 336 (June 22, 2012), pp. 1534-1541.
10
Historically, the term “dual-use” has referred to technologies that have both a military and a civilian application.
11
Department of Health and Human Services, National Science Advisory Board for Biosecurity Charter, March 4,
2004.
12
Declan Butler, “Fears Grow over Lab-bred Flu,” Nature, vol. 480 (December 22, 2011), pp. 421–422; and Marc
Lipsitch, Joshua B. Plotkin, and Lone Simonsen et al., “Evolution, Safety, and Highly Pathogenic Influenza Viruses,”
Science, vol. 336 (June 22, 2012), pp. 1529-1531.
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Possible Benefits
These H5N1 influenza research results provided previously unknown scientific information. In
particular, this research identified some of the genes involved in transmitting the disease between
mammals. Future experiments may build upon these results to further scientific understanding of
how influenza virus causes disease in different animals. Such experiments could create new
approaches to treating and preventing the disease.13 Prior to this work, scientists did not know
whether H5N1 virus could ever become easily transmissible between humans, and if so, how
likely it would be to occur.14 As discussed above, both groups found that some H5N1 viruses are
transmitted through the air between ferrets.
Additionally, the five genetic changes that Dr. Fouchier’s group found sufficient to cause
mammalian transmissibility have each been identified in naturally occurring H5N1 viruses.15 This
suggests the possibility that all five could appear in the same strain through natural processes.
This observation has led some experts to suggest that looking for these five genetic changes
together in nature may provide advanced warning of a coming pandemic.16 Other experts suggest
that current surveillance efforts are inadequate for this task. Additionally, focusing specifically on
these genetic changes may cause researchers to miss other genetic changes that would also cause
the virus to become transmissible between humans.17 Dr. Kawaoka suggested a slightly different
strategy, “rather than watching for specific genetic changes, it is more important to scan for the
traits they bestow.”18 That type of surveillance might identify strains with human pandemic
potential without relying on a list of known genetic changes associated with human transmission.
Current surveillance efforts might require enhancement to perform such activity.
Possible Harms
Some observers believe that the H5N1 influenza research could create new threats to public
health and homeland security. These threats might arise from accidental or deliberate release of H
5N1 virus from a laboratory or use of the information in the published manuscripts for malicious
purposes.
Possible harm from conducting these types of experiments could come from several different
mechanisms. Some observers worry that modified H5N1 virus might escape from laboratories
causing a human pandemic.19 Some of these experts assert that research that increases
13
Ron A.M. Fouchier, Sander Herfst, and Albert D.M.E. Osterhaus, “Restricted Data on Influenza H5N1 Virus
Transmission,” Science, vol. 335 (February 10, 2012), pp. 662-663; and Masaki Imai, Tokiko Watanabe, Masato Hatta
et al., “Experimental Adaptation of an Influenza H5 HA Confers Respiratory Droplet Transmission to a Reassortant H5
HA/H1N1 Virus in Ferrets,” Nature, published online May 2, 2012, http://www.nature.com/nature/journal/vaop/
ncurrent/full/nature10831.html.
14
National Science Advisory Board for Biosecurity, “Policy: Adaptations of Avian Flu Virus Are a Cause for
Concern,” Nature, vol. 482 (January 31, 2012), pp. 153–154.
15
Declan Butler, “Caution Urged for Mutant Flu Work,” Nature, vol. 481 (January 25, 2012), pp.421-422; and Sander
Herfst, Eefje J.A. Schrauwen, and Martin Linster et al., “Airborne Transmission of Influenza A/H5N1 Virus Between
Ferrets,” Science, vol. 336 (June 22, 2012), pp. 1534-1541.
16
Declan Butler, “Caution Urged for Mutant Flu Work,” Nature, vol. 481 (January 25, 2012), pp.421-422.
17
Paul S. Keim, “Q&A: Reasons for Proposed Redaction of Flu Paper,” Nature, published online January 31, 2012,
http://www.nature.com/nature/journal/vaop/ncurrent/full/482156a.html.
18
Ed Yong, “Mutant-flu Paper Published,” Nature, vol. 485 (May 3, 2012), pp. 13-14.
19
Lynn Klotz and Ed Sylvester, “Worry About Lab Infections,” Nature, vol. 481 (January 15, 2012), pp. 257-259;
(continued...)
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contagiousness or disease severity should not be done because of the danger posed by possible
release. Although it is not possible to accurately predict how a modified virus would affect
humans, some analysts warn that the 1918 influenza pandemic, which had devastating social
effects, was caused by a virus with a lower fatality rate than unmodified H5N1. They assert that
the potential harm from a pandemic outweighs any possible benefits from the research.20 Other
observers assert that this work can be safely conducted using appropriate precautions. For
example, Dr. Fouchier and Dr. Kawaoka performed these experiments following widely accepted
guidelines established by the National Institutes of Health (NIH) for working with potentially
dangerous pathogens. However, even laboratories licensed by the Centers for Disease Control and
Prevention for work with “select agents,” dangerous regulated pathogens, have known accidental
releases.21
Other potential harms could come from adversaries. Experts on a federal biosecurity advisory
board highlight the possibility that published research could provide adversaries a “roadmap” to
create a bioweapon.22 In general, scientific publication provides enough information so that the
experiments can be replicated. Such independent verification is a cornerstone of modern science.
However, experiments could be replicated for malicious purposes by those lacking sufficient skill
or experience to perform the original research. It is difficult to assess the risks posed by
publishing dual-use research results in general. In the present case of the H5N1 influenza
manuscripts, modifying the virus independently would require additional technical knowledge
and skill even with publication of experimental methods. In addition, the transmissibility and
severity of the disease from the modified H5N1 virus is unknown. On the other hand, if the
modified virus were highly transmissible between people and caused severe disease, it could
cause a pandemic with devastating societal effects. Given the potential effects, it is conceivable
that some adversary might attempt to use these research results for malicious purposes.
Stakeholder Recommendations
As information about the modified H5N1 influenza research results spread, various stakeholders
debated the merits of their publication. Domestic and international groups deliberated ethical,
scientific, and security issues and made recommendations concerning publication. The National
Science Advisory Board for Biosecurity (NSABB) issued recommendations adopted by HHS.
The World Health Organization (WHO) also issued recommendations. Science magazine,
published by the American Association for the Advancement of Science (AAAS), issued
statements and agreed to consider recommendations from other stakeholders. The U.K. magazine
Nature agreed to consider other stakeholder recommendations prior to publication. Many
(...continued)
Thomas Inglesby, “Engineered H5N1: A Rare Time for Restraint in Science,” Annals of Internal Medicine, vol. 156
(March 20, 2012), pp. 460-462; and Marc Lipsitch, Joshua B. Plotkin, and Lone Simonsen et al., “Evolution, Safety,
and Highly Pathogenic Influenza Viruses,” Science, vol. 336 (June 22, 2012), pp. 1529-1531.
20
Thomas Inglesby, “Engineered H5N1: A Rare Time for Restraint in Science,” Annals of Internal Medicine, vol. 156
(March 20, 2012), pp. 460-462; Lynn Klotz and Ed Sylvester, “Worry About Lab Infections,” Nature, vol. 481
(January 15, 2012), pp. 257-259.
