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

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the issue dual use research
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.
nrc report on dual use research
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)

nrc experiments of concern
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
national science advisory board for biosecurity nsabb
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.
nsabb charge
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
nsabb charge8
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
nsabb charge9
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
nsabb structure operations
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
nsabb expertise
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
nsabb ex officios
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
nih dual use research program role of nih oba
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
modus operandi
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
inaugural nsabb meeting
Inaugural NSABB Meeting
  • Dual Use Criteria
  • Communication of Dual Use Research Results and Technologies
  • Codes of Conduct
  • International Collaboration
  • Synthetic Genomics
criteria for identifying dual use research and results
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
communication of dur results methods technologies
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
codes of conduct for the life sciences
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.
international collaboration
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
synthetic genomics
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”
institutions and their ibcs significant challenges ahead
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
ibcs and biosecurity
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
nsabb website
NSABB Website

http://www.biosecurityboard.gov