During breakout sessions, in reports back from session rapporteurs, and in plenary discussions, participants raised a number of points about current approaches to the oversight for dual use life sciences research, gaps and challenges that remain, and suggestions for further actions that might continue to strengthen research oversight systems and promote greater common understanding internationally. These discussions are described thematically below.
The Importance of National and Institutional Spaces for Dual Use Discussions
Countries use varied approaches to address concerns about dual use of life sciences research. For example, a participant suggested that the U.S. Dual Use Research of Concern (DURC) policy described in Chapter 3 has resulted in researchers and research institutions paying more serious attention to the issue of dual use than they would have in the absence of such a policy, along with qualitative indications of increasing awareness among the scientific community. Similarly, it was noted that a national policy has increased awareness among the multiple U.S. agencies involved in life sciences research, since all are required to keep track of work with the 15 agents and 7 experiments captured by the policy.
Another participant noted that there is evidence that scientists and U.S. research-conducting institutions are using the list-based DURC policy as a starting point while going beyond the specific requirements, for example, to screen a wider portfolio of research for potential dual use. Because there is now an institutional focal point to serve as a resource, the participant noted that investigators can come voluntarily to discuss whether anticipated research would raise dual use concerns. These were all seen as positive developments. On the other hand, participants noted U.S. DURC policy is limited to certain pathogens and not all institutions work with such agents. This means not all universities or other research-performing institutions would have a relevant institutional review entity and implementation remains limited in scope.
Building on this discussion, many participants noted the value of national and institutional “homes” for discussions of dual use. At the national level, this may be a ministry, an advisory body or council focused on biosecurity, biosafety, or bioethics, or some other option. For example, France has a National Advisory Council for Biosecurity that is empowered to make recommendations for the funding, conduct, and dissemination of dual use research; Singapore has established a national Bioethics Advisory Committee;1 and Malaysia has developed a National Biosafety Board. A participant suggested that the online presence of such bodies can also act as a centralizing focus of activity and can help identify and circulate information on measures such as codes or oversight mechanisms at the national level. In addition, a national body such as a dual use research advisory committee could play a role in reviewing selected proposals and providing advice to relevant government agencies on risk assessment and risk mitigation plans. Such a role could be akin to the U.S. Recombinant DNA Advisory Committee, which is asked to review certain protocols and provide recommendations to the National Institutes of Health (NIH) “related to basic and clinical research involving recombinant or synthetic nucleic acid molecules.”2 Many workshop participants similarly saw having a home for dual use life sciences discussions within research institutions as a significant component of the oversight system. Models are
1 Background materials are available at Bioethics Advisory Committee Singapore. Available at http://www.bioethics-singapore.org/index/publications/reports/172-research-involving-human-subjects-guidelines-for-irbs.html (accessed September 4, 2018).
2 See NIH, “Recombinant DNA Advisory Committee.” Available at https://osp.od.nih.gov/biotechnology/recombinant-dna-advisory-committee (accessed September 4, 2018). At the time of publication, NIH had undertaken a process of formal public consultation about a proposal “to streamline oversight for human gene transfer clinical research protocols (i.e., gene therapy research) and reduce duplicative reporting requirements already captured within the existing regulatory framework” (https://osp.od.nih.gov/biotechnology/nih-guidelines; accessed October 2, 2018).
likely to vary but this responsibility currently appears to be carried out primarily through some type of institutional review committee.
The Importance of Context
It was widely acknowledged among participants that the context in which governance measures are applied is important, with differences in systems of government, culture, language, resources, and priorities requiring consideration in the development of governance measures. In many cases, they saw an important role for both government actions and self-governance activities by the scientific community. The balance between these approaches and how it is achieved is likely to vary. As an example, various participants pointed out that some countries take a more top-down legislative approach to addressing dual use issues, while others take a more bottom-up approach led by scientists. Certain countries view biosecurity and biosafety as components to be tackled together or feel that biosecurity can only be successfully addressed in the context of a strong, existing foundation in biosafety, while others see these as separate issues to be tackled discretely. There was, as such, no “one-size-fits-all” approach to dual use governance of life sciences research and specific measures need to be adapted to suit the context.
