Publishing Scientific Papers with Potential
Security Risks: Issues for Congress
Frank Gottron
Specialist in Science and Technology Policy
Dana A. Shea
Specialist in Science and Technology Policy
July 12, 2012
Congressional Research Service
7-5700
www.crs.gov
R42606
CRS Report for Congress
Pr
epared 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, scientific, 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 dual-use research while mitigating
its potential risks.
The current consideration of these issues 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 demonstrated flaws
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 a new
government-wide policy to address some of these flaws. It requires agencies that fund life science
research to regularly review research portfolios and develop methods to mitigate security risks.
It is not clear whether Congress will agree with the Administration that the new policy
sufficiently addresses all of the dual-use issues brought to light by this recent controversy.
Congress could decide to allow the new policy to be fully implemented before evaluating whether
it appropriately addresses the policy issues. Alternatively, Congress could require agencies to
implement robust 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.
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.
Congressional Research Service
Publishing Scientific Papers with Potential Security Risks: Issues for Congress
Contents
Introduction...................................................................................................................................... 1
H5N1 in Nature................................................................................................................................ 1
H5N1 Experiments under Debate.................................................................................................... 2
Dual-Use Results ............................................................................................................................. 3
Balancing Potential Benefits and Harms ................................................................................... 4
Possible Benefits ....................................................................................................................... 4
Possible Harms .......................................................................................................................... 5
Stakeholder Recommendations........................................................................................................ 6
National Science Advisory Board for Biosecurity (NSABB).................................................... 6
First Review ........................................................................................................................ 6
Second Review.................................................................................................................... 7
World Health Organization (WHO)........................................................................................... 8
Department of Health and Human Services (HHS)................................................................... 8
Scholarly Publishers .................................................................................................................. 9
Scientific Community.............................................................................................................. 10
Issues for Congress ........................................................................................................................ 11
Overseeing Dual-Use Life Science Research.......................................................................... 11
Publishing Dual-Use Research Results ................................................................................... 13
Prepublication Review and Export Control....................................................................... 13
Limited Access to Research Results.................................................................................. 14
Funding Dual-Use Research.................................................................................................... 15
Scope ....................................................................................................................................... 16
Options for Congress ..................................................................................................................... 17
Allow Current Policy Framework to Develop......................................................................... 17
Change Current Policy Framework ......................................................................................... 18
Early Identification of Dual-Use Research of Concern..................................................... 18
Prepublication Review of Dual-Use Results ..................................................................... 19
Federal Licensing of Research .......................................................................................... 20
Increase Biosafety Level ................................................................................................... 21
Concluding Thoughts..................................................................................................................... 21
Contacts
Author Contact Information........................................................................................................... 22
Congressional Research Service
Publishing Scientific Papers with Potential Security Risks: Issues for Congress
Introduction
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. Only in cases where security concerns rise to the level of classification does
the federal government bar publication of fundamental research. This policy has led to challenges
in the current era when advances in technology have lowered technical barriers in modern
biological sciences making it easier for people, including potential adversaries, to reproduce
biological experiments.
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. Some stakeholders believe the research results
should not be 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. The federal government moved first to restrict
publication of the manuscripts. Following additional discussions, the federal government
recommended publishing modified versions of the manuscripts.
The debate about the publication of scientific research with potential security implications cuts
across multiple policy issues, including federal support of research, maintenance of homeland
security, and the flow of research information. In addition, the controversy surrounding the
decision to publish these experiments demonstrated flaws in the existing mechanisms to identify
and balance the potential public health benefits and security trade-offs.
Congress has acted in the past to restrict access to pathogens where 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 assess the risks of information exchange to be lower and may not require 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.
H5N1 in Nature
Influenza is a virus that circulates through both human and animal populations. The form of the
influenza virus changes frequently, producing 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. This abbreviation indicates which variety of two specific disease-
related proteins (H for hemagglutinin and N for neuraminidase) the virus contains. For example,
the H1N1 influenza virus caused the 2007 “swine flu” human pandemic.
