Balancing Scientific Publication and National Security Concerns: Issues for Congress
Balancing Scientific Publication
and National Security Concerns:
Issues for Congress
Updated November 13, 2006
Dana A. Shea
Specialist in Science and Technology Policy
Resources, Science, and Industry Division
Balancing Scientific Publication and National Security
Concerns: Issues for Congress
Summary
The federal government has historically supported the open publication of
federally funded research results. In cases where such results presented a challenge
to national security concerns, several mechanisms have been employed. For
fundamental research results, the federal policy has been to use classification to limit
dissemination. For advanced technology and technological information, a
combination of classification and export and arms trafficking regulation has been
used to inhibit its spread. The terrorist attacks of 2001 increased scrutiny of
nonconventional weapons, including weapons of mass destruction, and publication
of some research results have increased concerns over whether publication of
federally funded extramural research results could threaten national security.
The current federal policy, as described in National Security Decision Directive
189, is that fundamental research should remain unrestricted and that in the rare case
where it is necessary to restrict such information, classification is the appropriate
mechanism. Other mechanisms restrict international information flow, such as
Export Administration Regulations (EAR) and International Traffic in Arms
Regulations (ITAR) that control export of items and technical information on specific
lists. Both EAR and ITAR do not apply to sharing fundamental research results, so
long as they are not subject to any governmental prepublication review.
Historically, the areas where export regulation and classification have
predominantly occurred have been in mathematical, engineering, and physical
sciences. Other contentious research areas, such as genetic engineering and
manipulation, have been overseen through scientists’ self-regulation and monitoring.
The 1975 Asilomar conference produced a consensus statement on recombinant
DNA research that formed the basis for the National Institutes of Health
Recombinant DNA Advisory Committee. Recent research publications that have
raised national security concerns have fallen outside of the areas traditionally
regulated through classification and export control, and it is unclear how effective
these mechanisms will be. The National Science Advisory Board for Biosecurity was
established to aid in determining whether proposed federally funded research presents
a biosecurity threat.
Stakeholders do not agree on the best method of balancing scientific publishing
and national security. Some believe that the current method of selective
classification of research results is the most appropriate. They assert that imposing
new restrictions will only hurt scientific progress, and that the usefulness of research
results to terrorist groups is limited. Others believe that self-regulation by scientists,
using an “Asilomar-like” process to develop a consensus statement, is a better
approach. They believe that, through inclusion of scientists, policymakers, and
security personnel in the development phase, a process acceptable to all will be
found. Relying on publishers to scrutinize articles for information which might
potentially have security ramifications is third option. Finally, mandatory review by
federal funding agencies, either before funding or publication, is seen as a potential
federally based alternative. This report will not be updated.
Contents
In troduction ......................................................1
Historical Overview and Context......................................1
Examples of Research Results of Concern..............................4
Past and Current Controls on Information...............................7
Current Federal Policy on Scientific Publication..........................8
Mechanisms of Governmental Control................................10
Classification ................................................10
Export Controls..............................................11
Export of Technologies....................................11
Export of Information.....................................12
Prepublication Review.........................................13
Policy Actions...................................................14
The Card Memorandum........................................14
Response of Scientific Community...............................16
Professional Societies.....................................16
The National Academies...................................17
Department of Homeland Security................................20
Department of Health and Human Services.........................21
Policy Options...................................................23
Using Classification...........................................23
Self-Regulation by Scientists....................................25
Regulation by Publishers.......................................28
Federal Regulation............................................28
Prepublication Review of Sensitive, But Unclassified Results......28
Security Review at the Funding Stage.........................30
Federal Licensing of Research...............................31
Oversight of Homeland Security-Related Research...................31
Concluding Observations...........................................32
Balancing Scientific Publication and National
Security Concerns: Issues for Congress
Introduction
Publication of scientific research results that might be used by terrorist groups
has led some policymakers to question whether the method used to control scientific
research results, namely classification, should be revisited. The Administration,
legislators, and scientific professional societies are reexamining policies relating to12
scientific information that might threaten national or homeland security.
Policymakers may wish to determine what changes, if any, should be made to current
government policy regarding publication of federally funded research results, and
whether the options currently under consideration adequately balance the concerns
and needs of the security and scientific communities.
This report presents examples of scientific research results whose publication
raised concern regarding the threat they potentially pose to national security. Past
and current information control mechanisms are discussed, along with current federal
policy concerning dissemination of fundamental research results through the open
literature. Recent policy actions regarding dissemination of federal information and
federally funded research results are outlined, along with the responses these actions
have evoked from various professional societies and publishers. The advantages and
disadvantages to potential policy actions addressing classification and other controls
over open publication of federally funded research results are also described.
Historical Overview and Context
Since the 1950s, the United States has developed an established policy of
identifying, prior to publication, areas of basic and applied research where
information controls may be required. This research, typically related to weapon
systems or nuclear technologies, may be designated classified and have strict
1 National security is defined in Executive Order 12356 as “the national defense or foreign
relations of the United States.” Both broader and narrower definitions of national security
have been suggested as well. For a discussion on this topic, see Arvin S. Quist, Security
Classification of Information. Volume 2. Principles for Classification of Information
(K/CG-1077/V2), (Oak Ridge, TN: Oak Ridge National Laboratory), September 1989,
Chapter 5.
2 Homeland security is a concerted national effort to prevent terrorist attacks within the
United States, reduce America’s vulnerability to terrorism, and minimize the damage and
recover from attacks that do occur. Office of Homeland Security, National Strategy for
Homeland Security, The White House, July 2002.
information controls placed upon it. When fundamental research is not classified,
the government generally did not place other information controls on it.
This policy remained essentially unchanged until the 1970s, when controls were
developed on the export of domestically developed, advanced, dual-use technologies
and technological information.3 Under export control regulations, even if a
technology is barred from export, the fundamental, basic science underlying the
technology is generally exempt from controls and can be published in the open
literature.
In the early 1980s, foreign student and scientist access to technological
information that might fall under export control regulations became the focus of a
Department of Defense effort to restrict such information presented in classrooms
and conferences. In 1985, following a report from the National Academy of Sciences
asserting that openness in science leads to stronger long-term security,4 President
Reagan issued National Security Decision Directive 189 (NSDD-189), reiterating that
fundamental research results were to be controlled only through classification.
NSDD-189 continues to define federal policy on restricting the dissemination of
fundamental research results.5
Since then, the conduct of science and the composition of the scientific
community have become increasingly international, and concerns about the
effectiveness of export control regulations have grown. The international spread and
independent development of dual-use technologies has made the United States the
sole technology source less often. Concern that export control regulation is
negatively impacting domestic business prosperity has led to attempts to lower the
trade barriers erected by export control. Additionally, the presence of foreign
students and scientists in the United States has increased the availability of education
and training in basic skills that may be transferred to other countries upon the return
of those individuals to their home countries.
Since the terrorist events of 2001, concern that open publication of scientific and
technological results may provide unwitting assistance to other nations or terrorist
groups in developing weapons of mass destruction has resurged. Scientific research
is conducted in many disparate areas. Historically, the areas where the balance
between scientific openness and national security required consideration have been
centered in the mathematical and physical sciences and their applications, such as
aerospace engineering, advanced computer technology, and cryptography. Research
in biology – such as the origins of virulence, development of vaccines, and the
genetic manipulation of biological agents – has emerged as an area of concern
because of its potential relevance to biological weapons of mass destruction.
3 Dual-use technologies are those technologies that have both a legitimate civilian and
military use.
4 National Academy of Sciences, Scientific Communication and National Security,
(Washington DC: National Academy Press), 1982.
5 Assistant to the President for National Security Affairs Condoleezza Rice, Letter to Dr.
Harold Brown, co-Chairman, Center for Strategic and International Studies, November 1,
Whether the current method of using classification to limit the dissemination of
fundamental research results is the best or most effective method of maintaining
national security is an open question. It is unclear whether classification will be
effective when applied to research areas that have not historically been classified, and
whether a system of classified research will be embraced by scientists working in
these areas.
In March 2002, executive branch agencies were instructed by then-Assistant to
the President and Chief of Staff Andrew Card to determine if government-owned
information, especially that regarding weapons of mass destruction, was being
inappropriately disclosed. Also in March 2002, the Department of Defense (DOD)
promulgated a draft regulation expanding information controls to basic and applied
science research and development.6 Scientific professional societies are engaged in
developing self-regulatory mechanisms to address the concerns of the national
security community. In 2003, at the annual meeting of the American Association for
the Advancement of Science, 32 editors of leading scientific journals issued a policy
statement regarding publication of research results that could be misused.
Additionally that year, the National Academy of Sciences held a meeting discussing
whether current publication policies and practices in the life sciences could lead to
the inadvertent disclosure of “sensitive” information to those who might misuse it.
In 2004, the National Research Council issued a report, Biotechnology Research in
an Age of Terrorism, which recommended an oversight structure, based on
institutional biosafety committees, for research in select areas of concern. Following
some of the recommendations presented in this report, the Department of Health and
Human Services established the National Science Advisory Board for Biosecurity to,
among other duties, provide advice, guidance, and leadership regarding biosecurity
oversight of dual-use research.
