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Research Story of the WeekLimiting the Contribution of the Scientific Literature to the BW Threat
Raymond A. Zilinskas and Jonathan B. Tucker Since World War II, security analysts and policymakers have worried that
information published in open scientific literature could benefit military
adversaries. Recently, research in the biosciences has caused particular concern
because of dramatic advances in this field and their potential application to
biological warfare and terrorism. Some open scientific publications in
microbiology and related fields contain information potentially relevant to the
development, production, formulation, and/or delivery of biological weapons. A
workshop in August 2002,[1] organized by the
Center for Nonproliferation Studies and supported by the U.S. Defense Threat
Reduction Agency, discussed possible approaches to minimize the risk that
"sensitive" research findings could be misused for biological
warfare (BW) or terrorism. The
full report
of this workshop was published in the Journal of Homeland Security on
December 2, 2002. Assessing the Threat of Sensitive Information Being Used for Malicious Purposes The participants generally agreed that the most serious threat arises not from lone terrorists or organizations with limited scientific expertise, but from scientists working in sophisticated, well-funded national BW programs or affluent terrorist organizations such as Aum Shinrikyo. Such experts read the scientific literature and are capable of using basic research findings to pursue weapons-related developments. A major challenge facing those who seek to stem the spread of biological weapons is the dual-use nature of applied microbiology and biotechnology. The same scientific knowledge, technical know-how, and equipment involved in the peaceful development and production of commercial products could be misused by those seeking to acquire biological weapons. This dual-use dilemma carries over into the scientific literature. When research papers are published that elucidate the infectious process, describe the molecular basis of pathogenesis, or examine the action of toxins on physiological systems, they add to the general body of scientific knowledge and facilitate the development of new medical treatments. Yet, the same information could be used by bioweaponeers to devise more deadly biological agents or means of delivery. To give just one example: an article on aerosol spray drug-delivery systems benefits those trying to replace insulin injections for diabetes and to develop intranasal delivery of a vaccine against influenza. But it could also be used by those seeking to disseminate biological warfare agents through aerosolization, the most effective means of attack. Prior to the terrorist attacks of September 11, few scientific journal editors worried about whether a research finding such as this could be misused. After the terrorist attacks and the subsequent incidents of anthrax-tainted letters, several new regulations on sensitive information and foreign scientists were proposed. In one of the most recent examples, the White House Office of Management and Budget announced its intention to develop rules for "the discussion and publication of information that could prove sensitive to national security." Historical Precedents for Regulating Scientific Regulation The conference participants reviewed the historical precedents for government-imposed restraints on the communication of scientific information. They noted that the U.S. government has long classified information that bears directly on national security, including technical data generated by universities performing government contract work. Some universities have set up subsidiary institutions that perform classified research for the federal government. Also, the U.S Patent and Trademark Office can prevent the release of information contained in a patent on security grounds. However, the guidelines for patent examiners reviewing applications for national security implication were developed in 1972, when modern biotechnology was in its infancy, and thus they are probably outdated. The Current Debate Biological scientists and their professional associations generally assert that the government should not restrict the dissemination of unclassified fundamental research, even when the findings are potentially hazardous. They argue that such restrictions would: 1) hinder valuable advances in the biosciences that might offer therapeutic benefits, 2) hamper research needed to develop effective countermeasures against bioterrorism, 3) delay only temporarily the spread of sensitive information, and 4) prevent scientists from replicating the claimed results to prove or disprove their validity. Other authorities counter that restrictions on sensitive research for national security reasons are warranted in cases where such information could be directly relevant to the production of biological and toxin weapons. This contingent argues that 1) some types of scientific knowledge are inherently dangerous, 2) publishing scientific advances in open literature could abet the development of new types of biological weapons that might not be countered effectively by defensive applications of the same research, 3) scientific research is already subject to numerous ethical guidelines and regulations, such as those on recombinant DNA research, and 4) some scientists are already voluntarily requesting that journal editors withhold key pieces of information from their papers to avoid providing details that might aid terrorists. Feasibility of Restricting Scientific Communications Whether or not restrictions on scientific information are advisable, the question of their feasibility remains. The original aim of the workshop was to suggest guidelines that the Department of Defense could consider when reviewing research contracts in the area of microbiology. But after preliminary discussions it became clear that the issue affects other government funding agencies as well. Since a wide range of scientific research funded by both military and civilian agencies might be misused, workshop participants decided to broaden the focus to include all government-funded research in microbiology and related fields. Given this scope, workshop participants agreed that if research is to be assessed for its potential national security implications, the review should take place when the project proposal is being considered for funding by a government agency. Also, the agency could require as a condition of funding that any papers resulting from the research project undergo security review prior to publication. Currently, such conditions can legally be imposed on research contracts but not on grants, the primary form of support for university research. The workshop discussed guidelines for the security review of research proposals, and procedures for restricting the distribution of sensitive research results so that only bona fide scientists are granted access to it. The effectiveness of the proposed guidelines and procedures would be judged by whether they are voluntarily accepted by the scientific community, and whether they strike a reasonable balance between scientific freedom and national security. Guidelines for the Security Review