Common Elements of the Layered Governance System
Despite variety in the details of how governance of dual use life sciences may be implemented in diverse contexts, some participants suggested components of research oversight systems that might provide useful common elements (see Table 4-1). These components are not intended to be comprehensive or to serve as consensus recommendations; rather, they provide inputs for further stakeholder discussions. The details of how such components would be designed and function in particular countries or research communities will vary with context, but building common understandings about these elements can further strengthen dual use governance.
Throughout the workshop discussions, it became clear that a considerable number of governance activities have been undertaken over the past decade or so. Efforts to develop and promote codes of conduct, education, and awareness, for example, have resulted in concrete initiatives around the globe, including in China, Germany, India, Indonesia, Japan, Malaysia, Morocco, the Netherlands, Pakistan, Switzerland, the United
|General||Having a “home” where discussions on governance of dual use research can occur, both nationally (such as a biosafety or biosecurity advisory body) and institutionally (such as through a review committee).
Proactive outreach by government regulators to researchers to inform them of their obligations and provide a mechanism for consultation as needed.
Efforts that promulgate awareness raising, norms of responsible conduct, and training on risk management for life sciences researchers.
Engagement with the private sector, which remains a relative gap among the activities discussed during the workshop.
|Research Conception and Funding||Processes for considering the potential dual use risks and benefits associated with research proposals, coupled with the development of risk management plans.|
|Conduct of Research||Oversight systems at research-conducting institutions, including oversight processes for research projects beyond a set of specified agents and experiments (e.g., options for addressing governance of experiments that do not fall within the particular limits of “DURC” as defined by U.S. policy).
Development and adoption of practices to prevent misuse of research materials and resources. For example, encouraging ongoing advances in nucleic acid screening and the universalization of screening best practices from organizations such as the International Gene Synthesis Consortium (IGSC).
Establishment of relevant norms and guidelines of practice by life sciences research communities (for example, analogous to the widely respected guidelines for stem cell research developed by the International Society for Stem Cell Research).
|Dissemination and Publication||Practices, frameworks, or capacity-building resources to enable prepublication archives, journal editors, and publishers to review submissions for dual use concerns. Legislative and regulatory measues to manage dissemination.|
Kingdom, and the United States, among other countries. Chapter 3 and the background materials in Appendix E provide a number of examples of activities that have been undertaken. The list is not comprehensive; it reflects what workshop organizers gathered in advance of the meeting and additions shared by workshop participants.
Several participants argued that, in the short term, it would be useful
to conduct further inventory mapping exercises to determine still more systematically who is doing what in a wider range of countries. Such a process could aid in the development of a library or repository of tools and materials that have been used in national, regional, and international dual use governance initiatives. Such an inventory might further inform interested stakeholders of the tools available as they articulate their requirements.
Participants commented on the continuing difficulties posed by confusion or disagreement over terminology. Translation of terms across languages is a major challenge. Perhaps the most familiar issue is that the term “biosecurity” either does not exist or is the same word as “biosafety” in a number of languages, including Chinese, French, German, Russian, and Spanish (NRC, 2011b: 20). Moreover, biosecurity does not always include dual use issues; the term “laboratory biosecurity” is used to describe measures focused on the physical security of agents and toxins, personnel reliability, and access to facilities (OECD, 2007; WHO, 2004). In response, some prefer the term “biorisk management” to encompass both biosafety and biosecurity, which may include dual use, but it has not yet achieved widespread use. And as mentioned in Chapter 1, “dual use” also has a traditional meaning in disarmament and arms control to describe “goods, software and technology that can be used for both civilian and military applications”3 rather than the workshop’s definition as research that, while intended for beneficial purposes, could also be misused to cause deliberate harm. Many participants thought that fostering shared definitions of what is encompassed by key terms will continue to be important in creating the common understanding necessary for effective dual use governance.
Building Common Understandings and Frameworks
In the longer term, the process of mapping governance activities and progress could facilitate sharing of information, lessons learned, and best practices. It could allow stakeholders to build common global understandings and to create templates for governance strategies, policy options, training, and awareness raising that interested parties could adapt, taking into account the local context. As several participants noted,
3 See European Commission, “Dual-use trade controls.” Available at http://ec.europa.eu/trade/import-and-export-rules/export-from-eu/dual-use-controls (accessed October 2, 2018).
such an effort would require someone to take the initiative, with some participants suggesting that a working group might be established to undertake this task.
