Oversight of Dual-Use Biological Research: The National Science Advisory Board for Biosecurity

Oversight of Dual-Use Biological Research: The National Science Advisory Board for Biosecurity

Order Code RL33342
Oversight of Dual-Use Biological Research: The
National Science Advisory Board for Biosecurity
Updated April 27, 2007
Dana A. Shea
Specialist in Science and Technology Policy
Resources, Science, and Industry Division

Oversight of Dual-Use Biological Research: The
National Science Advisory Board for Biosecurity
Summary
Policymakers have addressed the threat of biological weapons and biosecurity
issues for many years. An issue garnering increased attention is the potential for life
sciences research intended to enhance scientific understanding and public health to
generate results that could be misused to advance biological weapon effectiveness.
Such research has been called “dual-use” research because of its applicability to both
biological countermeasures and biological weapons.
The federal government is a major source of life sciences research funding.
Tension over the need to maintain homeland security and support scientific endeavor
has led to renewed consideration of federal scientific oversight policies. Balancing
effective support of the research enterprise and security risks generated by such
research is a complex challenge. Policies addressing science and security generate
tensions between federal funding agencies and federal funding recipients. To
minimize these tensions while maximizing effective oversight of research, insight
and advice from disparate stakeholders is generally considered essential.
The National Science Advisory Board for Biosecurity (NSABB) was established
as one tool to aid policymakers and researchers in assessing the risks of federally
funded, life-sciences research. It aims to provide the Secretary of Health and Human
Services and researchers a source for advice on dual-use research and other
biosecurity issues. Advice rendered by the NSABB may shape research activities and
standards practiced by researchers in life science research fields.
The NSABB is composed of experts in biological sciences, law, security, and
other areas and federal officials representing agencies that fund life sciences research.
Its responsibilities include identifying and defining dual-use research, advising the
Secretary of Health and Human Services on biosecurity issues, and providing
recommendations on an ethical code for life scientists. The issues the NSABB
addresses are also being explored by professional societies, non-profit organizations,
and other groups. Guidance and activities undertaken by the NSABB are likely to be
closely scrutinized and challenged by stakeholder groups.
The success of the NSABB in addressing federal concerns related to biodefense
and biosecurity may influence congressional action. Absent an existing, effective
mechanism to address potentially controversial issues raised by federally funded
dual-use research, policymakers could act to establish an oversight mechanism
through legislation. Should the NSABB be successful in linking the scientific and
security communities and developing guidelines for effective scientific self-
oversight, the board could evolve into a forum that policymakers may use to consider
the intersections of science and security. Whether the tools available to the federal
government are adequate to assess and control security risks from federally funded
research or if additional authorities may ultimately need to be developed is yet to be
determined. This report will be updated as events warrant.

Contents
Origins of the NSABB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Formation of the NSABB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Activities of the NSABB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Stakeholder Activities Related to NSABB Mandates . . . . . . . . . . . . . . . . . . . . . . 5
Investigating Pathogen Genomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Defining Dual-Use Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Establishing a Code of Conduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Policy Concerns Relating to the NSABB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Oversight of Federally Funded Dual-Use Biological Research . . . . . . . . . . . 8
Mechanism and Appropriateness of NSABB Review . . . . . . . . . . . . . . . . . . 9
Restricting Publication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
International Cooperation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Local Implementation of NSABB Guidelines . . . . . . . . . . . . . . . . . . . . . . . 12
Ethical Codes of Scientific Conduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Applicability to Other Research Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Oversight of Dual-Use Biological Research:
The National Science Advisory Board for
Biosecurity
Some scientific and technological advances that provide great benefits to society
can also be used maliciously. For example, biological research on the origins of
virulence, the development of vaccines, and the genetic manipulation of biological
agents are simultaneously relevant to public health and to biological weapons. Some
policymakers are concerned that publishing such dual-use research results in the open
literature could aid or further the goals of adversaries of the United States. The
National Science Advisory Board for Biosecurity (NSABB) was established to
facilitate understanding and oversight of such potentially contentious research.
Issues of potential congressional interest include the mechanism and appropriateness
of NSABB review of scientific research; the scope of NSABB recommendations with
respect to publication of scientific research; the domestic and international adoption
of practices or codes developed by the NSABB; the implementation of NSABB
guidelines at the local level; and applicability of NSABB recommendations to federal
agencies other than HHS.
Origins of the NSABB
Nonprofit organizations, professional associations, and other interested groups
have been active in weighing the need for additional oversight of dual-use biological
research.1 These groups have made a wide range of recommendations, including the
development of federal oversight schemes, self-regulation of research activities by
scientists, and development of ethical codes.
One prominent effort was by the National Academies, which convened the
Committee on Research Standards and Practices to Prevent the Destructive
Application of Biotechnology. This committee, chaired by Dr. Gerald Fink of
Massachusetts Institute of Technology, met between April 2002 and January 2003.
The committee considered ways to minimize threats from biological warfare and
bioterrorism without hindering the progress of life sciences research. The
1 Dual-use biological research, in this context, is defined as “biological research with
legitimate scientific purpose that may be misused to pose a biologic threat to public health
and/or national security.” Department of Health and Human Services, National Science
Advisory Board for Biosecurity Charter, March 4, 2004. See also Department of Health and
Human Services, National Science Advisory Board for Biosecurity Charter — Revised,
March 16, 2006.

