The workshop encouraged active participation, with the majority of the workshop spent in smaller breakout sessions designed to facilitate discussion and take advantage of the expertise of those present. To support the discussions, staff of the U.S. 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. The second document provided examples of regional and international forums, organizations, or bodies that were or could become involved in dual use governance. The document reflected that, while there are bodies that address the topic, in particular the Biological and Toxin Weapons Convention (BWC), additional organizations and venues could offer valuable opportunities
1 Special thanks to Tracy Kambara for assembling these materials and observations during her Mirzayan Science Policy Fellowship at the U.S. National Academies in spring 2018. We also wish to acknowledge contributions made by participants at a preliminary discussion held on May 18, 2018, at the U.S. National Academies, particularly to supplement information on the landscape of U.S. governance activities addressing dual use life sciences research.
to examine aspects of the current governance landscape and contribute to strengthening global governance of dual use life sciences research.
The two documents were intended to provide a starting point for discussions. 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. Reference links for the descriptive examples highlighted in this chapter are provided in these Appendixes.
Each breakout session was introduced by a plenary to outline its goals and procedures. Each breakout group had a chair and rapporteur, as well as a staff member from the U.S. National Academies to assist in collecting and collating the discussions. The rapporteurs reported the results of each breakout session back to the workshop participants, with time allotted for discussion during these plenary sessions.
Breakout Session #1
The goal of the first breakout session was to engage the participants in mapping the landscape of recent and current governance activities and contribute to building knowledge and awareness about the activities that have been conducted nationally and internationally. Because many participants had expertise in more than one type of activity or experience with more than one actor, the initial groups were encouraged to consider all aspects of governance. As illustrated in the opening plenaries and the background materials, multiple types of actors can carry out various activities. For example, codes of conduct can be developed by international and national scientific organizations, governments, industry associations, individual companies, or others. As part of the mapping exercise, participants were therefore encouraged to identify relevant actors as well as activities, with the lists below provided as a starting point.
2 Available at National Academies of Sciences, Engineering, and Medicine, “Governance of Dual Use Research in the Life Sciences: An International Workshop.” Available at http://nas-sites.org/dels/events/dual-use-governance (accessed September 4, 2018).
Types of Activity
- Laws and regulations for oversight of dual use research
- Multinational, regional, and international agreements and frameworks
- Policies and guidelines for oversight of dual use research (voluntary)
- Terms and conditions of funding
- Codes of ethics, conduct, and practice
- Education and engagement strategies and activities
- Technical advances/strategies to support governance
- National governments
- Multinational, regional, and international bodies
- Funders of life sciences research
- Scientists developing and conducting research (from academia, government, industry, etc.)
- Research performing institutions (such as universities and medical centers, industry, government laboratories, etc.)
- Journal publishers and others involved in disseminating research results
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. The three topics were “Governance at the National Level;” “Governance at the Regional and International Level;” and “Promoting and Sustaining Governance—Norms, Codes, Education and Training, and Outreach.” The groups remained together for both breakout sessions, and each group addressed the same set of questions.
Building directly on the discussions in the first breakout session, in breakout session #2 the three groups were asked to consider the following questions:
- Lessons learned
- What has worked well, what has not, and why?
- Are there key lessons and good practices from these experiences?
- Are there particular areas of agreement and disagreement about the experiences to date?
- Gaps and meeting needs
- Are there particular gaps and needs that, if addressed, could make a significant difference in the short and medium term for the development of effective oversight of research with dual use potential?
- Are there enduring challenges and have strategies emerged to overcome or cope with them?
- Filling the gaps and needs
- Who are the most important actors to fill the gaps and meet the needs? To carry out the strategies?
- Are the key actors already engaged? If not, how can they be brought into the discussions/deliberations and where could these discussions/deliberations happen?
- What resources would be needed (not just financial)?
The goal of the final breakout session was to identify opportunities to promote and sustain the governance of dual use life sciences research and concrete actions that could be undertaken in the short, medium, and longer terms to take advantage of these opportunities. It was recognized that participants may not agree on the most desirable actions and those differences of opinion were to be acknowledged. Participants were asked to address the following questions:
- Identifying opportunities and actions
- What are the most important opportunities to promote and sustain the governance of dual use life sciences research? What concrete actions can be undertaken in the short, medium, and longer terms to take advantage of these opportunities?
- Are there particular actions that, if taken in the short term, would contribute to the momentum for further development of governance?
- Recognizing obstacles and challenges
- Are there key differences among participants about the most important or effective actions, and if so what are they? What are the sources of those differences? Are there areas of common ground or ways to work around those differences?
- Thinking back to the discussions in breakout session #2, are there particular near-term gaps, needs, obstacles, or enduring challenges that will need to be addressed to take advantage of the opportunities?
Moving toward action
- Who are the most important actors to take advantage of the opportunities? To help overcome the obstacles and meet the challenges?
- Are the key actors already engaged? If not, how can they be brought into the discussions/deliberations and where could these discussions/deliberations happen?
- What resources would be needed (not just financial)?
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. The material provides an illustrative snapshot that is not intended to provide a complete accounting of actors and activities. That would be a substantial research task, although as several participants noted, the publicly available reports of States Parties to the BWC and of member states to the UN 1540 Committee provide significant amounts of basic information for those willing to undertake the search.
Fundamental Legal Norms
The current international regime for biological nonproliferation and disarmament rests on the 1925 Geneva Protocol, which bans the use of biological (and chemical) weapons, the BWC, which prohibits the development, production, and stockpiling of biological weapons, and United Nations Security Council Resolution (UNSCR) 1540, which focuses on preventing proliferation to non-State actors (UN Security Council, 2004). The BWC and UNSCR 1540 require the enactment of national legislation to support the implementation of their provisions. As of December 2016, for example, 152 countries had enacted legislation to prohibit the use of biological weapons by non-State actors in compliance with UNSCR 1540 (UN Security Council, 2016a: 16). In 2016, at the completion of a comprehensive review of the status of implementation of UNSCR 1540, the UN Security Council unanimously adopted Resolution 2325. This resolution “encourages States, as appropriate, to control access to intangible transfers of technology and to information that could be used for weapons of mass destruction and their means of delivery,” which provides greater potential to address dual use issues (United Nations, 2016b).
Countries may fulfill their obligations in different ways. In addition to any general legal prohibition, countries may enact legislation to address specific issues. As discussed further below, countries that undertake gov-
ernance of dual use research frequently undertake additional regulations and policies to supplement the legislation.
A limited number of countries explicitly reference “dual use” in the sense used during the workshop in their regulatory frameworks for the conduct of life sciences research. More commonly, efforts to address dual use issues draw on existing measures such as controls on access to and use of specific pathogens and toxins, regulations associated with genetically modified organisms, and export control regimes that apply to certain biological agents, equipment, and related technologies. This proceedings does not attempt to review national laws and regulations. Rather, examples in the chapter highlight a range of activities undertaken by governments, members of the scientific and civil society communities, and others to support the fundamental aims of such laws and regulations and to further the effective oversight of dual use research. How each country prohibits biological weapons and constructs the suite of legal and policy measures that provide for national security and research oversight varies, reflecting the legal traditions, experiences, and policy preferences of that country. Although no one size fits all, the BWC and UNSCR 1540, along with national implementing legislation and policy, provide a legal foundation and support the strong international norm against the misuse of advances in the life sciences.
Governance of life sciences research that raises dual use concerns occurs across the full life cycle of a research project, from initial conception and planning of an experiment through the process of obtaining research funding, the conduct of the research, and dissemination of its results at conferences and in publications. In addition, activities associated with translation and commercialization of research, including patenting and licensing activities, can provide opportunities to implement governance measures. Table 3-1 highlights stages of the research life cycle and examples of governance activities associated with them. 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. As the table aims to make clear, governance of dual use life sciences research thus involves multiple stakeholders beyond government regulators and draws on a layered system of approaches, intervention points, and activities to help ensure appropriate and effective oversight. Illustrative examples of the types of efforts identified in the table are briefly described in the chapter sections that follow.
|Examples of Activities That Cut Across the Life Cycle|
|Stages of the Life Cycle and Examples of Associated Activities|
|Conception and Initial Project Development||Funding||Conduct of Research||Dissemination of Results||Translation and Product Development|
Cross-Cutting National Government Measures
A variety of efforts undertaken by national governments aim to promote governance of dual use life sciences research across multiple stages of the research life cycle. These efforts reflect the utility of approaches that can both provide targeted interventions for particular phases and support governance at more than one stage.
