Biotechnology Research in an Age of Terrorism (2004) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-14
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The term "misuse of biotechnology" is a phrase that captures a wide spectrum of potentially dangerous activities from spreading common pathogens (e.g., spraying Salmonella on salad bars) to sci-fi plots of transforming pathogens into the next "Andromeda strain." Our Committee addressed one important part of this spectrum of risks of potential misuse: the capacity for advanced biological research activities to cause disruption or harm, potentially on a catastrophic scale.
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, designation of restricted individuals who may not possess select agents, and a regulatory system for the physical security of the most dangerous pathogens within the United States will provide a useful accounting of domestic laboratories engaged in legitimate research and some reduction in the risk of pathogens acquired from designated facilities falling into the hands of terrorists. The Committee stresses that implementation of current legislation must not be overly restrictive given the critical role that the develop
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In addition, no national or international review body currently has the legal authority or self-governance responsibility to evaluate a proposed research activity prior to its conduct to determine whether the risks associated with the proposed research, and its potential for misuse, outweigh its potential benefits. The Committee concluded that the existing fragmentary system must be adapted, enhanced, supplemented, and linked to provide a system of oversight that will give confidence that the potential risks of misuse of dual use research are being adequately addressed while enabling vital research to go forward.
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Recommendation 1: Educating the Scientific Community We recommend that national and international professional societies and related organizations and institutions create programs to educate scientists about the nature of the dual use dilemma in biotechnology and their responsibilities to mitigate its risks. Adequately addressing the potential risks that research in advanced biotechnology could be used by hostile parties will require educating the community of life scientists, both about the nature of these risks and about the responsibilities of scientists to address and to manage them.
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The Criteria for Review. The Committee identified seven classes of experiments that it believes illustrate the types of endeavors or discoveries that will require review and discussion by informed members of the scientific and medical community before they are undertaken or, if carried out, before they are published in full detail.
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The NIH Guidelines require creation of an Institutional Biosafety Committee (IBC) when research is conducted at or sponsored by an entity receiving any NIH support for recombinant DNA research.
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These aspects of the open culture in the life sciences emphasize how important it is to make scientists aware of their personal responsibilities to consider the balances of risks and benefits in their proposed research so they can responsibly inform the IBC. Experiments that need further consideration would be referred to an expanded Recombinant DNA Advisory Committee (RAC)
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The Committee believes that the statement produced by a group of editors from major life science journals in February 2003 is an important step in this process. On the broader question of classification, the Committee believes that the principle set out by the Reagan Administration in 1985 in National Security Decision Directive 189 that the results of fundamental research should be unrestricted to the maximum extent possible and that classification should be the mechanism for what control might be requiredremains valid and should continue to be the basis for U.S.
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The Board might also provide advice on request about particular manuscripts that raise concern, perhaps by organizing small groups of experts to assess the tradeoffs between the scientific merits of the research, especially that with the potential to advance knowledge relevant to biodefense, and the risks of publishing information that might assist terrorists or proliferant states.
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No solution meets all the criteria, but on balance we believe that the logical organizational location for the NSABB is within the Department of Health and Human Services providing advice to the secretary of that Department. DHHS already has a leading role in biotechnology research, particularly that related to the Experiments of Concern.
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General microbiological training sufficient for culturing and growing pathogenic microorganisms at levels of significant concern is available in high school and first-year college biology courses; majors in microbiology would be sophisticated enough to grow many select organisms. Moreover, training in basic microbiology is widely available outside the United States.
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These advisory boards could help members of the intelligence and law enforcement communities keep current in relevant areas of science and technology and provide a trusted set of advisors to answer technical questions. Recommendation 7: Harmonized International Oversight We recommend that the international policymaking and scientific communities create an International Forum on Biosecurity to develop and promote harmonized national, regional, and international measures that will provide a counterpart to the system we recommend for the United States.
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Among the topics for this international forum are: · Education of the scientific community globally, including curricula, professional symposia, and training programs to raise awareness of potential threats and modalities for reducing risks as well as to highlight ethical issues associated with the conduct of biological science. · Design of mechanisms for international jurisdiction that would foster cooperation in identifying and apprehending individuals who commit acts of bioterrorism.
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The Committee believes that building upon processes that are already known and trusted and relying on the capacity of life scientists to develop appropriate mechanisms for self-governance, offers the greatest potential to find the right balance. This system may provide a model for the development of policies in other countries.
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