21
For more information, see Richard D. Henkel, Thomas Miller, and Robbin S. Weyant, “Monitoring Select Agent
Theft, Loss and Release Reports in the United States—2004-2010,” Applied Biosafety, Vol. 17, No. 4, 2012, pp. 171180.
22
National Science Advisory Board for Biosecurity, “Policy: Adaptations of Avian Flu Virus Are a Cause for
Concern,” Nature, vol. 482 (January 31, 2012), pp. 153–154.
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prominent international influenza scientists agreed to temporarily suspend certain influenza
research to provide public policymakers time to consider issues raised by this research.23 The
following section summarizes various stakeholder position and concerns.
National Science Advisory Board for Biosecurity (NSABB)
The NSABB is the primary federal scientific board with responsibility for issues of biosecurity. It
consists of experts in biological sciences, law, security, and other areas. Federal officials
representing agencies that fund life science research serve as non-voting members. Its
responsibilities include advising the Secretary of Health and Human Services and providing
guidance to life scientists on dual-use research and other biosecurity issues.24
Prior to the debate about the H5N1 influenza research results, the NSABB recommended a
framework to help the federal government develop a comprehensive system for the “responsible
identification, review, conduct, and communication of dual-use research.”25 It established certain
categories of research that should draw additional attention and review. It termed this research
“dual-use research of concern.” The NSABB provided guidance on how to identify dual-use
research of concern, recommended that individual researchers and institutions evaluate research
projects for potential dual-use aspects, and identified possible ways to reduce potential harmful
results of their research. However, when the H5N1 influenza research manuscripts neared
publication, the federal government had yet to develop and implement a comprehensive, effective
system for oversight of dual-use research of concern. As part of its advisory duties, the NSABB
reviewed the submitted manuscripts and issued recommendations.
First Review
In October 2011, the NSABB initially reviewed the manuscripts. It found “that there was
significant potential for harm in fully publishing these results and that the harm exceeded the
benefits of publication.”26 The NSABB recommended that HHS ask the manuscript authors and
the journal editors to redact certain portions of the manuscripts. Due to the importance of the
findings to the public health and research communities, the NSABB recommended publishing the
general conclusions but excluding the methodological and other details that could enable
replication of the experiments. The NSABB also recommended adding to the manuscripts
additional explanation of the goals and potential public health benefits of the research and the
extensive safety and security measures taken to protect laboratory workers and the public. Also,
the NSABB recommended that the U.S. government develop a mechanism for providing select
access to the redacted information, stating “In order to manage the risks posed by communicating
23
Ron A. M. Fouchier, Adolfo García-Sastre, and Yoshihiro Kawaoka et al., “Pause on Avian Flu Transmission
Studies,” Nature, vol. 481 (January 26, 2012), p. 443; and World Health Organization, Report on Technical
Consultation on H5N1 Research Issues, February 16, 2012, p.4, http://www.who.int/influenza/
human_animal_interface/mtg_report_h5n1.pdf.
24
For more information on the NSABB responsibilities, see Department of Health and Human Services, Charter of the
National Science Advisory Board for Biosecurity, April 4, 2012, http://oba.od.nih.gov/biosecurity/PDF/NSABBCharter_Signed_2012.pdf.
25
National Science Advisory Board for Biosecurity, “Proposed Framework for the Oversight of Dual-Use Life
Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information,” June 2007.
26
National Science Advisory Board for Biosecurity, “Policy: Adaptations of Avian Flu Virus Are a Cause for
Concern,” Nature, vol. 482 (January 31, 2012), pp. 153–154.
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future cases of dual-use research of concern, the Board strongly urges the U.S. Government to
develop in an expeditious manner a practical and secure mechanism for sharing sensitive
scientific information in order to support public health, safety, and security efforts.”27 In such a
manner, those scientists requiring access to the sensitive portions of the manuscripts might gain
access, while the broader public and scientific community would be excluded.
Following weeks of debate among other stakeholders, including the World Health Organization
(see “World Health Organization” below), it became apparent that other stakeholders did not
share the NSABB view. Also, practical concerns regarding the ability to establish a limited
distribution network for methodological details and the ramifications of such a structure on
obligations to share information derived from international influenza virus samples spurred an
additional review by the NSABB. The NIH requested that the manuscript authors submit revised
manuscripts reflecting additional information presented during the evolving stakeholder debate to
the NSABB.
Second Review
In April 2012, following a second review of the manuscripts, the NSABB reversed its earlier
position, recommending the publication of both manuscripts. The members of the NSABB
unanimously supported the full publication of the Kawaoka manuscript. The panel also
recommended the publication of a revised version of the Fouchier manuscript on a 12-6 vote. The
panel stated that it reversed its earlier recommendations on the basis of “additional information in
the revised manuscripts, new non-public epidemiological information, and security information
… presented in a classified briefing.”28 The majority of the panel concluded that the data would
not immediately threaten public health or national security, the data may benefit public health and
surveillance efforts, and the research was conducted under appropriate biosafety conditions.
Factors the NSABB considered during the second review included how a decision not to fully
publish would affect pandemic preparedness activities,29 influenza research, and international
relations.30 The NSABB did not state the relative importance of these factors in reaching its
decision.
One of the members who disagreed with the majority opinion on the Fouchier manuscript
decision outlined his dissent in a letter to National Institutes of Health Office of Science Policy.31
27
National Science Advisory Board for Biosecurity, Findings and Recommendations, March 29-30, 2012, p. 6,
http://www.nih.gov/about/director/03302012_NSABB_Recommendations.pdf.
28
National Science Advisory Board for Biosecurity, Findings and Recommendations, March 29-30, 2012, p. 2,
http://www.nih.gov/about/director/03302012_NSABB_Recommendations.pdf.
29
Robert Webster, “Case Study: H5N1 Avian Influenza,” Presentation at National Academies of Science Workshop
“Issues Raised, Lessons Learned, and Paths Forward for Dual-Use Research in the Life Sciences: The H5N1
Controversy,” Washington, DC, May 1, 2012, http://sites.nationalacademies.org/PGA/stl/H5N1/index.htm.
30
Testimony of Paul S. Keim, Ph.D., Acting Chairman, National Science Advisory Board for Biosecurity, National
Institutes of Health, U.S. Department of Health and Human Services, before the Senate Committee on Homeland
Security and Governmental Affairs, April 26, 2012.
31
Letter from Michael T. Osterholm, Director of the Center for Infectious Disease Research and Policy, to Amy P.
Patterson, Associate Director for Science Policy, National Institutes of Health, April 12, 2012,
http://news.sciencemag.org/scienceinsider/NSABB%20letter%20final%2041212_3.pdf.
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He believes that a flawed NSABB review process produced flawed decisions. The NIH wrote a
letter to respond to his assertions.32
World Health Organization
The World Health Organization (WHO) is the primary international forum for coordinating
worldwide influenza pandemic preparedness efforts. In February 2012, after the first NSABB
review but before the second, the WHO convened a small group of public health and influenza
experts to discuss the publication of the H5N1 influenza manuscripts. This group of experts
determined that the potential benefits of publishing the results outweighed the risks. This panel
recommended publishing the results without redaction but advocated for the development of a
focused communications plan. This plan would aim to increase public awareness and
understanding of the significance of the H5N1 influenza studies, the rationale for their
publication, and their essential biosafety and biosecurity aspects.33
Like the NSABB, the WHO panel discussed the concept of publishing redacted manuscripts with
a mechanism for providing the restricted information to legitimate recipients. However, the WHO
panel identified complications with the creation of such a mechanism due to international
agreements and national legislation.34 One germane international agreement is the Pandemic
Influenza Preparedness (PIP) Framework. This agreement links international access to influenza
virus samples with sharing the benefits from research done with those samples. Some donor
countries might interpret efforts to restrict access to research results as counter to the PIP
Framework, possibly decreasing those countries’ willingness to share virus strains.