As highlighted during the workshop, a number of countries make use of advisory bodies to provide input and guidance to government ministries and to the scientific community. Examples of national bodies tasked with addressing biosecurity issues include the following:
National Advisory Council for Biosecurity (France). Established by decree in 2015, the mission of the Council is to
. . . reflect on the potential misuse of life sciences and ways to protect against them. Serving public institutions or recognized to benefit the public with a research mission, the Academy of Sciences, or public authorities, it carries out prospective studies and monitoring activities surrounding dual use research in the field of life sciences. It proposes measures to prevent, detect, and counter possible threats. To this end, it formulates recommendations to ensure that biological science innovations do not generate new threats. It informs the public and strengthens the fields of science and health. Finally, it ensures the respect and improvement of international commitments.3
Half of the six members come from government agencies and half are nominated by the French Academy of Sciences.
- Council for the Regulation of Research in Biological Pathogens (Israel). The legislation underpinning Israeli biosecurity policy, the Regulation 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). The 15-member Council, with a mix of technical experts from government ministries and academics from the fields of microbiology, infectious diseases, or biotechnology, advises the Ministry of Health on the implementation of the regulations.
- National Science Advisory Board on Biosecurity (United States). The National Science Advisory Board on Biosecurity (NSABB), created in 2004 in response to the Fink report (NRC, 2004), is a federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the U.S. government. Headquartered at the National Institutes of Health, “the NSABB has up to 25 voting members . . . [who] provide expertise in areas such as molecular biology, microbiology, clinical infectious diseases, laboratory biosafety and biosecurity, public health/epidemiology, health physics, pharmaceutical production, veterinary medicine, plant health, food production, bioethics, national security, biode-
3 See Le Conseil National Consultatif pour la Biosécurité. Available at http://www.sgdsn.gouv.fr/missions/lutter-contre-la-proliferation/le-conseil-national-consultatif-pour-la-biosecurite-cncb (accessed September 21, 2018). Translation by U.S. National Academies staff.
fense, intelligence, national security, law and law enforcement, recombinant or synthetic nucleic acid research, and export control. . . . In addition, the NSABB includes non-voting ex officio members from 15 federal agencies and departments.”4 Over the years it has produced a number of reports addressing dual use issues, most recently its recommendations for federal policy in response to the gain-of-function controversy (NSABB, 2016).
A number of national governments also make use of advisory bodies on biosafety and bioethics. Although not specific to concerns of dual use and biosecurity, such bodies help to promulgate safe laboratory practices, accepted standards of laboratory risk management, and norms of responsible conduct of research. The presence of these bodies and their activities also illustrates a point that arose during workshop discussions: although some countries address biosecurity as such, a number of other countries embed biosecurity considerations within a larger umbrella of biosafety or bioethics. This issue is discussed further in Chapter 4. Such a choice may meet the interests and needs of national scientific communities, reflect which ministries are in charge of particular topics (e.g., ministries of science or health versus ministries of defense), or arise from other national choices. Countries that have biosafety and bioethics bodies mentioned during the workshop include Malaysia, Singapore, and Ukraine.
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). The government of Kenya and many of its institutions have been active participants in biosecurity-related activities, such as capacity building for biosafety and awareness-raising activities, including dual use issues, for its scientific and health communities. One recent example is the project undertaken to raise awareness in Kenya’s universities about the need for increased laboratory biosecurity. The terrorist attack at Garissa University in 2015 called attention to the vulnerabilities of laboratories that conduct research or house collections of pathogens. A partnership among two Kenyan government departments (the National Commission for Science,
Technology and Innovation [NACOSTI] and the Commission for University Education) and the Danish Centre for Biosecurity and Biopreparedness led to the “Kenya National Biosecurity Workshop for Universities” in January 2018. NACOSTI is the National Focal Point to the BWC and the UN 1540 Committee, so the workshop reflected “NACOSTI’s role in coordinating the whole-government implementation of nonproliferation of biological weapons” (Amunavi, 2018).
- Department of Defence Export Control Branch (Australia). As discussed 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). The Guide uses real-life scenarios to explain export control requirements and exemptions. This is complemented with considerable outreach activities directed at universities, public health networks, and companies, including the use of a capital city roadshow to key cities in Australia, the appointment of export control managers at relevant facilities that serve as single points of contact, the development of a toll-free export control helpline, and frequent presentations at relevant conferences and expos. The Guide has been shared with members of the Australia Group as a potential model to be adapted for use in other countries.
- Biosecurity Office (The Netherlands). The Biosecurity Office, part of the Dutch government’s response to the gain-of-function controversy, has conducted a variety of education and outreach activities. The Office has hosted workshops that brought together various stakeholders (universities, medical centers, industry, veterinarians, plant scientists, etc.). “Toolkits,” self-assessment surveys that can help to identify biosecurity strengths and weaknesses within an organization, are available on its website.5 There is also a 5-minute movie on the “8 pillars of biosecurity.”
A number of European countries undertook measures in response to the pathogen gain-of-function controversy (see NASEM, 2016; NRC, 2015). The initiative for the systematic self-governance effort undertaken by the German scientific community in response to the potential for fur-
ther government oversight actions is one example. At the request of the German government, the German Ethics Council undertook a review of whether the current legal framework and the codes of conduct being used in the academic and private sectors provided an adequate foundation for making decisions about funding for such research. The report of the Council made a comprehensive set of recommendations that addressed the actors, institutions, and instruments that could govern the research in the future (German Ethics Council, 2014: 179).
The German scientific community undertook a number of initiatives aimed at supporting and strengthening research governance. The German Research Foundation (DFG) updated its Code of Conduct: Working with Highly Pathogenic Microorganisms and Toxins to ensure that it remained valid in light of the advances in genome editing and synthetic biology (DFG, 2013). The DFG and the German National Academy of Sciences Leopoldina also developed an alternative governance arrangement based on self-governance by the research community rather than additional regulation. Building on the report of a joint DFG-Leopoldina committee (DFG and Leopoldina, 2014), they appointed an interdisciplinary and cross-institutional committee to implement the report’s recommendations and oversee the creation and guidance of Committees for Ethics in Security-Relevant Research (KEFs) at research institutions. The committee produced a set of model statutes that provides guidance for setting up and operating the KEFs and that ensures uniformity across different institutions.6 At the time of the Zagreb workshop, more than 70 institutions had created KEFs (German Government, 2018). The German government considers the self-regulatory approach a first step and will await the outcome of this effort before reevaluating any need for legislation regarding biosecurity and dual use.
Activities Associated with Initial Research Conception and Planning
Principal investigators have a general responsibility to design experiments to meet ethical, legal, and institutional standards and to plan for their safe conduct, as do the research-performing organizations and institutions where such research occurs. Thus, the governance of life sciences research that may raise dual use concerns begins with the initial stages of developing a research project.
6 Further information is available at German National Academy of Sciences Leopoldina. Available at https://www.leopoldina.org/en/about-us/cooperations/joint-committee-dual-use (accessed October 2, 2018) and in the paper presented by the German government at the 2018 Meetings of Experts (German Government, 2018).
Awareness of Potential Concerns
An important first step in identifying that a proposed experiment or project may raise dual use concerns is the researcher being aware that there may be benefits and risks to evaluate or biosecurity concerns to consider that go beyond traditional biosafety issues. Members of some research communities, such as investigators working with pathogens with pandemic potential or those on the “Select Agents” list, are likely to have greater awareness of security than investigators from communities that have engaged far less frequently with safety and security issues. On the other hand, even with awareness, disagreements about the potential risks posed by a line of research may remain; one of the researchers whose work sparked the influenza “gain-of-function” debates in 2011, for example, had served on the Dutch academy committee that drafted its biosecurity code of conduct. Decisions on when benefits outweigh risk or when adjustments to a research plan are warranted to mitigate concerns are not always clear-cut. A subsequent section of the chapter addresses awareness-raising efforts and education in more detail. In addition, examples of training on laboratory risk management practices are covered under the “conduct of research” phase below.