One concrete proposal from some participants was the development of a document articulating principles for the governance of dual use research in the life sciences. Such a project would collect and collate the considerable body of work already produced by international, regional, and national scientific organizations. This material could include statements on the responsibility of scientists, materials elaborating ethical principles related to dual use, and other biosecurity-related resources. Illustrative examples such as the InterAcademy Partnership (IAP) Statement on Biosecurity and the document on Scientific Freedom and Scientific Responsibility developed jointly by the German Research Foundation and the German Academy of Sciences Leopoldina were described in Chapter 3. The document could be disseminated as a means of fostering continued dialogue and the building of common understandings.
Several participants also suggested that, while a principles document was being drafted, there could be a parallel process of developing evidence-based strategies for the uptake and implementation of governance measures. While examples of relevant governance principles are already available, they need to be operationalized to enable them to be put into practice, and these participants suggested that this aspect is likely to be a challenge. They also pointed out that implementation of dual use governance principles will require encouraging wider networks and actors to take ownership of the principles and adapt such materials to their local needs and contexts.
Contributions of Social and Behavioral Sciences
The workshop planning committee gave particular attention to the potential contributions that insights from the social and behavioral sciences could make to the design, implementation, and assessment of governance measures. The talks by Ruthanne Huising and Baruch Fischhoff described in Chapter 2 illustrate the contributions of several interdisciplinary fields, including decision science and organization studies. Other examples emerged during the breakout sessions. Table 4-2 provides a list of some of the challenges for governance identified during the workshop and the areas of social and behavioral sciences that participants cited as particularly relevant to addressing them. In addition, the field of Science and Technology Studies (STS) provides a range of analytic approaches that cut across the governance challenges listed in the table.
|Governance Challenge||Relevant Research Fields|
|Identifying and assessing risk||Decision Science|
|Fostering scientist engagement in security||Science of Science Communication|
|Promoting and sustaining a “culture of responsibility” in science||Organization Studies|
|Designing appropriate governance measures and strategies||Anticipatory Governance|
|Cross-cutting||Science and Technology Studies|
A number of workshop participants argued that longer-term progress will require aligning and organizing multiple opportunities and checkpoints for dual use governance that operate along a continuum of scientific activity beginning at the preaward stage.
Some participants argued that there is a foundational role for awareness among scientists of the potential for their research to raise dual use concerns. In addition, participants cited the governance examples discussed in the workshop as evidence of the important roles played by institutional review and oversight processes, as well as the contribution of further development and application of technical control and mitigation mechanisms. For example, as Kanabrocki’s presentation and other examples illustrated, there is scope for bodies at research-conducting institutions to review proposed research for dual use concerns. Some participants suggested a number of options that could be considered when concerns are identified. Binding recommendations for changes to research protocols, biosafety levels at which research is conducted, or other modifications to the conduct and dissemination of the research could be made as a condition of obtaining institutional approval. Funders may require documentation of institutional approvals addressing other aspects of research oversight (reviews for appropriate protection of human subjects, use of animals, use of recombinant DNA, etc.) prior to issuing an award or at least prior to such research commencing and one could envision similar institutional approvals for dual use research.
In addition to the changes in how research is conducted as described above, participants suggested that other types of technical measures could be considered at the conceptual or planning stage, as well as during the conduct of research. These measures include incorporating mechanisms aimed at improving biological control and mitigating concerns over misuse into the research. As noted by Charo, the Defense Advanced Research Projects Agency is investigating biological control mechanisms through its Safe Genes program. One example raised could be a strategy in which a gene drive is only active in the presence of a secondary substance, a mechanism intended to provide additional ability to regulate when gene editing does and does not occur.