Department of Health and Human Services
The HHS charters and oversees the NSABB and adopted both sets of NSABB recommendations.
Because the recommendations of the NSABB evolved over time, the actions and positions taken
by HHS also changed. Even though HHS, through NIH, had funded the H5N1 influenza research,
HHS actions were in response to the proposed publication of the research results by domestic and
foreign publishers. The HHS has no authority over publisher activities, and a previous attempt by
HHS to discourage a scientific journal from publishing a manuscript with security concerns had
been unsuccessful.35
The HHS endorsed the NSABB recommendations following the first review and issued them to
both the manuscript authors and the journal editors. The HHS also stated that the U.S.
government would work “to establish a mechanism to allow secure access to the information to
those with a legitimate need in order to achieve important public health goals. The U.S.
32
Letter from Amy P. Patterson, Associate Director for Science Policy, National Institutes of Health, to Michael T.
Osterholm, Director of the Center for Infectious Disease Research and Policy, April 25, 2012, http://blogs.nature.com/
news/files/2012/05/Response-to-Dr-Osterholm-04-25-2012.pdf.
33
World Health Organization, Report on Technical Consultation on H5N1 Research Issues, February 16, 2012, p.3,
http://www.who.int/influenza/human_animal_interface/mtg_report_h5n1.pdf.
34
World Health Organization, Report on Technical Consultation on H5N1 Research Issues, February 16, 2012, p.4,
http://www.who.int/influenza/human_animal_interface/mtg_report_h5n1.pdf.
35
Jocelyn Kaiser, “PNAS Publishes Botulinum Paper,” Science, vol. 309, July 1, 2005, p. 31.
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government is also developing a proposed oversight policy that would augment existing
approaches to evaluating research that has the potential to be misused for harmful purposes.”36
As the debate on the H5N1 influenza manuscripts progressed, HHS continued to respond to
developments. When scientists declared a temporary moratorium on H5N1 influenza research
(see “Scientific Community” below), HHS announced that U.S. government agencies that
conduct or fund such research would also abide by this moratorium.37 Following the February
2012 WHO meeting, in which HHS representatives participated, HHS continued “to stand by the
December 2011 recommendations of the National Science Advisory Board for Biosecurity
(NSABB) but we intend to consider carefully the information discussed during the WHO-hosted
meeting.”38
According to NIH, the WHO-hosted meeting revealed additional information about the
manuscripts. This led NIH to request that the authors submit to the NSABB revised manuscripts
reflecting this information. When the NSABB recommendation changed from withholding at
least part of the manuscripts to publishing the manuscripts, the HHS recommendations also
changed. The HHS concurred with the new NSABB recommendation that the information in the
manuscripts be communicated fully. The HHS Secretary and the NIH Director conveyed this
concurrence to the journals.39
In addition, the White House Office of Science and Technology Policy (OSTP) released through
HHS a new policy on dual-use life sciences research (see “Overseeing Dual-Use Life Science
Research” below). The HHS stated that
the recently released Federal policy on dual-use research of concern is an important step in
enhancing the oversight of federally funded life sciences research going forward. Through
implementation of this policy, the U.S. Government aims to preserve the benefits of vitally
important life sciences research that holds the promise of enhancing quality of life for all of
us, while minimizing the possibility that the knowledge, information, products, or
technologies provided by such research could be misused for harm.40
In addition, HHS developed a new policy framework that will guide its funding decisions for
research proposals that may create H5N1 influenza virus strains that may be airborne
transmissible between mammals.41
36
National Institutes of Health, Department of Health and Human Services, Press Statement on the NSABB Review of
H5N1 Research, December 20, 2011.
37
Francis S. Collins, Director, National Institutes of Health, Department of Health and Human Services, and Anthony
S. Fauci, Director, National Institute of Allergy and Infectious Diseases, Department of Health and Human Services,
NIH Statement on H5N1, January 20, 2012.
38
Francis S. Collins, Director, National Institutes of Health, Department of Health and Human Services, NIH Statement
on H5N1 and the World Health Organization Meeting, February 17, 2012.
39
Francis S. Collins, Director, National Institutes of Health, Department of Health and Human Services, Statement by
NIH Director Francis Collins, M.D., Ph.D. on the NSABB Review of Revised H5N1 Manuscripts, April 20, 2012.
40
Francis S. Collins, Director, National Institutes of Health, Department of Health and Human Services, Statement by
NIH Director Francis Collins, M.D., Ph.D. on the NSABB Review of Revised H5N1 Manuscripts, April 20, 2012.
41
U.S. Department of Health and Human Services, A Framework for Guiding U.S. Department of Health and Human
Services Funding Decisions About Research Proposals with the Potential for Generating Highly Pathogenic Avian
Influenza H5N1 Viruses That Are Transmissible Among Mammals by Respiratory Droplets, February 2013,
http://www.phe.gov/s3/dualuse/Documents/funding-hpai-h5n1.pdf; Amy P. Patterson, Lawrence A. Tabak, and
Anthony S. Fauci, et al., “A Framework for Decisions About Research with HPAI H5N1 Viruses,” Science, vol. 339
(continued...)
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Scholarly Publishers
As previously noted, Dr. Kawaoka and Dr. Fouchier submitted their manuscripts to the journals
Nature and Science respectively. Both publishers of these journals voluntarily delayed publication
of the submitted manuscripts while discussion and debate occurred. Neither journal publisher was
under a mandate not to publish; the recommendations of government bodies were not binding.
Both journals published the manuscripts after the NSABB changed its recommendation.42
Since 2003, many journal editors and publishers have voluntarily adopted the responsibility of
weighing the dual-use implications of submitted manuscripts.43 These journal editors screen,
review, and potentially reject manuscripts on the basis of their weapons potential. The editors
developed this policy during an earlier dual-use research result publication controversy; this
occurred while the federal government was considering imposing new requirements through
legislation or regulation.
The voluntary nature of the publisher review and the ability of a publisher to ignore non-binding
government recommendations may raise questions about the efficacy of such a process. For
example, the editors of Nature emphasized that although they voluntarily delayed publication
while NSABB and WHO considered the manuscripts, they were not bound by any external
recommendations. Rather, their decision to publish or not was based on internal considerations.
The journal commissioned an independent risk and benefit assessment that concluded the paper
should be published in full. Furthermore, the editors concluded that they will not consider
redacting key details from any paper or limiting access to select recipients in the future.44
Relying on an editor-based effort, such as the Nature example above, might not sufficiently
address the federal government’s security concerns. Even a consensus protocol for handling dualuse research results that addresses the U.S. government’s national security concerns may not stop
such information from entering the open literature. The competitive, international nature of
scientific publishing may lead foreign journals that lack such a protocol to legally acquire and
publish material prohibited from domestic publication. Finally, with the growing ability to
disseminate scientific information to a wide audience online without resorting to formal
publication, the effectiveness of a publisher-based policy in restricting the dissemination of
contentious research is an open question.