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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.1 Since then, the virus
has spread internationally, infecting humans in at least 15 countries. As of May 2012, the World
Health Organization (WHO) has confirmed 604 human cases and 357 deaths from this H5N1
influenza strain.2
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
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 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-to-
human transmission.3 This likelihood could have important public health policy ramifications. For
instance, if these changes are likely to occur, then policymakers might increase H5N1-related
countermeasure development efforts. Conversely, if such changes are very 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 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.4 Independently, and using different methods, each group
found specific genetic changes to the H5N1 influenza virus that make it transmissible between
ferrets in separate cages.
1 World Health Organization, H5N1 Avian Influenza: Timeline of Major Events, April 20, 2012; http://www.who.int/
influenza/human_animal_interface/H5N1_avian_influenza_update200412.pdf.
2 World Health Organization, Cumulative Number of Confirmed Human Cases for Avian Influenza A (H5N1) Reported
to WHO, 2003-2012, May 29, 2012. For the most current data available, see http://www.who.int/influenza/
human_animal_interface/H5N1_cumulative_table_archives/en/index.html.
3 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.
4 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.
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Dr. Kawaoka’s group used standard molecular biological techniques to create a 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.5
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
ferrets in separate cages.6 The scientists determined five specific genetic changes were sufficient
to convey airborne transmissibility among ferrets. They found that this new strain of H5N1 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.7
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 Untied 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 manuscripts from these two groups might be described as the results of “dual-use” research.
In this context, this term describes technologies or information that have the potential to both help
and harm society.8 The Department of Health and Human Services (HHS) has defined 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.”9
5 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.
6 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.
7 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.
8 Historically, the term “dual-use” has referred to technologies that have both a military and a civilian application.
9 Department of Health and Human Services, National Science Advisory Board for Biosecurity Charter, March 4, 2004.
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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 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.10 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.
Possible Benefits
These H5N1 influenza research results provide 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.11 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.12 As discussed above, both groups found that some H5N1 viruses can
be transmitted via airborne droplets between ferrets.
Additionally, the five mutations that Dr. Fouchier’s group found sufficient to cause mammalian
transmissibility have each been identified in naturally occurring H5N1 viruses.13 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 mutations together in
nature may provide advanced warning of a coming pandemic.14 Other experts suggest that current
surveillance efforts are inadequate for this task. Additionally, focusing specifically on these
mutations may cause researchers to miss other mutations that would also cause the virus to
become transmissible between humans.15 Dr. Kawaoka suggested a slightly different strategy,
“rather than watching for specific mutations, it is more important to scan for the traits they
bestow.”16 That type of surveillance might identify strains with human pandemic potential
10 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.
11 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.
12 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.
13 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.
14 Declan Butler, “Caution Urged for Mutant Flu Work,” Nature, vol. 481 (January 25, 2012), pp.421-422.
15 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.
16 Ed Yong, “Mutant-flu Paper Published,” Nature, vol. 485 (May 3, 2012), pp. 13-14.
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without relying on a list of known mutations 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
H5N1 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.17 Some these experts assert that research that increases
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.18 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.
Other potential harms could come from adversaries. Experts highlight the possibility that
published research could provide adversaries a “roadmap” to create a bioweapon.19 In general,
scientific publication is to provide 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. 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 the modified
H5N1 virus would cause in humans 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 social effects. Given the potential effects, it is conceivable that some adversary might
attempt to use these research results for malicious purposes.
17 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; 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.
18 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.
19 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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Stakeholder Recommendations
As information about the modified H5N1 influenza research results spread, various stakeholders
began to debate the merits of their publication. Domestic and international groups deliberated
ethical, scientific, and security issues and made recommendations. 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 prominent international
influenza scientists agreed to temporarily suspend certain influenza research to provide public
policymakers time to consider issues raised by this research. The following section summarizes
various stakeholder position and concerns.