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Committee’s 2004 report, Biotechnology Research in an Age of Terrorism, is usually
referred to as the Fink Report.2
The Fink Report contained seven recommendations to ensure responsible
oversight for biotechnology research with potential bioterrorism applications. One
of these recommendations was to create a National Science Advisory Board for
Biodefense within the Department of Health and Human Services to provide advice,
guidance, and leadership for a system of review and oversight of experiments of
concern.3
Formation of the NSABB
Following the publication of the Fink Report, the Secretary of the Department
of Health and Human Services (HHS) created the National Science Advisory Board
for Biosecurity and chartered it in March 2004. The NSABB responsibilities include
many of the recommendations suggested by the National Academies. The NSABB
charter outlines twelve responsibilities:4
! Develop criteria for identifying dual-use research and research
results.
! Develop guidelines for the oversight of dual-use research, including
guidelines for the risk/benefit analysis of dual-use biological
research and research results.
! Provide recommendations on the development of a code of conduct
for scientists and laboratory workers that can be adopted by
professional organizations and institutions engaged in the
performance of life science research.
! Provide recommendations on the development of mandatory
programs for education and training in biosecurity issues for all
scientists and laboratory workers at federally-funded institutions.
! Advise on national policies regarding the conduct of dual-use
biological research. This includes strategies for addressing national
security concerns while at the same time fostering continued rapid
2 National Research Council, Biotechnology Research in an Age of Terrorism, National
Academies Press, 2004.
3 Other recommendations from the Fink Report include educating the scientific community
on dual-use aspects of biological research, augmenting the existing recombinant DNA
oversight system to provide review of experiments of concern, relying on self-governance
by scientists and publishers to control publication of dual-use research results, relying on
current legislation and regulation for protection of biological materials, developing new
channels of communication between life scientists and the national security and law
enforcement communities, and creating an international biosecurity forum to harmonize
measures across national boundaries. National Research Council, Biotechnology Research
in an Age of Terrorism, National Academies Press, 2004.
4 Department of Health and Human Services, National Science Advisory Board for
Biosecurity Charter, March 4, 2004. General information regarding the NSABB can be
found online at [http://www.biosecurityboard.gov/].

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progress in public health research and food and agriculture research
(e.g., new diagnostics, treatments, vaccines and other prophylactic
measures, and detection methods).
! Advise on national policies governing publication, public
communication, and dissemination of dual-use research
methodologies and results.
! Advise on national policies governing local review and approval
processes for dual-use biological research, including the
development of guidelines for the case-by-case review and approval
by Institutional Biosafety Committees (IBCs).5
! Advise on criteria and processes for referral of classes of research or
specific experiments by IBCs to the NSABB for guidance.
! Review and provide guidance on specific experiments insofar as
they exemplify a significant or particularly complex permutation of
an existing category of dual-use research, or represent a novel
category of dual-use research that requires additional guidance from
the NSABB.
! Respond to requests submitted by research institutions for the
interpretation and application of the guidelines to specific research
proposals in instances where a proposal has been denied by an IBC
and the institution seeks additional advice.
! Recommend strategies for coordinated international oversight of
dual-use biological research.
! Address any other issues as directed by the Secretary of HHS.
The charter calls for both voting and non-voting NSABB members. The HHS
Secretary, in consultation with the heads of other federal departments and agencies
conducting life sciences research, appoints up to 25 voting members. Among these
appointees are experts in the biological sciences, law, security, and other related
areas. Voting members may not be federal government employees. Non-voting
members are ex officio representatives of the Executive Office of the President,
Department of Health and Human Services, Department of Energy, Department of
Homeland Security, Department of Veterans Affairs, Department of Defense,
Department of the Interior, Environmental Protection Agency, Department of
Agriculture, National Science Foundation, Department of Justice, Department of
State, Department of Commerce, Intelligence Community, National Aeronautics and
Space Administration, and other agencies as appropriate. Thus, agencies and
departments that conduct or support life sciences research are represented during
deliberations of the NSABB.
To meet the charge laid out by its charter, the NSABB has established working
groups, focused on development of criteria to identify dual-use research,
communication of results of dual-use research, development of a life sciences code
5 Institutional Biosafety Committees provide local oversight of recombinant DNA research.
They are established on the institutional level and are generally comprised of laboratory
technical staff and persons with expertise in recombinant DNA technology, biological
safety, and institutional policies. For more information on Institutional Biosafety
Committees, see online at [http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm].

