The Dual Use Research Issue and the National Science Advisory Board for Biosecurity

1. The Dual Use Research Issue and the National Science Advisory Board for Biosecurity Paul I. Lewis, Ph.D. Executive Director, NSABB

2. The “Dual Use” Dilemma • Life sciences research underpins: • Biomedical and public health advances • Improvements in agriculture • Safety and quality of food supply • Environmental quality • Strong national security and economy • However,good science can be put to bad uses

3. The Concept of“Dual Use” Research • Report of the National Research Council of the National Academies (2004) • “…the same technologies can be used legitimately for human betterment and misused for bioterrorism.”

4. US Government Response • Agreement that new biosecurity measures warranted • USG launched a series of biosecurity initiatives, including establishment of National Science Advisory Board for Biosecurity (NSABB)

5. NSABB: A USG-wide Initiative • Reports directly to the HHS Secretary • Staffed by NIH OBA • Advises 15 departments and agencies with a role/interest in life sciences research • Charged to make recommendations on strategies for mitigating the potential for misuse of dual use biological research • Consider both national security concerns and the needs of the research community

6. NSABB Reports

7. Proposed Oversight Framework Report: Key Elements • Introduction • Guiding principles for oversight • Key features of proposed oversight system • Roles and responsibilities • Major steps in local oversight • Criterion and considerations for identifying dual use research of concern

8. Key Elements (continued) • Evaluation of research for dual use potential • Review of potential dual use research of concern: risk assessment, management • Responsible communication of dual use research • Considerations for code of conduct • Outreach and education • Appendices (Tools for oversight of dual use research)

9. Guiding Principles for Oversight of Dual Use Life Sciences Research • Life sciences research, and the free and open communication of its results is essential to continued strong public health and other aspects of national security • Oversight is appropriate because of the potential for misuse of information • Effective oversight will help maintain public trust • Oversight must balance need for security with need for continued research progress • Foundation is investigator awareness, peer review, local institutional responsibility • Responsible conduct and communication of dual use research of concern depends upon the individual

10. Guiding Principles, cont. • Life sciences research is dynamic by nature and not always predictable, therefore need to periodically evaluate research for dual use potential • Effective oversight requires: • Harmonized governmental approach • Broad awareness of DUR issues • Ongoing dialogue • Responsible communication of DURC essential to public confidence in scientific community • Need to periodically evaluate oversight system • Effectiveness • Impact on research enterprise

11. Key Features of Proposed Oversight System • Federal guidelines • Awareness • Ongoing, mandatory education • Local evaluation and review of research for dual use potential • Risk assessment and risk management • Periodic evaluation • Compliance

12. DUR vs. DURC • Development of new technologies and generation of information with potential for benevolent and malevolent purposes = dual use research (DUR) • But most life sciences research has some potential for misuse – most could be considered DUR • Goal is to identify the subset that has highest potential for generating information that could be misused = DUR of concern (DURC)

13. Criterion for Identifying DURC • Research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to: • Public health • Agriculture • Plants • Animals • Environment • Materiel Elements of national security

14. Considerations for Identifying DURC The NSABB described several categories of research that may be more likely to meet the criteria for DURC. Knowledge, products or technologies that enable the following should be assessed especially carefully: • Enhance harmful consequences of a biological agent or toxin • Disrupt immunity or effectiveness of an immunization without clinical/agricultural justification • Confer to a biological agent/toxin resistance to clinically/agriculturally useful prophylactic or therapeutic interventions against that agent or toxin, or facilitate their ability to evade detection methodologies

15. Considerations for Identifying DURC • Increase the stability, transmissibility, or the ability to disseminate a biological agent/toxin • Alter the host range or tropism of a biological agent/toxin • Enhance the susceptibility of a host population • Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent

16. Roles and Responsibilities: Researchers • Most critical element in oversight system • Be aware of DUR issues and assess work for DURC potential on ongoing basis • Consider implications of their work • Understand local and federal policies for DUR oversight • Ensure training of self and research staff • Communicate DURC in a responsible manner • Annually attest to assessing their work for DURC potential

