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Feb 20, 2013 (4 years and 5 months ago)

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Enhancing Biosecurity

in the Life Sciences


National Science Advisory Board for
Biosecurity

The “Dual Use” Issue


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



National Academies

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)

Definitions


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)

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)


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


NSABB Expertise


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


NSABB: A USG
-
wide Initiative


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

NSABB
ex officios


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

Questions for the NSABB


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”





Concerns


Need for more
effective
oversight of dual
use research



Laws and
regulations may
be necessary


Scientific




Public


Community


Evidence of
problem?



Red tape and
restraints on
research and
communication
slow progress



Restricting
communication
-
-

starting down a
slippery slope to
censorship?


NSABB Considered

These Concerns


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


Draft Oversight
Framework
:

Main Elements


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





Identifying Dual Use Research of
Concern: Key Concepts



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

Considerations for Identifying
Dual Use Research of Concern


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




Principles of Communication


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
>

gene
-
length 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.


Available on the NSABB website:
www.biosecurityboard.gov

D
ECEMBER

2006

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 Response to NSABB Reports


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

Dual
-
Use Education Case
Studies


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

First 8 Modules


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

Overall PRELIMINARY results
show


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

Awareness

Communication

Cooperation

Coordination

Collaboration

Agreement

http://www.biosecurityboard.gov