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of conduct, development of international perspectives on dual-use research, and
guidance on chemical synthesis of bacterial and viral genomes.6 Subsequent to the
formation of these initial working groups, an additional working group on
development of an oversight framework was established.7 These working groups
discuss alternatives and develop proposals to be presented to the whole NSABB. The
working groups have provided draft recommendations or reports to the NSABB.8
Activities of the NSABB
The NSABB met for the first time on June 30 — July 1, 2005. Subsequent
meetings of the full board occur on a quarterly basis, while individual working
groups meet in closed session according to need. Each full board meeting contains
reports from the various working groups on progress made towards meeting their
chartered goals.
During its meetings, the NSABB has discussed different types of ethical codes,
ways of identifying dual-use research, publication and dissemination tools, and
mechanisms to assess research in emerging technology areas. Its working groups
outlined and scoped activities related to their tasks and missions and generated draft
reports and recommendations. The NSABB has also provided advice to the HHS
Secretary regarding dual-use research and reviewed the publication of scientific
research results related to the genome of the 1918 influenza virus.
In October 2005, a research article was published in Science magazine
describing the reconstruction of an influenza virus bearing all of the identified gene
sequences of the 1918 influenza virus.9 The genetic sequences of the final three gene
segments of the virus were published concurrently in the magazine Nature.10 The
decision to perform and publish these experiments was met with some public
concern.11 Prior to the publication of the research article, the HHS Secretary
6 Janet Coleman, “NSABB Working Groups Will Begin Discussions Soon,” Research Policy
ALERT, July 5, 2005.
7 This working group was established in July 2006. See National Science Advisory Board
for Biosecurity, Meeting Minutes, July 13, 2006.
8 Draft recommendations from the working groups can be found online at
[http://www.biosecurityboard.gov/].
9 Terrence M. Tumpey, Christopher F. Basler, Patricia V. Aguilar, et al., “Characterization
of the Reconstructed 1918 Spanish Influenza Virus,” Science, vol. 310, October 7, 2005, pp.
77-80.
10 Jeffery K. Taubenberger, Ann H. Reid, Raina M. Lourens, et al., “Characterization of the
1918 Influenza Virus Polymerase Genes,” Nature, vol. 437, October 6, 2005, pp. 889-893.
11 For example, see Sabin Russell, “Deadliest Flu Bug Given New Life in U.S. Laboratory;
Some Applaud Scientific Feat, but Others Decry Move as Reckless,” San Francisco
Chronicle, October 6, 2005, p. A1.

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consulted with the NSABB for guidance.12 The NSABB met and unanimously
agreed that the scientific benefit of the information outweighed the potential risk of
misuse. It recommended that publication of the article be accompanied by an
editorial discussing the potential biosecurity implications of the research.13 This
appears to be the first consultation by the HHS Secretary of the NSABB regarding
the publication of a research result prior to its publication.
The NSABB working groups have presented draft reports and recommendations
that have been adopted by the NSABB as a whole. These reports and
recommendations include draft criteria for identifying dual-use research of concern,
tools for the responsible communication of dual-use research, considerations for a
dual-use research code of conduct, consideration of biosecurity concerns related to
the synthesis of select agents, and a draft outline of an oversight framework.
While these draft reports and recommendations have been adopted by the board
as a whole, they have not yet been formalized and submitted to HHS for
consideration. Before the NSABB recommendations will be adopted by HHS, they
will be submitted for public comment, possibly through notice in the Federal
Register; and those comments weighed and addressed. Following such a process,
HHS will consider whether and how to incorporate the recommendations into official
policies or procedures.
Stakeholder Activities Related to NSABB Mandates
Both before and since the establishment of the NSABB, many stakeholders
participated in debates over the mechanisms for controlling or overseeing the
products of dual-use research. In general, no consensus has been reached on the best
approach. This section will briefly describe some of the stakeholder activities
undertaken in areas related to the NSABB’s mandate.
Investigating Pathogen Genomes
Pathogen genomes are considered critical to understanding pathogen
characteristics, such as virulence and antibiotic resistance. Genomic information
could be key to developing effective countermeasures to those pathogens, as well as
providing insight into basic science broadly applicable to other bacteria and viruses.
On the other hand, it may be that such genomic information could also be put to
malicious use to enhance the dangerous aspects of a particular pathogen or induce
virulence in a nonvirulent species.14
12 Centers for Disease Control and Prevention, “Researchers Reconstruct 1918 Pandemic
Influenza Virus; Effort Designed to Advance Preparedness,” Press Release, October 5,
2005.
13 This editorial was published in the same issue. Philip A. Sharp, “1918 Flu and
Responsible Science,” Science, vol. 310, October 7, 2005, p. 17.
14 Claire M. Fraser and Malcolm R. Dando, “Genomics and Future Biological Weapons: the
(continued...)