Competing proposals regarding how to control federally funded research results
have been proposed, ranging from strict information control on all federally funded
research to maintaining the status quo. Some scientific professional societies have
suggested that self-regulation, either by scientists themselves or through the editors
of scientific journals, would be an appropriate mechanism for limiting the publication
of research results that might aid terrorist groups. Others have advocated more
formal government oversight of potentially contentious research. The development
of a new category of “sensitive, but unclassified” information to protect information
which does not require classification, but may still have the potential to damage
6 Basic research is experimental or theoretical work undertaken primarily to acquire new
knowledge of the underlying foundation of phenomena and observable facts, without any
particular application or use in view. Applied research is also original investigation
undertaken in order to acquire new knowledge. It is, however, directed primarily towards
a specific practical aim or objective. Organisation for Economic Co-operation and
Development, Frascati Manual, (OECD), 2002, p. 30.
national security, might encompass such research results.7 The potential impact of
these options raises much concern and debate.
A fundamental trade-off between scientific progress and security concerns is the
crux of the policy debate. The scientific enterprise is based upon open and full
exchange of information and thrives on the ability of scientists to collaborate and
communicate their results. On the other hand, this very openness provides potential
enemies with information that may allow them to harm U.S. interests. The
technological advances arising from scientific breakthroughs contribute to economic
prosperity, but the openness required to continue this process creates risks, which
may be perceived as more acute since September 11, 2001. What level of risk caused
via publication of scientific advances is acceptable in the eyes of policymakers and
the public? How will controlling the publication of federally funded research results
increase safety? If policymakers determine that more control of these sorts of
research results is warranted, what possible mechanisms could be used to oversee
these results?
Examples of Research Results of Concern
The publication of several scientific articles reignited concerns that information
published in the open literature may aid terrorist groups in developing weapons of
mass destruction. Presented below is a selection of some of the more highly
publicized examples.
In 2000, researchers at the Co-operative Research Centre for the Biological
Control of Pest Animals (CRC) in Australia genetically modified mousepox virus
while conducting rodent fertility research. This modification unintentionally enabled
the virus to infect mice that had been previously vaccinated against mousepox.8 The9
publication of this result was greeted with criticism due to its weapons potential.
This experiment was repeated in 2003 by Dr. Mark Buller at the University of St.
Louis using funding supplied by the National Institute of Allergy and Infectious
Di seases. 10
7 This report does not address the development of federal standards of usage for the term
“sensitive, but unclassified” material. For more information on federal government use of
the term “sensitive, but unclassified” and efforts regarding its standardization, see CRS
Report RL33303, “Sensitive But Unclassified” Information and Other Controls: Policy and
Options for Scientific and Technical Information, by Genevieve J. Knezo.
8 R.J. Jackson, A.J. Ramsay, C.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 (2001), pp.
9 J. Stephenson, “Biowarfare Warning,” Journal of the American Medical Association, Vol.
10 Robert Roos, “Scientists Research Antidotes to Super Mousepox Virus,” CIDRAP News,
November 6, 2003.
Another article widely viewed as having bioweapon potential was published in
July 2002. Researchers at the State University of New York at Stony Brook
assembled functional poliovirus from chemical sequences ordered from a scientific
mail-order firm.11 Dr. Eckard Wimmer, the lead scientist, described the experiment
as graphic proof that bioterror agents can be made without a terrorist ever having
access to dangerous microbes.12
Other scientific publications have been viewed as potentially aiding
development of biological weapons by terrorist groups or countries. Publication of
successes in “reverse genetics” has led some to believe that other viruses could be
constructed in the laboratory without having access to actual virus ahead of time.13
In October 2001, the full genome of Yersinia pestis, the bacteria which causes
bubonic and pneumonic plague, was published in the journal Nature.14 Simultaneous
with the release of this article was the publication of an accompanying news article
in Nature Science Update that highlighted the existence of “a debate about whether
releasing genomic information for virulent diseases, such as plague or smallpox,
might aid malicious science.”15 The full genome sequence of Coxiella burnetii, the
causative agent of Q fever, was published in Proceedings of the National Academies
of Science of the United States of America (PNAS) in April 2003,16 and the annotated
genome of Bacillus anthracis, the causative agent of anthrax, was published in
Nature. 17
Researchers at the University of Pittsburgh identified key proteins which
provide Variola major, the causative virus of smallpox, with high virulence.18
Accompanying this article was a commentary explaining how “the work is far more
likely to stimulate advances in vaccinology or viral therapy than it is to become a
11 J. Cello, A.V. Paul, and E. Wimmer, “Chemical Synthesis of Poliovirus cDNA:
Generation of Infectious Virus in the Absence of Natural Template,” Science, Vol. 297
(August 9, 2002) pp. 1016-1018.
12 Rick Weiss, “Polio-Causing Virus Created in N.Y. Lab: Made-From-Scratch Pathogen
Prompts Concerns About Bioethics, Terrorism,” The Washington Post, July 12, 2002.
13 Sylvia Pagan Westphal, “Ebola Virus Could Be Synthesised,” New Scientist, July 17,
14 J. Parkhill, B.W. Wren, N.R. Thomson, et al., “Genome Sequence of Yersinia pestis, The
Causative Agent of Plague,” Nature, Vol. 413 (October 4, 2001) pp. 523-527.
15 J. Whitfield, “Black Death’s DNA,” Nature Science Update, October 4, 2001.
16 R. Seshadri, I.T. Paulsen, J.A. Eisen, et al., “Complete Genome Sequence of the Q-fever
Pathogen Coxiella burnetii,” Proc. Natl. Acad. Sci. USA, Vol. 100 (April 9, 2003) pp. 5455-
17 T.D. Read, S.N. Peterson, N. Tourasse, et al., “The Genome Sequence of Bacillus
anthracis Ames and Comparison to Closely Related Bacteria,” Nature, Vol. 423, 2003, pp.
18 A.M. Rosengard, Y. Liu, Z. Nie, and R. Jimenez, “Variola Virus Immune Evasion Design:
Expression of a Highly Efficient Inhibitor of Human Complement,” Proceedings of the
National Academy of Sciences of the United States of America, Vol. 99 (June 25, 2002) pp.
threat to biosecurity.”19 Researchers published in the Journal of Clinical
Microbiology a potential cause of enhanced virulence for some strains of Bacillus
anthracis.20 The assessment of antibiotic resistance in select Bacillus anthracis
isolates was also identified as an article of potential concern.21
Articles such as these have led some to question the wisdom of openly
publishing information that could be used to threaten national security. An editorial
in New Scientist stated:
That this mind-boggling quantity of information is going to transform medicine
and biology is beyond doubt. But could some of it, in the wrong hands, be a22
recipe for terror and mayhem?
Bioethicist Arthur Caplan from the University of Pennsylvania was reported as
saying:
We have to get away from the ethos that knowledge is good, knowledge should
be publicly available, that information will liberate us. ... Information will kill us23
in the techno-terrorist age, and I think it’s nuts to put that stuff on Web sites.
Stewart Simonson, then-Assistant Secretary for Public Health Emergency
Preparedness for the Department of Health and Human Services (HHS), when
discussing the decision of the Proceedings of the National Academy of Sciences of
the United States of America to publish an article on vulnerabilities of the milk
supply chain, reportedly stated through a spokesman that he regretted the journal’s
decision to publish the paper:
We recognize, of course, that this is an issue about which good and reasonable
people disagree. But I must say that if the Academy is wrong, the consequences
could be dire and it will be HHS–not the Academy–which will have to deal with24
it.
19 P.J. Lachmann, “Microbial Subversion of the Immune Response,” Proceedings of the
National Academy of Sciences of the United States of America, Vol. 99 (2002) pp.
20 P.R. Coker, K.L. Smith, P.F. Fellows, et al., “Bacillus anthracis Virulence in Guinea Pigs
Vaccinated with Anthrax Vaccine Adsorbed Is Linked to Plasmid Quantities and Clonality,”
Journal of Clinical Microbiology, Vol. 41 (March 2003) pp. 1212-1218.
21 A. Athamna, M. Athamna, N. Abu-Rashed, et al., “Selection of Bacillus anthracis Isolates
Resistant to Antibiotics,” J. Antimicrob. Chemother., Vol. 54 (2004) pp. 424-428.
22 “Surfing for a Satan Bug. Why Are We Making Life So Easy for Would-be Terrorists?”
New Scientist, July 20, 2002, p. 5.
23 Eric Lichtblau, “Response to Terror; Rising Fears That What We Do Know Can Hurt Us,”
Los Angeles Times, November 18, 2001, p. A1.
24 Alison McCook, “PNAS Publishes Bioterror Paper, After All,” The Scientist, 6(1), June
Past and Current Controls on Information
Past examples of research excluded from publication in the open literature have
focused on military applications such as cryptography and nuclear weapons. Prior
to U.S. entry into World War II, physicists in the private sector researching nuclear
fission voluntarily stopped publishing results in scientific journals, fearing that they
would provide crucial information to Germany’s nuclear bomb project.25 A joint
National Academy of Sciences–National Research Council Advisory Committee on
Scientific Publications was established to restrict publication on nuclear fission.
