Summary

The potential misuse of advances in life sciences research are raising concerns about national security threats. The current report examines the U.S. strategy for reducing biosecurity risks in life sciences research and considers mechanisms that would allow researchers to manage the dissemination of the results of research while mitigating the potential for harm to national security.

There is a growing tension between a scientific culture based on transparency and the need for secrecy to protect national security. While “most scientists would argue that the openness that characterizes much of the scientific research enterprise is the source of the extraordinary gains in scientific knowledge that have enriched us materially and intellectually,”¹ the ideal of a scientific culture based on principles of openness and transparency faces continuing challenges. One challenge relates to a concern that adversaries might take advantage of advances in science and technology for malicious purposes. This is particularly challenging in the biological sciences given recent dramatic advances, especially in the genetic engineering of pathogenic or potentially pathogenic micro-organisms, and fears that these advances could be exploited by non-state actors or terrorists. There is a recognition among some leaders in the scientific community of an informal social contract wherein “scientists as individuals and the international scientific community have a shared responsibility, together with other members of society, to do their utmost to assure that scientific discoveries are used solely to promote the common good.”² This premise is not, however, accepted by all scientific practitioners.

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¹ National Research Council, Biotechnology Research in an Age of Terrorism (Washington, DC: The National Academies Press, 2004), doi:https://doi.org/10.17226/10827, pp. 99-100.

² International Council for Science (ICSU), Freedom, Responsibility, and Universality of Science (Paris: International Council for Science, 2014), p. 5. Available at http://www.icsu.org/publications/cfrs/freedom-responsibility-and-universality-of-science-booklet-2014/CFRS-brochure-2014.pdf.

In today’s world of rapidly advancing science, where tools and technologies are more widely available than ever before and where the dissemination of scientific findings occurs through multiple channels and at multiple levels, developing policies for managing the dissemination of knowledge, tools, and techniques produced by scientific research has become ever more difficult.

In view of ongoing concerns about the communication of biological research results that might present significant risks and in the wake of incidents (such as the 2001 anthrax mailings)³ in which naturally occurring biological materials were used for nefarious purposes, the United States has given significant attention to policies and practices that can enhance biosecurity.

CHARGE TO THE COMMITTEE

Our committee was charged with reviewing policies associated with dual use research of concern (DURC).⁴ Its objective was to review possible mechanisms for managing dissemination of research findings that strike an appropriate balance between the value of openness in scientific research and the needs of national security. As such, this encompasses the roles and responsibilities of students, researchers, institutions, and the federal government in the conduct of research. While one might think of dissemination in terms of publication, the committee, with encouragement from the project’s sponsors, considered the management of dissemination as occurring along a spectrum from idea generation to the formal publication of research results in journals.⁵

The committee gathered information both at a public information gathering meeting on July 11-12, 2016, and at a public workshop on January 4, 2017. To assist in its deliberations, the committee commissioned papers on a range of topics including biosafety and biosecurity, international approaches to biosecurity, ethics, export controls, and current government policies on information control (these papers are available at https://www.nap.edu/catalog/24761 under the Resources tab). Authors were asked explicitly to consider the impli-

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³ Two sources of information about biosecurity incidents since 1900 are W. S. Carus, Bioterrorism and Biocrimes: The Illicit Use of Biological Agents Since 1900 (Washington, DC: Center for Counterproliferation Research, National Defense University, 2001) and K. Berger et al., “Biosecurity Risk Assessment of Acts Targeting a Laboratory” in Gryphon Scientific, Risk and Benefit Analysis of Gain of Function Research: Final Report–April 2016 (Takoma Park: Gryphon Scientific, 2016). Available at http://www.gryphonscientific.com/wp-content/uploads/2016/04/Risk-and-Benefit-Analysis-of-Gain-of-Function-Research-Final-Report.pdf.

⁴ As discussed further herein, “Dual use research of concern” is a term of art that refers to research that involves a particular set of agents and toxins and type of experiment.

⁵ Points along the spectrum include, for example, the point where research is funded, the period when research is being conducted, the transmission of information about research through informal communications among researchers, presentations at meetings and conferences, training and teaching, and the circulation of draft manuscripts and pre-prints or other self-published papers through traditional or electronic means.

cations of restrictions on the dissemination of scientific information, and it was expected that contrasting viewpoints would be expressed during the course of interaction between the committee, the audience, and session moderators. The authors of the commissioned papers presented their work at the January workshop and participated in a discussion with the committee and attendees.

The committee hopes that the current report and its findings will provide policymakers with information for further deliberation.