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In part because of the dual-use nature of pathogen genomes and continued
federal research efforts towards identifying these genomes, the National Academies
convened a panel and issued a report in 2004 addressing pathogen genome data
restrictions.15 The panel recommended that information on pathogen genomes not
be restricted, but instead that scientists be allowed open access to genomic
information.
The related area of synthetic genomics, by which existing or novel pathogens
might be constructed from their constituent nucleic acids, has also drawn attention
from the research and policy community. While generally viewed as a scientific field
still under development, community members, scientists, and policy experts have all
advocated a proactive stance with respect to ensuring safety, security, and scientific
productivity.16 Consensus regarding the manner that these goals can be achieved has
not yet been reached.
Defining Dual-Use Research
Defining dual-use research has been an area of much discussion, and several
competing approaches have been put forth. One is based on identifying particular
pathogens of concern. For example, some institutions identify dual-use research as
research involving specific pathogens, often relying on the select agent list.17 An
alternate approach is to identify extrinsic factors that raise particular concern. Some
biosecurity experts focus on whether such research could have immediate weapons
implications, rather than focusing on specific pathogens.18 Others suggest the use of
uniform criteria for comparison of pathogen research to identify those experiments
of concern.19 The National Academies have suggested seven classes of experiments
14 (...continued)
Need for Preventive Action by the Biomedical Community,” Nature Genetics, vol. 29, 2001,
p. 253.
15 National Research Council, Seeking Security: Pathogens, Open Access, and Genome
Databases, National Academies Press, 2004.
16 For example, see ETC Group, Extreme Genetic Enginering: An Introduction to Synthetic
Biology, January 2007; Stephen M. Maurer, Keith V. Lucas, and Starr Terrell, From
Understanding to Action: Community-Based Options for Improving Safety and Security in
Synthetic Biology — Draft 1.1, April 15, 2006; and Jonathan B. Tucker and Raymond A.
Zilinskas, “The Promise and Perils of Synthetic Biology,” The New Atlantis, Spring, 2006.
17 Select agents are those biological agents or toxins having the potential to pose a severe
threat to public health and safety. Select agents are defined by regulation. See 42 CFR 73.
18 Gerald L. Epstein, “Controlling Biological Warfare Threats: Resolving Potential Tensions
Among the Research Community, Industry, and the National Security Community,” Critical
Reviews in Microbiology, vol. 27, 2001, p. 321.
19 For example, Steinbruner et al. have suggested that a conceptual framework using three
criteria, transmissibility, infectivity, and pathogenicity, be used to identify the intrinsic
danger of research activities. John Steinbruner, Elisa D. Harris, Nancy Gallagher, and Stacy
Okutani, Controlling Dangerous Pathogens: A Prototype Protective Oversight System,
Center for International and Security Studies at Maryland, University of Maryland,
(continued...)

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that might warrant extra discussion or review.20 A joint approach might be possible,
identifying specific pathogens but also establishing other criteria that could be
applied more generally.
Establishing a Code of Conduct
Professional groups in the life sciences have adopted or are exploring the
potential for codes of conduct.21 For instance, in 2005, the American Society for
Microbiology revised and approved its code of ethics, which requires its members to
report misuses of microbiology information to “appropriate authorities.”22 The
American Medical Association guidelines require physician researchers to “lend their
expertise to the development of safeguards and oversight mechanisms.”23
Development of such codes has been an international, ongoing endeavor. For
example, in 2005 the Meeting of States Parties to the Biological Weapons
Convention held discussions on methods of developing and establishing ethical codes
for scientists. The Interacademy Panel on International Issues, an organization of the
national science academies, has identified key components to be considered in a code
of conduct or ethics.24 Other organizations have attempted to facilitate best practices
development, including ethical codes, to increase biosecurity.
Policy Concerns Relating to the NSABB
The establishment of the NSABB has raised several issues of potential
congressional interest. These include the mechanism and appropriateness of NSABB
review of scientific research, the scope of NSABB recommendations with respect to
publication of scientific research, the domestic and international adoption of practices
or codes developed by the NSABB, the implementation of NSABB guidelines at the
19 (...continued)
December 2005.
20 The seven classes of experiments include those that would demonstrate how to render a
vaccine ineffective, would confer resistance to therapeutically useful antibiotics or antiviral
agents, would enhance the virulence of a pathogen or render a nonpathogen virulent, would
increase transmissibility of a pathogen, would alter the host range of a pathogen, would
enable the evasion of diagnostic/detection modalities, or would enable the weaponization
of a biological agent or toxin. National Research Council, Biotechnology Research in an
Age of Terrorism, National Academies Press, 2004.
21 For a representative list of codes of ethics developed by professional groups, see online
at [http://www.biosecuritycodes.org/codes_archive.htm].
22 American Society for Microbiology, Code of Ethics, 2005, available online at
[http://www.asm.org/ASM/files/ccLibraryFiles/FILENAME/000000001596/ASMCodeo
fEthics05.pdf].
23 American Medical Association, Guidelines to Prevent Malevolent Use of Biomedical
Research, June 2004.
24 Interacademy Panel on International Issues, Statement on Biosecurity, December 1, 2005.