Participants also discussed how funding agencies, private foundations, and other funders can play valuable roles in dual use governance, particularly through requiring researchers to include an assessessment of dual use potential as part of the funding application process. As noted in Chapter 3, there are already examples of funding bodies, such as NIH in the United States and the joint initiative of the Wellcome Trust and the two government research councils for life sciences in the United Kingdom, that obligate applicants to consider dual use potential. Implementation of review measures for potential dual use at the proposal stage is intended to bring awareness and assessment of anticipated risks and benefits early in the research life cycle. On the other hand, participants noted that widespread adoption of dual use review by the funding community will require further discussions on the types or categories of experiments that should be assessed (e.g., a broad request or more narrowly focused set of pathogens and experiments), how to evaluate researcher responses, and methods to scale up checking funding applications for completion of the assessment requirement. Still others cautioned that the requirement to address dual use potential in research proposals could become a box-checking exercise and expressed concern that responsibility for completing these boxes would be delegated from the principal investigator to administrative or research assistants. Successes, challenges, and lessons may be drawn from the experiences of the funders who currently require dual use assessment and further discussions among the funding community on this topic may be useful.
Conduct of Research
Institutional Review Committees4
As noted above, a number of participants highlighted the important role of institutional review bodies that assess potential dual use concerns posed by life sciences research and are capable of stipulating and enforcing requirements for the appropriate conduct of research. One participant suggested that the Robert Koch Institute in Germany (see Chapter 3) can serve as a model for how a research institution can implement oversight of dual use research. Having a system that includes a code of conduct, risk assessment criteria, multiple evaluation points over the course of research, and identified institutional procedures for documentation and reporting could prove particularly useful in circumstances where unexpected results emerge in the conduct of research. Israel offers an example of a similar approach. In Israel, the Regulations of Research into Biological Disease Agents Act (2008) requires institutional biosafety and biosecurity committees comprised of scientists, security experts, and safety personnel to supervise certain types of research. Other participants noted that biodefense research laboratories use other approaches that could serve as models. These or other existing models for institutional oversight could be shared on a larger scale or adapted by other research-conducting institutions to suit their requirements.
Similarly, a participant suggested that the practice of peer review could serve as a potentially useful tool to inform practices around institutional review committees. Countries such as Germany, for example, had initiated peer-review exercises that could be adapted to analyze the practices employed by organizations to review experiments of concern. Convening such discussions among stakeholders from research-conducting institutions in a nonjudgmental manner could further facilitate the sharing of lessons learned and effective practices.
DNA Synthesis Screening
A number of research projects make use of nucleic acid sequences as part their activities. The growing capacity to reconstruct a pathogen from pieces of nucleic acid raises dual use concerns. The screening by commercial providers of DNA synthesis orders is thus one of the tools used to support dual use governance. Some participants cited the work
4 Different national systems, policies, or organizations may call such bodies by different names. These proceedings generally refer to such bodies as institutional review committees or institutional review bodies, intending to encompass whatever the relevant body would be called.
of the International Gene Synthesis Consortium (IGSC; see Chapter 3) as an example of a successful dual use governance initiative. However, other participants noted that the processes used for DNA synthesis screening and their effectiveness may become a more complex problem in the future as the industry becomes more decentralized and diversified. Moreover, synthesis screening is not universal, with potential gaps and inconsistencies across jurisdictions. Not all commercial providers are members of an organization that has adopted screening guidelines, such as IGSC, and existing screening guidelines would not necessarily capture sequences synthesized “in house” by a laboratory. As such, several participants cited synthesis screening as an important area to continue to discuss and develop as the industry and academic research environments evolve.
Dissemination of Results
Publication Reviews and Their Limits
Several participants raised the issue of prepublication editorial reviews as a tool of dual use governance. Publicly available information shows the number of articles flagged by editorial reviews as posing dual use issues is tiny. Some participants expressed concern that, despite leading scientific editors producing a statement committing to review publications for security sensitive content, such reviews are not sufficiently thorough. Moreover, these flagged articles have eventually been published, sometimes after revisions or accompanying commentaries, such as the articles at the center of the gain-of-function controversy.5 Given this, some workshop participants questioned how effective the process of reviewing publications for dual use content had actually been.
Participants raised several challenges to intervening at the publication stage. One is that the number of publications continues to grow. And while some journals employ professional editors, others rely on volunteer and academic editors who may not have the expertise or time to carry out thorough or consistent screening. Initial screening for potential dual use may be able to be accomplished by screening for key words, but this approach may not be sufficient. As a result, the capacity, resources, and knowledge to implement dual use oversight of articles submitted for publication varies. A second challenge is the pressure on researchers to publish their results, which makes the process of intervening at the point of publication significantly harder.