COMMITTEE FINDINGS

The committee considered expert presentations given before it, the content of commissioned papers and related external materials, and public discussions and engaged in private deliberations. It offers the following list of findings on the state of managing dissemination of DURC. It hopes that these findings provide a baseline for the development of principles that will, in turn, lay the framework for government policy for managing the dissemination of information about the conduct and results of DURC research by federal agencies, the research community, and the international scientific community. In alignment with its charge, the committee is not offering recommendations.

CONTEXT: CHANGES IN RESEARCH AND COMMUNICATION TOOLS

A confluence of factors—including advancing technologies and technical capabilities, globalization, rapid sharing of information, the changing nature of scientific publication, and the capacity and intent of some to cause harm—has led to concerns about the dissemination of scientific information that could be directly exploited for nefarious purposes.

Scientific information is disseminated through a wide range of means including education, training, presentations and posters at conferences, pre-print servers, informal communications, patents, and formal publication. The prevalence of digital information and online transmission and storage of information related to dual use research also makes information increasingly vulnerable to hacking. Much of current policy, however, tends to focus on formal publication.

There are some oversight mechanisms in place to make decisions about the publication of information that might pose risks to biosecurity. To date, the number of instances where detailed review has occurred and the frequency with which information has been restricted (by voluntary redaction, use of export controls, etc.) is small.

Findings

1. In general, the United States has a solid record with regard to the safe conduct of biological research. Given the lack of a comprehensive reporting system, knowledge of the nature and full extent of biosafety and biosecurity incidents is incomplete. Nevertheless, the number of documented, publicly known incidents of serious biosafety errors or lapses of biosecurity at laboratories has been small.⁶
2. In the wake of concerns that biological materials could be used for nefarious purposes and the significant risks that communication of the results of some biological research might convey, the United States has given significant attention to policies and practices that can enhance biosecurity.
3. Even with regard to research that could be directly applied to bioterrorism, there are concerns about excessive restrictions on the free flow of information. Open dissemination of research findings, a fundamental principle of research practice, can serve to alert relevant communities to a risk, provide the foundation for the development of countermeasures, and establish the foundation for scientific advances that could have significant public health benefits.

U.S. GOVERNMENT POLICY

Many policies potentially apply to the dissemination of DURC. U.S. DURC policies provide structures for managing the dissemination of information about certain pathogens and types of experiments that raise biosecurity concern, but they apply only to research that is conducted at institutions receiving federal funding. Non-compliance presents the potential risk of the withdrawal of federal funding, but it is not clear whether other sanctions would, in fact, be imposed.

Findings

4. The dissemination of life sciences information that may raise biosafety and biosecurity concerns is governed by fragmented policies and regulations.
5. Federal policies on DURC reach only a portion of the individuals conducting life sciences research. Those conducting research at institutions that do not receive federal funds (whether in private industry, in the “Do-It-Yourself” community, in other nations, etc.) are not bound

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⁶ The committee is not suggesting that errors and lapses are inconsequential, as it recognizes that a single lapse could have significant policy and public health consequences.

6. by these policies, but other regulations, such as export control laws, could apply.

7. Research that might be considered as DURC can, in principle, be identified before it is carried out or during the course of work when an unusual finding is encountered. Policies for identification of DURC in early phases, with consequent actions (a decision not to fund the research, withdrawal of funding, classification, mitigation plans, etc.), are in place for some types of research. Intervention at an early stage is more appropriate and likely to be more effective than at the time of publication.
8. The current policy focus and definition of DURC do not capture biosecurity concerns in all relevant areas of life sciences research, especially those that are emerging (e.g., synthetic and systems biology, computational modeling, genome editing, gene drives, neuroscience, the isolation of new micro-organisms and toxins). On the other hand, the current system of DURC policies and regulations may constrain certain types of research [e.g., research with select agents and toxins, research with pathogens of pandemic potential (PPPs)] more than is necessary to serve legitimate biosecurity goals.
9. When the government does not fund the research in question, the First Amendment imposes strong limits on the government’s ability to restrict the communication of research results, including research that could be used for bioterrorism. When the government funds the research in question, the First Amendment gives it more leeway to restrict the communication of research results, but even in that context, the government’s authority may be constrained.
10. Currently, no international organization is giving systematic attention to developing policy or guidance regarding the dissemination of scientific information of concern. Potential mechanisms and institutions [e.g., the World Health Organization (WHO), the Biological Weapons Convention (BWC), the Australia Group (AG), the United Nations (UN), etc.] exist that could fulfill this function. There has been a recent decline in policy activity at the international level despite the fact that there are ongoing concerns and discussions about specific technologies (e.g., CRISPR-Cas9).
11. Export controls do not limit communications among U.S. citizens within the United States. Export controls thus have a limited reach and do not offer a mechanism, in and of themselves, to control the dissemination of information.