17. Roles and Responsibilities: Institutions • General responsibilities for oversight: • Ensure research conducted per applicable policies • Mechanism for expert committee review (risk assessment/management) of research identified by PI as DURC • Internal policies/practices should minimize negative impact of conduct of life sciences research • Periodically evaluate for effectiveness and impact on research • Assist PIs in complying with DUR policies • Educate employees on DUR issues, policies

18. Roles and Responsibilities: Federal Government • Develop and implement oversight policy that is efficient and effective • Harmonization of: • Oversight policy • Implementation of policy • Interpretation of policy • Evaluate oversight policy for effectiveness and impact on research enterprise • Education and outreach

19. Roles and Responsibilities: NSABB • Continue to carry out functions specified in charter • Periodically evaluate DUR oversight system • Effectiveness • Impact on research enterprise • Serve as resource to research community, including scientific publishing community, on DUR issues

20. NSABB’s Recommended Oversight Framework for DURC Major Steps in Local Oversight of DURC PI Responsibilities Education Training Guidance Work conducted in accordance with risk management strategies Dual use research of concern identified • Institutional Review • Risk Assessment • Risk Management Initial Evaluation for Dual Use Potential by PI Responsible Communication of Research No dual use potential identified Periodic Reassessment of Dual Use Potential, Especially at Times of Communication Institutional Responsibilities

21. Evaluation of Life Sciences Research for Dual Use Potential • PI should conduct the initial evaluation of research for DURC potential • An independent assessment or consultation with other scientist(s) can be helpful • May be differences of opinion among experts • NSABB recommends a formal, annual attestation by researchers that they have been evaluating their work for DURC potential

22. Research that is Potentially DURC: Risk Assessment and Risk Management • Institutional review should address: • Potential for, and ways in which, information could be misused to threaten aspects of national security • Likelihood of misuse • Potential impacts of misuse • Strategies for mitigating the risks of misuse • NSABB tool: Points to Consider in Risk Assessment and Management of Research that is Potentially DURC

23. Foundation of Oversight Framework for DURC is Awareness • Culture of Awareness and Responsibility • Codes of conduct can foster dialogue and mindfulness regarding responsible behavior • Outreach and education is essential

24. Outreach and Education • Recommendations for: • Outreach during federal policy making process • Communication during rollout of federal policy • Ongoing educational and awareness-building strategies • Outreach and education should have a broad reach • Not just college and graduate level, but also high school and junior high school • International audiences • Commercial research environment

25. “It cannot be overemphasized that characterization of research as dual use research of concern should not be viewed pejoratively. Such a characterization does not automatically mean that this type of research should not be conducted or communicated, rather that the conduct and communication of that research should be carefully considered from the outset and throughout the research process. The oversight process is about the responsible conduct and communication of research, not the restriction of research.” -NSABB Proposed Framework for the Oversight of Dual Use Life Sciences Research

26. Culture of Awareness and Responsibility Throughout the Research Life Cycle Discuss work: Seminars Posters abstracts Conceptualize project Funding review Conduct research Peer review Publish or post online

27. NSABB Tool: Considerations in Developing a Code of Conduct for Dual Use Research in the Life Sciences • Three sections: • General considerations • Characterization of the dual use issue • Description of codes and their purpose • Possible uses of this guidance • Core responsibilities of life scientists with regard to dual use research of concern • Articulation of the most basic ethical responsibilities of life scientists • Specific responsibilities in the research process • Model standards of responsible research conduct applicable from the conceptualization of research through publication

28. Foundation of Oversight Framework for DURC is Awareness • Culture of Awareness and Responsibility • Codes of conduct can foster dialogue and mindfulness regarding responsible behavior • Outreach and education is essential

29. Outreach and Education on DURC Charge: Provide guidance on the development of programs for outreach, education, and training on dual use research issues for scientists and laboratory workers • NSABB developed a strategic plan for outreach and education efforts including: • Key considerations for target audiences, message points, and vehicles for disseminating information • Outreach strategies • Opinion leaders • At large constituencies • Key message points about the dual use research issue

30. International Engagement Charge: promote international dialogue on dual use issues • International Roundtables on Dual Use Life Sciences Research • February 2007 • October 2007 • November 2008 • Regional Webinars/Videocast • September 22, 2010 • Future webinars planned • Engaged over 40 countries and over 70 international organizations as well as private industry, philanthropies and NGOs