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local level, and applicability of NSABB recommendations to federal agencies other
than HHS.
Oversight of Federally Funded Dual-Use Biological Research
The NSABB draft criteria for identifying dual-use research, guidelines for the
local oversight of dual-use research, and advice on policies governing local review
and approval processes are contentious among stakeholders. The scope and
applicability of these definitions and guidelines are balanced against the practicality
of oversight activities. A trade-off between the scope of research activities falling
under the dual-use definition and the degree of scrutiny performed by local oversight
may exist.
If dual-use research is broadly defined, so as to capture the maximum number
of potentially dangerous research activities, a significant burden may be placed on
local oversight when attempting to apply NSABB-recommended policies and
guidelines. To minimize delaying research activities, local oversight on the conduct
of each research proposal may become cursory in order to process the large proposal
volume.
Conversely, if dual-use research is narrowly defined, so as to limit potential
adverse effects from overseeing a large volume of research, contentious dual-use
research may not be captured under this definition. This might lead to the conduct
of research later deemed inappropriate.
The draft framework report attempts to bridge this gap by using a relatively
broad definition, but placing the dual-use assessment at the local level, on the
researcher performing the dual-use research and on the research institution. The
NSABB draft report would have the federal government develop guidelines, based
on the NSABB-recommended criteria, that would be used to frame dual-use research
of concern. Using tools recommended by the NSABB, local entities may assess the
dual-use implications of research results and judge whether further review is needed.
By taking this approach, the NSABB spreads an administrative burden,
reviewing the research activities, among many persons, rather than creating a general
burden localized at a particular agency. Thus, the potential for increased costs and
delays in the review process are limited, as the strain on federal resources is
minimized. Critics, on the other hand, doubt the efficacy of such a local review.
They assert that researchers, and to some extent the research institutions, are vested
in the success of their research programs. As such, they are less likely to perceive
potential misuse or dangers of their research activities and may thus err on the side
of permissiveness.
Local review of dual-use research under a guideline paradigm, rather than a
regulatory paradigm, has been criticized by arms control advocates. These advocates
state that compliance with existing guidelines has not been uniform, even among
those entities receiving federal funds. Absent clear penalties from violating these
guidelines, it is not apparent how successful voluntary local review will be in

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capturing all dual-use research of concern. On the other hand, a regulatory
framework may be considered unwieldy and burdensome to the research enterprise.25
The NSABB draft framework suggests several layers in the local review of dual-
use research activities: to determine if dual-use research is of concern, to determine
the risk it may pose, and to determine what risk management techniques might best
mitigate this risk. As such, publication and dissemination of dual-use research of
concern may be appropriate, when such publication and dissemination best manages
the risk of such research results.26
The need for federal agencies to address and coordinate oversight of intramural,
potentially dual-use research has been highlighted by reports from agency Inspectors
General.27 Some federal agencies taking part in the NSABB are developing interim
guidelines to identify dual-use intramural research. Other agencies await output from
the NSABB before attempting such analysis. Absent a clear recommendation from
the NSABB regarding dual-use research, federal agencies will likely continue to
establish independent, interim guidelines for their own use. Proliferation of different
guidelines and standards between funding agencies may complicate future
compliance with a uniform standard recommended by the NSABB.
Mechanism and Appropriateness of NSABB Review
The use of the NSABB in vetting the publication of the 1918 flu research paper
has been identified by some as a successful exercise of the NSABB advisory mission.
The HHS Secretary sought input from the NSABB regarding the proposed
publication of research results that have dual-use aspects. Once that recommendation
was received, it was acted upon, and the research paper was published with an
accompanying editorial.
Nevertheless, the timing and mechanism of this process have been questioned.
The editor-in-chief of Science, Dr. Donald Kennedy, described the involvement of
the NSABB as an “11th-hour intervention from the [S]ecretary’s office.”28 He wrote
that prior to the intercession of the HHS Secretary’s office, both the Director of the
Centers for Disease Control and Prevention and the Director of the National Institute
of Allergy and Infectious Disease had reviewed the research article before the
25 For example, the select agent rule is considered by many scientists to be burdensome and
restrictive to research activities. See Sandia National Laboratories, International
Biosecurity Symposium: Securing High Consequence Pathogens and Toxins — Symposium
Summary, SAND2004-2109, June 2004.
26 Such an example might be the case where the public health benefits greatly outweigh the
risk of enhanced weapon potential. See the earlier discussion of the 1918 flu publication.
27 Office of Inspector General, USDA, Audit Report — Adequacy of Controls to Prevent the
Improper Transfer of Sensitive Technology, Report No. 02601-1-Ch, September 2005, and
Office of Inspector General, Department of Energy, Inspection Report — Coordination of
Biological Select Agent Activities at Department of Energy Facilities, DOE/IG-0695, July
2005.
28 Donald Kennedy, “Better Never Than Late,” Science, vol. 310, October 14, 2005, p. 195.