Scientific Community
The scientific community split over the decision whether to publish the H5N1 influenza
manuscripts. Some scientists supported publishing redacted versions. Others argued for full and
(...continued)
(March 1, 2013), pp. 1036-1037; and David Malakoff and Martin Enserink, “New U.S. Rules Increase Oversight of H
5N1 Studies, Other Risky Science,” Science, vol. 339 (March 1, 2013), p. 1025.
42
Masaki Imai, Tokiko Watanabe, Masato Hatta et al., “Experimental Adaptation of an Influenza H5 HA Confers
Respiratory Droplet Transmission to a Reassortant H5 HA/H1N1 Virus in Ferrets,” Nature, published online May 2,
2012; and Sander Herfst, Eefje J.A. Schrauwen, and Martin Linster et al., “Airborne Transmission of Influenza A/H
5N1 Virus Between Ferrets,” Science, vol. 336 (June 22, 2012), pp. 1534-1541.
43
Journal Editors and Authors Group, “Uncensored Exchange of Scientific Results,” Proceedings of the National
Academy of Science, vol. 100, February 18, 2003, p. 1464.
44
Editorial, “Publishing Risky Research,” Nature, published online May 2, 2012.
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open publication. Many prominent influenza researchers, including those that conducted the
experiments in question, agreed to a voluntary moratorium on research into modified H5N1
influenza transmission to allow some discussion of the policy issues.45 This moratorium ended in
January 2013.46
Some experts view this moratorium as similar to that enacted in the 1970s over genetic
engineering and recombination.47 At that time, scientists responded to criticism and public
pressure by establishing a voluntary moratorium on such research. In 1975, at the Asilomar
conference center in Pacific Grove, CA, scientists developed a consensus statement regarding a
voluntary moratorium on some types of recombinant DNA research and an increase in security
and containment requirements for other research areas. The statement and accompanying
moratorium successfully allayed many, but not all, public concerns and provided a uniform
framework to address such issues. This consensus statement became the starting point for
research rules developed by the National Institutes of Health Recombinant DNA Advisory
Committee, which was formed to oversee such research.48 With respect to H5N1 influenza
transmissibility research though, all stakeholders have not reached consensus regarding
appropriate controls, emerging government policy notwithstanding.49
Issues for Congress
The H5N1 influenza research case study highlights the general tensions among stakeholders and
the ramifications of various federal actions and policies. The controversy surrounding the
decisions to publish these manuscripts highlights deficiencies in the federal decision-making
processes related to dual-use life science research.50 Congressional policymakers may face many
issues when considering research with potential security risks, especially in the life sciences.
These issues include the appropriate federal government role in overseeing, funding, and
publishing dual-use research activities.
45
Ron A. M. Fouchier, Adolfo García-Sastre, and Yoshihiro Kawaoka et al., “Pause on Avian Flu Transmission
Studies,” Nature, vol. 481 (January 26, 2012), p. 443; and World Health Organization, Report on Technical
Consultation on H5N1 Research Issues, February 16, 2012, p.4, http://www.who.int/influenza/
human_animal_interface/mtg_report_h5n1.pdf.
46
Ron A. M. Fouchier, Adolfo García-Sastre, Yoshihiro Kawaoka, et al., “Transmission Studies Resume for Avian
Flu,” Science, Vol. 339 (February 1, 2013), pp. 520-52; and Ron A. M. Fouchier, Adolfo García-Sastre, Yoshihiro
Kawaoka, et al., “H5N1 Virus: Transmission Studies Resume for Avian Flu,” Nature, Vol. 493 (January 31, 2013), p.
609.
47
Paul S. Keim, “Q&A: Reasons for Proposed Redaction of Flu Paper,” Nature, published online January 31, 2012,
http://www.nature.com/nature/journal/v482/n7384/full/482156a.html.
48
An overview of the Asilomar conference can be read in Donald S. Fredrickson’s “Asilomar and Recombinant DNA:
The End of the Beginning,” found in Biomedical Politics (Washington, DC: National Academy Press), 1991, pp. 258298.
49
Editorial, “Vigilance Needed: Experiments That Make Deadly Pathogens More Dangerous Demand the Utmost
Scrutiny,” Nature, vol. 493 (January 24, 2013), pp. 451-452.
50
For a historical perspective on the development of current policy framework, see Gerald L. Epstein, “Preventing
Biological Weapon Development Through the Governance of Life Science Research,” Biosecurity and Bioterrorism:
Biodefense Strategy, Practice, and Science, vol. 10, no. 1 (2012).
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Overseeing Dual-Use Life Science Research
The federal government funds a variety of life science research activities. The private sector
performs much of these activities, which are funded via contracts and grants. It performs
oversight of these activities through standard procedures and protocols generally identified as
contract or grant terms and conditions. Examples of such terms and conditions include regularly
issuing technical and business reports to program managers regarding the expenditure of federal
funds and complying with generally accepted best practices.
Federal agencies funding life science research do not systematically review all research-related
activities, such as publication, for dual-use ramifications. To review all such activities for all
federally supported life science research would place enormous burdens on the research
community and the federal government. However, the current controversy highlights the flaws in
the current processes to identify and mitigate potential security risks associated with performing
some research. Even though both H5N1 influenza researchers received federal funding, NIH, the
funding agency, was unaware of the dual-use nature of the actual results until the manuscripts
were submitted for publication.
To help correct perceived flaws in agency process, the Administration issued new policy for
federal agencies titled “United States Government Policy for Oversight of Life Sciences DualUse Research of Concern” on March 28, 2012.51 This new policy aims to
establish regular review of United States Government funded or conducted research with
certain high-consequence pathogens and toxins for its potential to be dual-use research of
concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect information
needed to inform the development of an updated policy, as needed, for the oversight of
DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences
research while minimizing the risk of misuse of the knowledge, information, products, or
technologies provided by such research.52
This new policy for federal agencies defines “dual-use research of concern” as specified types of
experiments using specified pathogens or toxins that “can be reasonably anticipated to provide
knowledge, information, products, or technologies that could be directly misapplied to pose a
significant threat with broad potential consequences to public health and safety, agricultural crops
and other plants, animals, the environment, material or national security.”53 Seven types of
experiments are subject to this policy, and the pathogens and toxins covered by this policy are
also regulated as select agents.54
This new policy requires every federal department and agency to review all sponsored life science
research projects and identify those that meet the dual-use research of concern criteria. The
sponsoring agency must “assess the risks and benefits of such projects, including how research
methodologies may generate risks and/or whether open access to the knowledge, information,
51
United States Government Policy for Oversight of Life Sciences Dual-Use Research of Concern, March 28, 2012.
http://oba.od.nih.gov/oba/biosecurity/pdf/
united_states_government_policy_for_oversight_of_durc_final_version_032812.pdf.
52
Ibid.
53
Ibid.
54
The possession, use, and transfer of all of the pathogens and toxins covered by this policy are also subject to the
select agent regulations (see 7 C.F.R. 331, 9 C.F.R. 121, 42 C.F.R. 72, and 42 C.F.R. 73).