While the United States was involved in World War II, this committee secured the
cooperation of scientific journals in restricting the transfer of select scientific26
information within the United States.
Nuclear power is another area where information controls have been instituted.
Private industry was permitted to explore applications of nuclear power under the
Atomic Energy Act of 1954. Prior to this act, nuclear energy activities were
protected by the federal government with security and secrecy programs. The federal
government retains authority over results which relate to atomic weapons, production
of special nuclear material, and use of special nuclear material in the production of27
energy. Information developed in those areas, even if developed privately without
federal government aid, is regarded as “born classified.”
Genetic engineering and recombinant species were an area of great contention
in the 1970s, and there were calls for regulation of the methods for manipulating
DNA and of experiments containing genetically engineered species. In response to
criticism and public pressure, a voluntary moratorium on such research was set. In
1975, at the Asilomar conference center in Pacific Grove, California, discussion on
how scientists could self-regulate such research was held. 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
successfully allayed many public concerns, and provided a uniform framework to
address such issues. This consensus statement formed the starting point for research
rules developed by the National Institutes of Health Recombinant DNA Advisory28
Committee, which was formed to oversee such research.
25 Peter J. Westwick, “In the Beginning: The Origin of Nuclear Secrecy,” Bulletin of the
Atomic Scientists, Vol. 56, (November/December 2000), pp. 43-49.
26 Rexmond C. Cochrane, The National Academy of Sciences: The First Hundred Years,
27 Harold Relyea, Silencing Science: National Security Controls and Scientific
Communication, (Norwood, New Jersey: Ablex Publishing Corporation), 1994, pp. 94-96.
28 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.
Current Federal Policy on Scientific Publication
In the United States, there has long been support for a policy of not restricting
publication of federally supported extramural and intramural research results, except
where classified for national security reasons. This position was restated in 1985 by
President Ronald Reagan in National Security Decision Directive 189, which said:
It is the policy of this Administration that, to the maximum extent possible, the
products of fundamental research remain unrestricted. It is also the policy of this
Administration that, where the national security requires control, the mechanism
for control of information generated during federally-funded fundamental
research in science, technology and engineering at colleges, universities and
laboratories is classification. Each federal government agency is responsible for:
a) determining whether classification is appropriate prior to the award of a
research grant, contract, or cooperative agreement and, if so, controlling the
research results through standard classification procedures; b) periodically
reviewing all research grants, contracts, or cooperative agreements for potential
classification. No restrictions may be placed upon the conduct or reporting of
federally-funded fundamental research that has not received national security29
classification, except as provided in applicable U.S. Statutes.
Fundamental research is also defined within NSDD-189:
‘Fundamental research’ means basic and applied research in science and
engineering, the results of which ordinarily are published and shared broadly
within the scientific community, as distinguished from proprietary research and
from industrial development, design, production, and product utilization, the
results of which ordinarily are restricted for proprietary or national security30
reasons.
NSDD-189 has not been superceded and continues to be the government policy
regarding controls on federally funded research results. In the wake of the terrorist
attacks of September 2001, then-Assistant to the President for National Security
Affairs Condoleezza Rice reaffirmed this position in a letter to the Center for
Strategic and International Studies, by stating,
...this Administration will review and update as appropriate the export control
policies that affect basic research in the United States. In the interim, the policy
on the transfer of scientific, technical, and engineering information set forth in31
NSDD-189 shall remain in effect...
Executive branch agencies have followed this general policy by requiring that
the results of agency-funded extramural research be published promptly and with
29 White House, Office of the President, National Security Decision Directive-189, 1985.
30 Ibid.
31 Assistant to the President for National Security Affairs Condoleezza Rice, Letter to Dr.
Harold Brown, co-Chairman, Center for Strategic and International Studies, November 1,
wide dissemination. For example, the National Science Foundation research policy
states:
NSF expects significant findings from research and education activities it
supports to be promptly submitted for publication, with authorship that
accurately reflects the contributions of those involved. It expects investigators
to share with other researchers, at no more than incremental cost and within a
reasonable time, the data, samples, physical collections and other supporting32
materials created or gathered in the course of the work.
Research performed with National Institutes of Health funding is also to be
disseminated to the public:
It is NIH policy to make available to the public the results and accomplishments
of the activities that it funds. Therefore, PIs [principal investigators] and grantee
organizations are expected to make the results and accomplishments of their
activities available to the research community and to the public at large, and to33
effect their timely transfer to industry for commercialization.
The Department of Defense also encourages the publication of research it funds.
For example, Office of Naval Research policy states:
Publication of results of the research project in appropriate professional journals
is encouraged as an important method of recording and reporting scientific34
information.
In general, federal agencies appear to agree that there should be open publication
of research results when the research has been funded by taxpayer dollars. The
exception is when research is classified. Classified research projects, even those
performed by scientists outside of government laboratories, are not published in the
open literature, with information being transferred only between those who possess
requisite clearance.35 Some classified research areas are later declassified, and the36
advances developed in these programs used more generally.
32 The National Science Foundation, National Science Foundation (NSF) Grant General
Conditions (GC-1), March 15, 2006, p. 27.
33 National Institutes of Health, NIH Grants Policy Statement (Rev. 03/01), U.S. Department
of Health and Human Services, March, 2001, p. 122.
34 Office of Naval Research, Educational Institutions, Nonprofit Institutions, and For-profit
Organizations: Research Grant Terms and Conditions, U.S. Department of Defense,
December, 2005, p. 6.
35 Some classified research is contracted to private industry or academic groups.
36 An example would be adaptive optics technology, which was declassified in 1991 and
now is used in astronomical telescopes.
Mechanisms of Governmental Control
Current mechanisms for federal agencies to control the publication of federally
funded extramural research results include classification, export and arms trafficking
regulations, and specifications in federal contracts, such as prepublication review.
Classification
Generally, classification is to be used when it is necessary to control scientific
information.37 The advent of classified extramural research led most universities to
clarify their positions on acceptance of funding for classified research. Significant
debate exists over the propriety of conducting classified research in an academic
setting.38 Some universities elect not to perform classified research on campus,
espousing that this is contrary to the founding beliefs of the university or their
university charters. For example, Duke University maintains:
No research can be undertaken at the University that involves information,
research, or results of research that are, or would be, classified by the sponsor or
any third party. For example, research for the federal government under a
subcontract which is classified as secret is not permitted.39
Universities that perform classified research typically establish research
facilities specifically to handle classified materials and research. These research
facilities are often located off-campus. Examples of such universities include the
Massachusetts Institute of Technology and the Johns Hopkins University.40 Some
universities have developed mechanisms by which classified research may be
approved on a case-by-case basis.41
37 In addition to NSDD-189, Executive Order 12958, which was issued on April 17, 1995,
describes the general classification policy of the federal government. This Order was
amended on March 25, 2003 via Executive Order 13292. Section 1.4e states that scientific,
technological, or economic matters relating to the national security, which includes defense
against transnational terrorism, may be classified, and, in section 1.7b, reiterates that basic
scientific research information not clearly related to the national security may not be
classified.
38 See, for example, Steven Aftergood, “Classified Research on Campus,” Secrecy News,
September 26, 2003, for a discussion of one debate regarding classified research performed
at an academic institution.
39 Faculty Handbook, Duke University, September, 2004, Chapter 5, Section 5.2.7.
40 D. Malakoff, “Universities Review Policies for Onsite Classified Research,” Science, Vol.
41 For example, University of North Carolina at Chapel Hill, University of Colorado,
University of Virginia, and University of Michigan have each established mechanisms for
faculty members who wish to engage in classified research to apply to for permission from
the university administration on a case-by-case basis.
Export Controls
Export of Technologies. Another federal control mechanism for private
research results occurs through export control and arms trafficking regulations. The
Department of Commerce implements Export Administration Regulations (EAR),
which bar the export of items, technology, and technological information found on
the Commerce Control List without appropriate export license.42 The Department of
State implements the International Traffic in Arms Regulations (ITAR), which
regulate the export of items, technology, and technological information maintained43
on the Munitions Control List.
Export control laws primarily constrain the flow of technology and technical
information from the United States to other nations. The EAR covers the transfer of
dual-use commercial goods, while ITAR is focused on armaments and military
technologies. These regulations exist to prohibit the proliferation of certain specific
technologies for either national security or trade reasons.
Because of the technological breadth of EAR and ITAR, private researchers,
using private funds, sometimes perform research in areas that fall within these
regulations. For example, research relating to aerospace technology or cryptography
could fall under export regulation. Universities performing basic research are
sometimes uncertain whether the research being performed at the institution falls
under EAR or ITAR restrictions.
Both EAR and ITAR possess exemptions for “fundamental research.”
Fundamental research is defined under ITAR as:
... basic and applied research in science and engineering where the resulting
information is ordinarily published and shared broadly within the scientific
community, as distinguished from research the results of which are restricted for
proprietary reasons or specific U.S. Government access and dissemination
controls. University research will not be considered fundamental research if:
(i) The University or its researchers accept other restrictions on publication of
scientific and technical information resulting from the project or activity, or
(ii) The research is funded by the U.S. Government and specific access and
dissemination controls protecting information resulting from the research are44
applicable.