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NSABB was consulted, and both felt the public health benefits outweighed the public
health risks. While the NSABB supported the decision to publish the 1918 flu
research article, Dr. Kennedy wrote that even if the NSABB had not approved, he
would have published the research article unless it had been classified.
The late inclusion of the NSABB review raises questions regarding the role the
board plays in advising policymakers on publication of potentially contentious
research results. The editor-in-chief of Science argued that the NSABB’s role is not
to provide advice on specific research papers, but instead to develop broader guiding
principles.29 However, the NSABB’s charter explicitly requires the NSABB to
review and provide guidance on specific experiments insofar as they exemplify
a significant or particularly complex permutation of an existing category of
dual-use research, or represent a novel category of dual-use research that requires
additional guidance from the NSABB.30
An apparent point of dissension is whether the 1918 flu publication qualifies
under the NSABB charter as a specific experiment requiring additional guidance,
and, if so, whether such review extends to publication. Depending on what threshold
is used for such a determination, the NSABB may be placed in the position of
providing additional guidance on many submitted publications or relatively few.
A further concern relates to the mechanism by which the federal government is
informed of potential dual-use articles. If such notification occurs late in the
publication process, then the business of publishing could be disrupted. It may be
argued that in the case of the 1918 flu publication, since several of the authors were
federal employees, the government should have been self-informed and involved the
NSABB earlier so as to avoid possible private sector disruption. When federally
funded research is performed outside the federal government, however, it seems less
likely that the government will be informed before the results are submitted for
publication. An area of potential congressional interest may be how federal research
agencies are informed of federally funded research results before their publication
and what mechanisms may exist to assess any dual-use nature.
Finally, the advice of the NSABB in the case of the 1918 flu publication was
unanimous; all NSABB members recommended publication augmented by an
accompanying editorial. In future cases, the NSABB voting members may not all
agree. In that case, what is the appropriate mechanism and threshold for action?
Should the advice given by the NSABB be based on a consensus approach, majority
vote, or some other mechanism?
Restricting Publication
Another concern is whether the federal government, or by extension the
NSABB, which advises policymakers, has the authority to prevent the publication of
29 Donald Kennedy, ibid.
30 Department of Health and Human Services, National Science Advisory Board for
Biosecurity Charter, March 4, 2004.

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federally funded life sciences research based on its potential dual-use implications,
and if so, whether this power extends to non-federally funded research. There is at
least one example of the publication of non-federally funded research raising dual-
use concerns. Prior to the inaugural meeting of the NSABB, a research article
describing the potential impact of contaminating the milk supply with botulinum
toxin was to be published in Proceedings of the National Academy of Sciences.31 The
article’s publication was delayed, but eventually published over the objections of
HHS.32 Unlike the 1918 flu publication, the authors of this article were not federal
employees, and the research was not funded by the federal government.
Congress may be asked to provide oversight of government activities related to
publication of dual-use research results to determine what statutory authorities, if
any, may need to be enacted to meet homeland security requirements.
International Cooperation
One of the recommendations of the Fink Report was to develop an international
forum to develop and harmonize international approaches towards biosecurity issues.
While the NSABB has been charged with developing policies for publication,
communication, and dissemination of dual-use research results, it is a U.S.
government body. The extent to which these policies will be adopted by or
harmonized with other nations is yet to be determined.
The publication of the 1918 flu research may again serve as a case study for this
potential difficulty. The article on reconstructing the influenza virus was published
in Science, a U.S. journal, but the genetic sequence was published in Nature, a U.K.
journal. Even if the NSABB had recommended that the research not be published
and Science had followed this recommendation, the companion article might still
have been published in Nature.
The extent to which the NSABB incorporates other countries’ norms into its
guidance may influence harmonization of norms with other nations. Development
of guidance that is not adopted by other nations may cause U.S. journals to be at a
competitive disadvantage with respect to foreign journals because of potential
restrictions on publication. If publication in a foreign journal bypasses NSABB
guidance procedures, the increase in biosecurity expected from the NSABB
guidelines may not be realized.
On the other hand, adoption of other nations’ norms and guidance in an attempt
to maximize efforts at harmonization may have drawbacks. If harmonization makes
U.S. policy less stringent, it may make the NSABB guidance less effective.
Alternately, if other nations’ have more stringent norms and guidances,
31 Lawrence M. Wein and Yifan Liu, “Analyzing a Bioterror Attack on the Food Supply: the
Case of Botulinum Toxin in Milk,” Proceedings of the National Academy of Sciences of the
United States of America, vol. 102, July 12, 2005, p. 9984.
32 J. Kaiser, “ScienceScope,” Science, vol. 309, July 1, 2005, p. 31. Alison McCook, “PNAS
Publishes Bioterror Paper, After All,” The Scientist, June 29, 2005.