Institutional Review Committees
An institutional oversight committee such as an Institutional Biosafety Committee (IBC) is a mechanism used in many parts of the world to oversee the appropriate conduct of research. Participants who believed in a strong nexus between biosafety and biosecurity, for example, would be likely to prefer making use of an arrangement grounded in biosafety to also now address biosecurity issues. Investigators provide information to IBCs and other institutional oversight committees (such as Institutional Review Boards, Institutional Animal Care and Use Committees, and others) to describe research they plan to conduct and to demonstrate that they have considered how to address issues or concerns it may present. In the United States, an additional type of institutional committee, an Institutional Review Entity (IRE), may be involved in the assessment of whether a research project poses dual use concerns. To comply with U.S. policies on Dual Use Research of Concern (DURC), proposals that involve particular types of research on specific agents and toxins are referred to the institution’s IRE for further review. 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
plans are needed. However, not all research that could potentially pose dual use issues for the life sciences, such as in engineering or computer science departments, is likely to be captured by these review committees.
Embedding Safety and Security into Research Planning: Example of iGEM
Through its annual competition and other programs, the International Genetically Engineered Machine (iGEM) Foundation now reaches thousands of high school and undergraduate students interested in synthetic biology. To educate participants in appropriate research design and to address safety and security concerns, iGEM maintains a Safety and Security Hub with information on its policies in areas such as organisms with which teams can work and tools to aid in assessing a project’s risk.7 Teams must also complete a safety and security form on their proposed project. Although the program is primarily directed toward student researchers, it represents a case example in which security and risk considerations are embedded into the initial stages of research conception and planning.
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. Other examples include engineered auxotrophy, in which a molecule necessary for an organism’s growth must be provided in the laboratory, or strategies in which gene expression is induced only in the presence of a specific substance. The Safe Genes program through the U.S. Department of Defense’s Defense Advanced Research Projects Agency illustrates also this concept for one approach to genome editing. Safe Genes supports the development of “tools and methodologies to control, counter, and even reverse the effects of genome editing—including gene drives—in biological systems across scales;” these approaches are in the early stages of development.8 Types of strategies investigated through the program include the ability to inhibit or block genome editing activity in an organism (for example, with genome editors whose activity is
regulated by the presence or absence of certain molecules), to reverse genome editing to restore a previously edited genome to its initial state, or to design gene drives that are limited in their number of generations and thus have a reduced ability to spread uncontrollably. 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. Ideally, such research could be identified much earlier and additional procedures or safeguards implemented as necessary. The funders of life sciences research have considerable leverage to request that scientists applying for support consider dual use issues, to require the adoption of procedures to mitigate concerns, or to require that adjustments to research plans be made as conditions of funding. Thus, the funding stage has become an important opportunity to support governance and oversight. Several funders have created or expanded dual use proposal review systems in recent years.
Ethics Self-Assessment Under the European Commission (EC). In its oversight of research under the Horizon 2020 program, the European Commission maintains a distinction between traditional dual use research and what it terms research that “involves materials, methods or technologies or generates knowledge that could be misused for unethical purposes (emphasis added). Although such research is usually carried out with benign intentions, it has the potential to harm humans, animals or the environment” (European Commission, Undated: 1), which corresponds to the concept developed in the Fink report (NRC, 2004). A researcher applying for funding addresses questions of whether his or her research has the potential for misuse as part of the mandatory Ethics Self-Assessment that is part of the proposal process. As an EC guidance note explains:
If you are planning research that may give rise to concerns about potential misuse, you will need to do the following when preparing your proposal:
- tick the box in the ethics table in part A
- provide a risk-assessment in part B and explain how you will prevent misuse
- if required, attach copies of authorisations, security clearances, and ethics approvals Describe in the risk table in the management section what action you would take if the national authorities do not grant authorisation (European Commission, Undated: 2).
- Grant Requirements of the Medical Research Council/Biotechnology and Biological Sciences Research Council (BSBRC)/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. In 2015, partly in response to the gain-of-function controversy, the three funding bodies revised and updated the statement (BBSRC et al., 2015). The new statement adopts a focus on DURC rather than dual use,9 but asserts that “we as research funders must take a proactive lead” (BBSRC et al., 2015: 5). It retains the expectation that researchers, research-performing institutions, and the research community more broadly have responsibilities across the full life cycle of research to address potential risks of misuse. The statement also endorses education and training to enable researchers to fulfill these responsibilities effectively. The statement includes specific guidance for reviewers and applicants and expresses support for an approach based on self-governance by the scientific community, noting that “Effective self-governance requires the research community to take clear and proportionate steps to ensure the risks of dual use research of concern are identified and addressed appropriately where they arise” (BBSRC et al., 2015: 5).
- Processes in Use by Other National Funders. The main government research funding agency in Croatia, the Croatian Sciences Foundation, requires applicants to provide information concerning ethics and dual use issues when submitting project proposals. The self-governing organization for science and research in Germany, the DFG, which receives the large majority of its funds from the federal government and has the federal states represented in all grants com-
9 The statement notes that “other types of potentially harmful misuse of research exist, such as risks of research findings being used to stigmatise or discriminate against particular population groups” and “It is also important to note that these risks are by no means exclusive to research which directly involves the use of hazardous agents, and are not restricted to misuse for terrorist purposes” (BBSRC et al., 2015: 1).
mittees, has established a procedure for reviewing research proposals with dual use potential. Principal investigators must address the presence of dual use in their research and reviewers will then assess and make recommendations before funding is approved.
- Funding Reviews Under U.S. Government Policies. The U.S. government has a series of sometimes overlapping policies and regulations to provide oversight of dual use research. 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. Government, 2012). The 2014 policy sets out specific obligations of researchers and research-performing institutions that are consistent with the 2012 policy on government funding (U.S. Government, 2014a). As the culmination of the U.S. government’s deliberative process for gain-of-function research, in January 2017 the White House Office of Science and Technology Policy issued its Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight (U.S. Government, 2017), which applies to any agents that meet certain criteria rather than to a predefined list. In December 2017 the U.S. Department of Health and Human Services released its policy for review of proposed funding for research on enhanced potential pandemic pathogens consistent with the 2017 OSTP guidance (HHS, 2017). The policy updated and expanded an earlier 2013 funding review process for certain H5N1 influenza experiments (HHS, 2013), maintaining the interagency review process, while replacing the previous policy’s limitation to specific agents with the criteria-based definition from the 2017 OSTP guidance. The HHS policy also provided criteria to guide funding decisions and a review and oversight framework. As of the time of this report, this was the only federal agency to have adopted a specific policy for pathogens with pandemic potential.
The funding policies cited above are all either from governments or private foundations. Depending on the country or region, the percentage of research supported by these sources can vary significantly. Over the years, the funding landscape has diversified so that, particularly in developed countries, it now includes private industry, crowdsourcing, charitable organizations other than foundations, venture capital, and foreign investors and funders. Depending on the circumstances, this diversity of funding sources can be a challenge for the use of funding as a lever for research oversight.
Activities Associated with Conduct of Research
A number of the case examples highlighted in background materials and during the workshop featured governance measures applicable to the conduct of research. These include the implementation of risk management plans for research that raises dual use concerns, as well as awareness-raising and technical training on safety and security best practices for such research. 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. In the United States, for example, federal DURC policies require agencies that fund life sciences research to work with the researcher or research-performing institution to develop a mitigation plan to address any identified risks (U.S. Government, 2012, 2014a). The European Commission and UK funding policies described above have similar provisions for the development and implementation of risk mitigation plans. Provisions requiring regular reporting and immediate reporting of unexpected results that could pose new or increased dual use risks reflect the recognition that it may not be possible to predict the outcomes of research at the funding stage.
Other countries may use approaches such as research licensing and institutional inspections to oversee the conduct of life sciences research that raises dual use concerns.10 In Denmark,11 for example, the Centre for Biosecurity and Biopreparedness (CBB) is responsible for implementation and has a variety of means to secure dual use technology.12 Public and
10 The U.S. Select Agent Program, which is based on formal regulations, also has licensing, personnel reliability, and inspection provisions, but other U.S. policies for dual use do not. Additional information may be found at https://www.selectagents.gov (accessed September 4, 2018).