Universities generally rely on the fundamental research exclusion to exempt the
research performed there from export control. If the university research is not
exempt through the fundamental research exclusion, export licensing must be
42 The Commerce Control List for Export Administration Regulation can be found online
at [http://www.access.gpo.gov/bis/index.html].
43 The Munitions Control List for the International Traffic in Arms Regulations can be found
online at [http://www.access.gpo.gov/nara/cfr/waisidx_01/22cfr121_01.html].
44 The definition given here is from 22 CFR 120.11. It varies slightly from the definition
given in NSDD-189 and from the definition given in 15 CFR 734.8.
obtained and information controls with respect to foreigners performed. Failure to
obtain such a license can result in prosecution and large fines.
Export of Information. A further complication to export regulation is the
concept of a “deemed export.” A deemed export is transfer of information, not
physical items, to a foreign national from select countries without first obtaining an
export license for that technology. This provision has been especially troubling for
universities, as foreign students and researchers who attend graduate-level classes
may be exposed to information relating to technology which falls under export
controls.
There have been cases where export control of information and scientific
research have coincided. In the 1980s, research papers were removed by the
Department of Defense from a scientific convention because foreign nationals
ineligible for export licenses would be attending, and other conventions were held
in private session, to avoid violation of the deemed export aspect of these45
regulations. Some universities have reported problems in collaborations with
foreign researchers, and cited, as an example, difficulty in transferring some46
technologies developed by foreign graduate students to industry.
The Export Administration Act of 1979 (P.L. 96-72) has not been reauthorized.
As a consequence, President George W. Bush invoked the International Economic
Emergency Powers Act (P.L. 95-223) to maintain export administration regulation.
While the International Economic Emergency Powers Act continues export
administration regulation, the penalties for violating this act and the enforcement
authority granted under this act are less than those under the Export Administration47
Act of 1979.
The USA PATRIOT Act (P.L. 107-56) created another mechanism to block
certain foreign nationals from obtaining specific information. Access to or48
information about biological and toxin agents on the “select agent” list is barred to
individuals, including students, originating from countries which support terrorism.
Under the USA PATRIOT Act, universities are charged with improving security and
access controls to select agents, and the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (P.L. 107-188) requires sites with select
45 For example, in 1984, the 25th Structures, Structural Dynamics and Materials Conference
closed two proceedings sessions to foreign nationals. For other examples, see Harold
Relyea, Silencing Science: National Security Controls and Scientific Communication,
(Norwood, New Jersey: Ablex Publishing Corporation), 1994, pp. 125-126.
46 Testimony by the Association of American Universities before the Senate Committee on
Foreign Relations, Subcommittee on International Economic Policy, Export, and Trade
Promotion, June 15, 2000.
47 For more information on the reauthorization of the Export Administration Act of 1979,
see CRS Report RL31832, The Export Administration Act: Evolution, Provisions, and
Debate, by Ian F. Fergusson.
48 The select agent list consists of viruses, bacteria, rickettsiae, fungi, and toxins and is
determined by the Secretary of Health and Human Services. Agents on the select agent list
are considered to have the potential to pose a severe threat to public health and safety.
agents to keep a current inventory of those agents and register their possession with
the Department of Health and Human Services or with the Department of
Agriculture, depending on the nature of the select agent.
Most universities generally reconcile their dual roles, that of providing
educational and research opportunities to their students while simultaneously
remaining in compliance with the limits of export regulations, by relying on the
fundamental research exclusion. Some universities affirm their role as disseminators
of knowledge and do not identify the nationality of students attending classes, citing
the incompatibility of closed classrooms with their academic charter.49
Prepublication Review
Some federal funding agencies, for example, the U.S. Army Research
Laboratory, Army Corps of Engineers, the Department of Energy, and the Federal
Aviation Administration, have occasionally incorporated publication restrictions in
the terms and conditions of their research contracts when the area of research either
may have potential defense applications or contain sensitive material.50 In general,
these restrictions have not been applied to entire research fields, but, instead, have
been targeted at specific research considered to be of import or relevance to national
defense or where portions of a contract may contain classified information.
University administrators have been reportedly uneasy about such
prepublication review clauses within funding vehicles. Officials at Duke University
reportedly renegotiated and rejected contracts that had prepublication clauses inserted
into them by the Department of Defense.51 Administrators at the Massachusetts
Institute of Technology have refused contracts including prepublication review
language.52 While prepublication review clauses within Department of Defense
funding vehicles have caused concern among the academic community that they may
violate NSDD-189, the Director of the Office of Science and Technology Policy
(OSTP), Dr. John Marburger, has stated that the Department of Defense use of
49 For example, access to classrooms, libraries, laboratories, and specialized research
facilities of the University of California is open, without regard to citizenship, residency
status, or visa category. Questions regarding citizenship status may not be asked of those
entering such facilities unless a special exception has been granted. Office of the President,
University of California, Operating Guidance Memo No. 00-05, October 30, 2000. The
University of California asserts such guidance does not hinder the University’s compliance
with legal obligations under federal law.
50 Anne Marie Borrego, “Colleges See More Federal Limits on Research,” Chronicle of
Higher Education, November 1, 2002, p. 24 and Connie Cass, “Science Community
Struggles With Terror-Wary Feds,” Associated Press, January 2, 2003.
51 David Malakoff, “Universities Review Policies for Onsite Classified Research,” Science,
Vol. 295 (February 22, 2002) pp. 1438-1439.
52 Anne Marie Borrego, “Colleges See More Federal Limits on Research,” Chronicle of
Higher Education, November 1, 2002, p. 24.
prepublication clauses in contracts has been consistent with prior policy.53 Dr.
Marburger requested that the academic community provide OSTP with examples of
such clauses. The Council on Government Relations and the American Association
of Universities prepared a joint report submitted to OSTP documenting 103
prepublication clauses presented over a six month period to a sample of 20
universities.54
Some universities fear that federal prepublication review clauses might
invalidate the fundamental research exemption that such research results normally
enjoy. As a consequence, university research done in an export-controlled area
would no longer be excluded from export control regulations.55
Policy Actions
The catastrophic terrorist attacks of 2001 led to an executive branch
reevaluation of the treatment of government-owned information. In the wake of
these events, many government agencies evaluated information which was available
to the public through government websites and began to reassess documents that had56
recently been declassified.
The Card Memorandum
This process was marked by a memorandum on March 19, 2002 sent by
Assistant to the President and Chief of Staff Andrew Card to executive branch
departments and agencies.57 This memorandum became known as the “Card memo.”
It cautioned that information possessed by the federal government which could be
reasonably expected to assist in weapons of mass destruction development or use
should not be inappropriately disclosed. Additionally, the guidance contained within
the Card memo reinforced the need to protect “sensitive, but unclassified”
information related to homeland security.
53 Remarks of Dr. John Marburger, Director, Office of Science and Technology Policy, at
the National Academies of Science Roundtable on Scientific Communication and National
Security, June 19, 2003.
54 American Association of Universities/Council on Government Relations, Restrictions on
Research Awards: Troublesome Clauses, April 8, 2004.
55 Eugene B. Skolnikoff, “Protecting University Research Amid National-Security Fears,”
The Chronicle of Higher Education, May 10, 2002, pp. B10-B12.
56 William J. Broad, “Nation Challenged: Domestic Security: U.S. Is Tightening Rules On
Keeping Scientific Secrets,” The New York Times, February 17, 2002.
57 The Card memo contained guidance from the Acting Director of the Information Security
Oversight Office, National Archives and Records Administration, and the Co-Directors of
the Office of Information and Privacy, Department of Justice. A copy of this memo is
available at [http://www.fas.org/sgp/bush/wh031902.html].
The term “sensitive, but unclassified” was not defined in the memorandum and
it is not clear how sweepingly construed this category might be.58 Further guidance
regarding the use of this category is found within the memo itself:
The need to protect such sensitive information from inappropriate disclosure
should be carefully considered, on a case-by-case basis, together with the
benefits that result from the open and efficient exchange of scientific, technical,59
and like information.
Several comparable, but still dissimilar, definitions of “sensitive, but60
unclassified” are in use at different agencies. The Department of State describes
“sensitive, but unclassified” information as:
...information which warrants a degree of protection and administrative control
that meets the criteria for exemption from public disclosure set forth under
Sections 552 and 552a of Title 5, United States Code: the Freedom of61
Information Act and the Privacy Act.
The Department of Energy’s use of “sensitive, but unclassified” is described as:
Information for which disclosure, misuse, alteration or destruction could
adversely affect national security or government interests. National security
interests are those unclassified matters that relate to the national defense or
foreign relations of the Federal Government. Governmental interests are those
related, but not limited to, the wide range of government or government-derived
economic, human, financial, industrial, agricultural, technological, and law
enforcement information, as well as the privacy or confidentiality of personal62
information provided to the Federal Government by its citizens.
58 For more information on “sensitive, but unclassified” information, see CRS Report
RL33303, “Sensitive But Unclassified” Information and Other Controls: Policy and
Options for Scientific and Technical Information, by Genevieve J. Knezo.