31. Synthetic Genomics DNA synthesis technology is rapidly advancing. Can be used to make organisms de novo, without needing access to natural sources of organisms or their nucleic acids. + Open availability of DNA sequence data of pathogens = Concerns that this technology and information could be misused to make dangerous pathogens to threaten public health

32. Synthetic Genomics Charge: Examine the potential biosecurity concerns raised by the synthesis of select agents, and synthetic biology in general, and recommend strategies for addressing these concerns • NSABB recommended: • Development and dissemination of harmonized guidance to investigators and nucleic acid providers • Development of standards & practices for sequence providers to include nucleic acid screening • A review of current biosafety guidelines to ensure that they are adequate for synthetically derived DNA • Continued consultation with experts to develop a predictive framework for determining pathogenicity

33. Synthetic Biology Charge: To identify, assess and recommend strategies to address any biosecurity or dual use research concerns that may arise from work being performed in the nascent field of synthetic biology • NSABB recommended: • Synthetic biology should be subject to institutional review/oversight since some aspects of this field pose biosecurity and biosafety risks • Oversight of dual use research should extend beyond the boundaries of life sciences and academia • Outreach and education strategies should be developed to engage the diverse research communities • The USG should include advances in synthetic biology in “tech-watch” endeavors

34. Personnel Reliability Charge: Recommend strategies for enhancing personnel reliability among individuals with access to biological select agents and toxins • NSABB recommended: • A formal, national PRP is unnecessary at this time • Strengthening the current Security Risk Assessment • Enhancing the culture of responsibility and accountability • Professional societies should engage in dialogue with their communities regarding biosecurity, DURC, and PR • Shortening or stratifying the list of select agents

35. New NSABB Tasks • Recommend specific strategies and guidance for enhancing the culture of responsibility among individuals with access to biological select agents and toxins (BSATs) • Develop specific guidance on how best to implement practices such as self- and peer-reporting, including how to “de-stigmatize” such reporting • Delineate the good hiring practices that will help to optimize personnel reliability • Recommend ways for local institutional leadership to communicate that security and personnel reliability is valued and a priority

36. New NSABB Tasks • Recommend outreach strategies for non-traditional synthetic biology communities • Provide recommendations on the development of programs for outreach, education, and training in dual use research issues for “non-traditional” scientists who may not be affiliated with universities or institutions

37. New NSABB Tasks • Engage journal editors on lessons learned and future directions regarding review of dual use research of concern • Engage science journal editors and publishers on policies for review of potentially sensitive material and specifically, on review for and of DURC. • Solicit input on whether journal editors have utilized the NSABB guidance and on ways the existing NSABB guidance might be improved. • Continue raising awareness within the scientific editorial and publishing community about dual use research of concern • Encourage the adoption of policies and procedures for authors, manuscript reviewers, and editors to follow on identifying and managing DURC.

38. New NSABB Tasks • Develop strategies for promoting codes of conduct to professional societies and other relevant professional groups • Develop strategies to promote the development of codes of conduct for life sciences research with dual use potential • Engage scientific societies, research institutions, and other relevant professional organizations to identify strategies for refining and promoting the wider adoption of codes of conduct, both domestically and internationally

39. New NSABB Tasks • Continue international engagement on dual use biological research issues • Continue raising awareness of the dual use issue internationally • Facilitate communications among countries regarding approaches to the oversight of dual use research, lessons learned, and challenges to addressing the issue. 

40. New NSABB Tasks • Develop strategies for enhancing interdisciplinary biosecurity • Advise on the Federal Select Agent Program, as requested 

41. Summary • A robust life sciences enterprise is critical to promoting human, plant and animal health and well-being • Important to acknowledge the potential that the information or technology that results might be misused • Researchers are the most critical element of a dual use research oversight system • Institutions should develop a mechanism for assessing and managing the risks from research identified by PIs as DURC • Overall goal should be to promote and facilitate the responsible conduct of life sciences research

42. Dual Use Research Educational Material

43. Dual Use Research Educational Material

44. www.biosecurityboard.gov

45. Contact Information Email:paul.lewis@nih.gov Phone: (301) 451-3950