A third challenge raised during discussion is that the point of pub-
lication is too late, and dissemination needs to be managed throughout the research life cycle. As a participant pointed out, the gain-of-function controversy was triggered, in part, by a conference presentation by one of the authors prior to publication. Other participants cited the growing use of prepublication servers such as bioRxiv that enable materials to be uploaded and made publicly available prior to copy editing and peer review. One participant estimated that the Public Library of Science (PLOS) journals receive around 1,000 papers each week with at least 20 percent of these prepublished online before being formally peer reviewed. Workshop participants did not know whether these papers received any screening for dual use. Several participants stressed the need to continue to engage publishers of scientific research, and particularly to include prepublication services, in conversations about dual use oversight as part of addressing the changing nature of publication in the life sciences. Other participants suggested that it might be useful to encourage scientists undertaking dual use research not to engage in prepublication.
The workshop discussions suggested that the research translation phase could be explored further for the governance of dual use life sciences research. A number of workshop participants identified tools that could be applied in this regard. Some participants highlighted the potential role of intellectual property (IP) as a tool of dual use governance and noted that this is a key point at which private-sector organizations make their research visible, for example, through patent filings. Several participants suggested the need to engage the private sector more systematically in dual use conversations. Moreover, as Alta Charo had noted in her presentation, IP can also act as a significant source of governance through placing conditions on patent licenses and material transfer agreements to control uses and third-party dissemination. Such governance strategies and tools could be an area for further exploration.
Several participants argued that conventional export control approaches were necessary but imperfect for contemporary governance of life sciences research. Established export control regimes, such as the Australia Group, which includes 42 countries and the European Union, have achieved a number of successes. However, the Group plays a limited role for in-country transfers. Furthermore, some countries that are emerging leaders in biotechnology research or are leading technology suppliers in emerging areas such as 3D printing are not members. In addition, a
participant suggested that determining which materials and technologies should be on export control lists is a particular challenge in the life sciences. The difficulty of separating materials and equipment for legitimate beneficial research from ones that could be misused, especially as the life sciences research enterprise is becoming increasingly global, diverse, and decentralized, was recognized at a number of points during the workshop. Such challenges can frustrate scientists, especially in countries that face difficulties and delays in getting access to these items.
Governing the transfer of intangible assets such as knowledge, data, and IP remains particularly difficult as noted by Bowett (see Chapter 2). Some participants also expressed concerns that the multiple regimes covering export controls, material transfer agreements, intellectual property, and resource sharing (such as the Nagoya Protocol on Access and Benefit Sharing of the Convention on Biological Diversity) can have the net effect of making it more difficult to transfer materials and equipment in crisis situations. The Ebola outbreak in West Africa was discussed as a specific example of how the multiple competing imperatives of different regimes made it difficult to transfer samples out of the affected countries. Some participants argued it would be preferable if the use of controls such as export regimes did not stand alone but instead were incorporated as part of a layered governance system.
The themes of engagement, awareness raising, outreach, and education arose frequently during the workshop. The number of activities undertaken in the areas of engagement and awareness raising has continued to increase. However, many participants indicated that more inclusive engagement will be required to reach a broader range of relevant actors and stimulate governance activities across the research life cycle.
In the short term, it was suggested that participants could take advantage of immediate opportunities such as engaging with professional biosafety societies, disciplinary societies, or international organizations. Circulating the Zagreb meeting proceedings could be useful for reaching out to scientists, organizations, and countries not represented at the workshop or that have not yet undertaken activities related to dual use governance. In the medium term, further engagement could be pursued through follow-on regional or cross-regional conferences or be focused on particular dual use governance topics, such as publishing or funding. In the longer term, a number of participants highlighted the need to build networks of networks and further engage with the private sector, individuals within the scientific community, and the wider public.
Several participants recognized the significant role played by champions from within the scientific community in advancing dual use governance. Further work could be undertaken to engage a wider range of scientists with a view to raising awareness and identifying and supporting champions that could take the lead in dual use governance. As noted above, many scientists are under pressure to publish and generate project funding, and discussions on dual use governance may not be an immediate area of interest. Accordingly, it might be more fruitful to engage on the science first as a means of building bridges between communities.