59 Ibid.
60 For example, a GAO study identified 56 different sensitive but unclassified designations.
Government Accountability Office, Information Sharing: The Federal Government Needs
to Establish Policies and Processes for Sharing Terrorism-Related and Sensitive but
Unclassified Information, GAO-06-385, March 2006.
61 Definition taken from the U.S. Department of State, Foreign Affairs Manual, located at
62 Definition taken from Office of Security Affairs, Safeguards and Security Glossary of
Terms, U.S. Department of Energy, December 18, 1995, as cited in Commission on Sciencest
and Security, Science and Security in the 21 Century: A Report to the Secretary of Energy
on the Department of Energy Laboratories, The Center for Strategic and International
Studies, April, 2002.
The Department of Defense maintains several types of controlled, unclassified
information. The Department of State category of “sensitive, but unclassified” is a
document designation comparable to For Official Use Only.63 The criteria for
allowing access to For Official Use Only and “sensitive, but unclassified”
information are the same. The Department of Defense describes For Official Use
Only as:
... a designation that is applied to unclassified information that may be exempt
from mandatory release to the public under the Freedom of Information Act64
(FOIA).
Response of Scientific Community
Scientists are divided about how to balance scientific openness and national
security concerns. While recognizing that security concerns are valid, some scientists
assert that the value of publication of research results is greater than the potential
risks. Others state that publication of select research results is troublesome and that
mechanisms for determining which research results fall into this category and
addressing publication of these results need to be determined. The National
Academies of Science and multiple scientific professional societies have engaged
with other stakeholders in exploring the role of scientists, publishers, and the
government in assessing the security concerns of such research results.
Professional Societies. While many professional societies have wrestled
with the balance between scientific openness and security concerns, the actions of the
American Society for Microbiology will be highlighted here as an example of the
actions taken to address these concerns.
The American Society for Microbiology, a professional organization which
publishes many scientific journals, including the Journal of Virology in which the
mousepox article was printed, has received requests by authors to be allowed to omit
certain information from their submissions.65 By omitting such information, the
experiments described in the article would be much more difficult to reproduce,
perhaps impossibly so.
63 As reported on the Defense Security Service website at
[http://www.dss.mil/search-dir/training/csg/security/S2unclas/Intro.htm] .
64 Department of Defense, “Information Security Program,” Department of Defense
Directive 5200.1-R, January 1997.
65 Andrew Moesel, “Scientists Call For Withholding Sensitive Data,” University Wire,
August 12, 2002.
The American Society for Microbiology has adopted the position that all
information necessary to reproduce an experiment must be included in any
submission for publication. Former American Society for Microbiology president,
Dr. Ronald Atlas, testified:
Omission of materials and methods from scientific literature would compromise
the scientific process and could lead to abuses as well as the perpetuation of
errors. Independent reproducibility is the heart of the scientific process. Even
within the context of heightened scrutiny, research articles must be published
intact. If scientists cannot assess and replicate the work of their colleagues, the66
very foundation of science is eroded.
Recognizing as valid the concern that scientific information in journals might
be inappropriately used, the American Society for Microbiology has developed and
established policy guidelines for reviewers and editors of their journals. These
guidelines establish a procedure for special review of submissions concerning select
agents, as defined by regulation, and for those submissions which reviewers feel may67
possess the potential for inappropriate use.
The American Society of Microbiology’s guidelines for publishing potentially
contentious research were tested with the publication of a manuscript in March 2003
in the journal Infection and Immunity. This paper described the effects of proteins
that accompany botulinum toxin during natural production and assessed the proteins’
effects when inhaled. Upon receipt of the manuscript, editors requested that some
portions of the paper be modified, in order to allay the editors’ security concerns.68
The National Academies. The Presidents of the National Academies
released a joint statement and background paper which avers that the federal
government should continue its current practice of classification and not further
develop a less well-defined category to encompass sensitive research results.69 They
asserted that scientific creativity and national security would both be lessened if clear
distinctions are not drawn between areas where open publication is acceptable or not.
They also emphasized that wide dissemination of research results and peer review are
important aspects of research science.70
66 Written testimony from Ronald M. Atlas, President, American Society for Microbiology,
before the House of Representatives Committee on Science, October 10, 2002.
67 The guidelines developed by the American Society for Microbiology for authors, editors,
publishers, and reviewers are found online at
[ ht t p: / / www.j our nal s .asm.or g/ mi sc/ Pat hogens_and_T oxi ns.sht ml ] .
68 Nell Boyce, “Keeping Details From the Devil,” U.S. News & World Report, March 10,
69 Statement on Science and Security in an Age of Terrorism from Bruce Alberts, Wm. A.
Wulf, and Harvey Fineberg, Presidents of the National Academies, October 18, 2002.
70 Background Paper on Science and Security in an Age of Terrorism, National Academies
of Science.
A meeting entitled “Scientific Openness and National Security” was held at the
National Academy of Sciences on January 9, 2003.71 It addressed some aspects of
the debate regarding scientific publication and national security. Members of the
academic scientific community, the non-profit community, and the federal
government met for a day-long symposium identifying the significant contentious
issues.
At this meeting, Dr. Marburger reiterated that NSDD-189 continues to define
policy for publication of federally funded research results. He suggested that
research should be designated as classified prior to awarding a federal grant or
contract, and that the need for deviation from this policy should be uncommon. He
also stated that previous precedents of control in the physical sciences may not
provide adequate guidance for bioterrorism.72 Dr. Penrose Albright, then of the
Office of Science and Technology Policy and the Office of Homeland Security, also
stated that an articulated and defensible criteria for inappropriate research, able to
distinguish dangerous and benign research results, combined with a mechanism for
identifying articles containing dangerous but valuable information would be well
received by the Executive Branch.73
Following the National Academies’ meeting, journal editors, scientist-authors,
and other stakeholders met and discussed the challenges posed by publication of
certain research results, eventually issuing a statement calling for renewed vigilance
and personal responsibility for potentially dangerous research presented to them for
publication.74 This joint statement provided the base for subsequent announcements
in Science, Proceeding of the National Academies of Science of the United States of
America, and the British journal Nature affirming editorial policy to both deal
responsibly and effectively with security issues while maintaining the integrity of the
scientific publishing process.75 It has been asserted that the joint statement should
be understood as augmenting, but not supplanting, existing editorial policy at the
signatory journals.76 For example, the American Association for the Advancement
of Science, the professional organization which publishes Science, has implemented
71 This meeting was co-hosted by the National Academy of Sciences and the Center for
Strategic and International Studies.
72 “NAS Forum on Scientific Openness Considers National Security Concerns,” Washington
Fax, January 10, 2003.
73 Public comments, Penrose Albright at “Scientific Openness and National Security,”
National Academy of Sciences, January 9, 2003.
74 Lila Guterman, “Journal Editors and Scientists Call for More Caution in Publishing
Potentially Dangerous Research,” The Chronicle of Higher Education, February 17, 2003.
75 Journal Editors and Authors Group, “Uncensored Exchange of Scientific Results,”
Proceedings of the National Academy of Sciences of the United States of America, Vol. 100,
No. 4, (February 18, 2003) 1464. “Statement on Scientific Publication,” Science, Vol. 300,
(February 21, 2003) 1149. “Statement on the Consideration of Biodefence and Biosecurity,”
Nature, Vol. 421, (February 20, 2003) 771.
76 See, for example, William Schulz, “Journal Editors Deal With Security Issues,” Chemical
and Engineering News, February 17, 2003, p. 15.
a formal policy on how to deal with potentially dangerous reports in conjunction with
existing editorial policy.77
While consensus was not achieved among the attendees of the National
Academies’ meeting regarding the potential solutions, there was general agreement
that a growing dialogue between the scientific and security communities would aid
in satisfying community members’ concerns. Towards this goal, the National
Academy of Sciences and the Center for Strategic and International Studies convened
a two-year, joint Roundtable on Scientific Communication and National Security.
Both the scientific and security community were invited to informally discuss, and
potentially develop, solutions to the tension over publication.78 This led to the
formation of a Commission on Scientific Communication and National Security by
the Center for Strategic and International Studies. This Commission published a
white paper in 2005, recommending that the federal government maintain NSDD-189
and that research institutions establish mechanisms to ensure informed compliance
with applicable regulations regarding dissemination of scientific information.79
The National Academies continue to explore the issue of performing and
publishing research that has potential homeland security impact. Committees have
been empaneled to consider these impacts and possible mitigating approaches. The
National Academies have released several reports containing recommendations for
the federal government on handling contentious research and research results.
One report recommended that the policies of NSDD-189 be continued and that
other mechanisms should be developed to address the difficulties of assessing and
responding to contentious research.80 The report identified seven research areas
where results might pose a security concern and advocated that proposed research in
these areas be reviewed, and potentially rejected, by a committee, specifically the
institutional biosafety committee within each research institution, before the research
is performed. Thus, research of concern could be identified and weighed before
results were generated. Editors and publishers would continue to exercise their
professional judgement in the publishing of manuscripts, without federal review or
requirements.
