Governance of Dual Use Research in the Life Sciences Advancing Global Consensus on Research Oversight: Proceedings of a Workshop (2018) / Chapter Skim
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3 The Current Governance Landscape
3 The Current Governance Landscape
Pages 37-78
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From page 37... ...
National Academies of Sciences, Engineering, and Medicine (the National Academies) assembled two background documents that were provided to participants in advance of the meeting.1 The first provided examples of relevant governance activities and actors and reflected the broad array of activities encompassed under the term "governance." This included national, regional, and international laws, regulations, and policies, as well as efforts to develop and promulgate norms of responsible conduct, raise awareness about biosecurity and dual use concerns, and create educational materials.
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Over the course of the workshop, participants were encouraged to suggest additional activities, venues, and ideas. Updated versions of the two documents reflecting those contributions may be found in Appendixes E and F as well as on the project website.2 They provide a snapshot of examples of activities and actors in an effort to illustrate the range and variety of the current governance landscape.
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• Research‐performing institutions (such as universities and medical centers, industry, government laboratories, etc.) • Journal publishers and others involved in disseminating research results • Other Breakout Sessions #2 and #3 Unlike the first breakout session, where participants were assigned randomly so they could address all of the topics in the background materials, for the second and third breakout sessions participants were assigned to groups based on their expertise and experience.
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Are there areas of common ground or ways to work around those differences? o hinking back to the discussions in breakout session #2, are T there particular near-term gaps, needs, obstacles, or enduring challenges that will need to be addressed to take advantage of the opportunities?
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? W THE CURRENT LANDSCAPE The remainder of this chapter offers examples of the current governance landscape taken from the background documents and the discussions at the workshop in Zagreb and the special session in Washington, DC.
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These categories do not necessarily have clear dividing lines, and relevant governance activities frequently apply to more than one phase. However, the stages of the research life cycle provide valuable opportunities to identify dual use concerns and to develop appropriate mitigation plans well in advance of research publication.
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Examples of national bodies tasked with addressing biosecurity issues include the following:
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. The legislation underpinning Israeli biosecurity policy, the Reg ulation of Research into Biological Disease Agents Act of 2008, was created in response to the report of the Steering Committee on Issues in Biotechnological Research in an Age of Terrorism, a joint project of the Israel National Security Council and the Israel Academy of Sciences and Humanities (Israel National Security Council and the Israel Academy of Sciences and Humanities, 2008)
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Government Outreach to the Relevant Communities A number of national governments have undertaken extensive outreach to their relevant scientific communities, addressing governance challenges and issues across the research life cycle. • Cooperation on Government Outreach (Kenya and Denmark)
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. As dis cussed in Chapter 2, the Australian government's approach to export controls places great emphasis on outreach, and the Life Sciences Guide was developed through outreach and consultations with the life sciences sector to inform and assist Australian life scientists (Australian Government Department of Defence, 2016)
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6 Further information is available at German National Academy of Sciences Leopoldina. Avail able at https://www.leopoldina.org/en/about-us/cooperations/joint-committee-dual-use (accessed October 2, 2018)
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From page 48... ...
Although U.S. DURC policies require institutions to examine research on 7 types of experiments and 15 agents, Kanabrocki's presentation illustrated that a number of universities use their investigator, IBC, and IRE structures to survey proposed research more broadly than required in order to evaluate whether research poses biosecurity concerns and to consider whether additional risk mitigation
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From page 49... ...
Technical Approaches to Risk Mitigation In some cases, it may be possible for investigators to change the design of an experiment or to incorporate other technical safeguards into their research to help mitigate dual use and biosecurity concerns; such approaches represent an opportunity to implement technical strategies to support research governance. For example, an investigator could choose to conduct an experiment with a modified or less pathogenic strain of a microorganism.
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Where scientists are able to incorporate strategies that improve control or reversibility into genetic engineering research from initial planning stages, such efforts could help prevent misuse or mitigate negative effects in organisms and environments, supporting risk management, biocontainment, and biosecurity goals. Activities Associated with Funding Since the early 2000s when concerns about potential risks from research with dual use potential arose, a commonly raised point is that waiting until the stage of journal publication is far too late in the process to be introducing debates over whether a particular research effort should be disseminated.