In this context, one approach raised was the idea of regional science and technology dialogues. Such meetings of regional and international experts from the public and private sectors would focus primarily on the role of science and technology in addressing regional challenges. However, a secondary component of such dialogues would involve discussion around aspects of dual use governance. The process could provide leverage for engaging with a wider community of actors who could subsequently relay their experiences to others in their respective organizations. The series of regional workshops on the implications of science and technology for the Biological and Toxin Weapons Convention (BWC) convened with support from the European Union might provide an example.6
Engaging the Private Sector
Several participants mentioned the role of the private sector in determining norms of practice and highlighted the need for better engagement with this community—including those funding and insuring life sciences research. Suggestions to enhance private-sector engagement in dual use governance included incentives and levers that would be effective, such as framing biosecurity as a business case to industry. Reputational risk was one possible lever identified by participants, who suggested that gene synthesis companies and related organizations had established the IGSC to screen synthetic gene orders for regulated pathogen sequences, in part, because of concerns over reputational risks.7
Industry association meetings were also suggested as a useful
6 Further information is available at UNOG, “Project 2: Interaction with non-governmental stakeholders on science and technology.” Available at https://www.unog.ch/80256EE600585943/(httpPages)/F5CE37B03894C50EC125809E0057420F?OpenDocument (accessed September 5, 2018).
intervention point for discussing dual use governance and moving private-sector engagement forward. Another proposed approach was organizing meetings between public- and private-sector actors to analyze dual use case studies to identify where effective interventions could have been made. Participants also suggested that industry meetings could help in understanding the likely impacts of prospective interventions among a range of life sciences stakeholder communities before money was spent on their implementation.
Engaging Additional Communities: Dialogues with Do-It-Yourself (DIY) Biology and the Public
Although the workshop was focused on life sciences research in settings such as universities, several participants raised the need to engage with members of community laboratories and DIY biology. The Open Philanthropy Project was cited for its support of more projects on biosafety and biosecurity practices targeted to such groups, such as the work being done by iGEM. Similarly, several participants emphasized the need for sustained dialogue and engagement between the life sciences and general public in order to ensure that issues of dual use were not subject to misinformation, manipulation, or alarmism. In some cases, journalists could be briefed prior to publication to ensure a more nuanced understanding around potentially alarming research. Some participants also suggested that a process of public dialogue on dual use and biosecurity could benefit from lessons learned about public engagement from other fields.
Networks of Networks
A wide range of international and regional organizations and networks could play roles in addressing issues related to dual use governance. Several participants noted that the convening capacity of international meetings had proven useful in bringing networks together to move issues forward. One example was the 2005 discussions on codes of conduct under the BWC described in Chapter 3, which resulted in several national and international scientific organizations developing and disseminating an actual code or a set of principles to underlie one. Some participants suggested that the BWC and other international organizations might aid in broadening engagement on dual use governance by bringing together networks of stakeholders. They identified a number of relevant networks for furthering dual use governance of the life sciences, including the European Biosecurity Regulators Forum and the International Expert
Group of Biosafety and Biosecurity Regulators for government officials, and the IAP and international unions for the scientific community.
The topic of education received considerable attention over the course of the meeting. During the breakout sessions, a number of concrete initiatives on dual use education from around the globe over the past decade were discussed, including activities in Argentina, Australia, Canada, China, Egypt, Germany, Malaysia, Morocco, Pakistan, Switzerland, and Ukraine, among others (Australia et al., 2011; NRC, 2011b; see also Chapter 3 and Appendix E).
Participants with experience in developing and undertaking education efforts emphasized that how education is conducted is important to its effectiveness. These participants found particular success using active learning methods and team-based learning exercises. However, they also identified continuing challenges, including the need for sustained effort, the need to assess the effectiveness and impact of activities, the lack of staff trained to teach this aspect of responsible science, and the lack of time lecturers and teachers had to dedicate to understanding this topic.8 To help overcome these challenges, this group of participants identified a need to foster academic networks for promoting education and training on biosecurity and dual use; younger scientists were also noted as key in the delivery of education in a sustainable manner. Building such capacity will also require mechanisms to duly credit and reward faculty for attention to dual use governance in the life sciences, they noted.
Should Education Be Mandatory?