Response to this proposal has been mixed. While many in the scientific
community have supported this framework as an appropriate balance of scientific
self-regulation and federal advisory oversight, others have criticized the proposal for
not being legally binding or requiring such review of government or industrial
77 The new policy for potentially dangerous reports is described in Information for
Contributors, Science, January 3, 2003.
78 “National Security, Scientific Openness,” Center for Strategic and International Studies
Press Release, March 14, 2003.
79 Commission on Scientific Communication and National Security, Security Controls on
Scientific Information and the Conduct of Scientific Research, June 2005.
80 National Research Council, Biotechnology Research in an Age of Terrorism,
(Washington, DC: National Academies Press), October, 2003.
research.81 Additionally, it would not act as a barrier to informal dissemination of
research results that might fall in one of the seven research areas. As an example of
the limitations of the National Academies proposal, critics refer to the open
discussion of mousepox research results by Dr. Buller at a biosecurity convention in
Geneva, Switzerland.82
A different report suggested the creation of an independent advisory body to
partner with intelligence officials and government leaders to analyze science and
technology in order to anticipate future biological threats.83 The report asserted that
scientists need to adopt a common culture of awareness and responsibility regarding
research in the life scientists, to prevent the malevolent use of such research’s results.
While some professional societies have adopted codes of conduct, biosecurity experts
assert that these codes are not all equivalent and may not pose a sufficient barrier to
prevent the misuse of benevolent science.
Department of Homeland Security
The Homeland Security Act (P.L. 107-296) created the Department of
Homeland Security, within which many research and development functions relating
to homeland security were aggregated under the Science and Technology directorate.
This directorate is responsible for researching, developing, and deploying biological,
chemical, nuclear, and radiological countermeasures. It also has management of the
Homeland Security Advanced Research Projects Agency, which funds extramural
homeland security research.
How homeland security information shall be handled by the Department of
Homeland Security is further described in the Homeland Security Act. While to the
greatest extent practicable, the results of research funded by the Department of
Homeland Security are to be unclassified,84 the President is also instructed to:
prescribe and implement procedures under which relevant Federal agencies ...
identify and safeguard homeland security information that is sensitive but
unclassified. ... The President shall ensure that such procedures apply to all85
agencies of the Federal Government.
Congress has held many hearings to perform oversight of the Department of
Homeland Security. Issues raised in these hearings indicate that some policies are
not yet in their final form. Since extramural scientific research funded by the
Department of Homeland Security might be reasonably expected to also have security
81 See, for example, John Dudley Miller, “National Academy Proposes Scientists Self-
Police,” The Scientist Online, October 9, 2003.
82 See, for example, John D. Steinbruner and Elisa D. Harris, “When Science Breeds
Nightmares,” International Herald Tribune, December 3, 2003.
83 National Research Council, Globalization, Biosecurity, and the Future of the Life
Sciences, (Washington, DC: National Academies Press) 2006.
84 P.L. 107-296, Section 306.
85 P.L. 107-296, Section 892(a).
ramifications, an explicit policy relating to publication of such sensitive but
unclassified information will likely be needed.
The Department of Homeland Security has not, as of this writing, developed the
methods by which potentially contentious extramural research results will be
identified and handled or publicly disseminated policies regarding these results.
Then-DHS Secretary Ridge, in remarks to the Association of American Universities
in April 2003, stated that the federal government continued to uphold NSDD-189,
and that he did not plan to apply sensitive but unclassified or sensitive homeland
security information guidelines to federally funded research. Instead, sensitive
homeland security information and sensitive but unclassified information would only
be information that the federal government already possesses.86
Then-Under Scretary for Science and Technology Charles McQueary told the
American Association for the Advancement of Science Colloquium on Science and
Technology Policy that scientific organizations should establish their own criteria for
prepublication review of risky research articles and that scientists and journal
publishers should set the bar for themselves.87
It has been reported that the Homeland Security Advanced Research Projects
Agency follows a Department of Defense model for quasi-classified broad agency
announcements. The Homeland Security Advanced Research Projects Agency
reportedly holds back, in some circumstances, information from broad agency
announcements in order to avoid revealing vulnerabilities.88 The criteria for these
circumstances has not been made publicly available. Whether research results arising
from such broad agency announcements could be freely published has not been made
clear.
Department of Health and Human Services
Following the publication of Biotechnology Research in an Age of Terrorism,
the Department of Health and Human Services announced the establishment of a
National Science Advisory Board for Biodefense (NSABB), building on several of
the National Academies’ recommendations.89 The NSABB is, among other duties,
to provide advice, guidance, and leadership regarding biosecurity oversight of
dual-use research.90 While the NSABB is managed and supported by the National
86 Remarks by Secretary Tom Ridge to the Association of American Universities,
Washington, DC, April 14, 2003.
87 Shirley Haley, “Scientists Should Decide For Themselves What Research Is Too Risky
To Publish, DHS S&T Chief Says,” Washington Fax, April 15, 2003.
88 Judi Hasson, “Research Arm Puts Lid on Contracts,” Federal Computer Week, August 14,
89 Department of Health and Human Services, “HHS Will Lead Government-wide Effort to
Enhance Biosecurity in "Dual Use" Research,” Press Release, March 4, 2004.
90 Dual-use research is defined as biolgoical research with legitimate scientific purpose that
may be misused to pose a biologic threat to public health and/or national security.
(continued...)
Institutes of Health (NIH), it is to advise the Secretary of HHS, the Director of NIH,
and the heads of all federal departments and agencies that conduct or support life
sciences research.91
The NSABB is composed of not more than 25 non-federal voting members
appointed by the Secretary of Health and Human Services in consultation with the
heads of other federal departments and agencies conducting life sciences research.
It also contains non-voting ex officio federal members who represent agencies and
departments that conduct or support life sciences research.92
The NSABB is developing guidelines and an oversight framework for
considering federally funded research that might pose security challenges. So far, the
guidelines developed have closely followed those suggested by the National
Academies, while the issue of what oversight framework would be most optimal is
still under discussion.
The NSABB has also provided advice to the HHS Secretary regarding dual-use
research and reviewed the publication of specific scientific research results. 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.93 Prior to the publication of the research article, the HHS
Secretary consulted with the NSABB for guidance.94 The NSABB met and
unanimously recommended 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 and how they compare with its potential benefits.95
The use of the NSABB in vetting the publication of the 1918 flu research paper
has been identified by some observers as a successful exercise of the NSABB
advisory mission. Nevertheless, others have criticized the timing and mechanism of
the review process, questioning the role the board plays in advising policymakers and
90 (...continued)
Department of Health and Human Services, National Science Advisory Board for
Biosecurity Charter, March 4, 2004.
91 For more discussion on the National Science Advisory Board for Biosecurity, see CRS
Report RL33342, Oversight of Dual-Use Biological Research: The National Science
Advisory Board for Biosecurity, by Dana A. Shea.
92 For more information on the National Science Advisory Board for Biosecurity, see online
at [http://www.biosecurityboard.gov/].
93 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.
94 Centers for Disease Control and Prevention, “Researchers Reconstruct 1918 Pandemic
Influenza Virus; Effort Designed to Advance Preparedness,” Press Release, October 5,
95 This editorial was published in the same issue: Philip A. Sharp, “1918 Flu and
Responsible Science,” Science, vol. 310, October 7, 2005, p. 17.
the threshold used for determining whether NSABB guidance would be sought on a
submitted publication.96
Policy Options
The balance between publication of federally funded research results and
protecting national security raises numerous questions, such as: Should there be
regulation of the publication of federally-funded research results? Is the potential
impact on scientific quality, productivity, and advancement resulting from
publication controls worth the added potential security gained through such controls?
How might relevant policy be uniformly employed by all agencies of the federal
government? Should such policy vary by scientific and technical disciplines? At
what stage, if any, of the civilian research process might regulation or restriction
occur? How much authority, if any, does the federal government have over the
publishing of research results developed through private funding? How might
development or implementation of such authority introduce first amendment
conflicts? Since science is an increasingly international discipline, how would
national security concerns regarding federally funded research results be
implemented in a global context? How might the federal government encourage
scientists to develop guidelines for self-regulation? Given the international nature
of scientific publication, might self-regulation by domestic publishers cause sensitive
research results to be published in international journals rather than domestic
journals? How might Congress provide oversight of this issue with respect to
extramural research and development funded by the Department of Homeland
Security?
Using Classification
Some members of the scientific community advocate that the status quo, where
the mechanism for blocking publication of federally-funded research results is
classification, should remain the federal government’s policy on controlling research.
They assert that this mechanism has been sufficient in the past, and that the vigor of
scientific research could be unduly, and perhaps seriously, impeded if new controls
were developed and added.97 Advocates of classification assert that, with the
addition of the Secretary of Health and Human Services,98 the Secretary of
Agriculture,99 and the Administrator of the Environmental Protection Agency100 to
the list of those persons authorized to classify information, the federal government
96 See also CRS Report RL33342, Oversight of Dual-Use Biological Research: The National
Science Advisory Board for Biosecurity by Dana A. Shea.