of Research Proposals In brief, most participants agreed that to limit damage to the scientific enterprise, restrictions on the dissemination of unclassified research results, if any, should be confined to the small proportion of findings directly relevant to the military or terrorist use of pathogens and toxins. One proposal put before workshop participants would consider placing restrictions on research that involves a Select Agent (as defined by the U.S. Centers for Disease Control and Prevention) and aims to achieve one or more of six weaponization-related goals: 1) enhance pathogen infectivity, pathogenicity, antibiotic resistance, or resistance to host immunological defenses; 2) improve the ability of a microbial pathogen to remain viable and virulent during prolonged storage and/or after release into the environment; 3) facilitate the dissemination of biological agents as a fine-particle aerosol; 4) facilitate the dissemination of a biological agent by contamination of food or water sources; 5) create a novel pathogen or one whose characteristics have been altered to evade current detection methods or host immune defenses; and 6) assemble oligonucleotides to synthesize the genome of a pathogenic microorganism. Under this proposed security review process, reviewer(s) would place a research proposal in one of two categories. Studies involving a Select Agent that did not contain any of the six weaponization criteria listed above would be designated "Unrestricted," with no limits on public release. Studies that involve a Select Agent and one or more of the six weaponization criteria would be considered for placement in the "Restricted" category, which would entail certain controls on public release of the research results. "Restricted" designations--expected to be applied to only a small fraction of academic research projects--could also be applied in the later stages of the research project. Investigators would be obligated to notify the funding agency if an experiment was modified in such a way as to invoke listed criteria, or if unexpectedly sensitive results were obtained. Compliance of research institutions could be encouraged by withholding federal funding from those that refused to participate; non-governmental funders could apply the same security review criteria voluntarily. Thoughts on Restricting the Dissemination of Sensitive Results Under the proposed guidelines, when a paper containing results of a "Restricted" research project was submitted to a scientific publisher, it would be accompanied by a letter from the funding agency denoting which portions of the paper were sensitive and warranted restrictions on distribution. Dissemination of the restricted material to legitimate scientists would then be controlled by the journal editor, in cooperation with the funding agency, perhaps through passwork-controlled web sites and other secure means. Given the wide range of print and electronic outlets for communication of research findings, sensitive information could not be restricted effectively unless the author was persuaded not to distribute it publicly in any form. Moreover, because scientific publishing is an international enterprise, a system focused exclusively on U.S. scientists or publishers would be ineffective. Many implementation questions remain to be answered, such as who should be given access to the sensitive information and how long the restrictions on public access should apply. Critiques of the Proposed Review Process Workshop participants identified significant problems with the proposed regulatory system, including several issues that would have to be addressed by any scheme for controlling research or the information it produced. Some of the drawbacks mentioned include: 1) the proposal appears to establish a system of national censorship, with scientific journals as the guardians of sensitive materials; 2) research universities and scientific journals would not agree to the proposed mechanism; 3) the proposal ignores the fact that the intellectual knowledge generated under grants (as opposed to contracts) is the property of the investigators, many of whom are foreign nationals; 4) scientists may be unwilling to take on the responsibility of reviewing a potentially "sensitive" paper; 5) scientific journals are not set up to deal with the segregation of sensitive data or to provide for secure means of review and publication; 6) once a document has been designated "Restricted," it must be tracked and its security monitored; and 7) the proposed system would impose high legal and professional risks on journals, with minimal benefits. It was the sense of the workshop that if a system for restricting the publication of "sensitive" information is to be workable, it requires the broad support of the international scientific community, which must perceive that the security benefits of restricting open publication outweigh the possible costs to science. The two groups of
professionals attending the workshop--scientists and security
experts-- could not reach a consensus on how sensitive information from
scientific research should be handled. Most participants did agree that under
rare circumstances, the open communication of unclassified research could pose
such a high risk of substantial harm as to warrant controlling the distribution
of that information. It is essential that bioscientists and their professional
organizations take the lead in informing security experts about how best to meet
the threats of biological warfare and terrorism in a way that will not cause
undue harm to the scientific enterprise.
[1] The "Workshop on Guidelines for
the Publication of Scientific Research Potentially Related to Biological and
Toxin Warfare" was held in Washington, D.C., on August 12, 2002. Workshop
participants were Ronald M. Atlas, American Society for Microbiology; Beverly
Berger, U.S. Department of Energy; Eileen R. Choffnes, National Academy of
Sciences; Charles Cooke, Defense Threat Reduction Agency; Eric Eisenstadt,
Defense Advanced Research Project Agency; Lynn W. Enquist, Princeton University,
Editor, Journal of Virology; Gerald L. Epstein, Defense Threat Reduction
Agency; Mark S. Frankel, American Association for the Advancement of Science;
Clem Gaines, Defense Threat Reduction Agency; Asha M. George, Nuclear Threat
Initiative/Biological Programs; Janet R. Gilsdorf, University of Michigan
Medical Center; Brooks Hanson, Science Journal; Elisa D. Harris,
University of Maryland; Maryanna Henkart, National Science Foundation; Peter B.
Jahrling, U.S. Army Medical Research Institute of Infectious Diseases; Jonathan
Knight, American Association of University Professors; Rachelle E. Levinson,
Office of Science and Technology Policy; Jeffrey Milstein, Defense Threat
Reduction Agency; Dorothy B. Preslar, ILIAAD; Ariella M. Rosengard, University
of Pennsylvania; Jeffery A. Schloss, National Institutes of Health; Ron Sentell,
U.S. Department of Energy; Leonard Spector, Monterey Institute of International
Studies (MIIS); Ernest Takafuji, National Institute of Allergy and Infectious
Diseases; Jonathan B. Tucker, MIIS; Gillian Woollett, Pharmaceutical Research
and Manufacturers of America; Raymond A. Zilinskas, MIIS, and one participant
who did not wish to be identified.
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