National Science Advisory Board for Biosecurity (NSABB)
The NSABB is the primary federal scientific board for issues of biosecurity. It consists of experts
in biological sciences, law, security, and other areas. Federal officials representing agencies that
fund life sciences 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.
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.”20 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.”21 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
20 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.
21 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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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
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.”22 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 WHO (see “World Health
Organization (WHO)” below), it became apparent that the NSABB view was not uniformly
shared among stakeholders. Also, practical concerns regarding the ability to establish a limited
distribution network for methodological details and the ramifications of such a structure on
international obligations 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.”23 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,24 influenza research, and international
relations.25 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.26
22 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.
23 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
24 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.
25 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.
26 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,
(continued...)
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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.27
World Health Organization (WHO)
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.28
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 a such a mechanism due to international
agreements and national legislation.29 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 (HHS)
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 similarly evolved. Key context is the nonbinding nature of HHS actions. 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 sway publishers
regarding a manuscript with security concerns had been unsuccessful.30
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
(...continued)
http://news.sciencemag.org/scienceinsider/NSABB%20letter%20final%2041212_3.pdf.
27 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.
28 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.
29 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.
30 Jocelyn Kaiser, “PNAS Publishes Botulinum Paper,” Science, vol. 309, July 1, 2005, p. 31.
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those with a legitimate need in order to achieve important public health goals. The U.S.
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.”31
As the debate on the H5N1 influenza manuscripts progressed, HHS continued to respond to
events. 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.32 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.”33
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.34
In addition, HHS was the vehicle for the release of 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.35
Scholarly Publishers
As previously noted, Dr. Kawoaka and Dr. Fouchier submitted their manuscripts to the journals
Nature and Science respectively. Both publishers of these journals voluntarily suspended
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 in this
31 National Institutes of Health, Department of Health and Human Services, Press Statement on the NSABB Review of
H5N1 Research, December 20, 2011.
32 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.
33 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.
34 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.
35 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.
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case were not binding. Both journals published the manuscripts after the NSABB changed its
recommendation.36
Since 2003, many journal editors and publishers have voluntarily adopted the responsibility of
weighing the dual-use implications of submitted manuscripts.37 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 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 a paper or limiting access to select recipients in the future.38
Relying on an editor-based effort might not sufficiently address the federal government’s security
concerns. Even a consensus protocol for handling dual-use 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 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
open publication. Many prominent influenza researchers, including those that conducted the
experiments in question, agreed to a voluntary, short-term moratorium on research into modified
H5N1 transmission to allow some discussion of the policy issues.39 This moratorium remains in
effect.40
36 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/H5N1 Virus Between Ferrets,” Science, vol. 336 (June 22, 2012), pp. 1534-1541.
37 Journal Editors and Authors Group, “Uncensored Exchange of Scientific Results,” Proceedings of the National
Academy of Science, vol. 100, February 18, 2003, p. 1464.
38 Editorial, “Publishing Risky Research,” Nature, published online May 2, 2012.
39 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.
40 David Malakoff, “How Much Longer Will the Moratorium Last?” Science, vol. 336 (June 22, 2012), pp. 1495-1496.
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Some experts have cited this moratorium as similar to that enacted in the 1970s over genetic
engineering and recombination.41 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 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.42
Issues for Congress
The controversy surrounding the decisions to publish these manuscripts highlights deficiencies in
the federal decision-making processes related to dual-use life science research.43 Congressional
policymakers face many issues when considering the current debate over H5N1 influenza
research. These issues include the appropriate federal government role in overseeing, funding,
and publishing dual-use research activities.
Overseeing Dual-Use Life Science Research
The federal government funds a variety of life science research activities. It performs oversight of
these activities through standard procedures and protocols generally identified as a contract or
grant term and condition. 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 results until the manuscripts were
submitted for publication.
41 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.
42 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. 258-
298.