11 The legislative basis for biosecurity in Denmark is the 2008 Act on securing biological substances, delivery systems, and related materials (Act no. 474 of June 2008), with additional authorities under the Executive Order on securing specific biological substances, delivery systems, and related materials (EO no. 981 of October 15, 2009, with Updated Annex 1 to EO 2017 [under Related Materials section j]).
12 Dual use research is treated under the Executive Order and is generally referred to as “technology with dual-use potential” or “dual-use technology.”
private laboratories that intend to work with controlled materials must file an application for a license to do so. In the application, they must also assess whether they have any dual use technology, which will be checked by CBB during inspections. Inspections may also be carried out in institutions and companies without a license from CBB, but which have research activities that suggest dual use technology potential. If inspections indicate that the companies conduct research that is deemed to have misuse potential, the organization or company must apply for a license from CBB. Spot checks and screening of publications are also conducted on a regular basis. If dual use technology is detected the company is categorized according to the risk potential and must obtain a license to continue its research activities and/or receive mandatory guidance and advice from CBB. Violations could result in fines or imprisonment.13
Criteria for Assessing the Dual Use Potential of Research
The Robert Koch Institute (RKI), a federal institute within the portfolio of the Federal Ministry of Health, is the German government’s central scientific institution in the field of biomedicine and the national public health institute. The Institute has developed and adopted a code of conduct for risk assessment and risk mitigation that is obligatory for employees of RKI. In addition to basic principles intended to reduce the potential for dual use risks, the code provides criteria for assessing the dual use potential of research projects and their results, as well as additional information on the research project and risk assessment evaluation to be conducted, including steps to mitigate any risks identified and the points during research at which evaluation must occur. RKI also plans to raise awareness through seminars and training (RKI, 2013).
Biosafety Associations and Capacity Building in Biosafety
Many consider biosafety to be the essential foundation for biosecurity, including oversight of dual use research. Substantial effort has gone into capacity building for individuals and institutions around the world, reflected in the growth of biosafety associations since the early 2000s. The International Federation of Biosafety Associations (IFBA) 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).
associations include Africa, the Asia-Pacific, Central Asia and the Causasus, and Europe.14
Training and Professional Certification for Biorisk Management and Biosafety Professionals
IFBA “has launched a new certification program for biorisk management and biosafety professionals worldwide. . . . An IFBA certificant is an individual who has met the eligibility requirements and achieves acceptable performance levels on examinations. The IFBA certifies individuals at the ‘Level 1 – Professional Certification’ and ‘Level 2 – Specialist Professional Certification’ in a number of specializations and technical disciplines related to the field of biosafety, biosecurity, and biorisk management. Certifications are valid for a period of 5 years and require ongoing maintenance demonstrating active upgrading of skills and participation in the profession.”15
Changing Organizational Culture in Support of Biosecurity
The talk by Ruthanne Huising described in Chapter 2 lays out some of the challenges and options for achieving change in the ways that organizations operate, from specific practices to broad “culture.” In 2014, a series of significant lapses involving the handling of pathogen inventories at federal laboratories in the United States led to a substantial effort to assess and improve biosafety and biosecurity. The White House ordered any federal laboratory that shipped or worked with infectious plant or animal agents or toxins to carry out a “Safety Stand-Down” to review its practices and protocols (Kaiser, 2014). The White House also tasked the Federal Experts Security Advisory Panel (FESAP) to
1) identify needs and gaps and make recommendations to optimize biosafety, biosecurity, oversight, and inventory management and control for BSAT; 2) identify actions and any regulatory changes to improve biosafety and biosecurity; and 3) identify an approach to determine the appropriate number of high-containment U.S. laboratories required to possess, use, or transfer BSAT [Biological Select Agents and Toxins]. (U.S. Government, 2014c: 3)
14 The list of members is available at IFBA, “Member Associations.” Available at https://www.internationalbiosafety.org/index.php/ifba-members/ifba-membership/member-associations (accessed September 4, 2018).
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).
Based on that report and additional interagency reviews, in 2015, the White House announced a comprehensive plan to implement the recommendations, which included efforts to “Create and strengthen a culture that emphasizes biosafety, laboratory biosecurity, and responsible conduct in the life sciences” (U.S. Government, 2015: 1). Interagency work to develop and implement training to achieve appropriate cultural change continues.16
Screening Orders for Research Materials
Controls may also be implemented around access to certain types of research materials. For example, many life sciences research projects make use of commercially acquired DNA sequences. In 2010 the U.S. government produced Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (HHS, 2010). The industry has developed its own guidance through the International Gene Synthesis Consortium (IGSC). Initially established in 2009 and incorporated in the United States in 2015, the members of the IGSC represent about 80 percent of current gene synthesis screening capacity internationally. The Consortium’s original 2009 protocol was updated in 2017 to the Harmonized Screening Protocol © v2.0. “By uniformly screening the sequences of ordered genes and vetting gene synthesis customers, IGSC members collaborate to establish and continuously improve best practices, safeguard the many benefits of gene synthesis technology while minimizing risk, and help ensure broad compliance with HHS Guidance for Double-Stranded DNA Providers and other international standards” (IGSC, 2017: 1).
Activities Associated with Dissemination of Results
The results of research efforts are publicized in conferences, made available in prepublication form on preprint servers such as bioRxiv,17 and published in numerous scientific journals. Controversies over the publication of articles containing the results of dual use research in the life sciences became particularly intense in the early 2000s amid rising concern about terrorists’ interest in acquiring weapons of mass destruction. As a result, a number of groups involved in scientific publishing have addressed biosecurity or recommended policies on research publication.
16 Additional information is available at U.S. HHS, “Federal Experts Security Advisory Panel (FESAP).” Available at https://www.phe.gov/Preparedness/legal/boards/fesap/Pages/default.aspx (accessed September 4, 2018).
Journals including Science, Nature, PLOS, and the journals published by the American Society for Microbiology have dual use review policies. In addition:
- Journal Editors and Authors Group. At the urging of the American Society for Microbiology and others, the U.S. National Academy of Sciences and the Center for Strategic and International Studies organized a one-day public meeting of publishers, scientists, security experts, and government officials in January 2003 to explore the issues and discuss potential actions that could address the concerns. The following day a group of journal editors, along with invited scientists, officials, security experts, and others held a separate private meeting. On the basis of the discussions and further consultations, a “Statement on Scientific Publication and Security” by the Journal Editors and Authors Group was published in Science, Nature, and the Proceedings of the National Academy of Sciences from February 18 to 21 (Journal Editors and Authors Group, 2003). The statement offered principles to guide scientists and journal editors in devising processes for reviewing and managing the dissemination of dual use research.
- White Paper on Promoting Integrity in Scientific Journal Publications from the Council of Science Editors. The Council of Science Editors (CSE) is an international membership organization whose aim is to be “an authoritative resource on current and emerging issues in the communication of scientific information.”18 Since 2006 CSE has published a White Paper on Promoting Integrity in Scientific Journal Publications, which is periodically revised and, beginning in 2018, will be added to and updated on a rolling basis to keep pace with new information and best practices. The most recent guidance regarding dual use research states that “Editors can educate journal boards, reviewers, and authors; establish screening methods to recognize DURC; obtain reviews of these manuscripts from individuals with technical and security expertise; and create an ongoing network to share experiences and further refine ways for managing DURC. Editors should develop guidelines and procedures to allow the scientific evaluation as well as the evaluation of the possible risk of communicating information with dual use potential” (Council of Science Editors, 2018: 7).
18 See Council of Science Editors, “About CSE.” Available at https://www.councilscienceeditors.org/about/about-cse (accessed October 2, 2018).
Activities Associated with Product Development and Translation
As noted in Chapter 2, the private sector is a stakeholder in addressing dual use research, whether as funders and investors in research, as organizations that conduct research and development, or as organizations that license or translate research into products. Governance of life sciences developments can be implemented at these later stages of the research life cycle. For example, conditions placed on the acceptable uses of intellectual property through patent licenses and material transfer agreements can function as governance mechanisms and may have applicability to dual use research. The workshop did not focus on engagement with the private sector to advance life sciences governance or discuss such mechanisms in detail. This remains an area in which future work or further discussions may be useful.