97 D.J. Galas and H. Riggs, “Global Science and U.S. Security,” Science, Vol. 300, (June
98 66 Fed. Reg. 64,345 (December 12, 2001).
99 67 Fed. Reg. 61,463 (September 30, 2002).
100 67 Fed. Reg. 31,109 (May 9, 2002).
has greater capacity to identify information for classification. They assert that, in line
with NSDD-189, information which is not classified should be freely publishable and
distributable. Advocates of this position claim that areas of proscribed research
should be well defined and protected by strong barriers, such as those provided under
classification.
Advocates of retaining the status quo also cite substantial concern about the
impact of publication controls on science, especially in biological sciences.101 Some
have claimed that there would be a flow of scientists out of contentious research
areas into areas where there is less concern about the legal ramifications of their
work. 102
Additionally, some scientists believe that an unimpeded flow of scientific
information is important to maintaining national security. They assert that national
security will be increased if many researchers have access to information that may
lead to new vaccines, detectors, and treatments, or conversely, that impeded access
may limit the development of countermeasures.103 Dr. Paul Keim, a scientist at
Northern Arizona University, stated:
If the Bacillus anthracis genome had not been released, we would not have been
able to develop the high-resolution system that is currently so important [to the104
investigation of the anthrax attacks].
On the other hand, advocates for changing the current system contend that
scientists are currently making available to terrorist groups information that can be
used to harm the populace. Classification is not applied to information already
published in the open literature, and research results that threaten national security
may arise from normally unclassified fields. Thus, advocates of changing the current
system assert that classification is insufficient to stop dissemination of information
arising from normally unclassified fields, as it may enter into the open literature
before it is identified as potentially harmful to national security. These proponents
claim that the continued publication of such information will harm national security,
and that changes should be made so that such federally funded research results can
be classified before they are distributed.
Some policymakers have also asserted that the current classification system may
not be appropriate for all sciences. They emphasize the difficulties in clearly
101 Charles Vest, “Response and Responsibility. Balancing Security and Openness in
Research and Education,” Report of the President for the Academic Year 2001-2002,
Massachusetts Institute of Technology, September 2002.
102 For example, see Mark Clayton, “Academia Becomes Target for New Security Laws,”
The Christian Science Monitor, September 24, 2002, p. 11.
103 Daniel J. Kevles, “Biotech’s Big Chill,” Technology Review, July/August 2003, pp. 41-
104 Debora MacKenzie and Sylvia Pagan Westphal, “Should the Genetic Sequences of
Deadly Diseases Be Kept Secret?” New Scientist, July 20, 2002, p7.
defining what aspects of biological research should be subject to regulation,105 and
that, unlike other classified research areas, much of microbiology is performed
outside of the federal government.106 They suggest that classifying basic biological
research might be necessary for homeland security, but also might unduly restrict
future applied research. Thus, they claim a different method for handling such results
may be necessary.107
Advocates for adjusting the current system also assert that information
published in scientific journals may undermine biodefense efforts. For example,
publishing which portion of a pathogen’s genome is used in a new biodetection
device could inform terrorists how to create a pathogen which would avoid detection
by that method.108, 109
The scientific and export communities interact when changes to export control
regulation are suggested. These interactions may indicate how different policy
approaches regarding publication of potentially dangerous research results may be
discussed and developed in a mutually acceptable manner. In export control, the
concerns of national security are met while simultaneously allowing research to
continue. That said, implementation of export control regulations has posed some
challenges to researchers. Application of deemed export provisions and proposed
revision of these provisions have raised concerns among the academic community
as being unwieldy and potentially injurious to the research process.110
Self-Regulation by Scientists
While many individual scientists may identify reasonable and valid concerns
regarding the potential inappropriate use of information in scientific journals,
opinions vary about how to best address these concerns. Some have advocated a self-
policing framework where scientists regulate themselves through a combination of
ethical agreements and publishing oversight.111 They claim that scientists are in the
best position to determine the threshold for responsible science and to respond to new
scientific developments. As was shown through the experience of the National
105 Gigi Kwik, “Biosecurity: Science in the Balance,” Biodefense Quarterly, (Winter 2003).
106 Peg Brickley, “CIA Openness Report To Be Classified?” The Scientist, April 7, 2003.
107 D. Malakoff, “Researchers Urged to Self-Censor Sensitive Data,” Science, Vol. 299,
(January 17, 2003) 321.
108 Nicholas Wade, “Traces of Terror: Bioterrorism; Scientists Worry Journals May Aid
Terrorists,” The New York Times, July 26, 2002, p. A19.
109 Richard Monastersky, “Publish and Perish? As the Nation Fights Terrorists, Scientists
Weigh the Risks of Releasing Sensitive Information,” The Chronicle of Higher Education,
October 11, 2002, p. A16.
110 For one view of the concerns of the academic community regarding export control
regulations, see Donald Kennedy, “A Welcome New Look,” Science, Vol. 312, No. 5780,
June 16, 2006, p. 1573.
111 See for example Joseph G. Perpich, “The Recombinant–DNA Debate and Bioterrorism,”
The Chronicle of Higher Education, March 15, 2002, p. 20.
Institutes of Health Recombinant DNA Advisory Committee, amendment or
adjustment of regulation and rules related to science is often needed, as the subject
matter continues to evolve and progress.
Several mechanisms are possible within a self-regulating framework. One
might involve review boards within institutions to assess research results. Much
research involving human subjects, for example, is governed by local institutional
review boards. A board’s purview generally extends to all human research at the
institution, irrespective of funding source. Although required by the Public Health
Service Act and the Federal Food, Drug and Cosmetic Act for certain human
experimentation, the boards at extramural research institutions are not federal
entities.112 These institutional review boards have the ability and authority to
approve, require modifications within, or disapprove research projects. Similar
review boards established within research facilities could be given the role of
screening manuscripts in a formal or informal manner prior to their publication.
Another possibility would be to convene a new “Asilomar-like” conference,
where members of the scientific and national intelligence communities, along with
public input, come together and craft codes of conduct which will satisfy the varying
needs of these disparate groups.113 By doing so, a framework could be developed to
identify sensitive research results and provide alternate dissemination routes.114
NIH National Institute of Allergy and Infectious Diseases Director Anthony
Fauci has voiced support for the establishment of an oversight panel. For example,
he suggested the formation of a panel to determine the appropriateness of certain
types of biomedical research and stated:
There should be a committee – a combination of academics and societies and
perhaps journal editors – to discuss [publication], so if there is a question in the
mind of someone, you can bring it to a body who can, in an unbiased way, give115
you an idea about whether or not you should [publish].
112 More information about institutional review boards can be found online at
[http://www.fda.go v/ oc/ohr t/irbs/faqs.html ].
113 Ronald M. Atlas, “National Security and the Biological Research Community,” Science
Vol. 298, (October 25, 2002) pp.753-754.
114 For example, see Letter to the Editor, “Science Publishing and Security Concerns,”
Science, Vol. 300, (May 2, 2003) p. 737.
115 Anthony Fauci, quoted in “Security Exceptions to Transparency in Publishing NIH-
funded Research Will Be Rare, Fauci Says,” Washington Fax, October 11, 2002.
Whether scientific researchers would be able to properly weigh the security
concerns of research results is uncertain as well. For example, Dr. Stephen Morse,
in endorsing the idea of an Asilomar-like conference, pointed out:
Scientists are not in the age of innocence anymore. And they should be aware116
of the moral implications of what they’re doing.
Some have maintained that the natural inclination of scientists is to err on the side of
openness and publication,117 while others posit that since the science and security
communities are separated, trust in the actions of the opposing community is difficult
to develop.118 Other complications to self-regulation exist as well. As scientific
research has become more international in scope, it would be necessary for such a
self-regulatory framework to be adhered to on an international basis for optimal
effectiveness. Without the agreement of international scientists to maintain similar
codes of conduct, contentious research results generated by international scientists
would continue to enter the open literature. Also, scientists within the U.S. might
preferentially publish in international journals, should the barrier to publication in a
domestic journal be raised significantly higher than found in international publishing.
The NIH guidelines developed out of the Asilomar conference are generally
followed on an international level, but the scientific community is much larger now
than in the 1970s, and developing agreement among such a community may be more
difficult to achieve.119 Genetically modified foods and stem cell research are
examples of biological research areas around which a community-wide, international
consensus has not evolved.
The National Research Council report Biotechnology Research in an Age of
Terrorism provides recommendations for a potential self-regulatory mechanism. It
identifies seven areas where “experiments of concern” might exist, and recommends
that experiments within these areas be reviewed by an institutional biosafety
committee to determine whether the experiments present some degree of concern.
The institutional biosafety committees would thus provide an initial review of
proposed experiments. If further review or consultation was needed to determine
whether an experiment was of concern, then the experiment could be referred to an
expanded Recombinant DNA Advisory Committee or to a higher authority for120
adjudication. The establishment of the National Science Advisory Board for
Biosecurity may be interpreted as fulfilling this role and function, but issues
regarding the authority and scope of the NSABB have yet to be fully resolved.
116 Laurie Garrett, “Scientists Advocate Greater Security,” Newsday, October 14, 2001, p.
A5.