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/Wellcome Trust. In 2005, the three major funders of life sciences research in the United Kingdom, two government and one private, introduced a joint requirement that grant applicants and reviewers address potential dual use risks of proposed research.
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The 2012 and 2014 DURC policies apply to 15 agents and toxins and 7 categories of experiments. The 2012 policy requires all federal agencies that fund life sciences research to review their portfolios regularly to identify any DURC and assess potential risks, working with researchers to develop risk mitigation plans as necessary (U.S.
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From page 53... ...
An important component recognized during the workshop is the role of organizational culture in helping to ensure that safety and security considerations are seen as more than "check the box" compliance activities. Research Oversight and Risk Mitigation As noted in the preceding sections, both research funders and institutional review committees may identify potential biosecurity concerns arising from proposed research projects and request that experimental procedures be adjusted or risk mitigation plans developed and implemented to address such issues.
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From page 54... ...
is a global not-for-profit nongovernmental organization whose members include national and regional associations. Its 33 national association members, from developed and developing countries, cover the globe, and regional 13 Available at Centre for Biosecurity and Biopreparedness, "How to Apply" and "Technology." Available at https://www.biosecurity.dk/526 and https://www.biosecurity.dk/689 (accessed September 4, 2018)
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. 15 See IFBA, "About the Program." Available at http://www.internationalbiosafety.org/ index.php/professional-certification/ifba-professional-certifications/about-the-program (accessed September 18, 2018)
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. 17 See Cold Spring Harbor Laboratory, "bioRxiv." Available at https://www.biorxiv.org (accessed September 4, 2018)
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. 18 See Council of Science Editors, "About CSE." Available at https://www.councilscience editors.org/about/about-cse (accessed October 2, 2018)
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These influential statements help to establish the foundation for acceptable behavior and for what it means to be a responsible member of the scientific community: • Freedom, Responsibility, and Universality of Science from the Interna tional Science Council (ISC)
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Principles for Biosecurity - InterAcademy Partnership (IAP) - Hague Ethical Guidelines Codes of Ethics and Conduct - Codes developed and promulgated by multiple international and national organizations Awareness Raising and - Croatian Society for Biosafety and Biosecurity Outreach - Moroccan Biosecurity Caravan Education Programs - Danish Centre for Biosecurity and Biopreparedness - Dual Use Education in Pakistan - European Union engagement efforts under Project 18 - Responsible Science Institutes (United States)
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Discussion, development, and promulgation of biosecurity codes of ethics and codes of conduct20 have been one of the most commonly undertaken global governance activities, with a number of examples from different sectors of the scientific community and from multiple countries provided below. 20 Rappert makes a widely used distinction: "aspirational codes (often designated as ‘codes of ethics')
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In creating the principles, the scientists meeting under OPCW's auspices collected and analyzed more than 140 codes of ethics and conduct relevant to chemistry -- highlighting how many codes already exist, many of which may have common 21 See Organisation for the Prohibition of Chemical Weapons, "Ensuring an Ethos of Science for Peace: The Hague Ethical Guidelines." Available at https://www.opcw.org/ special-sections/science-technology/the-hague-ethical-guidelines (accessed October 2, 2018)
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As a direct result of their participation in the MX, the leaders of two international scientific unions created codes of conduct that explicitly addressed biological weapons. In addition, the IAP created a Biosecurity Working Group in 2004 specifically to take advantage of the opportunity offered by the meeting and released its Statement on Biosecurity at the BWC (IAP, 2005)
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In particular, IUMS also strives to promote ethical conduct of research and training in the areas of biosecurity and biosafety so as to prevent use of microor ganisms as biological weapons and therefore to protect the public's health and to promote world peace."24 Member societies are also encouraged to adopt codes. Examples of Codes from National Scientific Organizations A number of national academies of sciences and scientific professional societies have also developed and adopted codes: • American Society for Microbiology (ASM)
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. Examples of National Codes, Including Government–Science Community Partnerships In other cases, codes of ethics and codes of conduct applicable to the governance and oversight of dual use research have been developed by national governments, sometimes in partnership with agencies or 25 See ASM, "Code of Ethics." Available at https://www.asm.org/index.php/governance/ code-of-ethics (accessed September 21, 2018)