As discussed frequently during the workshop, effective governance requires more than “check-box” compliance with regulations, policies, and practices. Acceptance and engagement by the affected communities are essential and this requires sustained and continuing effort. Governments may play a role in fostering and promoting governance, while self-governance depends on the actions of the affected communities themselves. The scientific community frequently asserts its capacity to govern itself with regard to key aspects of the conduct of research, including dual use issues. This section provides examples of some of the activities that can promote and sustain governance (see Table 3-2).
Foundational Principles: Norms on the Responsibility of Science and Scientists
The responsibility of the scientific community to consider social and ethical issues beyond the conduct of science itself, including the possibility that research could be misused to cause harm, has been addressed by several global scientific bodies. 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 International Science Council (ISC). Published by the Council’s Committee on Freedom and Responsibility in the Conduct of Science (CFRS) in 2014, this publication discusses both the norms of scientific freedom and the responsibilities of science and individual scien-
|Types of Activities||Examples|
|Norms for Responsible Scientific Conduct||
|Principles for Biosecurity||
|Codes of Ethics and Conduct||
|Awareness Raising and Outreach||
|Networks and Clearinghouses||
a This is the new name of the organization formed in 2018 by the merger of the International Council for Science (ICSU) and the International Social Science Council (ISSC).
tists.19 One of the broad statements of principle in the document is that “Science depends on society’s respect for its processes and support for its activities. It is widely acknowledged that there is an informal, social contract between science and society. This contract implies certain responsibilities from society to science, and from science to society” (ICSU, 2014: 4). With regard to potential misuse and individual responsibility, the publication states that, “Given this potential for multiple-use, the demands on scientists to pay careful attention to their individual and communal responsibilities are higher than in many other areas of work. Scientists have
19 ICSU established the CFRS in 2006. “This Committee differs significantly from its predecessors that, since 1963, had focused on scientific freedom, in that it is explicitly charged with also emphasizing scientific responsibilities” (ICSU, 2014: 3).
an obligation to critically reflect upon how their expertise is used, particularly when asked to support decision-making and policy processes” (ICSU, 2014: 17).
- Recommendation on Science and Scientific Researchers from UNESCO. The document, adopted by the UNESCO General Conference at its 39th meeting in 2017, lists responsibilities and freedoms of individual researchers, institutions, and funding agencies. Researchers have a responsibility “to express themselves freely and openly on the ethical, human, scientific, social or ecological value of certain projects, and in those instances where the development of science and technology undermine human welfare, dignity and human rights or is ‘dual use’, they have the right to withdraw from those projects if their conscience so dictates and the right and responsibility to express themselves freely on and to report these concerns” (UNESCO, 2017). A report on member states’ progress in implementing the recommendations is to occur every four years, starting in 2019. The Annex, which contains a list of other conventions, recommendations, and initiatives, is a helpful resource for self-governance. The UNESCO World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) also provides a potential forum for further discussions of dual use and biosecurity.
Codes of Ethics and Conduct as a Strategy for Addressing Biosecurity and Dual Use
Efforts aimed at providing ethical guidance for the scientific community focused on biosecurity and dual use build on this more general framework of scientific responsibility. 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’) set out ideals that practitioners should uphold, such as standards of research integrity, honesty, or objectivity. . . . Educational/Advisory codes (often designated as ‘codes of conduct’) would go further than merely setting aspirations by providing guidelines suggesting how to act appropriately. . . . and enforceable codes (often designated as ‘codes of practice’) seek to further codify what is regarded as acceptable behaviour. Rather than inspiring or educating in the hopes of securing certain outcomes, enforceable codes are embedded within wider systems of professional or legal regulation” (Rappert, 2004: 14–18).
Principles to Be Used in Developing Codes
One approach taken by international scientific and ethics communities has been to develop a set of principles for addressing biological and chemical security concerns, rather than a “code” itself. This approach is motivated by a desire to enable common understanding of the broad aspects that should be encompassed by codes, while the translation of these principles into more specific provisions is undertaken by scientific disciplines or at national or institutional levels. That enables the principles to be reflected in ways that are most suited to the scientific needs and legal and regulatory frameworks of the local context and, it is hoped, increases the sense of “ownership” by those the codes are intended to influence. Two examples reflect the idea of developing principles focusing on security concerns:
- Statement on Biosecurity from the InterAcademy Partnership (IAP). The Statement, developed for the 2005 discussions at the BWC, sets out five guiding principles that should be considered for inclusion in codes of conduct: awareness, safety and security, education and information, accountability, and oversight. Researchers should “always bear in mind the potential consequences—possibly harmful—of their research and recognize that individual good conscience does not justify ignoring the possible misuse of their scientific endeavor” (IAP, 2005).
- The Hague Ethical Guidelines. The Organisation for the Prohibition of Chemical Weapons (OPCW) is the organization that administers the Chemical Weapons Convention, the international treaty prohibiting the use of chemicals in warfare. In 2015 the organization supported the development of principles aimed at “Applying the norms of the practice of chemistry to supporting the Chemical Weapons Convention.”21 The Guidelines have been translated into the six official languages (Arabic, Chinese, English, French, Russian, and Spanish) and endorsed by chemistry organizations from academia and industry, including the International Union of Pure and Applied Chemistry and the International Council of Chemistry Associations. 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).
underlying elements. The Ethical Guidelines articulate nine key elements: a core principle that “chemistry should be used to benefit humankind and to protect the environment,” along with sustainability, education, awareness and engagement, ethics, safety and security, accountability, oversight, and exchange of information. The principles are intended to enable stakeholder engagement in taking ownership of translation into codes, along with recognition that codes will need to be adaptable and evolve over time. Thus, the Ethical Guidelines reflect a model from chemistry that might be relevant to promoting governance and security in the life sciences.
The BWC’s Convening Capacity: Fostering Action on Codes
In 2005 the topic for the Meeting of Experts (MX) of the BWC was the “content, promulgation and adoption of codes of conduct for scientists” (BWC, 2005). A number of national and international scientific organizations were invited to make presentations as “guests of the chair” and there were numerous side events and opportunities for informal discussions during the meeting. 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). And, as a result of the statement, the Dutch government asked the Royal Netherlands Academy of Arts and Sciences (KNAW) to create a biosecurity code (KNAW, 2008).
In 2014, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Italy, Mexico, and Spain submitted a Code of Conduct for Scientists as a draft document meant to be a code “of general application” for life scientists (Chile et al., 2014). The code discusses professional integrity, personal responsibility (including the improper use of information), and the responsibility of scientific institutions.
In December 2015, the government of China introduced a proposal to develop a code of conduct for scientists under the auspices of the BWC (China, 2015). By the time of the Eighth Review Conference in 2016, Pakistan had joined as a co-sponsor and the draft of a model code had been developed by scholars at the Center for Biosafety Research and Strategy at Tianjin University (China and Pakistan, 2016). Codes of conduct were included in the topics for the 2018–2020 intersessional discussions of developments in science and technology, and, as part of the preparations for the first Meeting of Experts, the BWC Implementation Support
Unit and the Tianjin Center co-hosted an international workshop in June 2018.22
Examples of Codes from International Scientific Organizations
The development and implementation of a code has been used as one critical strategy for governance. Codes of ethics relevant to biosecurity developed by international organizations include those from the International Union of Biochemistry and Molecular Biology (IUBMB) and the International Union of Microbiological Societies (IUMS), both of which were motivated by the BWC’s attention to this issue in 2005:
- IUBMB Code of Ethics. The code lists the members’ obligation to the public, to other investigators, and to trainees, and also includes that statement that “They will not engage knowingly in research that is intended for the production of agents of biological warfare or bioterrorism, nor promote such agents.”23
- IUMS Code of Ethics. “IUMS is opposed to the misuse of microbiological knowledge, research and resources. 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 microorganisms 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) Code of Ethics. The code lists aspirational guiding principles as well as “rules of conduct,” which are more specific. Guiding principle 6 states that “ASM members
22 Reports about the workshop may be found in the plenary presentations and a side event hosted by the government of China during the BWC Meeting of Experts in August 2018 (see https://www.unog.ch/unog/website/disarmament.nsf/(httpPages)/6FF7D93E1F743543C125827C0028667D?OpenDocument for the plenary presentations and https://www.unog.ch/80256EE600585943/(httpPages)/A8850DE2E9D56A20C125825C003B0E88?Open Document for the side event) (accessed October 5, 2018).