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products, or technologies generates risk.”55 This policy directed departments and agencies to
report the results of their reviews to the Assistant to the President for Homeland Security and
Counterterrorism within 90 days and then biannually.
Based on this assessment, and in collaboration with the institution or researcher, the agency must
develop a risk mitigation plan. When appropriate, the agency is to incorporate the risk mitigation
plan into the grant, contract, or work agreement with the researcher. For existing projects, the
agency should consider modifying the existing agreement or seek voluntary implementation of
the risk mitigation plan. For proposed projects that have not yet been funded, the agency is to
consider incorporating a risk mitigation plan into the grant, contract, or agreement. The policy
does not require specific risk mitigation procedures, but contains examples, such as modifying the
design or conduct of the research; performing periodic progress reviews by the agency; and
determining how the results will be published or otherwise communicated. If the agency
determines that risk mitigation efforts prove insufficient, the agency is to consider requesting
voluntary redaction of any publication or communication; classifying the research; or terminating
project funding.56
In accordance with the new policy, NIH conducted its review and found 381 extramural and 404
intramural projects using pathogens or toxins covered by the new policy. Of these projects, NIH
designated 10 extramural and no intramural projects as dual-use research of concern. Seven of the
designated dual-use research of concern projects use influenza virus, while one project each uses
the pathogens that cause anthrax, plague, and botulism.57 The NIH determined appropriate risk
mitigation steps with researchers in each case.58
Once fully implemented, this policy might address some of the deficiencies highlighted by the
recent publishing controversy. Reviews of proposed research and periodic reviews of funded
research might alert the funding agency of potentially challenging results early enough for
agencies to mitigate their potential harmful effects. However, some of the risk mitigation steps in
this policy, including the use of prepublication manuscript review and the possibility of limiting
distribution of research results, raise additional issues, such as compliance with export control
regulations, that likely complicate implementation of this policy.
While NIH has performed the requisite reviews, guidance for grantees is still under development.
This may raise challenges to proper implementation of risk mitigation steps if grantees lack
knowledge of their responsibilities and the potential consequences of compliance and noncompliance.
On February 22, 2013, the White House Office of Science and Technology Policy released for
public comment the proposed policy “United States Government Policy for Institutional
Oversight of Life Sciences Dual Use Research of Concern.”59 This proposed policy describes the
55
United States Government Policy for Oversight of Life Sciences Dual-Use Research of Concern, March 28, 2012,
http://oba.od.nih.gov/oba/biosecurity/pdf/
united_states_government_policy_for_oversight_of_durc_final_version_032812.pdf.
56
Classified research results are not published in generally accessible scientific journals.
57
Testimony of Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases, National
Institutes of Health, U.S. Department of Health and Human Services, before the Senate Committee on Homeland
Security and Governmental Affairs, April 26, 2012.
58
Ibid.
59
Office of Science and Technology Policy, “United States Government Policy for Institutional Oversight of Life
(continued...)
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responsibilities of researchers and institutions that receive federal funding to perform research
that may qualify as DURC.60
Publishing Dual-Use Research Results
The federal government generally supports the open publication of unclassified, federally funded
research results. Many federal grants and contracts supporting scientific research urge the
publication of research results. The current federal policy, as described in National Security
Decision Directive 189, is that access to fundamental research results should remain unrestricted
with respect to dissemination, and that in the rare case where it is necessary to restrict access to
such information, classification is the appropriate mechanism.61 For non-fundamental research,
additional mechanisms may be used to restrict dissemination, such as contract clauses related to
release of information and export controls. Implementation of the new dual-use research of
concern policy may create significant exceptions to this general policy.62
Prepublication Review and Export Control
The Department of Commerce regulates the export of some dual-use technologies and research
results through administration of the Export Administration Regulations (EAR), which apply to
technologies (and technical information) listed on the Commerce Control List (CCL).63 The CCL
includes the pathogens and toxins covered by the new federal dual-use research of concern policy.
Noncompliance with export controls can result in fines and imprisonment.
Research that qualifies as “fundamental research” is exempt from export controls.64 To qualify as
“fundamental research,” research activities must be ordinarily published and shared broadly
within the scientific community. They must also be free of prepublication review, except for
purposes of determining whether proprietary information is being divulged or patent rights are
being compromised. Thus, information resulting from government-sponsored research where the
government has required prepublication review for national security reasons is not “fundamental
research.” Research funded with such prepublication agreements would be subject to export
regulation and potential control.
The concept of “deemed export” further complicates this issue. A deemed export is the transfer of
information, not physical items, to a foreign national within the United States.65 Deemed exports
(...continued)
Sciences Dual Use Research of Concern,” 78 Federal Register 12369-12372, February 22, 2013; and
http://www.phe.gov/s3/dualuse/Documents/oversight-durc.pdf.
60
David Malakoff and Martin Enserink, “New U.S. Rules Increase Oversight of H5N1 Studies, Other Risky Science,”
Science, vol. 339 (March 1, 2013), p. 1025.
61
White House, Executive Office of the President, “National Policy on the Transfer of Scientific, Technical and
Engineering Information,” National Security Decision Directive-189, 1985.
62
Mark S. Frankel, “Regulating the Boundaries of Dual-Use Research,” Science, vol. 336 (June 22, 2012), pp. 15231525.
63
For more on export controls, see CRS Report R41916, The U.S. Export Control System and the President’s Reform
Initiative, by (name redacted) and (name redacted).
64
15 C.F.R. 734.3(b)(3)(ii).
65
For more on deemed export issues, see the Department of Commerce Bureau of Industry and Security’s Deemed
Export FAQ at http://www.bis.doc.gov/deemedexports/deemedexportsfaqs.html.
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are treated the same as other exports. Thus, foreign nationals may require export licenses or be
completely prohibited from performing some research if the contract or grant contains
prepublication review provisions, since these would disqualify it for the fundamental research
exemption. In contrast, equivalent research conducted under a grant or contract without
prepublication review provisions would likely qualify as “fundamental research,” would not
require an export license, and would not raise deemed export issues.
Limited Access to Research Results
In order to address the security challenges presented by the H5N1 influenza manuscripts, the
NSABB recommended that the government develop a mechanism to provide controlled access to
sensitive scientific information:
the Board also recognizes that research findings will likely emerge in the very near future
that should not be widely disseminated because of a high risk of misuse but that nevertheless
should be made available to certain researchers and public health officials around the world
who have a legitimate need to know. The need for an effective, practical, and feasible
mechanism for selectively sharing sensitive scientific information has never been more
apparent. In order to manage the risks posed by communicating future cases of dual-use
research of concern, the Board strongly urges the U.S. Government to develop in an
expeditious manner a practical and secure mechanism for sharing sensitive scientific
information in order to support public health, safety, and security efforts.66
The Department of Health and Human Services initially endorsed this approach and began
exploring how to establish such a mechanism, but HHS ultimately rejected this option as
infeasible for the two H5N1 influenza manuscripts.
Limiting general access to research results has several challenges. These challenges include
formalizing the criteria for identifying this information; the need to identify what entity would
establish the infrastructure to store and retain control of the restricted information; how access to
the restricted information can be assessed for current and future researchers; what penalties or
other mechanism would be invoked to limit secondary dissemination of the information (either
through subsequent publication of research building on the restricted information or through more
informal information exchange); and how to facilitate restricted information exchange across
international borders in order to meet treaty and other obligations.