117 M. Mechanic, “Publish and Perish?” East Bay Express, September 11, 2002.
118 D. Kennedy, “Two Cultures,” Science, Vol. 299, (February 21, 2003) p. 1148.
119 See G.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, No. 4, (2001) pp. 321-354.
120 National Research Council, Biotechnology Research in an Age of Terrorism,
(Washington, DC: National Academies Press), October, 2003.
Regulation by Publishers
The actions undertaken by select journal editors for handling the results of
potentially sensitive research may be models for publishing houses to adhere to in the
face of potential legislation or federal regulation. By empowering journal editors to
screen, review, and reject research papers on the basis of their weapons potential,
advocates hope to avoid new laws or regulations that might constrain the research
process and scientific productivity. The revelation that some journal papers have
been modified because of ethical concerns raised through the editorial process has
been seen as a success for this style of oversight.121
Still, some cite the opinions of the editor of Science and chief executive of the
American Association for the Advancement of Science initially expressed regarding
the need for open publication122 as indicative that the publishing community is not
unified in perspective, and that an editor-based effort might yield unsatisfactory
results. Even if domestic publishers develop a consensus protocol for handling
research results which might threaten national security, it is unclear if this would 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 that is prohibited from publication in domestic
journals. Finally, with the growing ability to disseminate scientific information to
a wide audience without resorting to formal publication, it has been questioned
whether a publisher-based policy will be effective in restricting the dissemination of
contentious research.123
The National Research Council report Biotechnology Research in an Age of
Terrorism recommends that journal editors continue to assess whether potentially
contentious manuscripts should be published. It asserts that a voluntary approach,
where scientists and editors can continue to refine and respond to criticism or other
input, is essential to the credibility of such a system within the research
community.124 Without such credibility it is believed that scientists may not take part
in potentially contentious biodefense research.
Federal Regulation
Prepublication Review of Sensitive, But Unclassified Results. An
option is the imposition by the federal government of sensitive, but unclassified
status and subsequent prepublication review of scientific research resulting from
federal government sponsorship or funding. Application of this standard would
121 Shaoni Bhattacharya, “Bioterrorist Fears Prompt Journal Paper Censorship,”
NewScientist.com, February 17, 2003.
122 J. Couzin, “A Call for Restraint on Biological Data,” Science, Vol. 297, (August 2, 2002)
pp. 749-751.
123 Steven Aftergood, “Science Journals Will Screen Papers For Hazards,” Secrecy News,
February 18, 2003.
124 National Research Council, Biotechnology Research in an Age of Terrorism,
(Washington, DC: National Academies Press), October, 2003.
likely allow scientists with appropriate credentials or need-to-know access to such
scientific literature, but would bar others’ access. Advocates of such a standard point
out that such information could be transferred among scientists with fewer controls
than classified information. It has been suggested that access to sensitive, but
unclassified research results could be controlled by the publisher through secure,
password-controlled websites.125 Other options might include dissemination of such
material via professional societies or directly from the federal government.
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 of such a label would be implemented; and
determining how such sensitive, but unclassified material would be disseminated to
those scientists eligible to receive it. A further complication is that the categorization
of what information might be sensitive, but unclassified is still not clear or uniformly
codified across all federal scientific funding agencies.126 Additionally, some
scientists or universities might choose not to participate in a process which would
determine access eligibility. A Massachusetts Institute of Technology report rejects
such security reviews as potentially becoming arbitrary.127
Another concern is the effectiveness of such a federally based review. The
federal government funds about 30% of the total research and development efforts
in the United States. In terms of basic and applied research, the federal government
funds 62% and 38% respectively.128 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.
A strong sentiment held by many members of the scientific community is that
all unclassified scientific results should be shared widely. Results are sometimes
construed to include actual samples of research materials and all information
necessary to reproduce an experiment. For example, the National Academy of
Sciences’ Board on Life Sciences has recommended that authors of scientific papers
allow unrestricted access to data and supporting materials related to published
125 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
126 Potential new regulations regarding the definition of sensitive, but unclassified
information being studied by the Office of Management and Budget may address these
issues.
127 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.
128 Percentages calculated in constant 200 dollars. Total research and development funding
information taken from National Science Foundation, National Patterns of R&D Resources:
2004 Data Update, Table 2. Basic research funding information taken from National
Science Foundation, National Patterns of R&D Resources: 2004 Data Update, Table 4.
Applied research funding information taken from National Science Foundation, National
Patterns of R&D Resources: 2004 Data Update, Table 6.
findings.129 Such a position indicates a potential lack of support within the science
community for any credential system barring access to research results.
Lastly, universities fear that federal prepublication review to determine the
sensitive, but unclassified status of material in a publication might invalidate the
fundamental research exemption that such research results normally enjoy under
EAR and ITAR. As a consequence, university research done in an export-controlled
area would no longer be excluded from export control regulations.130
Security Review at the Funding Stage. Another suggestion to addressing
research with security implications is to categorize such research at the funding stage,
rather than at the publication stage.131 Including voluntary or mandatory
prepublication review for federally funded research or the development of new
funding opportunities containing prepublication review as a condition of acceptance
are potential remedies. Individual funding vehicles have been offered to universities
which would provide the funding agency with access to research results prior to132
publication.
Opponents of this approach cite the general unwillingness that universities have
towards restricted research funding.133 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 not134
allowed as in areas where publication is encouraged. As a consequence, the pool
of eligible scientists competing for federal funding might decrease, potentially
lowering the quality of research and development performed in these areas.
Additionally, determining at the funding stage whether research will lead to sensitive
results is considered difficult. For example, the often cited mousepox experiments
129 National Research Council, Sharing Publication-Related Data and Materials:
Responsibilities of Authorship in the Life Sciences, (Washington, DC: National Academies
Press) 2003.
130 Eugene B. Skolnikoff, “Protecting University Research Amid National-Security Fears,”
The Chronicle of Higher Education, May 10, 2002, pp. B10-B12.
131 For example, see Joan Lowy, “Debate Flares on Bioterror Research,” Scripps Howard
News Service, October 2, 2002.
132 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,
133 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].
134 Philip Cohen, “Recipes For Bioterror: Censoring Science,” NewScientist.com, January
September 11, 2003.
were part of a fertility research program aimed at techniques for pest control, and the
results of the experiment were unexpected.135
Federal Licensing of Research. Some experts have suggested that the role
of the federal government should be expanded beyond a gatekeeping role when
considering 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,
Dr. John Steinbruner has suggested, as part of a Biological Research Security System,
that a national federal authority be established to license qualified researchers and
research facilities and oversee research by licensed researchers in licensed
facilities.136 Some scientists have asserted that licensing researchers, facilities, or
experiments would have a strong, negative impact on scientific productivity in those
areas.137 The registration of life scientists wishing to work with select agents has138
shown though that some scientists are willing to engage in such licensed research.
Oversight of Homeland Security-Related Research
Congress may continue to oversee development of policies relating to
publication of extramural research results funded by the Department of Homeland
Security’s Science and Technology directorate. Whether the Department of
Homeland Security should adopt a currently existing policy on extramural research
or create a new policy; how this policy might be implemented; and the degree to
which extramural research funded by the Department of Homeland Security might
present security concerns may be areas where further congressional direction occurs.
Additional oversight may focus on the activities underway in the Department
of Health and Human Services, where the National Science Advisory Board for
Biosecurity has been established. The charter of the NSABB is broad and
recommendations brought forth from the body may impact much federally funded,
homeland security-related research. The degree of impact, the comprehensiveness
of such recommendations, and their ramifications may be areas of congressional
interest. Alternately, should the NSABB be unable to provide practical
recommendations, the difficulties and barriers encountered by the board may draw
attention.
135 “Biowarfare Warning,” Journal of the American Medical Association, Vol. 285, No. 6
February 14, 2001, p. 725.
136 An initial local level of review and an international review agency are also established
as part of the Biological Research Security System. J.D. Steinbruner and E.D. Harris,
“Controlling Dangerous Pathogens,” Issues in Science and Technology, Vol. 19, Spring
2003. For a regularly revised version of this system, see online at
[ ht t p: / / www.ci ssm.umd.edu/ document s / pat hogensmonogr a ph.pdf ] .
137 Peg Brickley, “Science Police Needed?”, The Scientist, April 8, 2003.
138 For more information on the Select Agent Program, see online at
[ h t t p : / / www.c d c . go v/ od/ s a p/ ] .
Concluding Observations
Developing policy in this area balances many concerns, some of which may be
more difficult to address than others. How would a federal policy that encouraged
self-regulation of manuscript submissions, either by journal publishers or scientists,
be enforced? How would the concerns of security officials regarding national
security be met if scientists are relied upon to review articles? Conversely, how
would the concerns of scientists regarding scientific openness and academic freedom
be met if security officials review articles? A policy involving review of research
may require the cooperation of members of both the scientific and security
community, two communities that generally have limited interaction. Finally, how
would the success of a program controlling scientific research results be measured?
Some aspects of such a program, like the economic costs involved in processing the
articles, might be directly measurable, while others, such as the success in blocking
terrorist group access to this information, might not be so easily measured.