23 See IUBMB, “Code of Ethics.” Available at https://iubmb.org/about-iubmb/mission-code-of-ethics (accessed September 21, 2018).
are obligated to discourage any use of microbiology contrary to the welfare of humankind, including the use of microbes as biological weapons. Bioterrorism violates the fundamental principles upon which the Society was founded and is abhorrent to the ASM and its members. ASM members will call to the attention of the public or the appropriate authorities misuses of microbiology or of information derived from microbiology.”25
- Indonesian Academy of Sciences Code of Conduct on Biosecurity. The code was created by the Indonesian Academy of Sciences, with support from the Royal Netherlands Academy of Arts and Sciences and the U.S. National Academies. Introduced in 2015 at the Academy’s 25th anniversary, the code has been disseminated widely within the Indonesian research community (Indonesia, Malaysia, the Netherlands, and the United States, 2015).
- KNAW Code of Conduct for Biosecurity. Developed at the request of the Dutch government after the 2005 BWC discussion of codes, the code was released in 2008 and included a dissemination campaign with the research community. Section 4.3 on “dual use” uses a definition similar to that proposed by the U.S. National Science Advisory Board on Biosecurity. The code was reviewed in the wake of the gain-of-function controversy, but revisions were not considered necessary in light of the creation of an extensive outreach program by the Dutch government (KNAW, 2008).
- Swiss Academies of Arts and Sciences document on “Misuse potential and biosecurity in life sciences research: A discussion basis for scientists on how to address the dual use dilemma of biological research.” In 2017 the Swiss Academies released a discussion document based on the outcomes of three workshops with life scientists to explore the potential for creating a code of conduct for Swiss researchers. Rather than a code, the consultations resulted in the establishment of six principles that should be considered when doing science, including awareness and assessing misuse potential (Swiss Academies of Arts and Sciences, 2017).
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).
representatives of national scientific communities. Examples include the following:
- Code of Professional Ethics for Science Workers in Cuba. The code lays out ethical principles and rules (both aspirational and advisory). 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). With regard to ethics related to dual use, the revised code states that “Scientists shall recognize that there exist possibilities that their research results, contrary to their own intentions, may be used for destructive actions, and shall select appropriate means and methods as allowed by society in conducting research and publicizing the results” (Science Council of Japan, 2013).
- Malaysian Code of Conduct. Developed by STRIDE, an institute of the Ministry of Defense, in collaboration with the Ministry of Health, the draft code incorporates feedback and guidance of academic and industry scientists, including the Academy of Sciences Malaysia, collected from workshops held throughout Malaysia in 2015.27
- Robert Koch Institute and other German Institutions. As noted earlier in the chapter, the Robert Koch Institute has a code addressing dual use research to which its scientists must adhere. Other German institutions make use of codes to help manage and mitigate dual use as well, including the Technische Universität Darmstadt, Philipps-Universität Marburg, and Fraunhofer Gesellschaft (RKI, 2013).
Systematic outreach by governments to inform the relevant communities of their responsibilities and seek their active engagement in imple-
26 See Code of Professional Ethics for Science Workers in Cuba. No official translation. Available at https://documents-dds-ny.un.org/doc/UNDOC/GEN/G16/221/05/pdf/G1622105.pdf (accessed September 21, 2018).
27 See ISSUU, “Code of Conduct for Biosecurity, Workshop Handbook.” Available at https://issuu.com/asmpub/docs/code_of_conduct_for_biosecurity_wor (accessed September 23, 2018).
mentation was discussed earlier in the chapter. The issue of engagement was raised by participants over the course of the workshop, with participants suggesting that engagement allowed norms and ideas to be planted and adapted as science changes. Awareness-raising efforts support and supplement other governance activities related to dual use and are often undertaken by professional societies and nongovernmental organizations. Whether included in regularly scheduled events such as annual conferences or held as special meetings, hundreds of such activities take place each year. The workshop discussions suggest that, unfortunately, relatively few organizations have the resources to carry out such activities in a sustained and strategic manner and there is no systematic evidence of their effectiveness. Nonetheless, they constitute a continuing global effort to bring the issues to the attention of the scientific community:
- Croatian Society for Biosafety and Biosecurity. As an example of civil society engagement in awareness raising, the Croatian Society conducts training and education programs, organizes conferences, and works on the development of strategy and laws. Future activities are expected to include more attention to dual use issues.
- Moroccan Biological Safety Association. The Moroccan Biosafety Caravan was developed through the Moroccan Biological Safety Association with the objective of raising awareness on biosafety and biosecurity in public and in private universities throughout the country. The caravan approach is composed of a traveling series of conferences led by Moroccan biosafety professionals. The outreach is supported with presentations and materials on biosafety, its challenges, and its strategic importance for Morocco.28
Many participants raised the topic of education and training, with education of scientists as a foundational element for the governance of dual use research. This includes modules and courses, as well as materials that can be used to teach and engage with scientists about dual use issues. Activities that introduce dual use issues and biosecurity within a wider context, such as the responsible conduct of science, can serve as the basis for more advanced and specialized training.
28 Further information is available at https://www.slideshare.net/UNESCOVENICE/caravane-bio-mohammed-benbouida-ambs-morocco-12664659 (accessed October 7, 2018).
Education was seen by a number of participants in the workshop as an ongoing activity, not something that happens once and for which researchers will never need additional engagement as science advances. This includes building networks of faculty who can support each other, share best practices, and sustain capacity-building efforts.
- European Union CBRN Centres of Excellence Projects Project 18. The “International Network of universities and institutes for raising awareness on dual-use concerns in bio-technology” was a 2-year activity (2013–2015) “To raise awareness of dual-use (peaceful use and misuse) concerns in bio-technology for academics, scientists, researchers, technicians and students, as well as to foster the sharing and transfer of best practices in biosafety and biosecurity.”30 Information about the implementation of the project is available on the website of the implementer, the Landau Network Centro Volta. A similar project (#42) was carried out for chemistry. This example reflects a multilateral (EU) government activity in support of awareness raising.
- International Educational Institutes on Conducting Responsible Science, United States. The U.S. National Academies has carried out a program in cooperation with a number of global partners focused on responsible science. Collegiate-level researchers and educators took part in a program for up to 18 months, first attending a 5-day-long Educational Institute on Responsible Science. The “immersive learning experience [is] constructed to educate on three core themes: the development of professionalism in science, conducting research responsibly, and being part of the responsible scientific 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-18-International-Network-of-universities-and-institutes-for-raising-awareness-on-dual-use-concerns-in-bio-technology.aspx (accessed October 4, 2018). And “Project 42: Chemical safety and security in Central and Eastern Africa.” Available at http://www.cbrn-coe.eu/Projects/TabId/130/ArtMID/543/ArticleID/78/Project-42-Chemical-safety-and-securityin-Central-and-Eastern-Africa.aspx (accessed October 4, 2018).
31 See National Academies of Sciences, Engineering, and Medicine, “About the Institutes.” Available at http://nas-sites.org/responsiblescience/iircs/about-the-institutes (accessed October 4, 2018).
the project strives to reach—to engage the attendees in learning. Following the Institute, attendees were able to competitively apply for modest funds to help them implement teachings of responsible science in their home institutions. A reunion meeting at the end of the program brought together the grantees to provide assessment and feedback and discuss with the program faculty and staff their experience from implementing activities in their home institutions. Six 18-month-long Educational Institutes have been held to date: three regional Institutes in the Middle East and North Africa; one in South and Southeast Asia (MENA); a combined program in Egypt composed of two institutes (two opportunities for funds and one combined reunion was led by Egyptian alumni of previous regional MENA activities); and a shorter 4-day institute in India. Numerous workshops have originated from these activities, delivering aspects of active learning and the message of responsible science, including dual use issues, in a more compressed manner.