Experts have questioned whether such controls would be effective.67 Scientists and other
professionals regularly exchange preliminary information through seminars, conferences, and
other informal gatherings. If, at a later date, federal government deems such information should
be restricted, it may be difficult or impossible for the government to prevent its spread. Similarly,
publishers of scientific research generally distribute information, not restrict information, and
may lack the infrastructure or inclination to compartmentalize information with respect to their
subscribers. For example, the editors of Nature have stated that they will not consider limiting
distribution of any data that have been submitted to them.68 The editors of Science support the
66
National Science Advisory Board for Biosecurity, Findings and Recommendations, March 29-30, 2012, p. 6,
http://www.nih.gov/about/director/03302012_NSABB_Recommendations.pdf.
67
Bruce Schneier, “Securing Medical Research: A Cybersecurity Point of View,” Science, vol. 336 (June 22, 2012), pp.
1527-1529.
68
Editorial, “Publishing Risky Research,” Nature, published online May 2, 2012.
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development of an international system to provide access to information deemed not openly
publishable to those with a “need to know.”69
International ramifications of a limited access approach may be significant. The WHO determined
that controlling the distribution of influenza research results would likely damage worldwide
pandemic influenza preparedness by reducing the willingness of countries to share samples of
influenza virus. In addition, other countries’ export regulations might or might not limit
dissemination of information restricted by another country, requiring further harmonization with
treaty obligations and mechanisms to determine scientific credentials.70
These challenges may be surmountable with sufficient federal investment. The federal
government maintains information with access restrictions, has cataloged publications and best
practices, and oversees a credentialing system for researchers who wish physical access to certain
pathogens known as select agents. While these systems do not currently serve the purpose of
limiting access to dual-use research results, they may provide a potential model for developing
necessary systems. However, it remains unclear whether policymakers would deem increasing the
federal role in this manner an appropriate response to address this issue.
Funding Dual-Use Research
A key component of the OSTP policy on dual-use life sciences research of concern is the
identification of the dual-use nature of research programs when they begin. The federal
government historically has funded a wide array of research including that with dual-use
implications. The prevailing rationale for supporting such research is the belief that the benefits
from dual-use research outweigh the potential risks of misuse since many more people will use it
for beneficial purposes than for malicious ends.
The OSTP policy requires each funding agency to review its existing and future research
portfolios and identify those research activities that are potential dual-use research of concern.
This new policy raises several challenges, including the completeness of such a review, the
mechanism and criteria for identifying research projects, and the mechanism and criteria for
assessing risk and its mitigation. While this policy initially may identify some dual-use research
of concern, it also may not identify all dual-use research of concern. In some cases, the research
results that might qualify as dual-use research of concern arise unexpectedly out of the research
activities. Periodic review of ongoing research projects could identify these unforeseen results,
but may create its own set of challenges.
The effort to review existing and future research activities may require clear guidance and
oversight. Federal agencies often fund dual-use research, only some of which reaches the higher
threshold of being “of concern.” Thus, those program managers or other officials reviewing
research projects could spend most of their reviews identifying activities that are not dual-use
research of concern. This may affect the accuracy of review if program managers develop
expectations regarding their research portfolio based on past reviews.
69
Bruce Alberts, “H5N1,” Science, vol. 336 (June 22, 2012), p. 1524.
Ron A.M. Fouchier, Sander Herfst, and Albert D.M.E. Osterhaus, “Restricted Data on Influenza H5N1 Virus
Transmission,” Science, vol. 335 (February 10, 2012), pp. 662-663.
70
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In addition, some experts have argued that the dual-use implications of a research activity vary
depending on an analyst’s perspective. Some analysts, for example, question whether the risks of
performing federal biodefense research activities outweigh the potential benefits.71 The
experience and expertise of officials or scientists performing the risk and benefit assessment may
vary between or within agencies, which could lead to inconsistent appreciation of risks or benefits
both of performing the research and in publishing its results.
The NIH efforts to develop policy for NIH-funded H5N1 influenza transmissibility research
highlights the challenges of addressing dual-use research funding. While the NIH intentionally
established a narrow scope to its policy deliberation, it has not achieved stakeholder consensus on
the details of its policy. Efforts to broaden the approach taken by NIH regarding the specific H
5N1 influenza transmissibility research policy may be even more difficult because of the
expanded stakeholder base and diversity of research activity. On the other hand, the NIH process
may serve as a template and provide lessons learned for future efforts to develop similar policies
in other life-science areas, research fields, or funding agencies.
Scope
Concomitant with the other policy considerations is the issue of how broadly to apply new federal
dual-use policies. The new dual-use research of concern policy discussed above is limited to
government-sponsored life science research using a few specific organisms and toxins for defined
types of experiments. This policy does not encompass other research or technologies outside this
scope which may pose equivalent risk and benefit trade-offs.
Once fully implemented, the new policies may not identify all government-sponsored life science
research with potentially significant national security concerns. The list of covered organisms and
toxins does not include all those that have been deemed by the federal government to pose a
significant potential threat to national security or public health in other contexts, such as under the
select agent regulations72 or included as NIAID Category A, B, and C priority pathogens. Thus,
research on such pathogens that increases their harmful effects or decreases their response to
countermeasures would not be identified by this policy.
Additionally, research on unlisted pathogens that could also apply to related covered pathogens
may not be identified by this policy. In 2001, researchers serendipitously discovered
modifications to mousepox virus that rendered mousepox vaccination in mice ineffective. This
raised fears that similar modification to the closely related smallpox virus would render smallpox
vaccination in humans ineffective.73 It is not clear that the new dual-use research of concern
policies would identify this type of research.
Another challenge may come from emerging technologies. Non-life science research may
produce enabling technologies that increase the risk of malicious use of the pathogens and toxins
71
Malcolm Dando, The United States National Institute of Allergy and Infectious Diseases (NIAID) Research
Programme on Biodefense: A Summary and Review of Varying Assessments, Bradford Disarmament Research Center
(Bradford, UK), July 2004.
72
42 C.F.R. 73, 7 C.F.R. 331, and 9 C.F.R. 121.
73
Ronald J. Jackson, Alistair J. Ramsay, Carina D. Christensen et al., “Expression of Mouse Interleukin-4 by a
Recombinant Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and Overcomes Genetic Resistance to
Mousepox,” Journal of Virology, vol. 75 (February 2001), pp. 1205-1210.
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covered by the dual-use research of concern policy. For example, advances in encapsulation or
aerosolization technologies could significantly increase the effectiveness of the malicious use of
one of the listed pathogens. Such research, although possibly directly applicable to increasing the
risk of bioterrorism, appears unlikely to be identified by this new dual-use research of concern
policy.
The OSTP has also proposed additional policies for oversight of dual use research of concern.
The “United States Government Policy for Institutional Oversight of Life Sciences Dual Use
Research of Concern” would establish institutional review and oversight requirements for certain
categories of federally funded life sciences research. The OSTP acknowledges that its scope is
limited, but states that it may be broadened in the future to cover additional pathogens or types of
experiments. It grants research institutions discretion to consider other types of life sciences
research under it proposed DURC framework.74
Stakeholders may also note that this proposed policy applies only to federal-governmentsponsored research. The government only funds about 53% of basic research and 39% of applied
research conducted domestically.75 Research not sponsored by the government is not covered by
this new dual-use research of concern policy. However, research institutions that do not receive
federal life science funding are “strongly encouraged to implement similar oversight procedures
consistent with the culture of shared responsibility underpinning this Policy.”76
Broadening the scope of the OSTP policies on federal oversight of dual-use research of concern
may address many of these potential shortcomings. However, such broadening will likely
increase the administrative burden on both the research community and government agencies.
