 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

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

 Dual Use Research
– Biological research with legitimate scientific purpose that may be misused to pose a biologic threat to public health and/or national security
(NSABB Revised Charter)
 Dual Use Research of Concern
– 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 and safety, agricultural crops and other plants, animals, the environment, or materiel
(Oversight Framework Document)

 Agreement that new biosecurity measures warranted
 USG launched a series of biosecurity initiatives, including establishment of National Science
Advisory Board for Biosecurity (NSABB)
– NSABB to recommend strategies for the efficient and effective oversight of federally funded dual use life sciences research
 Consider both national security concerns and needs of the life sciences research community

 Molecular/genomics
 Microbiology
 Clin. ID/diagnostics
 Lab biosafety/security
 PH/epidemiology
 Health physics
 Pharm. 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

 Advisory to heads of all Federal entities that conduct/support life sciences research
 Supported by 15 USG agencies with a role/interest in life sciences research
 Appoint ex officio member(s)
 Consider recommendations of NSABB when developing and implementing life sciences research programs and policies

 Exec. Office of the President
 Department of Health and
Human Services
 Department of Energy
 Department of Homeland
Security
 Department of Veteran’s Affairs
 Department of Defense
 Environmental Protection
Agency
 United States Department of
Agriculture
 Department of Interior
 National Sciences
Foundation
 Department of Justice
 Department of State
 Department of Commerce
 National Aeronautics and
Space Administration
 Intelligence community

 How do we recognize dual use research?
 How should research be reviewed? By whom?
When?
 How do we raise awareness of dual use research and foster strategies to minimize its misuse?
 Should dual use research of concern be communicated? If so, how can this be done responsibly?
 How can we promote international engagement on these issues?
 “Other duties as assigned”

Scientific
Community
 Evidence of problem?
 Red tape and restraints on research and communication slow progress
 Restricting communication -
- starting down a slippery slope to censorship?
Public
 Need for more effective oversight of dual use research
 Laws and regulations may be necessary

 NSABB Deliberations
– What is the problem?
– How big is it?
 NSABB Conclusions
– Threat of misuse exists and consequences could be severe
– Response to threat of misuse of research findings must be carefully measured

Continued rapid progress of life sciences is paramount

 Guiding principles
 Roles and responsibilities
 Criterion for identifying dual use research of concern
 Risk assessment and management
 Responsible communication of dual use research
 Considerations for code of conduct

 Most life sciences research could be considered dual use research
– Need to identify that subset with highest potential for misuse to threaten public health and safety (dual use research of concern)
 Evaluation should be based on current understanding of ways information could be directly misused
 Scope of potential threat is important
– e.g., broad potential consequences for public health rather than for individuals

Criterion for Identifying Dual Use
Research of Concern
 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

 Anticipated to be a very small subset of life sciences research
 Characterization of research as dual use of concern should not be viewed pejoratively
 Applying the criterion is subjective and can be challenging
 To assist in application of the criterion, NSABB identified categories and examples of information, products, or technologies that, if produced by research, might make that research considered dual use of concern

 Communication is vital for scientific progress and occurs throughout the research process
 Communicate research to the fullest extent possible
• Restriction of scientific communication should be a rare exception
 Important to consider whether the disclosure of certain information might pose a significant threat to national security
 Consider a range of communication options
—
The decision to communicate information is not necessarily binary

Considerations in Developing a
Code of Conduct
 Provides a key resource document outlining core principles
 Intended to foster development of codes of conduct on dual use research by scientific associations and institutions

Core Responsibilities
 At any stage of life sciences research, individuals are ethically obligated to avoid or minimize the risks and harm that could result from malevolent use of research outcomes.
 Towards that end, scientists should:
—
—
—
—
—
Assess their own research efforts for dual use potential and report as appropriate;
Seek to stay informed of literature, guidance, and requirements related to dual use research;
Train others to identify dual use research of concern and manage it appropriately and communicate it responsibly;
Serve as role models of responsible behavior, especially when involved in research that meets the criteria for dual use research of concern; and
Be alert to potential misuse of research.

Available on the NSABB website: www.biosecurityboard.gov
Status: Submitted to HHS OS

Biosecurity Concerns and
Synthetic Genomics

State of the Science and Technology
•
Increasingly feasible to synthesize > genelength DNA constructs
• Reagents and machines readily available
• Methods, technology, sequences in public domain
• Gene/genome synthesis is a globalized and largely privatized industry
– Currently no accepted “best practices” in record keeping, sequence tracking, etc.

D ECEMBER 2006
Available on the NSABB website: www.biosecurityboard.gov

Selected Findings and
Recommendations
 Increase awareness among investigators and service providers about their responsibility to know what they possess, manufacture and/or transfer
 Need for additional guidance and tools for screening orders and interpreting results
 Foster international dialogue and collaboration
Develop and implement universal standards and preferred practices for screening sequences
 Need to ensure that biosafety guidelines address synthetic nucleic acids
 18 USC 175c (aka “Variola Amendment”) is highly problematic

• USG has thoroughly reviewed the recommendations of the NSABB regarding
Synthetic Genomics and is engaged in an inter-agency process to implement most of the recommendations
• USG is in the process of carefully considering the NSABB’s proposed
Oversight Framework

Federation of American Scientists www.fas.org
•
Computer-based modules to extend lessons beyond the classroom.
•
Multimedia presentations that will teach graduate students and advanced undergraduates awareness of dual use research.
•
Use real case scenarios to illustrate the ethical dilemmas and the potential misuse of research.
•
Spark discussion of the responsibility of scientists to limit risks.

Federation of American Scientists www.fas.org
• 1. Introduction
• 2. Polio from scratch: Eckard Wimmer
• 3. Inhalation drugs: David Edwards
• 4. Mousepox virulence: Ron Jackson
• 5. Antibiotic Resistance: Stuart Levy
• 6: RNAi: Greg Hannon
• 7: 1918 Influenza: Chris Basler
• 8. Public Concerns: ??????

Federation of American Scientists www.fas.org
• Fear of power and unhealthy paranoia.
• They respect scientific credentials over authority.
• Misunderstanding of what LE would contact them for.
• Worried about being monitored.
• Worried about having their research interfered with.
• However, 62% agreed to be contacted by FAS again.

A Continuum of Strategies for
International Engagement
Agreement
Collaboration
Coordination
Cooperation
Communication
Awareness