43 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:
Biodfense Strategy, Practice, and Science, vol. 10, no. 1 (2012).
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To help correct flaws in agency process, the Administration issued new federal policy titled
“United States Government Policy for Oversight of Life Sciences Dual-Use Research of
Concern” on March 28, 2012.44 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.45
This new policy 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.”46 Seven types of experiments are
subject to this policy, and the pathogens and toxins covered by this policy are also regulated as
select agents.47
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,
products, or technologies generates risk.”48 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. In the future, such reviews and reports are to occur 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
44 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.
45 Ibid.
46 Ibid.
47 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).
48 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.
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voluntary redaction of any publication or communication; classifying the research; or terminating
project funding.
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.49 The NIH is determining which risk
mitigation steps are appropriate for each case.50
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 that likely complicate implementation of
this policy.
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,
and that in the rare case where it is necessary to restrict such information, classification is the
appropriate mechanism.51 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.52
Prepublication Review and Export Control
The Department of Commerce regulates the export of some dual-use technologies and research
results.53 It administers the Export Administration Regulations (EAR), which apply to
technologies (and technical information) listed on the Commerce Control List (CCL). 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.
49 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.
50 Ibid.
51 White House, Executive Office of the President, “National Policy on the Transfer of Scientific, Technical and
Engineering Information,” National Security Decision Directive-189, 1985.
52 Mark S. Frankel, “Regualting the Boundries of Dual-Use Research,” Science, vol. 336 (June 22, 2012), pp. 1523-
1525.
53 For more on export controls, see CRS Report R41916, The U.S. Export Control System and the President’s Reform
Initiative, by Ian F. Fergusson and Paul K. Kerr.
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Research that qualifies as “fundamental research” is exempt from export controls.54 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 transfer of
information, not physical items, to a foreign national within the United States.55 Research
conducted under a grant or contract that contained prepublication review provisions would not
qualify as fundamental research and thus might increase the likelihood that a deemed export
violation might occur. Without the protection of the fundamental research exemption foreign
students and researchers conducting research or attending graduate-level classes may be exposed
to information relating to technology which falls under export controls. Such information transfer
may require an export license and may be completely prohibited for some foreign nationals. 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.56
The HHS initially endorsed this approach and began exploring how to establish such a
mechanism.
Limiting general access to nonproprietary research results has several challenges, both practical
and philosophical in nature. These challenges include 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
54 15 C.F.R. 734.3(b)(3)(ii).
55 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.
56 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.
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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 the effectiveness of such controls.57 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 has been submitted to them.58 The editors of Science support the development of an
international system to provide access to information deemed not freely publishable to those with
a “need to know.”59
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 limit dissemination of such
restricted information, requiring further harmonization with treaty obligations and mechanisms to
determine scientific credentials.60
These challenges may be surmountable with sufficient federal investment. The federal
government maintains information with access restrictions, has several databases of 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.
Funding Dual-Use Research
A key component of the new policy on dual-use life sciences research 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 new policy requires each funding agency to review its research portfolio and identify those
research activities that are potential dual-use research of concern. Review of research activities at
the funding stage raises several policy challenges, including the completeness of such a review,
57 Bruce Schneier, “Securing Medical Research: A Cybersecurity Point of View,” Science, vol. 336 (June 22, 2012), pp.
1527-1529.
58 Editorial, “Publishing Risky Research,” Nature, published online May 2, 2012.
59 Bruce Alberts, “H5N1,” Science, vol. 336 (June 22, 2012), p. 1524.
60 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.
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the mechanism for identifying research projects, and the mechanism 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 research activities may require clear guidance and oversight. Federal
agencies often fund dual-use research, only some of which is potentially of concern. Of that
smaller number of research activities, an even smaller number are actually 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.
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
federal biodefense research activities outweigh the potential benefits.61 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.
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, this policy 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 regulations62 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
61 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.
62 42 C.F.R. 73, 7 C.F.R. 331, and 9 C.F.R. 121.