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. Annex II focuses on biosecurity issues and includes principles similar to those in the IAP Statement, including that scientists must "always bear in mind the potential repercussions -- possibly damaging -- of their research and recognize that a clear individual conscience does not justify ignoring the possible misuse of their scientific endeavors."26 • Science Council of Japan Code of Conduct for Scientists (revised in 2013 to include dual use)
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28 Further information is available at https://www.slideshare.net/UNESCOVENICE/ caravane-bio-mohammed-benbouida-ambs-morocco-12664659 (accessed October 7, 2018)
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constructed to educate on three core themes: the development of professionalism in science, conduct ing research responsibly, and being part of the responsible scien tific community."31 Dual use issues are treated as a component of responsible conduct of research. The Educational Institute used a diverse collection of active learning and assessment techniques -- diverse both in the goals and methods used and in the audiences 30 See CBRN Centres of Excellence, "Project 18: International Network of universities and institutes for raising awareness on dual-use concerns in bio-technology." Available at http://www.cbrn-coe.eu/Projects/TabId/130/ArtMID/543/ArticleID/46/Project-1 8-International-Network-of-universities-and-institutes-for-raising-awareness-on-dual-use -concerns-in-bio-technology.aspx (accessed October 4, 2018)
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. • Workshop participants described a number of additional educa tion and training programs that have been undertaken around the globe, including in Algeria, which has developed a training pro gram that looks at dual use issues for scientists; in China, which offers an elective course on dual use to students; through the Jap anese National Defence Medical College, which has established a dual use biosecurity education program; in Switzerland, which
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• Materials Developed by the Bradford Disarmament Research Centre, United Kingdom.32 Over the years, the group at Bradford has pro duced a series of online educational resources: o he Dual-Use Bioethics Education Module Resource (EMR) , T which is a joint project among the Bradford Centre, the National Defence Medical College of Japan, and the Landau Network Centro Volta in Italy, provides an online collection of 21 lectures with notes, references, and videos.
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The agricultural biosecurity modules are intended to raise awareness about agricultural biosecurity issues in the United States and are targeted toward the educated public. These modules address two different aspects of agricultural biosecurity: the nexus of agricultural production and international security.
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Available at https://www.unog.ch/80256EDD006B8954/(httpAssets) /DB56FEF FA3325E82C12582E4006A837A/$file/INB_Presentation_BWC+MXaug2018_9+Aug+2018.pdf (accessed October 4, 2018)
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Most relevant here are the example of the BWC's convening capacity in relation to promoting codes of conduct as a governance tool and the adoption of UNSCR 2325 in 2016, which explicitly encourages states to address intangible technology and information. Other Intergovernmental Organizations Intergovernmental organizations that address issues that are relevant to the governance of dual use research include the World Health Organization (WHO)
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WHO, OIE, and FAO are partners in the Global Health Security Agenda described below. In addition: • World Organisation for Animal Health (OIE)
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hrough the harmo nization of export controls, [the AG] seeks to ensure that exports do not contribute to the development of chemical or biological weapons."35 Common control lists for "dual use biological equip ment and related technology and software, biological agents, and plant and animal pathogens" serve to promote common standards and regulations.
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is an example of a complex international initiative that, although primarily focused on traditional biosafety and laboratory biosecurity issues, acknowledges dual use risks and may address research oversight in cases where it is relevant. 37 See WHO, "Food Safety." Available at http://www.who.int/foodsafety/areas_work/ antimicrobial-resistance/tripartite/en (accessed October 4, 2018)
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Thirty countries and the European Union are 38 See https://www.ghsagenda.org (accessed October 4, 2018)
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The organization aims to give "researchers, teach ers, funding agencies, government officials, journal editors, senior administrators, and research students opportunities to share expe 41 See GP, "Biological Security." Available at http://www.gpwmd.com/bswg (accessed October 4, 2018)
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The bulk of the chapter focused on providing examples of current governance activities along the various stages of the research life cycle, as well as efforts in awareness raising and education that provide the foundation for implementation. The examples illustrate the range and variety of initiatives from governments and the scientific community to create and support governance of dual use research.
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