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3 Managing Dual Use Research of Concern
Pages 45-72

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From page 45...
... 3 To assist it in answering questions such as these, the committee invited presentations and commissioned papers to explore options for the management of dual use research of concern (DURC)
From page 46...
... Acknowledging the limitations of current mechanisms for the management of life sciences research of concern, many expressed support for more effective policies and for guidance for researchers, research institutions, journal editors, and funders with regard to the conduct and dissemination of such research.4 FOUNDATIONAL U.S. POLICIES ON THE DISSEMINATION OF RESEARCH National Security Decision Directive 189 (NSDD-189)
From page 47...
... Department of Commerce, Bureau of Industry and Security, apply to the dissemination of life sciences research.11 Of course, export controls are 5 Michael Imperiale and David A Relman, Options for Management of Potentially Dangerous Information Generated by Life Science Research (commissioned paper available at https://www.nap.
From page 48...
... The ITAR have a public domain exemption and do not cover unrestricted information released into the public domain via eight specific modes of release, including libraries, newsstands, open conferences in the United States, and others. A federal appeals court in September 2016 ruled that, unlike the EAR, search and National Security (commissioned paper available at https://www.nap.edu/catalog/24761 under the Resources tab)
From page 49...
... When export controls might apply to the results of unrestricted research, a key issue is whether the information has been or will be released to the public through a designated means. A researcher's decision to release such unrestricted and unclassified information to the public can remove EAR controls on publicly available material, regardless of the content of the communication.
From page 50...
... government. As an example, they explained that increased enforcement or stricter export control rules might encourage researchers to avoid important prepublication national security reviews by relying on the EAR and ITAR public domain exceptions.
From page 51...
... Campbell said that Nature has had a few papers of dual use concern since the 2011 GOF controversy. "There are six examples of such papers from 2015 17 Journal Editors and Authors Group, "Statement on Scientific Publication and Security." See also A
From page 52...
... had policies in place to review their intramural research for potential DURC. The 2012 policy required all "federal departments and agencies that conduct or fund life sciences research" to "conduct a review to identify all current or proposed, unclassified intramural or extramural, life sciences research projects" involving specific select agents and types of experiments to determine whether they met the definition of DURC.
From page 53...
... Citing his own academic experience in a highly regarded biology department, he relayed how few faculty are familiar with the work of the National Science Advisory Board for Biosecurity (NSABB) or with DURC and security concerns in general: "it is possible to function at a very high level in the research community with essentially no engagement with this issue." Anecdotally, he noted that many of his colleagues believe that DURC "regulations are for researchers working on explicitly ‘concerning' 24 Tim Stearns, Moving Beyond Dual Use Research of Concern Regulation to an Integrated Respon sible Research Environment (commissioned paper available at https://www.nap.edu/catalog/24761 under the Resources tab.)
From page 54...
... 8. 33 Duane Lindner and Winalee Carter, Sandia National Laboratories, Control of Sensitive Infor mation: Policy, Procedure, and Practice in a National Security Context (commissioned paper available at https://www.nap.edu/catalog/24761 under the Resources tab)
From page 55...
... 37 Sam Weiss Evans, The Construction of New Security Concerns in the Life Sciences (commis sioned paper available at https://www.nap.edu/catalog/24761 under the Resources tab)
From page 56...
... there are some excellent examples of individual efforts in the government [that] can have a large effect."39 In his paper commissioned for the committee, Joseph Kanabrocki discussed how, at The University of Chicago, "all research staff involved with" select agent research "are committed to the ethical and responsible conduct of science."40 He described their code of conduct, one element of a culture of awareness about biosafety, which is signed annually by life sciences researchers who work with select agents.
From page 57...
... With regard to laboratory practice, Kanabrocki believes that, "lab accidents and laboratory-acquired infections [are] under-reported and the opportunities for sharing our best practices are missed as a result." Further, "Lessons that are learned through the investigations of accidents and injuries or illnesses should be shared so that we can learn from each other's mistakes." While data on laboratory safety are incomplete, 43 biosafety and biosecurity data are available for research involving select agents.
From page 58...
... Elements of their culture of awareness include signs throughout the laboratory spaces reminding workers of the presence of sensitive information, risks inherent in mishandling it, and researchers' individual responsibility; the regular dissemination of information about malicious attempt to gain access to sensitive information; and briefings to researchers about threats to sensitive information generated at the laboratories.50 Local, national, and international approaches can provide awareness-raising, education and training, and ongoing guidance and opportunities to share best practices and develop common approaches to manage the dissemination of 47 See Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function Research. 48 Report of the Federal Experts Security Advisory Panel, p.
From page 59...
... , doi:https://doi.org/10.17226/12013; National Research Council, Responsible Research with Biological Select Agents and Toxins (Washington, DC: The National Academies Press, 2009) , doi:https://doi.org/10.17226/12774; and National Research Council, Challenges and Opportunities for Education about Dual Use Issues in the Life Sciences (Washington, DC: The N ­ ational Academies Press, 2011)
From page 60...
... In the 2008 Meeting of States Parties to the BWC, parties were encouraged to "be alert to potential misuse of research, and assess their own 54 Piers D Millett, Biosecure Ltd., Gaps in the International Governance of Dual-Use Research of Concern (commissioned paper available at https://www.nap.edu/catalog/24761 under the R ­ esources tab)
From page 61...