Additionally, extending oversight to include non-government-sponsored research will likely raise
additional issues such as appropriate enforcement mechanisms and possible decrease in
international competitiveness.
Options for Congress
Congressional policymakers have a variety of options before them. They may decide that the
current policy framework serves as a good starting point and allow the executive branch to further
develop and implement the proposed policies. Alternatively congressional policymakers might
increase oversight activities and direct the Administration, either through hearings, report
language, or legislation, to take specific actions to address scientific or security concerns.
74
Office of Science and Technology Policy, “United States Government Policy for Institutional Oversight of Life
Sciences Dual Use Research of Concern,” February 22, 2013, p.3, http://www.phe.gov/s3/dualuse/Documents/
oversight-durc.pdf.
75
Percentages presented for 2011, the most recent available data. Mark Boroush, National Science Foundation, U.S.
R&D Spending Resumes Growth in 2010 and 2011 but Still Lags Behind the Pace of Expansion of the National
Economy, NSF 13-313, January 2013.
76
Office of Science and Technology Policy, “United States Government Policy for Institutional Oversight of Life
Sciences Dual Use Research of Concern,” February 22, 2013, p.7, http://www.phe.gov/s3/dualuse/Documents/
oversight-durc.pdf.
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Allow Current Policy Framework to Develop
Policymakers may choose to continue to allow the executive branch to address dual-use research
concerns through the NSABB, voluntary advisory processes with publishers, and the new
government-wide dual-use research of concern policy. Federal agencies are currently developing
rules and procedures to implement the new dual-use research of concern policy. Congress could
decide to wait to act until agencies complete implementation before determining whether the new
policies adequately address the challenges highlighted by the recent H5N1 influenza manuscripts.
Alternatively, Congress could decide to more closely monitor the development and
implementation of these policies through oversight activities such as requests for information
from the Administration or additional oversight hearings.77
Change Current Policy Framework
Rather than rely solely on executive branch action, congressional policymakers might choose to
increase oversight activities or introduce legislation to provide greater direction or focus to the
relevant executive branch agencies, or to directly address perceived policy gaps. Alternatively,
Congress could agree with the overall policy direction but decide that codifying the policies in
statute would more effectively address the issues.
Early Identification of Dual-Use Research of Concern
Congressional policymakers interested in the extent of dual-use research funded by the federal
government might direct funding agencies to identify and tabulate prospective dual-use concerns
prior to funding the research. Since the federal government lacks a fully implemented framework
to assess or value such dual-use research concerns currently, congressional policymakers likely
would need to formalize the criteria against which such research would be measured. Measures
developed by the NSABB and the dual-use research of concern policy might apply. The current
policy is narrowly focused and affects a relatively small portion of federally funded research.
Assessment of all research activities might require significant investment by executive branch
agencies, due to the large number of research grants and contracts awarded by the federal
government annually. Such concerns might be weighed against the prospective benefits to assess
the dual-use impact of the research investment and risk mitigation measures used to manage the
risk and benefit relationship.
Voluntary or mandatory prepublication review for federally funded research or the development
of new funding opportunities containing prepublication review as a condition of acceptance may
improve the government’s ability to identify and mitigate dual-use concerns of particular results.
Individual funding vehicles have been offered to universities which would provide the funding
agency with access to research results prior to publication.78
77
For examples, see Letter from Congressman F. James Sensenbrenner, Jr., Vice-Chairman House Committee on
Science, Space and Technology, to John D. Holdren, Director of the White House Office of Science and Technology
Policy, March 1, 2012, http://sensenbrenner.house.gov/UploadedFiles/Letter_to_John_Holdren.pdf; and U.S. Congress,
Senate Committee on Homeland Security and Governmental Affairs, Biological Security: The Risk of Dual-Use
Research, 112th Cong., 2nd sess., April 26, 2012.
78
Examples of contracts containing prepublication review being offered by federal funding agencies is found in Peg
Brickley, “Contract Conflicts,” The Scientist, January 7, 2003; D. Malakoff, “Universities Review Policies for Onsite
(continued...)
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Opponents of this approach cite the general unwillingness that universities have towards
restricted research funding.79 Some universities have explicit policies barring acceptance of
federal funding requiring prepublication review. Also, scientists may not be as willing to work in
research areas where publication is not allowed as in areas where publication is encouraged.80 As
a consequence, the pool of eligible scientists competing for federal funding might decrease,
potentially lowering the quality of research and development performed in these areas.
Additionally, determining at the funding stage whether research will lead to sensitive results is
considered difficult. For example, the previously cited mousepox experiments were part of a
fertility research program aimed at techniques for pest control, and the results of the experiment
were unexpected.81
Alternatively, congressional policymakers might identify the recipients of research funding as
more appropriate to perform the review. In such an approach, federal agencies might require
contract and grant recipients to identify when their research activities either have, or might be
expected to produce, dual-use ramifications. Again, the criteria against which recipients would
judge their research activities would have to be identified. As with the federal review option, a
framework and guidance would need to be established.82
Prepublication Review of Dual-Use Results
Congressional policymakers might increase federal oversight by mandating federal funding
agencies perform prepublication review of dual-use research results and identify those
publications with security concerns. The NSABB recommended the government develop
mechanisms for limiting distribution.83 If combined with credentialing scientists able to receive
such information, potentially in a manner similar to select agent registration, this approach could
allow scientists with appropriate credentials or need-to-know access to such scientific literature,
but would bar others’ access. Access to such information might be controlled by the federal
government or by the publisher through secure, password-controlled websites.84 Other options
might include dissemination of such material via professional societies.
(...continued)
Classified Research,” Science, Vol. 295 (February 22, 2002) pp. 1438-1439; and Andy Fell, “Homeland Security Goals
Create Impact: Campus Responds To Satisfy Range of New Terrorism Laws,” Dateline UCDavis, November 22, 2002.
See also American Association of Universities/Council on Government Relations, Restrictions on Research Awards:
Troublesome Clauses, April 8, 2004.
79
See, for example, AAU/COGR/NASULGC Letter to OSTP Director on Scientific Openness, found online at
http://www.aau.edu/research/Ltr1.31.03.pdf.
80
Philip Cohen, “Recipes For Bioterror: Censoring Science,” NewScientist.com, January 18, 2003; Paul Elias,
“Academic Freedoms Said Hindered by 9/11,” Washington Post, September 11, 2003; and Gerald L. Epstein,
“Preventing Biological Weapon Development Through the Governance of Life Science Research,” Biosecurity and
Bioterrorism: Biodefense Strategy, Practice, and Science, vol. 10, no. 1 (2012).
81
“Biowarfare Warning,” Journal of the American Medical Association, Vol. 285, No. 6 (February 14, 2001), p. 725.
82
Gerald L. Epstein, “Preventing Biological Weapon Development Through the Governance of Life Science
Research,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, vol. 10, no. 1 (2012), p. 30.