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harmonization might lead to guidance that overly inhibits research efforts or research
publication.
Local Implementation of NSABB Guidelines
The advice and guidance developed and promulgated by the NSABB may be
acted upon at the institutional level by Institutional Biosafety Committees (IBCs).
IBCs were established under the NIH Guidelines for Research Involving
Recombinant DNA Molecules to provide local review and oversight research with
recombinant DNA.33 The effectiveness of such oversight may vary among
institutions, especially as IBCs are typically staffed by volunteers. While some
institutions have expanded the oversight role of the IBC, this expansion of oversight
is done on the institutional, rather than the federal, level.
Critics have claimed that the IBC system is highly flawed and in many cases
does not provide rigorous oversight of current research activities.34 In addition, no
clear enforcement mechanism has been enunciated for the event that an IBC
concludes that research should not be conducted or disseminated on biosecurity
grounds, but the researcher disagrees. This raises questions regarding the actual
impact of NSABB guidance. Currently, potential penalties for violating recombinant
DNA guidelines, which are implemented by IBCs, include possible revocation of
federal funding.35
An alternate mechanism for implementing NSABB guidelines might be through
consulting researchers at NIH Regional Centers of Excellence for Biodefense and
Emerging Infectious Diseases Research.36 Advocates of such a plan suggest that
scientists at these Regional Centers of Excellence might draw on a large pool of
participating institutions and institutional knowledge and may consider the broader
biodefense implications of specific research experiments. Researchers may resist
submitting research plans and results to another, potentially competing, institution,
preferring their research to be reviewed either at their own institution or by the
federal government.
Another possibility would be to establish another, new institutional review
committee to solely address dual-use research concerns. Creating a parallel review
committee for dual-use research may remove strain from existing review boards, but
tax the resources of individual institution. Many review boards are staffed by persons
who volunteer their time and effort. Finding additional appropriately qualified
33 NIH Guidelines for Research Involving Recombinant DNA Molecules is found online at
[http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Gdlnes_lnk_2002z.pdf].
34 The Sunshine Project, Mandate for Failure: The State of Institutional Biosafety
Committees in an Age of Biological Weapons Research, October 2004.
35 See National Institutes of Health, NIH Guidelines for Research Involving Recombinant
DNA Molecules, April 2002.
36 For more information on the Regional Centers of Excellence, RCEs, for Biodefense and
Emerging Infectious Diseases Research, see online at [http://www.rcebiodefense.org].

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individuals to sit on a new review board may prove challenging to smaller
institutions.
Since the adequacy of the IBC system has been challenged, it is unclear whether
the NSABB will rely upon this system for implementation of its guidelines. The
NSABB may recommend an alternate system or a composite system, where decisions
by the IBCs are validated by a third party in the case of conflict. The potential cost
of any such system has not yet been addressed.
Ethical Codes of Scientific Conduct
Some researchers have suggested that a uniform code applicable to all life
sciences, perhaps similar to the Hippocratic Oath for medical doctors, be developed
to raise awareness of scientists’ ethical obligations.37 A federal advisory code of
ethics or conduct for life scientists may have limited effect and application. An
advisory code not placed in regulation would only apply to federally funded research
and exist as a policy statement with respect to the conduct of that research. Sanctions
for violating such policies usually are limited to withdrawal of federal financial
support and the potential for barring violators from future federal support.
A code of conduct or ethics promulgated by a scientific body or community may
reach more scientists, including those not engaged in federally funded research.
Therefore, a greater number of scientist might take part, and the overall effectiveness
of the code may be greater. The greater the number of scientists participating in such
a code, the more likely scientists will be aware of the potential security risks posed
by their dual-use research. A code promulgated by a scientific body though would
generally lack substantive sanctions, except in those research areas where
accreditation by the scientific body is necessary.
Some advocates for the establishment of codes recommend that code
implementation be self-directed by the scientific community, rather than by
government oversight. Some scientists claim that a code developed by the scientific
community is more likely to be adopted and applied than one developed by an
external body. They assert that a code developed by scientists through consensus
may become incorporated into scientific practice, even if unanimous support is not
initially found within the scientific community.38
The NSABB’s proposal for a code of ethics or conduct for life scientists has
drawn some criticism. Some experts question the value of such a code absent formal
37 Margaret A. Somerville and Ronald M. Atlas, “Ethics: A Weapon to Counter
Bioterrorism,” Science, Vol. 307, March 25, 2005, pp. 1881-1882.
38 A similar approach was taken in the development of practices related to recombinant DNA
research at the Asilomar conference. The consensus document established at Asilomar
lacked unanimous support, but became standard practice among the life scientist community.
For an overview of this process see Donald S. Fredrickson’s “Asilomar and Recombinant
DNA: The End of the Beginning,” found in Biomedical Politics National Academy Press,
1991, pp. 258-298.