- Centre for Biosecurity and Biopreparedness (CBB), Denmark. Among its activities, the CBB has a large number of outreach and educational activities where dual use technology is addressed specifically. Teaching and awareness-raising activities are arranged for biosecurity officers, university life sciences students at all levels, and researchers. There is also a Code of Biosecurity Ethics.
- Dual Use Education in Pakistan. “Previously, the results of the survey on ‘Awareness and Opinions on Biosecurity and Dual Use among Pakistani Life Sciences Students’ revealed that overall awareness level about dual-use related concepts was low among a sample of students surveyed from Pakistani universities” (Shinwari, 2015: 38). Subsequently, several workshops have been conducted in Pakistan by the Pakistan Academy of Sciences and Quaid-i-Azam University for teaching “responsible science conduct” to the scientists, with young researchers as the main target audience. In order to make the program of scientific training more effective, participatory and interactive learning has been encouraged during the workshops. This approach has proved effective in promoting education on dual use issues in the context of Pakistan (Shinwari, 2015).
- Workshop participants described a number of additional education and training programs that have been undertaken around the globe, including in Algeria, which has developed a training program that looks at dual use issues for scientists; in China, which offers an elective course on dual use to students; through the Japanese National Defence Medical College, which has established a dual use biosecurity education program; in Switzerland, which
has developed a course on the dual use dilemma using online resources; and in Thailand, where educational workshops have been held.
Educational Materials and Resources
Coupled to the increasing number of workshops, courses, and educational opportunities are an increasing number of available resources for scientists wishing to learn about dual use and biosecurity concerns, or to teach them to their students.
- Malaysian Educational Module on Responsible Conduct of Research from the Academy of Sciences Malaysia. The module, which is described in the presentation by Abhi Veerakumarasivam (see Chapter 2), includes dual use as one of the elements that make up responsible conduct of research. The chapter on dual use includes reading materials, discussion questions, and suggestions for various active learning activities.
Materials Developed by the Bradford Disarmament Research Centre, United Kingdom.32 Over the years, the group at Bradford has produced a series of online educational resources:
- The Dual-Use Bioethics Education Module Resource (EMR), 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. It covers BWC history and background, dual use issues, and governance issues.
- The National Series (NS) resource collection provides teaching guidelines and materials for facilitators, whether or not they are biosecurity subject matter experts, that can be adapted for different countries beyond the countries for which specific materials are available.
- Preventing Biological Threats: What You Can Do is an edited volume intended to raise awareness and knowledge of biological security of everyone active in the life sciences, ranging from those engaged in research to those engaged in management and policy making, both nationally and internationally. The companion handbook, Biological Security Education Handbook: The Power of Team-Based Learning, provides a number of the exer-
cises related to dual use issues and/or the responsibilities of scientists.
In addition to this work, the Bradford Centre has produced material focused on dual use issues related to neuroscience.
- Case Studies in Dual Use Biological Research and Case Studies in Agricultural Biosecurity from the Federation of American Scientists. The Federation of American Scientists in the United States developed dual use case studies intended to help define the issues associated with dual use research and security in the research laboratory. They include interviews with researchers whose legitimate scientific work could potentially be used for questionable or harmful endeavors, as well as a historical perspective on their research, bioterrorism, and research regulations. The materials include primary scientific research papers and discussion questions that are meant to raise awareness about the importance of responsible biological research. 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. They include interviews with experts, historical perspectives on agroterrorism, and regulations.
Networks and Clearinghouses
Throughout the workshop, a number of participants noted the importance of creating and sustaining networks of people interested in education on dual use life sciences research, as well as repositories of relevant materials that can be used by those wishing to implement educational activities.
International Network on Biotechnology (INB), UNICRI. The INB is a global network of academic and research institutions, nongovernmental and international organizations, and other stakeholders in Asia, Europe, the MENA, and North and South America committed to advancing responsible and secure conduct in the life sciences. Its primary goals are to
- Raise awareness about the opportunities and risks enabled by advances in biotechnology,
- Advance responsible life sciences education,
- Advocate practical (policy) measures to ensure sustainable progress in biotechnology, and
- Enable partners to fulfil their international obligations.33
In its clearinghouse role, the INB is developing a digital platform to view, download, upload, and share customizable and user-friendly teaching and training materials, which include technology briefs, case study videos, scenario-based exercises, and immersive learning (VR laboratory tours). The INB also provides a sustainable platform for Network Partners to (co-)develop and share educational resources tailored to local needs.
A recurring theme in the Zagreb workshop reflected in the meeting’s title—Advancing Global Consensus on Research Oversight—was the potential need to develop greater common understandings about effective means and measures for the oversight of research with dual use potential that could support both security and continuing, globally accessible scientific progress. The second background document provided to participants contained a list of current and potential international forums and initiatives where such understandings could be built, promoted, and, where appropriate, implemented at the international, regional, or national level. Some of the forums have security as their primary mission, but others engage key stakeholders or address issues that can support more effective governance of research with dual use potential. None are devoted to dual use issues.
Some of the intergovernmental forums, based on formal treaties, have the capacity to make decisions that impose legally binding obligations on member states. Some serve as policy coordination bodies, and these may lead to increased harmonization of national policies and actions. Other intergovernmental forums primarily provide an opportunity for discussion among member states—and sometimes relevant stakeholders—about key issues. And to add to the complexity, there are also initiatives that seek to coordinate and enhance the work of the intergovernmental bodies themselves in areas where there are common interests.
Moreover, there are many international nongovernmental organizations that also provide valuable forums that have the capacity to build common understandings. The background document concentrates on those related to the workings of the scientific community. These bodies
33 See INB. Available at https://www.unog.ch/80256EDD006B8954/(httpAssets)/DB56FEFFA3325E82C12582E4006A837A/$file/INB_Presentation_BWC+MXaug2018_9+Aug+2018.pdf (accessed October 4, 2018).
|Disarmament Conventions and Forums||
|Other Intergovernmental Organizations||
|Security Policy Coordination and Action Forums||
|International Science Forums||
focus largely on traditional research integrity issues in the context of the rapid globalization of science, but they could in principle include security. And there are scientific communities of practice that provide examples of the ways that the scientific community can self-organize.
The workshop did not attempt a comprehensive review of the potential international venues. The remainder of this section offers a few of the examples that were discussed in an effort to give a sense of the variety and potential for seeking greater international consensus (see Table 3-3).
Disarmament Conventions and Forums
The two examples most frequently cited during the workshop were the BWC and the UN1540 Committee, both of which have been described earlier. 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), the World Organisation for Animal Health (OIE), the Food and Agriculture Organization of the United Nations (FAO), and the
Convention on Biological Diversity and its Nagoya Protocol. Some of the work of UNICRI, another example, was described above. WHO, OIE, and FAO are partners in the Global Health Security Agenda described below. In addition:
- World Organisation for Animal Health (OIE). As the Biological Threat Reduction Strategy released by OIE in 2015 notes: “At least 75% of emerging infectious diseases of humans (including Ebola, HIV, and influenza) have an animal origin” and “80% of agents with potential bioterrorist use are zoonotic pathogens” (OIE, 2015a: 2). This provides the organization with a strong rationale and role in international efforts to reduce biological risks, whether natural, accidental, or deliberate, particularly as a partner in a “one health” approach to combating infectious disease. The clearest link in the strategy to dual use issues is the goal to “Advocate that fostering of altruistic scientific networks at the national, regional, and global level is a means of sustaining expertise, and preventing scientists from contributing to bioweapons development by encouraging a culture of responsible and transparent science” (OIE, 2015a: 7). OIE is a regular participant in the work of other intergovernmental organizations and has held two international conferences on biosecurity of its own, one in 2015 and one in 2017, both of which included discussions of dual use issues.34
- WHO has become involved in dual use issues over the past 15 years, although they have never been a consistent focus for the organization. For example, the organization released a paper in 2005, Life Science Research: Opportunities and Risks for Public Health (WHO, 2005), and held a workshop in 2006 on “Life Science Research and Global Health Security” (WHO, 2007). Several regional workshops during the same period addressed both biosafety and biosecurity issues, and a guidance document released in 2010 offered researchers and laboratories a self-assessment tool to evaluate their oversight of dual use research (WHO, 2010). Most recently, WHO, which has a key role in research and policy related to influenza, was an active participant in the international debate over gain-of-function research.