MECHANISMS AND PROCESSES

A key issue identified during the committee’s public meetings and private discussions was how to provide researchers—and particularly journal editors—with guidance about potentially problematic research findings or manuscripts. DURC policies provide mechanisms to guide those carrying out federally funded research or working at institutions that receive federal funds, including requirements to develop, in appropriate cases, risk mitigation plans. Other researchers and journal editors do not have ready access to such guidance. In light of the increasing number of journals in many parts of the world and the utilization of pre-print servers and other means of online publication prior to (or in lieu of) traditional peer review, the situation is significantly more complicated. The following findings relate to U.S. researchers and their international collaborators.

Findings

11. There is no systematic process through which journal editors and researchers outside federally funded institutions can seek guidance from U.S. government experts on the management of manuscripts or on research activities that raise potential biosecurity concerns.
12. There is no shared, consistent policy among U.S. and international journals for addressing DURC.
13. There are limited mechanisms [e.g., the National Science Advisory Board for Biosecurity (NSABB),⁷ Federal Bureau of Investigation Weapons of Mass Destruction Directorate coordinators] for ongoing engagement between the scientific community and the national security and intelligence communities on biosecurity issues.
14. As a federal advisory body, the NSABB does not have the legal authority to restrict the dissemination of information. The NSABB may provide advice regarding the publication of information only under narrowly defined circumstances. Moreover, knowledge and use of the NSABB throughout the research community is limited.
15. In contrast to the Recombinant DNA Advisory Committee process, the oversight of DURC does not include mechanisms for assessing and sharing of best practices in the management of biosecurity among research institutions or opportunities for high-level review and consultation.
16. In principle, the NSABB could provide a mechanism to fulfill many of the functions described above, but its current mandate is limited.

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⁷ Information about the National Science Advisory Board for Biosecurity (NSABB) may be found at http://osp.od.nih.gov/office-biotechnology-activities/biosecurity/nsabb. The work of the NSABB is discussed further herein.

EDUCATION AND TRAINING

Reaching consensus on the management of DURC is complicated by the fact that experts have fundamentally divergent views about the nature of the biosecurity threat.⁸ Any effort to place controls on information for biosecurity purposes involves a careful consideration of the nature of the research, the risks of malevolent uses of the research results, the benefits for scientific advance or the development of countermeasures through open communication, and evaluation of means to reap the benefits while limiting the risks. Effective assessment relies on an appropriate knowledge of risk and policy options among the international community of researchers, funders, and publishers.

Findings

17. Despite the attention given to periodic controversies over DURC, the available evidence suggests that most life scientists have little awareness of issues related to biosecurity. Those training to become life scientists are rarely introduced to the topic in a systematic way. Education and training programs at the undergraduate, graduate, and post-doctorate levels generally do not include courses or discussions about dual use research or DURC, unless the student or trainee is involved in research with a select agent. Even in this case, biosafety is the primary focus. This situation hampers efforts to implement policies to address potential biosecurity risks, particularly in emerging research fields that may pose concerns.
18. The management of the dissemination of scientific information requires local, national, and international approaches to provide awareness-raising, education and training, and ongoing guidance and opportunities to share best practices and develop common approaches.
19. There are some extensive and effective programs at research institutions that deal with specific pathogens that ensure that researchers are trained in biosafety, but they are not systematically in place across U.S. research institutions. In a number of cases, the scope of these programs includes biosecurity and enables these particular communities to develop sophisticated views about these issues. Expanding these programs beyond a focus solely on specific pathogens could increase the ability of the broader research community to take greater responsibility for safeguarding dangerous information in ways that do not impede scientific advances.

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⁸ See, e.g., C. Boddie et al., “Assessing the Bioweapons Threat,” Science, August 21, 2015, Vol. 349, No. 6250, pp. 792-793.

20. Lessons learned from experiences with efforts to manage the dissemination of research information are not being adequately assessed or shared so as to promote more effective practice.
21. Many investments have been made by major donors to assist foreign countries with enhancements to their biosafety capacity. Investments have also been made in some aspects of biosecurity (e.g., physical security, access controls, pathogen accounting, etc.). Far fewer resources have been devoted to awareness-raising, education and training, and policy development related to the conduct of research and the dissemination of scientific information that could be employed for bioterrorism.

CONCLUSION

Despite decades of effort, there is little national or international consensus with regard to appropriate policies for addressing issues associated with the conduct and dissemination of life sciences research that might qualify as DURC. The absence of an international commitment to addressing such issues; the lack of agreement regarding a framework for assessing risk, uncertainty, and benefit; and the difficulties the U.S. government has faced in developing policies that effectively manage DURC illustrate the challenges of resolving the issues concerning information dissemination raised by DURC.