Several participants argued that education was more effective when it was mandated and/or supported by the government. On this basis, some argued for comprehensive, mandatory biosecurity education throughout the career cycle of life scientists. However, others argued that earlier enthusiasm for extensive, mandatory education about dual use issues for life scientists had diminished. This was, in part, because although a general awareness of the potential for misuse should be part of the social responsibility of life scientists, some argued that only those involved in
high-containment laboratory work required an in-depth knowledge of dual use risks. Moreover, academic curricula are already crowded and it seemed more practical to fit dual use modules into existing courses. Participants commented that scientists already receive information on issues such as animal care and use, environmental protection, and sexual harassment, among others, without always resorting to comprehensive, mandatory measures. As such, it might be possible to integrate discussions of dual use governance into a unified education process that addresses responsibilities of scientists and encourages thinking beyond work on the bench.
Participants’ experiences with educational materials suggested they were most effective when using concrete real-life examples that resonated with the local context. Some participants identified limited access to context-relevant materials, including active learning materials, as a barrier to further work on education. This could be achieved through the development of databases and one-stop centers for information and online teaching materials, such as the International Network on Biotechnology being developed by the UN Interregional Crime and Justice Research Institute. They also stressed the need to improve the accessibility of relevant educational materials through translation into at least the six official UN languages and whenever possible into local languages as well.
Codes of Ethics and Conduct
The topic of codes of ethics, conduct, and practice was frequently linked with the discussions of education. Codes of various types have been one of the most commonly undertaken dual use governance activities. A number of participants saw codes as important complements to education and an area in which there had been some progress since 2005. Multiple examples of codes were identified, including those of China, Cuba, Germany, Indonesia, Japan, Malaysia, the Netherlands, Pakistan, Switzerland, and the United States. In addition, some industry groups and DIY groups have codes as well. Some participants argued that codes worked well for the medical profession, where students were encouraged to consider the relevance and application of the Hippocratic Oath throughout their studies and beyond. However, others pointed to the lack of empirical data on whether codes work, with one participant suggesting that, to be effective, codes needed to be translated into measurable action in the workplace, adding that there is little point trying to implement codes of conduct without an organizational culture that views such codes
as important. Other participants laid emphasis on the value of the process of formulating such codes in a way that was culturally sensitive; the process of discussing what should be included in a code can be viewed as an educational exercise. Yet, others stressed the importance of making individuals aware of existing codes.
Developing Evidence-Based Policies
A number of participants noted the need to develop evidence-based policies and strategic approaches to biosecurity. Multiple countries, universities, and nongovernmental organizations have now undertaken governance efforts; although the landscape can seem like a patchwork of activities, these efforts provide a base that can be built on to draw lessons, disseminate information on successful models, and improve coordination. Developing and building in assessment and gap analysis mechanisms to support evidence-based reporting would be useful, recognizing that one would be assessing the contributions of specific measures to mid-level goals since it would generally not be possible to “prove” that any initiative directly prevented the misuse of life sciences research. Although the importance of an evidence-based approach to governance was noted, a number of participants emphasized that it is unrealistic to expect a perfect, comprehensive policy system from the beginning. Rather, these participants suggested it was valuable to start somewhere, usually by implementing targeted policies and partial solutions that national governments and research communities could accept while enabling oversight mechanisms to evolve. Engaging the affected communities in the development of policies and recognizing the complementary roles of self-governance were also considered essential parts of the growth of effective governance.
Participants suggested such an approach is particularly important in order to seed ideas and awareness as science and technology continue to progress, contributing to a system that could be proactive in identifying potential security concerns that may arise from new developments. The Neuroenhancement, Responsible Research, and Innovation project described in Chapter 2 is an example of such an anticipatory approach, in this case to emerging concerns related to neuroscience. Similarly, the promulgation of norms and principles that set what is acceptable behavior and what it means to be a responsible scientist with regard to biosecurity help form a foundation as new research emerges and existing systems may need to adapt.
Assessment and Evaluation
Several participants noted that there is little empirical evidence of what works and what does not with regard to the implementation of dual use governance measures, including the foundational aspects of education, codes, norm formation, and fostering a culture of scientific responsibility around dual use. Furthermore, what works well in one context may not work as effectively in another. Some metrics for assessing the immediate, short-term impacts of education and training have been developed. However, these metrics would need to be further developed, tested, and refined within the context of broader evaluation methodologies for systematically monitoring progress and assessing results. A number of participants highlighted this as an area requiring further work.