... This consultation identified key concerns surrounding DURC, gaps in existing management systems, and potential ways these gaps might be addressed. It concluded that DURC is an issue of relevance to all countries, affirmed the importance of oversight mechanisms, noted that oversight pertains to the entire research cycle, and considered that while the "establishment of a legally binding global agreement or regulation is theoretically possible, such an approach would be expensive, slow, likely impractical and would not necessarily yield the desired benefits," recommending instead "guiding principles, toolkits, best practices and other forms of technical assistance would help countries formulate their own policies and procedures for managing DURC." The WHO highlighted that "communication and continuing dialogue across a broad range of sectors and stakeholders are essential to create a culture of responsibility, cooperation and trust," including an exploration of different ways of assessing risk.
From page 62...
... 61 This is encapsulated in the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern.
From page 63...
... 62 Imperiale and Relman argued that the criteria for triggering special consideration of research results need to be broader than those currently articulated by the NSABB in its May 2016 guidelines for GOF research, which are focused on pathogenic infectious agents, and should encompass as-yet-unknown situations in the future in other research areas, for example, synthetic biology and systems biology. They observed that the 2005 paper that modeled an introduction of botulinum toxin into the milk supply63 provided a particularly "important case study because it did not involve wet lab research, but rather was a theoretical modeling study, and can be viewed as representative of an increasingly common type of research involving ‘big data' and data mining tools." "Work of this type," they said, "typically arises outside of science research settings routinely subjected to biosafety and biosecurity oversight, and is typically undertaken by individuals unfamiliar with the history of biosafety guidelines."64 At the January 2017 workshop, Stearns agreed that the NSABB has failed to embrace all research that could potentially be of concern within its definition of DURC, including unpredictable developments in the life sciences, such as the genome editing tool CRISPR/Cas9 or research in gene therapy.
From page 64...
... It remains so for an important part of the scientific community.65 However, given the complex ethical, legal, social -- and security -- issues posed by continuing scientific advances, there is increasing support for a view that scientific research must operate within a broader social context and that scientific freedom comes with important responsibilities. The struggle to develop effective policies for GOF research is illustrative of how these issues are playing out in the life sciences.66 Several presenters acknowledged the difficulty of arriving at clear criteria for what constitutes DURC, but identified elements that they believe are important.
From page 65...
... the tools to make their own determinations of how concerned we should be about potential security issues.68 Evans supported the creation of "networks for constructing security concerns" that would provide flexible governance for emerging DURC concerns and include the scientific community, government, nongovernmental organizations, and industry. He also noted that, among the recommendations issued from past reports from the National Academies of Sciences, Engineering, and Medicine on DURC, such as the Corson Report and Fink Report, the recommendations that were often not implemented were those that see science and 67 Imperiale and Relman, pp.
From page 66...
... He criticized the "combination of a linear model of innovation and a hard line between academic freedom and national security" because they lead to the viewpoint that the security concerns of life sciences research are "a zero-sum game between freedom and security" and can "be resolved by drawing a line in the innovation process where societal concerns like security can come in." He critiqued principle four's focus on the technical elements of risk assessment and its exclusion of political and broader public concerns.70 In place of the NSABB's eight principles, Evans suggested seven new ones -- "principles for crafting new objects of security concern within the life sciences" (see Table 3-1) -- noting that they share many elements with the 2006 NRC report Globalization, Biosecurity, and the Future of the Life Sciences.71 These seven principles assert that "decisions about which [research]
From page 67...
... Life sciences research should be  acceptance of the security concerns communicated to the fullest extent possible around an area of research, such as to ensure the continued advancement of ‘experiments of concern' done on human, animal, plant, and environmental Select Agents with federal funds, health. Consequently, any restriction of established procedures for conduct scientific communication should be the rare and oversight of research should be exception rather than the rule.
From page 68...
... Investigators and sponsors of research with dual use potential should recognize that the communication of certain dual use information is likely to raise biosecurity concerns, not only within the scientific community but also within the general public. Consideration should be given to the potential for public concern and misunderstanding and for sensationalism.
From page 69...
... and Sam Weiss Evans, The Construction of New Security Concerns in the Life Sciences (commissioned paper available at https:// www.nap.edu/catalog/24761 the Resources tab)
From page 70...
... Evans recommended that a "relationship of mutual trust and shared expertise should be fostered in particular between the life science and intelligence communities." He recommended that the NSABB resume its efforts to build a network between the intelligence community and journal editors. He noted that the relationship between law enforcement and the scientific community has not always been optimal but highlighted the Federal Bureau of Investigation's Weapons of Mass Destruction Directorate, which has become a resource for the scientific community's security concerns, and urged that it be strengthened, institutionalized, and studied for how it might be shared more broadly.
From page 71...
... The group would be agile and responsive yet forward-looking: "Ideally, this group would appreciate the need in some cases for taking action far in advance of the generation of the information." The authors' recommendation is that one or more entities take responsibility for controlling the sensitive information. They suggested 79 Lindner and Carter, p.
From page 72...
... During the committee's discussions and review of materials, the following elements were raised as important in the effective management of DURC: • Ongoing, interactive education and training of individuals in the broader life sciences community; • Engagement with advisory bodies with monitoring and/or enforce ment capabilities; • International harmonization of policies and approaches; • Engagement with extant or newly convened international entities; • Uniform roles and responsibilities for publishers; • Legislative, regulatory, or policy mechanisms positioned at critical stages of the dissemination process; and • Increased engagement with the public. Implementation may necessitate additional resources, the establishment of best practices, refinement of policies and guidances, adoption of new laws, broader stakeholder engagement, and appropriately positioned and empowered advisory bodies.


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