34 The proceedings of the first event have been published (OIE, 2015b) and information about the second may be found at http://www.oie.int/eng/BIOTHREAT2017/introduction.htm (accessed October 4, 2018).
Security Policy Coordination and Action Forums
Over the years, a number of bodies have been created to enable governments to discuss, formulate, and sometimes implement action in specific areas such as export controls. The focus is often on technical issues and is intended to support coordinated and consistent policy. The narrower membership sometimes makes the bodies subject to criticism and they do not normally include key stakeholders in their deliberations. But forums of this type may be most able to achieve “harmonization” across at least some policy areas.
- The Australia Group (AG). Created in 1985, the AG seeks to improve consultation on export controls among its “participants.” Its original focus on chemical weapons was expanded to biological weapons in the 1990s. Forty-two countries now participate in the AG—India joined in January 2018—and the European Union takes part as an institution. According to its website, “[T]hrough the harmonization 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 equipment and related technology and software, biological agents, and plant and animal pathogens” serve to promote common standards and regulations. The AG also provides a forum for discussion of dual use issues, including dissemination of information. For example, when the Netherlands chose to rely on export controls as the policy mechanism for its response to the experiments in a Dutch laboroary that provoked the gain-of-function controversy, the AG discussed the issues.
- European Biosecurity Regulators Forum (EBRF). Initiated in 2013 in the context of the EU CBRN Action Plan, the group began with a focus on “ways of securing biological substances with dualuse potential”36 and produced a guideline with best practices and examples of national implementation of biosecurity. In 2014, the group continued cooperation with an expanded focus toward awareness-raising activities of biosecurity and dual use issues. Since an inaugural meeting in 2015, representatives of national regulatory bodies of the seven current EBRF members (Denmark, France, Germany, the Netherlands, Sweden, Switzerland, and the United Kingdom) have continued to meet to discuss important biosecurity and dual use topics. In 2016, the EBRF produced a
working paper on securing “immaterial technology” as a particularly important dual use issue (EBRF, 2016).
- The International Experts Group of Biosafety and Biosecurity Regulators (IEGBBR). IEGBBR is an ad hoc group of representatives from national regulatory programs in biosafety and biosecurity. The group, which meets biennially to discuss issues in the regulation of biological pathogens, is not an official organ of the United Nations or any national government. The first meeting was held in Canada in February 2007 with participants including experts from Australia, Brazil, Canada, Denmark, France, Germany, Japan, the Netherlands, Singapore, Switzerland, the United Kingdom, and the United States. The IEGBBR cites fives major goals: “to act as the focus point for the development of an international network of advisors in matters related to the regulation of human pathogen biosafety and biosecurity; to benefit members through active discussion of current and emerging issues relating to human pathogen biosafety and biosecurity and to share best practices and lessons learned; to benefit members through discussion and sharing of related programs, expertise, and approaches; to encourage coordination among national regulators in order to ensure greater compatibility and interoperability of biosecurity and biosafety systems and processes; and to promote the development of effective biosafety and biosecurity regulation internationally including the building of capacity in fields such as inspections, risk assessment, safety measures, [and] oversight mechanisms” (Weyant, 2013).
Complex global issues increasingly cut across the interests and jurisdictions of traditional intergovernmental organizations. In response, rather than create new bodies to tackle the problems, less formal “networks of networks” provide a way to develop and coordinate initiatives. The Tripartite Collaboration established by WHO, OIE, and FAO to provide a coordinated approach to reducing the threat of increasing antimicrobial resistance is an example of the type of activity that could be developed to enhance oversight of dual use research.37 The Global Health Security Agenda (GHSA) 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).
Global Health Security Agenda (GHSA). Launched in early 2014, the GHSA is a partnership among intergovernmental organizations, individual countries, and nongovernmental stakeholders with a mission to “strengthen both the global capacity and nations’ capacity to prevent, detect, and respond to human and animal infectious diseases threats whether naturally occurring or accidentally or deliberately spread.”38 The GHSA now has more than 60 member countries, and the three original intergovernmental partners—WHO, OIE, and FAO—have now grown to include Interpol, the UN Office for Disaster Risk Reduction, and two regional bodies, the European Union and the Economic Community of West African States. One way that GHSA member states participate is through their commitment to specific Action Packages that support the three overarching themes of “Prevent, Detect, and Respond.” Each package includes 5-year targets and performance indicators. Of the 11 Action Packages, “Prevent 3: Biosafety and Biosecurity” is the only one that addresses issues relevant to the workshop, with the following 5-year target:
A whole-of-government national biosafety and biosecurity system is in place, ensuring that especially dangerous pathogens are identified, held, secured and monitored in a minimal number of facilities according to best practices; biological risk management training and educational outreach are conducted to promote a shared culture of responsibility, reduce dual use risks, mitigate biological proliferation and deliberate use threats, and ensure safe transfer of biological agents; and country-specific biosafety and biosecurity legislation, laboratory licensing, and pathogen control measures are in place as appropriate.39
- Global Partnership Against the Spread of Weapons and Materials of Mass Destruction (Global Partnership or GP). The GP is “an international initiative aimed at preventing the proliferation of chemical, biological, radiological and nuclear weapons and related materials.”40 It was launched at the summit of the then G8 countries in 2002, with a focus on preventing terrorists from acquiring weapons of mass destruction. Thirty countries and the European Union are
39 See GHSA, “Biosafety and Biosecurity Action Package.” Available at https://www.ghsagenda.org/packages/p3-biosafety-biosecurity (accessed October 4, 2018).
now active members and, among other activities, participate in GP Working Group meetings twice per year, including one devoted to biological threats. Of the five deliverables that form the Biological Threats Working Group strategy and underpin its collective programming, two are directly relevant to oversight of dual use research: “Reinforce and strengthen biological non-proliferation principles, practices and instruments” and especially “Reduce proliferation risks through the advancement and promotion of safe and responsible conduct in the biological sciences.”41
International Science Forums
The discussion earlier in this chapter of norms and codes of conduct as ethical foundations for governance of research with dual use potential introduced a number of international scientific organizations. In addition, there are additional venues where biosecurity governance issues could be addressed as part of efforts to engage the government officials who make science policy and fund research. Two other examples are provided below. To date, these organizations have not shown a systematic interest in dual use or security issues, so trying to engage them could be a significant new effort. The potential reward would be the addition of authoritative voices from the scientific community that are already deeply engaged in responsible conduct of science to the promotion of dual use governance.
- The oldest activity is the biennial World Science Forum (WSF), which began as a collaboration among the Hungarian Academy of Sciences, UNESCO, and the International Science Council in the late 1990s. In 2011, the decision was made to expand the WSF beyond its traditional home in Hungary, and now the biennial event alternates between Budapest and a venue outside Europe. The consensus statements produced at the end of each Forum provide an additional foundation for the social responsibility of science but do not address security issues. The theme of the 2019 WSF, to be held in Budapest, will be “The Ethics and Responsibility of Science.”
- The World Conferences on Research Integrity (WCRI) began in Lisbon in 2007. The organization aims to give “researchers, teachers, funding agencies, government officials, journal editors, senior administrators, and research students opportunities to share expe-
riences and to discuss and promote integrity in research.”42 The first five conferences were organized on an ad hoc basis but, as of 2017, the World Conferences have been established as a nonprofit organization with headquarters in the Netherlands. The sixth conference is to be held in Hong Kong in 2019 with the theme of “New Challenges for Research Integrity,” with a discussion planned about “the importance of embedding education on responsible conduct of research into institutions and evidence on how this can be delivered in the most effective way.”43 Three of the conferences have produced consensus statements (“Guidance”); the statement produced by the second conference in Singapore included “Societal Considerations: Researchers and research institutions should recognize that they have an ethical obligation to weigh societal benefits against risks inherent in their work” (Second World Conference on Research Integrity, 2010).
This chapter has provided an overview of the discussions that took place during the workshop’s breakout sessions. 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. The chapter also describes a number of international forums that provide the opportunity to develop—and in some cases implement—common understandings about specific approaches to governance, as well as norms of scientific responsibility that support effective implementation. The next chapter presents a review of the ideas and issues, arranged thematically, that emerged from the discussions.