The sustainability of governance activities and initiatives was widely seen as essential to longer-term success. A participant provided an example of one project that built substantial networks over the course of the project lifetime, only to see them fade away once the project concluded. Participants therefore stressed the need to build in mechanisms for the sustainability of networks and project activities, including funding for the transition, as part of planning the initiatives.
The workshop convened scientific and policy experts who brought perspectives from many types of governance activities and from multiple countries. The format was designed to consider these perspectives in the context of individual participants’ experience and expertise rather than to formulate specific conclusions and recommendations. From this process several broad points consistently emerged. Governance of life sciences research that raises dual use concerns is likely to require a complex and layered system that occurs at multiple stages across the research process. There are thus roles for a range of stakeholders, who may be best positioned to conduct different types of activities. Such stakeholder communities can include government policy makers, research-conducting institutions, practicing researchers from academia and industry, biosafety officers, laboratory risk management professionals, journal publishers, specialists in education and outreach, and many others. Creating effective systems for dual use life sciences governance is not a simple task, and it is important to take the national context of priorities, concerns, incentive systems, and government, research, and educational structures into account when developing the specific practices that will work well.
However, it was also seen as particularly valuable to share models and information, to build networks, and to continue to move toward common understandings. To this end, having places for ongoing discussions at the national, regional, and international levels continues to be important, as is moving toward governance and research oversight systems that can be proactive, rather than reactive, in anticipating potential security concerns. Finally, a number of concrete suggestions for next steps to support the governance of dual use life sciences research arose during the workshop. Table 4-3 provides examples of these ideas.
|Category||Ideas and Next Steps Suggested at the Workshop|
|Provide Venues to Further Dual Use Discussions||Encourage existing multilateral forums on emerging science and technology to incorporate and discuss the issue of dual use life sciences research.
Consider convening a regular event, workshop, or interest group to discuss issues in the governance of dual use life sciences research.
|Build Shared Understandings of Key Governance Components||Foster shared definitions of what is encompassed by dual use life sciences research as well as understanding across languages (where there can be differences in terminology, for example).
While the details will vary with context, foster common understandings of essential elements that could be included in national systems for governance and oversight of dual use life sciences research (such as those identified in Table 4-1).
|Produce Materials and Provide Resources||Compile and analyze principles for governance of research from existing sources. From these, develop a set of principles for the governance of dual use life sciences research.
Assemble systematic descriptions of national dual use oversight systems to foster analysis and comparative discussions.
Circulate a discussion paper among networks to orient diverse communities to the topic of dual use life sciences research and to continue to foster development of common understandings and approaches.
Assemble teaching resources and case examples. Create an informational video with key messages.
|Category||Ideas and Next Steps Suggested at the Workshop|
|Establish a Clearinghouse or Information Hub||Provide a virtual space that can function as a one-stop shop to share materials and information and to connect stakeholders.|
|Build Networks||Identify and foster champions who can promote awareness of dual use among their national scientific communities and government agencies. Such champions might serve as points of contact in each country.|
|Incorporate Dual Use Guidance into the Programs of Work of Other Organizations||A number of organizations and networks that do not have a primary focus on biosecurity may still be relevant to addressing aspects of this broad issue. Include information or guidance on dual use life sciences research where appropriate, for example, in reports and guidelines produced by the World Health Organization, the World Organisation for Animal Health, the Food and Agriculture Organization of the United Nations, the UN Education, Scientific and Cultural Organization, scientific professional societies, and other organizations.|
|Improve Policy Options and Implementation||Incorporate social sciences expertise into the process of developing and implementing life sciences governance policies.
View research oversight as a “Design-Build-Test-Learn” cycle (an approach common in engineering fields) and discuss implementation, lessons learned, and how to adjust the system on a more regular basis.
Convene those involved in publication and dissemination of scientific research to address dual use practices in an era of prepublication.
Further discuss the changing technical landscape of the life sciences and how dual use oversight systems can prepare (including advances in sequencing and synthesis technologies, use of biofoundries, the role of DIY biology, potential advances in technical mitigation controls, and others).