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requirements and an enforcement framework to ensure its effectiveness.39 They posit
that developing and implementing ethical codes along with other efforts, such as
intelligence activities and export controls, might better prevent misuse of biological
information.40
Other scientists have challenged the external imposition of a code as restricting
the role and independence of the scientific community. Asserting that scientific
research is most productive when minimally fettered, these scientists express concern
that restrictive codes of conduct will limit research activities. Such limitations may
occur through active measures, such as determining a research area to be
inappropriate for further research, or through passive measures, such as additional
administrative burdens or increased peer pressure with respect to the scope of
research activities.41
The practical impact of a code of ethics may be somewhat limited should the
code be contingent on federal funding, rather than arising through an educational
mechanism. For example, state and private universities and federal laboratories, both
of which rely on federal funding, would likely implement ethical training if federal
funding was contingent on ethics or conduct training. Private sector life science
research, for example, that found in pharmaceutical companies, that lack federal
research funding would not be required to develop equivalent training. This
difference might lead to gaps in adherence of the code of conduct.
Because of the many different types of potential codes, the level of detail
developed in any code for dual-use research, whether it from an outside body or from
the scientific community, is yet undetermined. Some codes are quite detailed, while
other codes are aspirational in nature, stating high-level aims and goals. In
developing a code of ethics or conduct, a tension exists between describing overly
specific behaviors or activities and stating sufficiently actionable items. A code that
is too vague or generally stated may be viewed as unenforceable and lacking effect,
while a code that enumerates many prohibited activities may be viewed as overly
restrictive and unable to adapt to scientific progress.
Applicability to Other Research Fields
While dual-use activities in the biological sciences have received much
attention, other research fields may also yield research results that raise security
concerns. Members of the NSABB have been appointed for their ability to advise on
biosecurity issues, but not necessarily for their ability to advise on other research
areas. One possible issue facing policymakers is the extent to which NSABB advice
39 See, for example, Brian Rappert, “Responsibility in the Life Sciences: Assessing the Role
of Professional Codes,” Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and
Science, July 2004, vol. 2, pp.164-174.
40 Eugene Russo, “Biosecurity Advisory Board Considers Code of Ethics,” Research Policy
ALERT, July 6, 2005.
41 For an example of research in an areas where ethical concerns have been raised, see CRS
Report RL33554, Stem Cell Research: Ethical Issues, by Erin D. Williams and Judith A.
Johnson.

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will be applicable to interdisciplinary research results, where research from other
disciplines intersects with life sciences research. For example, mechanical
engineering and aerosol science research results that could increase the effectiveness
of biological weapons through more effective delivery or dissemination might not be
captured in NSABB advice regarding life sciences.
The NSABB, though established by the Secretary of HHS and managed by NIH,
appears to be expected to advise and provide guidance to all federal agencies and
departments performing life sciences research. As Rajiv Venkayya, Special Assistant
to the President for Health and Biodefense, told the NSABB,
[E]very Cabinet secretary is going to be listening to what you have to say and
they’re going to be taking your recommendations seriously as they decide what
to do about experiments that raise biosecurity concerns.42
Members of agencies performing life sciences research have been appointed to the
NSABB in an ex officio capacity, but it is unclear if a more formal mechanism exists
for these agencies to request the aid of the NSABB. Whether advice requested by an
outside agency must flow through the HHS Secretary’s office, or whether another
agency can request advice directly from the NSABB, is not described in the NSABB
charter.
The ability of other agencies to draw upon the NSABB may relate to how
broadly NSABB guidance is applied outside of research funded by HHS. Each
agency represented by ex officio members has agreed to consider any
recommendations developed by the NSABB when establishing oversight for dual-use
research. These federal funding agencies may be more inclined to directly use
NSABB guidance if they have previously drawn on the advice of the NSABB.
Conversely, if it is difficult for agencies other than HHS to use the advisory
capability of the NSABB, other federal funding agencies may choose to
independently generate dual-use guidelines for research results. Such proliferation
of dual-use guidelines might complicate oversight and decrease compliance.
42 Andrew J. Hawkins, “National Biosecurity Advisory Board Members Stress Balance,
International Implications,” Research Policy ALERT, July 1, 2005.