Browsing by Author "Okutani, Stacy"
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Item Controlling Dangerous Pathogens: A Prototype Protective Oversight System(2005-12-01) Steinbruner, John; Harris, Elisa D.; Gallagher, Nancy; Okutani, Stacy; CISSMAs has become increasingly evident in recent years, advances in biology are posing an acute and arguably unprecedented dilemma. The same basic science that could in principle be highly beneficial could also be enormously destructive, depending on how it is applied. Although the scope of actual consequence remains uncertain, the potential is clearly extraordinary with the health of individuals, the stability of societies and the viability of the global ecology all apparently at stake. Since compelling good and appalling harm cannot be disentangled at the level of fundamental science, a burden of management is being imposed that human institutions are not currently prepared to handle. The dilemma itself has been exemplified in several widely noted experiments1 and professionally acknowledged in reports issued by the United States National Academies of Science (NAS) and by the British Royal Society. Not surprisingly, however, and perhaps inevitably, efforts to devise an effective response are still at an embryonic stage. The proposals separately advanced by the two scientific societies are directed at their own communities and are largely voluntary in character. Those are natural initial steps but would not alone provide robust global protection. In an effort to encourage productive discussion of the problem and its implications, this monograph discusses an oversight process designed to bring independent scrutiny to bear throughout the world without exception on fundamental research activities that might plausibly generate massively destructive or otherwise highly dangerous consequences. The suggestion is that a mandatory, globally implemented process of that sort would provide the most obvious means of protecting against the dangers of advances in biology while also pursuing the benefits. The underlying principle of independent scrutiny is the central measure of protection used in other areas of major consequence, such as the handling of money, and it is reasonable to expect that principle will have to be actively applied to biology as well. The monograph outlines an advanced oversight arrangement, provisionally labeled the Biological Research Security System (BRSS), which is designed to help prevent destructive applications of biology, whether inadvertent or deliberate. The arrangement is put forward with full realization that meaningful protection can only be achieved by imposing some constraint on freedom of action at the level of fundamental research, where individual autonomy has traditionally been highly valued for the best of reasons. Constraints of any sort on research will not be intrinsically welcome and will have to demonstrate that the protection provided justifies the costs entailed. A great deal of conceptual innovation, legal specification, institutional design and political accommodation would admittedly be required to establish such an oversight process, and there is very little precedent to work with. Because of the demands imposed and the inconvenience involved, the monograph concedes that human societies after due reflection might choose at least initially to accept lesser standards of protection and it discusses more limited incremental measures that might be undertaken. The central contention, however, is that the eventual outcome should be a fully considered choice and not the default result of inertia or neglect. John Steinbruner is the Director of the Center for International Security Studies at Maryland.Elisa D. Harris is a Senior Research Scholar at the Center. Nancy Gallagher is the Associate Director for Research at the Center. Stacy Okutani is a Graduate Fellow in the Advanced Methods of Cooperative Security Program.Item Federal Regulation of Scientific Research(2001-08-23) Okutani, Stacy; CISSMThe enclosed review of federal regulations of scientific research is a draft and is based on an initial survey of the available information. As such, it is not intended as a final, or authoritative accounting of the web of federal regulations applicable to biotechnology research and development in corporate, academic, or government institutions. I must clarify the overlapping roles USDA and EPA play on plant and animal pathogens and environmental release and the extent of voluntary compliance with the various regulations (especially non-federally funded research). To the extent that this account is accurate, however, four important implications can be derived. First, a comprehensive government review like that undertaken in 1986 has apparently not been conducted since although the technology has progressed and the scale of work has increased. Second, research with human pathogens seems to require less federal oversight than for plant and animal pathogens. Even for rDNA research that falls under mandatory federal guidelines (e.g. the NIH Guidelines) it is uncertain how rigorous the review process " the work of the Institutional Biosafety Committees (IBCs) " is. It is at least possible that a large amount of research on human pathogens falls outside mandatory federal oversight. For example, although the Office of Biotechnology Activities (OBA)/NIH has over 400 IBCs registered, their office could not give an approximation as to what percentage of the total rDNA work in the US was thereby covered. (BIO estimates that there are over 1200 biotechnology companies in the US, PhRMA has 67 members, with 24 affiliated research organizations.) Third, because the regulations are based on the products of biotechnology and not the process, oversight increases as an organism moves further from the laboratory (less oversight of research before it is pursued and more of field trials and environmental release). Fourth, non-commercial research that is not federally funded seems to require no regulatory oversight.Item Global Governance of 'Contentious' Science: The Case of the World Health Organization's Oversight of Smallpox Virus Research(2004-12-01) Tucker, Johnathan; Okutani, Stacy; CISSMA major challenge facing efforts to prevent the spread of biological weapons to "rogue" states and terrorist organizations is the dual-use nature of biotechnology: the fact that the same technical know-how and equipment involved in the peaceful development and production of vaccines and other commercial products can be diverted into offensive applications. This "dual-use dilemma" carries over into basic research in the life sciences. When microbiologists publish research papers that elucidate the process of infection, describe the molecular basis of pathogenesis, or explore the physiological action of toxins, they add to the existing body of knowledge and contribute to the development of medical therapies. Yet countries seeking biological weapons could utilize the same information to devise more deadly infectious agents and methods of delivery. Examples of such dual-use research include the unexpected discovery that inserting the gene for an immune-system protein renders mousepox virus more lethal and vaccine-resistant in mice; the identification of a smallpox protein that contributes to the virulence of the disease in humans; and the synthesis of poliovirus in the test tube. The most serious threat of misuse of this information does not arise from terrorist organizations, which have limited scientific expertise, but rather from scientists employed by sophisticated, well-funded national BW programs. These individuals keep up with the scientific literature and are capable of exploiting basic research findings to pursue weapons-related developments. It is therefore important to address these biological security concerns in a way that does not cause serious harm to the scientific enterprise. Stacy Okutani is a Graduate Fellow in the Advanced Methods of Cooperative Security Program.Item U.S. National Security and Global Health: An Analysis of Global Health Engagement by the U.S. Department of Defense(2009-04) Bonventre, Gene; Hicks, Kathleen; Okutani, StacyDespite a broadening consensus that global health care efforts have an impact on national and global security, the U.S. national security community’s efforts to address global health are weak and uncoordinated. The 2006 National Security Strategy states that “development reinforces diplomacy and defense, reducing long-term threats to our national security by helping to build stable, prosperous, and peaceful societies.” While the U.S. government struggles to find the right balance among the “three Ds” of defense, diplomacy, and development, the U.S. military has increased its involvement in global health where it perceives the diplomacy and development to be underresourced—or to achieve its own specific objectives. As efforts to renew the capabilities of civilian agencies proceed, it is an appropriate time to step back and consider the role that the U.S. Department of Defense (DoD) currently plays in global health, the impact of its health activities on national and regional security, and the role it could play to support a newly balanced U.S. foreign policy.Item The U.S. Threat Assessment Process and Oversight for Biological Research at NBACC(2007-12) Okutani, StacyThe US Department of Homeland Security finished its first bioterrorism risk assessment in January 2006. That and the upcoming 2008 assessment employs a probabilistic risk assessment methodology designed to guide prioritization of ongoing biodefense-related research, development, planning and preparedness. The methodology and the scientific work it subsequently identifies as necessary have generated some discussion about both its design and consequence. This paper clarifies the current debate, describes the current processes in place, and identifies issues that merit further discussion.