Biotechnology Research in an Age of Terrorism (2004) / Chapter Skim
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4. Conclusions and Recommendations
4. Conclusions and Recommendations
Pages 107-130
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From page 107... ...
However, they do not currently address the potential for misuse of the tools, technology, or knowledge base of this research enterprise for offensive military or terrorist purposes. 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.
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From page 108... ...
The system relies heavily upon voluntary self-governance by the scientific community and expansion of an existing regulatory process that itself grew out of an earlier response by the scientific community to the perceived risks associated with gene-splicing research. The heart of the system would be a set of guidelines to help identify research that could raise concerns because of its potential for diversion to offensive military applications.
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From page 109... ...
Internationally, other countries are also increasing their investments in civilian bioterrorism defense research. These increased domestic and international investments in basic and applied public health and bioterrorism defense research will inevitably create an increased number of research activities that raise concerns about misuse.
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From page 110... ...
Without international consensus and consistent guidelines for overseeing research in advanced biotechnology, limitations on certain types of research in the United States would only impede the progress of biomedical research here and undermine our own national interests. It is entirely appropriate for the United States to develop a system to provide oversight of research activities domestically, but the effort will ultimately afford little protection if it is not adopted internationally.
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From page 111... ...
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 misused 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 manage them.
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From page 112... ...
Substantive knowledge of the potential risks is not sufficient, however. The Committee believes that biological scientists have an affirmative moral duty to avoid contributing to the advancement of biowarfare or bioterrorism.
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From page 113... ...
augment the already established system for review of experiments involving recombinant DNA conducted by the National Institutes of Health to create a review system for seven classes of experiments (the Experiments of Concern) involving microbial agents that raise concerns about their potential for misuse.
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From page 114... ...
Over time, however, the Committee believes that it will be necessary not only to expand the experiments of concern to cover a significantly wider range of potential threats to humans, animals or crops but also to include oversight of work conducted for or performed within the private sector as well as non-NIH government facilities and sponsored activities that are not already voluntarily complying with the Guidelines. Experiments of Concern would be those that: 1.
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From page 115... ...
We note that funding agencies also have a potentially important role to play in flagging experiments of concern at the proposal review stage. Like the broader life sciences community, the members of the IBCs will require substantial education in the potential risks associated with advanced biotechnology research in order to handle this task competently.
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From page 116... ...
As we envision this review of the experiments of concern, when an IBC refers a project to the RAC, the RAC would carefully weigh the potential benefits and dangers of the project, and come to its own independent judgment. The RAC may approve some projects referred by IBCs to go forward at this point, recommend that the research not be undertaken, or that modifications be made to the research design to minimize the potential risks.
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From page 117... ...
It was also an important example of the ability of the scientific community to address the potential risks of its activities. Ultimately, any process to review publications for their potential national security risks would have to be acceptable to the wide variety of journals in the life sciences, both in the United States and internationally.
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From page 118... ...
We believe that the risks of a chilling effect on biodefense research vital to U.S. national security as the result of inevitably general and vague categories is at present significantly greater than the risks posed by inadvertent publication of potentially dangerous results.
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From page 119... ...
So far, we have only discussed the functions of the Board that relate to the potential risks of research in advanced biotechnology. But we also recommend that the Board have the capacity to advise the government on how the life sciences can contribute to alleviating the risks of bioterrorism and biological weapons through new research in areas such as vaccine and antibiotic development, new detection devices and technologies, and preventative public health measures.
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From page 120... ...
In addition, this approach would fit within the division of labor created under the Bioterrorism Response Act, where HHS provides tactical advice as the NSABB would do on specific issues and cases and the Department of Homeland Security is charged with formulating overall strategy. We note that the Board will require significant financial resources to carry out its responsibilities, although the Committee did not attempt to estimate an amount.l2 It would be important for the Board to monitor the development and operation of the system we recommend and perhaps of other processes that the government or private organizations may put in place as well.
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From page 121... ...
These were established as an outgrowth of the Asilomar conference in 1975. In the same manner, other countries should be encouraged to establish counterparts to the NSABB so that the community of life scientists globally can work together to reduce the risks of the offensive applications of life sciences research.
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From page 122... ...
A similar caution exists in assessing the risks of handling DNA fragments from select agents, which may pose no potential risk at all. Rules for containment and registration of potentially dangerous materials must be based on scientific risk assessment and informed by a realistic appraisal of their scientific implications.
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From page 123... ...
Prompt action is needed.~4 Recommendation 6: A Role for the Life Sciences in Efforts to Prevent Bioterrorism and Biowarfare. We recommend that the national security and law enforcement communities develop new channels of sustained communication with the life sciences community about how to mitigate the risks of bioterrorism.
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From page 124... ...
These advisory boards could help members of these communities keep current in relevant areas of science and technology and provide trusted sets 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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From page 125... ...
The Committee therefore recommends, as a next step, convening an "International Forum on Biological Security" to begin a dialogue within and between the life sciences and the policymaking communities internationally. 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.
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From page 126... ...
No international agreement addresses the potential threats posed by the misuse of research in the biological sciences, and no intergovernmental organization has relevant oversight authority to promulgate guidelines or procedures. The Committee believes that convening an international forum to address these gaps demands international and interdisciplinary mobilization of resources and capabilities.
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From page 127... ...
. Among them are Jonathan Tucker, Raymond Zilinskas, George Poste, John Steinbruner, Tara O'Toole, Steve Block, Gerald Epstein, Malcolm Dando, and Mark Wheelis, and organizations such as Johns Hopkins Center for Civilian Biodefense Studies, the Center for International Security Studies at Maryland, the Center for Nonproliferation Studies of the Monterey Institute for International Studies, the Chemical and Biological Arms Control Institute, the Royal Society, and the International Committee of the Red Cross.
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From page 128... ...
~ These include the U.S. Department of Agriculture and the Department of Veterans Affairs, as well as Department of Energy laboratories such as the Lawrence Livermore National Laboratory, the Los Alamos National Laboratory, and Sandia National Laboratories, and various VA medical centers and military research institutes such as the Uniformed Services University of Health Sciences; the Walter Reed Army Medical Center and the U.S.
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From page 129... ...
See further details available at http://www.cdc.gov/nip/acip/ charter.htm. i2 For the ACIP, the estimated annual cost for operating the Committee, including compensation and travel expenses for members (but excluding staff support)
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