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Introduction

WORKSHOP GOALS

Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, in Zagreb, Croatia. Hosted by the Croatian Academy of Sciences and Arts, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies).¹ The workshop was organized by an international committee under the auspices of the National Academies. The opening remarks from the host organizations provided the context for the workshop.

Continuing rapid developments in the life sciences offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances also bring with them new social, ethical, legal, and security challenges. Governance questions form an increasingly important part of the discussions about these advances—whether the particular issue under debate is the development of ethical

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¹ Information about the collaborating organizations may be found in Appendix D. The workshop agenda may be found in Appendix A, the list of participants in Appendix B, and the biographies of the members of the planning committee in Appendix C.

principles for human genome editing, how to establish regulatory systems for the safe conduct of field trials of gene drive-modified organisms, or many others. The international community, including the workshop participants and their organizations, is similarly engaged in discussions about the implications of new scientific developments and the implementation of strategies to achieve effective oversight. This workshop reflects continuing concerns that the knowledge, tools, and techniques resulting from life sciences research could also enable the development of bioweapons or facilitate bioterrorism. Certain life sciences research is thus “dual use;” that is, although intended to serve beneficial purposes, it could also be misused to cause harm.² The workshop did not address the broader set of social, ethical, and legal implications associated with international governance of life sciences research, although experiences in other domains may be relevant to approaches to governance in response to biosecurity concerns.

The workshop focused on the critical challenge of how to create and support effective systems of governance for life sciences research that may raise dual use concerns. A number of countries in different parts of the world have developed oversight policies that apply to specific experiments, often those that seek to make particular types of changes to certain pathogens. Research funding bodies, both public and private, are considering and incorporating dual use assessments into their funding reviews. Journal publishers have released statements on biosecurity and scientific publishing and created policies to include biosecurity issues in manuscript reviews and respond if concerns emerge. Members of the scientific and policy communities have been conducting outreach to raise awareness of biosecurity concerns and scientific responsibilities. The Biological and Toxin Weapons Convention (BWC), a key part of the foundation of the wider regime, and other venues provide opportunities where the security implications of life sciences advances are considered. This landscape provides a set of diverse efforts and activities on which to draw.

An important goal for this workshop was to contribute to ongoing

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² Traditionally, “dual use” has been used in disarmament and arms control to denote “goods, software and technology that can be used for both civilian and military applications” (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). The different concept was introduced by a 2004 National Research Council report, Biotechnology Research in the Age of Terrorism, which called the potential for such unintended consequences “the dual use dilemma” (NRC, 2004: 1; known as the Fink report for the committee’s chair, Gerald Fink). This latter use is the focus of this proceedings, recognizing that there can be confusion because, as discussed in the text, laws and regulations designed to address traditional dual use issues are now frequently used to address oversight of research with dual use potential.

global dialogue and the building of common understandings of the essential elements of governance for life sciences research that raises biosecurity and dual use concerns. Fostering such global discussion and coordination will ultimately be necessary to achieving a strong and effective governance system.

Sue Meek, Chair of the Planning Committee, built on the opening remarks to outline the specific goals of the workshop. The workshop had been designed to bring together people actively involved in developing or implementing governance of dual use research to

• Share experiences and better understand the recent and current landscape of dual use governance activities;
• Discuss what has worked and not worked, analyze lessons learned, and explore gaps and opportunities; and
• Identify concrete actions and next steps to fill gaps and take advantage of opportunities.

She also provided further background, noting that while “dual use” research comprises “research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that could be misused to cause deliberate harm,” many efforts toward dual use governance are focused on pathogen research (U.S. Government, 2012: 5). For example, the U.S. governance system focuses on Dual Use Research of Concern (DURC), a subset of dual use that covers only certain types of experiments with specified biological agents and toxins.

Meek emphasized that, for the purpose of the workshop, discussion should encompass the wider definition and not be limited to the narrower scope of U.S. DURC policy. She also encouraged participants to think broadly about how to create strong, flexible, and anticipatory systems of governance for dual use life sciences research. Additionally, she suggested that there were new developments, such as the genome editing technology CRISPR,³ that represent a step-level change in the capacity and availability of technology that may require existing governance systems to be adapted and amended.

To set the stage for the next portion of the workshop, Meek provided an introduction to the topic of governance, indicating that, while some see this as fundamentally about legislation and regulation, there are other

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³ Clustered regularly interspaced short palindromic repeats (CRISPR) “refers to short, repeated segments of DNA originally discovered in bacteria. These segments provided the foundation for the development of a system that combines short RNA sequences paired with Cas9 (CRISPR associated protein 9, an RNA-directed nuclease), or with similar nucleases, and can readily be programmed to edit specific segments of DNA” (NASEM, 2017a: 2).

ways of achieving this objective. As the plenary speakers would discuss, dual use governance cuts across multiple organizations and involves multiple actors, each of whom may make valuable contributions. Governance can thus be developed through additional means, such as networks and codes of conduct.

She suggested that effective implementation required going beyond “box-checking” exercises, where there may be inadequate consideration of the context or meaning of the boxes, adding that the effectiveness of governance frameworks depends on a number of different factors. These include

• principles for dual use governance that are well written, encompassing, and understood by those affected;
• established norms of responsible conduct of research, something that requires engaging with scientists and encouraging them to consider such issues proactively, ideally before starting research projects;
• cultural change, and she suggested that there is no point in introducing codes of conduct if the organizational culture does not view compliance with such codes as important; and
• outreach, education, and training efforts to make sure that people are aware of codes and other governance measures.

Meek commented that this last element required an understanding of suitable methods and approaches to encourage engagement. In conclusion, she argued that regulation was not necessarily always the answer and that no one system was going to fit all circumstances, as different regulatory systems and cultures demand different solutions. She suggested that a network of networks could be a valuable concept to increase awareness and to share knowledge.

ORGANIZATION OF THE PROCEEDINGS

The planning committee designed the workshop to encourage participation and frank discussion, with a mix of plenary and breakout discussion sessions and participants from diverse countries reflecting a range of expertise. The plenary sessions devoted to particular topics and issues are summarized in Chapter 2, while examples of the landscape of current governance activities are presented in Chapter 3. The results of the workshop discussions are presented thematically in Chapter 4. The workshop proceedings, prepared by rapporteurs and produced by the U.S. National Academies, summarizes the remarks of speakers and views expressed by individual workshop participants. In her opening remarks

Meek encouraged the participants to engage actively and noted that their contributions would form the basis of the eventual content of the workshop proceedings.

This proceedings was prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. The planning committee’s role was limited to organizing and convening the workshop. This workshop and proceedings address a major and complex set of issues in governance of life sciences research. The workshop could not give full consideration to all issues, arguments, and references relevant to this topic; the views contained in the proceedings are those of individual workshop participants and do not necessarily represent the views of all workshop participants, the planning committee, or the U.S. National Academies.

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