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vaccination in humans ineffective.63 It is not clear that the new dual-use research of concern
policy 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
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.
Stakeholders may also note that this new policy applies only to government-sponsored research.
However, the government only funds about 53% of basic research and 42% of applied research
conducted domestically.64 Research not sponsored by the government is not covered by this new
dual-use research of concern policy.
Broadening the scope of the new policy 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.
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
policies 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 deficiencies highlighted by the recent H5N1 influenza
manuscripts. Alternatively, Congress could decide to more closely monitor the development and
63 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.
64 Percentages presented for 2009. Mark Boroush, National Science Foundation, U.S. R&D Spending Suffered a Rare
Decline in 2009 but Outpaced the Overall Economy, NSF 12-310, March 2012.
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implementation of these policies through oversight activities such as requests for information
from the Administration or additional oversight hearings.65
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
Administration, 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. 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.66
Opponents of this approach cite the general unwillingness that universities have towards
restricted research funding.67 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.68 As
65 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.
66 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
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.
67 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.
68 Philip Cohen, “Recipes For Bioterror: Censoring Science,” NewScientist.com, January 18, 2003; Paul Elias,
(continued...)
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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.69
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.70
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.71 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.72 Other options
might include dissemination of such material via professional societies.
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.73
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
(...continued)
“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: Biodfense Strategy, Practice, and Science, vol. 10, no. 1 (2012).
69 “Biowarfare Warning,” Journal of the American Medical Association, Vol. 285, No. 6 February 14, 2001, p. 725.
70 Gerald L. Epstein, “Preventing Biological Weapon Development Through the Governance of Life Science
Research,” Biosecurity and Bioterrorism: Biodfense Strategy, Practice, and Science, vol. 10, no. 1 (2012), p. 30.
71 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.
72 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).
73 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.
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basic and applied research, the federal government funds 53% and 42% respectively.74 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.75 Some
observers believe that efforts to restrict access to the data will be impractical or ineffective.76
However, in contrast, some prominent members of the scientific community support developing
such a system.77
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 export-
controlled area might not be excluded from export control regulations (see “Prepublication
Review and Export Control”).
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.78 Some
scientists have asserted that licensing researchers, facilities, or experiments would have a strong,
negative impact on scientific productivity in those areas.79 However, the registration of life
scientists wishing to work with select agents has shown though that some scientists are willing to
engage in such licensed research.80 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 endemic countries.
74 Percentages presented for 2009. Mark Boroush, National Science Foundation, U.S. R&D Spending Suffered a Rare
Decline in 2009 but Outpaced the Overall Economy, NSF 12-310, March 2012.
75 Carrie Wolinetz, “Implementing the New U.S. Dual-Use Policy,” Science, vol. 336 (June 22, 2012), pp. 1525-1527.
76 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.
77 Bruce Alberts, “H5N1,” Science, vol. 336 (June 22, 2012), p. 1524.
78 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.
79 Peg Brickley, “Science Police Needed?”, The Scientist, April 8, 2003.
80 For more information on the Select Agent Program, see online at http://www.cdc.gov/od/sap/.
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Increase Biosafety Level
Congressional policymakers could reduce the risk of accidental release of modified H5N1
influenza strains by requiring such research to be done at a higher biosafety level (BSL). 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.81
Current 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. Canada has increased the required biosafety level from
BSL 3 to BSL 4 following a review of the various risks.82
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.
Concluding Thoughts
Policymakers faced with assessing dual-use issues are particularly challenged by the multi-
disciplinary 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.
81 Richard H. Ebright, “Mitigate the risks of release,” Nature, vol. 481 (January 15, 2012), pp. 257-259.
82 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.
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Author Contact Information
Frank Gottron
Dana A. Shea
Specialist in Science and Technology Policy
Specialist in Science and Technology Policy
fgottron@crs.loc.gov, 7-5854
dshea@crs.loc.gov, 7-6844
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