83
National Science Advisory Board for Biosecurity, Findings and Recommendations, March 29-30, 2012, p. 6,
http://www.nih.gov/about/director/03302012_NSABB_Recommendations.pdf.
84
R.A. Zilinskas and J.B. Tucker, “Limiting the Contribution of the Open Scientific Literature to the Biological
Weapons Threat,” Journal of Homeland Security, (December 2002).
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Opponents of such an approach cite the logistical difficulties in determining those scientists with
a bona fide reason for access to this information; determining how and in what manner
application the dual-use label would be implemented; and determining how such material would
be disseminated to those scientists eligible to receive it. Additionally, some scientists or
universities might choose not to participate in a process which would determine access eligibility,
especially if the process lacked transparency or was viewed as potentially arbitrary.85
Another concern is the effectiveness of such a federally based review. The federal government
funds about 31% of the total research and development efforts in the United States. In terms of
basic and applied research, the federal government funds 53% and 39% respectively.86 If
prepublication review resides within the federal government, in contrast to a voluntary
submission to professional societies or an ethical or moral statement developed and overseen by
journal publishers, then all basic and applied research would not be reviewed.
Many members of the scientific community strongly believe that all unclassified scientific results
including all information necessary to reproduce an experiment should be shared widely.87 Some
observers believe that efforts to restrict access to the data will be impractical or ineffective.88
However, in contrast, some prominent members of the scientific community support developing
such a system.89
Finally, some universities may fear that federal prepublication review to determine whether the
results pose a security risk would invalidate the fundamental research exemption that such
research results normally enjoy. As a consequence, university research done in an exportcontrolled subject area might not be excluded from export control regulations (see
“Prepublication Review and Export Control”), potentially exposing the institution and researchers
to significant penalties if such regulations were violated.
Federal Licensing of Research
Congressional policymakers might believe that the role of the federal government should be
expanded beyond a gatekeeping role when considering dual-use biological research. Since much
research that has potential terrorism concerns also may play a role in biodefense, it has been
suggested that such research should continue, but only performed by select researchers at specific
facilities. For example, a national federal authority might license qualified researchers and
research facilities and oversee research by licensed researchers in licensed facilities.90 Some
scientists have asserted that licensing researchers, facilities, or experiments would have a strong,
85
Massachusetts Institute of Technology, In the Public Interest. Report of the Ad Hoc Faculty Committee on Access to
and Disclosure of Scientific Information, June 2002.
86
Percentages presented for 2011, the most recent available data. Mark Boroush, National Science Foundation, U.S.
R&D Spending Resumes Growth in 2010 and 2011 but Still Lags Behind the Pace of Expansion of the National
Economy, NSF 13-313, January 2013.
87
Carrie Wolinetz, “Implementing the New U.S. Dual-Use Policy,” Science, vol. 336 (June 22, 2012), pp. 1525-1527.
88
Bruce Schneier, “Securing Medical Research: A Cybersecurity Point of View,” Science, vol. 336 (June 22, 2012), pp.
1527-1529. Carrie Wolinetz, “Implementing the New U.S. Dual-Use Policy,” Science, vol. 336 (June 22, 2012), pp.
1525-1527.
89
Bruce Alberts, “H5N1,” Science, vol. 336 (June 22, 2012), p. 1524.
90
John Steinbruner, Elisa D. Harris, and Nancy Gallagher et al., Controlling Dangerous Pathogens: A Prototype
Protective Oversight System, The Center for International and Security Studies at Maryland, the University of
Maryland, College Park, MD, March 2007, http://www.cissm.umd.edu/papers/files/pathogens_project_monograph.pdf.
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Publishing Scientific Papers with Potential Security Risks: Issues for Congress
negative impact on scientific productivity in those areas.91 However, the registration of life
scientists wishing to work with select agents has shown that many scientists are willing to engage
in such licensed research.92 Such a licensing approach might limit the rate of advance of scientific
discovery due to the lessened amount of discussion and degree of research diversity. Additionally,
in influenza research this approach may be incompatible with international agreements and
increase the difficulty of obtaining viral samples from countries with endemic influenza.
Increase Biosafety Level
An alternative approach to addressing concerns raised by specific research might be to mandate
increased biosafety for those activities. For example, such an approach might allow for a tailored
response to emerging concerns while not adversely impacting similar research with, for example,
other pathogens or techniques. Conversely, this approach might undercut biosafety best practices
by creating a patchwork of biosafety requirements based on criteria unrelated to pathogen safety,
such as national security concerns.
In the case of H5N1 influenza transmissibility research, Canada has increased the required
biosafety level from BSL 3 to BSL 4 following a review of the various risks.93 Some experts
assert requiring such research to be conducted only at the highest level of biosafety containment
and under the most secure conditions would effectively reduce the possibility of an accidental
release or a deliberate release by a disgruntled or disturbed laboratory worker.94 Current U.S.
requirements for H5N1 influenza research require research activities to be done at the BSL 3
level. Many laboratories meet the BSL 3 standards. In contrast, the number of BSL 4 laboratories,
built to a much more stringent—and expensive—standard, is significantly smaller, even though
the number of BSL 4 laboratories has increased since 2001. Increasing the required biosafety
level would limit the number of locations where the research could be performed and the number
of researchers with access.
While increasing the biosafety level might limit the risks of an unintentional release due to
biocontainment failure, it would also likely limit the rate of scientific advance. Such limitations
could arise, for example, from logistical issues, such as insufficient research space for the number
of interested researchers; and cost issues, due to the higher overhead cost for performing work in
a BSL 4 laboratory. As a consequence, congressional policymakers may wish to balance both the
potential outcomes and the potential likelihood of events. For example, increasing near-term
biosafety may make it less likely that a release of transmissible H5N1 virus occurs due to a
laboratory accident, but at the potential cost of not having important research results to mitigate
potentially more likely naturally occurring outbreak of transmissible H5N1 influenza.
91
Peg Brickley, “Science Police Needed?” The Scientist, April 8, 2003.
For more information on the Select Agent Program, see online at http://www.cdc.gov/od/sap/.
93
Public Health Agency of Canada, “Biosafety Advisory: Efficiently Transmissible Engineered Influenza A H5N1
Viruses,” February 1, 2012, http://www.phac-aspc.gc.ca/lab-bio/res/advi-avis/sbn-asb-2012-01-31-eng.php.
94
Richard H. Ebright, “Mitigate the risks of release,” Nature, vol. 481 (January 15, 2012), pp. 257-259.
92
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Conclusion
Policymakers faced with assessing dual-use issues are particularly challenged by the multidisciplinary nature of dual-use activities. Dual-use issues cut across traditional policy areas,
involving simultaneous consideration of security, scientific, health, export, and international
policy. Because of the complexity of dual-use issues, analysis of a topic according to one set of
policy priorities may lead to unforeseen complications due to its intersection with other policy
priorities. For example, maximizing security may lead to detriments in public health and
scientific advancement, while maximizing scientific advancement may lead to security risks.
Accounting for such trade-offs may allow policymakers to establish regulatory frameworks that
more effectively maximize the benefits from dual-use research while mitigating its potential risks.
Author Contact Information
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Specialist in Science and Technology Policy
/redacted/@crs.loc.gov, 7-....
Congressional Research Service
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Specialist in Science and Technology Policy
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