Enhancing National Oversight of Dual Use Life Sciences Research

1. Enhancing National Oversight of Dual Use Life Sciences Research Allan Shipp, M.H.A.

2. The Issue: “Dual Use” Research • Dual use research includes life sciences research: • with legitimate scientific purpose • that may be misused to pose a biologic threat to public health and/or national security.

3. NRC Report on Dual Use Research Report of the National Research Council of the National Academies: “Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma” (October 2003)

4. NRC “Experiments of Concern” • Demonstrate how to render a vaccine ineffective • Confer resistance to therapeutically useful antimicrobials • Confer pathogenicity or enhance the virulence of a pathogen • Increase transmissibility of a pathogen • Alter the host range of a pathogen • Enable evasion of diagnostic/detection modalities • Enable weaponization of a biological agent or toxin

5. HHS Biosecurity Initiatives

6. National Science Advisory Board for Biosecurity (NSABB) • THE SECRETARY OF HEALTH AND HUMAN SERVICES • WASHINGTON. D.C. 20201 • CHARTER • NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY • PURPOSE • The purpose of the National Science Advisory Board for Biosecurity (NSABB) is to provide advice, guidance, and leadership regarding biosecurity oversight of dual-use research, defined as biological research with legitimate scientific purpose that may be misused to pose a biologic threat to public health and/or national security. The NSABB will advise the Secretary of the Department of Health and Human Services (HHS), the Director of the National Institutes of Health (NIH), and the heads of all federal departments and agencies that conduct or support life science research. The NSABB will advise on and recommend specific strategies for the efficient and effective oversight of federally conducted or supported dual-use biological research, taking into consideration both national security concerns and the needs of the research community.

7. NSABB Charge • Develop criteria for identifying dual use research • Develop guidelines for oversight of dual use research • Including risk-benefit analysis • Recommend code of conduct for life sciences workers • Advise on development of education and training in biosecurity issues for federally-funded institutions

8. NSABB Charge • Advise on national policies for conduct of dual use research • Strategies to address national security concerns while still fostering continued rapid progress in life sciences research • Advise on national policies for communication and dissemination of dual use research methodologies and results

9. NSABB Charge • Recommend national polices for local review and approval processes • Guidelines for case-by-case review and approval by IBCs • Advise on criteria/processes for referral of issues to NSABB • Review/provide guidance on certain specific experiments, interpret guidelines • Recommend strategies for coordinated international oversight of dual use research

10. NSABB Structure / Operations • 25 voting members appointed by Secretary, HHS, after consultation with other Federal Agencies • Meets quarterly and as needed • Meetings open to public, unless otherwise determined by the Secretary, HHS • Managed and administered by Office of Biotechnology Activities, NIH

11. Molecular/genomics Microbiology Clinical ID/diagnostics Lab biosafety/security Public Health/ Epidemiology Health physics Pharmaceutical production Veterinary medicine Plant health Food production Bioethics National security Intelligence Biodefense IBCs Export controls Law, law enforcement Scientific publishing Perspectives from academia, industry, public, RAC NSABB Expertise

12. Exec. Office of the President Department of Health and Human Services Department of Energy Department of Homeland Security Department of Veterans Affairs Department of Defense Environmental Protection Agency Department of Interior National Sciences Foundation Department of Justice Department of State Department of Commerce National Aeronautics and Space Administration Intelligence community United States Department of Agriculture NSABB ex officios

13. NIH Dual Use Research Program: Role of NIH OBA • Staff and manage the NSABB • Plan and execute meetings • Develop background materials for NSABB activities • Support/oversee development of NSABB work products • Coordinate and support NSABB ex officios • Maintain website as resource for public • Identify and analyze dual use research issues • Coordinate trans-government activities regarding dual use research • Implement, maintain, interpret federal guidelines for dual use research • Train, educate, and oversee IBCs involved in dual use research

14. Modus Operandi • Engage the research and IBC communities in the development of the guidelines, the code of conduct, and training programs • Recognize, and develop strategies to address, the significant challenges that will face: • Researchers • IBCs • Institution leadership and research administrators • Publishers

15. Inaugural NSABB MeetingJune 30 – July 1, 2005

16. Inaugural NSABB Meeting • Dual Use Criteria • Communication of Dual Use Research Results and Technologies • Codes of Conduct • International Collaboration • Synthetic Genomics

17. Criteria for Identifying Dual Use Research and Results • Define criteria for identifying dual use research and research results • Criteria will need to evolve as science progresses

18. Communication of DUR Results, Methods & Technologies • Identify principles that underpin the communication of dual use research findings and technologies • Identify practices and mechanisms for applying the principles and carrying out consistent decision making

19. Codes of Conduct for the Life Sciences • In consultation with the research community, develop codes of conduct to address dual use research. • May take the form of core tenants and principles that could be adopted by professional societies in the development of group specific codes of conduct.

20. International Collaboration • Recommend strategies for fostering international collaboration in the development of appropriate biosecurity policies • Gather information/develop outreach network • Promote exchange of information • Develop strategies for engaging international community

21. Synthetic Genomics • Evaluate the dual use biosecurity concerns involving advanced DNA synthesis technologies • Develop potential strategies working with the scientific community and genome services providers to facilitate the development of “best practices”

22. Institutions and Their IBCs: Significant Challenges Ahead • Expanded purview • rDNA research ≠ full range of “dual use” research • Historical precedent • Initial scope = rDNA • By mid-80’s, many institutions expanded scope of their IBCs of to encompass infectious agents, carcinogens, other biohazards • Expanded scope of duties • Biosafety risk assessment ≠ full range of issues to be considered in “dual use” research • Expanded range of expertise

23. IBCs and Biosecurity • At present: • Current requirements for IBC biosafety review and oversight still apply • Use of the IBC for biosecurity issues is an institutional decision • Future: • NSABB will advise on biosecurity role and recommend new requirements

25. NSABB Website http://www.biosecurityboard.gov