dual use research of concern
TRANSCRIPT
DUAL USE RESEARCH
OF CONCERN
Environment, Health & Safety
University of North Carolina @ Chapel Hill
Overview – The Fink Report
2003 - The National Research Council’s “Committee on Research
Standards & Practices to Prevent the Destructive Application of
Biotechnology” published a report entitled “Biotechnology
Research in An Age of Terrorism: Confronting The Dual Use
Dilemma”. (Fink Report)
The Committee recommended the creation of the National Science
Advisory Board for Biosecurity (NSABB) to educate scientists &
advise the government on the oversight of “dual use” research.
National Science Advisory Board
for Biosecurity (NSABB)
The NSABB provides advice, guidance, and leadership
regarding biosecurity oversight of dual use research to
all Federal departments and agencies with an interest in
life sciences research (including Institutional Biosafety
Committees-IBCs).
Dual Use Research vs.
Dual Use Research of Concern
“Dual Use Research” is research that has the potential
to be misused for nefarious purposes.
Almost all life science research has some potential for
misuse and therefore can be considered to be Dual
Use Research.
The NSABB thus defined a special category: “Dual Use
Research of Concern”, or DURC
that warrants particular attention.
Dual Use Research of Concern
(DURC)
* “The National Science Advisory Board for Biosecurity
(NSABB) has defined Dual Use Research of Concern
(DURC) as: “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”.
*NSABB 2004
2012 U.S. Government Policy on
Dual Use Research of Concern
Partly in response to public concerns over experiments
aimed at broadening the host range of highly
pathogenic avian influenza to mammals, the U.S.
Government issued a policy on oversight of dual use
research of concern (DURC) in March 2012. This policy
requires funding agencies to review ongoing research
for DURC and to establish criteria for the management
of any research that is identified as DURC.
2012 U.S. Government Policy on
Dual Use Research of Concern
Although all life sciences research has the potential to
meet NSABB’s definition of DURC, the 2012 U.S.
Government policy on DURC applies only to research
with certain infectious agents and toxins that are utilized
in experiments with potential to cause seven
experimental effects.
In the future, the policy’s scope may be broadened.
2014 Policy on Institutional Oversight of
Dual Use Research of Concern
In September of 2014 the U.S. Government issued an
additional policy on institutional oversight of dual use
research.
The 2014 policy goes into effect on September 25, 2015
and provides a framework for local oversight of life
sciences research.
The UNC policy on Dual Use Research of Concern ensures
compliance with the 2012 and 2014 federal policies.
Scope of the DURC Policies:
Agents or Toxins
Under the 2012 and 2014 policies, DURC review will focus on research that involves
one or more of the following select agents or toxins:
Avian influenza virus (highly
pathogenic)
Bacillus anthracis
Botulinum neurotoxin
Burkholderia mallei
Burkholderia pseudomallei
Ebola virus
Foot-and-mouth disease virus
Francisella tularensis
Marburg virus
Reconstructed 1918 Influenza
virus
Rinderpest virus
Toxin-producing strains of
Clostridium botulinium
Variola major virus
Variola minor virus
Yersinia pestis
Scope of the DURC Policies:
Seven Experiments of ConcernThe NSABB identified 7 categories of experiments that pose DURC potential. The scope of the 2012
and 2014 DURC policies are limited to the 15 select agents listed in the previous slide when utilized in
experiments that may be associated with any of the following experimental effects. Such experiments
are not prohibited but their risks vs. benefits, and how to communicate the results, must be approved
before starting the research.
1. Enhances the harmful consequences of an agent or toxin.
Example: Modify an agent’s genome to express biological toxins it previously lacked.
2. Disrupts the immunity or the effectiveness of an immunization without clinical and/or agricultural
justification.
Example: Information on the insertion of an immunosuppressive cytokine into a viral genome to render the antiviral
immune response less effective.
3. Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin or facilitates their ability to evade detection
methodologies.
Example: Creation of Y. pestis (plague) or B. anthracis (Anthrax) that is resistant to all clinically relevant
antibiotics.
Scope of the DURC Policies:
Seven Experiments of Concern4. Increases the stability, transmissibility, or the ability to disseminate a biological agent or toxin.
Example: Creation of an aerosol delivery device for Anthrax spores.
5. Alter the host range or tropism of the agent or toxin
Example: Converting nonzoonotic agents into zoonotic agents, altering the tropism of viruses so they can
infect new host species.
6. Enhance the susceptibility of a host population to an agent or toxin.
Example: Engineering research animals to be susceptible hosts for the select agents covered by the
DURC policy.
7. Generates or reconstitutes an eradicated or extinct agent or toxin.
Example: Information on how to construct a de novo microbial pathogen using unique gene sequences or
combinations of sequences that do not exist in nature; or on how to reconstitute a pathogen that no longer
exists in nature, such as the 1918 pandemic influenza virus.
Scope of the DURC Policies:
The Definition of DURC
Additionally, other research meeting the definition of
DURC (below) may be considered as DURC.
“Dual use research of concern” (DURC) is life sciences
research that, based on current understanding, can be
reasonably anticipated to provide knowledge,
information, products, or technologies that could be
directly misapplied to pose a significant threat with
broad potential consequences to public health and
safety, agricultural crops and other plants, animals, the
environment, materiel, or national security.
2014 U.S. Government Policy on DURC
2014 Policy on Institutional Oversight of
Dual Use Research of Concern
In September of 2014 the U.S. Government issued an
additional policy on institutional oversight of dual use
research.
The 2014 policy goes into effect on September 25, 2015
and provides a framework for local oversight of life
sciences research.
The UNC policy on Dual Use Research of Concern ensures
compliance with the 2012 and 2014 federal policies.
Requirements Under the 2014 DURC
Policy
• Institutions will be required to certify, or attest, to complying with the
federal DURC policy on applicable grants.
• Institutions must provide DURC training to individuals working with
applicable agents.
• Institutions must name an ICDUR, the Institutional Contact for Dual Use
Research of Concern. (UNC Biological Safety Officer)
• Institutions must establish an IRE, Institutional Review Entity, to review
DURC. (At UNC, the IRE is a subcommittee of the Institutional Biosafety
Committee)
• DURC must have an IRE approved risk mitigation plan.
• The risk mitigation plan must be approved by the funding agency.
• Non-compliance may result in suspension, limitation or termination of
funding or loss of future funding opportunities for the project or
Institution.
PI Responsibilities
-Assess their own research and the research of those under their supervision for dual use potential and report as appropriate;
-Stay abreast of literature, guidance, and requirements related to dual use research, and particularly Dual Use Research of Concern (DURC);
-Ensure that their lab personnel are able to identify DURC and manage it properly;
-Conduct research responsibly, especially research that may meet the criteria for DURC;
-Give thought as to how the results of such research should be communicated to others, including the public; and
-Always be alert to potential misuse of research.
PIs/Researchers should cultivate and sustain a culture of responsibility, accountability and safety!
UNC’s Responsibility
UNC’s Institutional Biosafety Committee (IBC) and
Environment, Health & Safety (EHS) Biological Safety
section currently reviews research proposals (Schedule
G) & determine if they qualify as DURC.
If a protocol meets the criteria for DURC, the
Investigator will be asked to submit a risk mitigation
plan for review by the IRE. Further safety measures
may be taken or if necessary the protocol may be
revised or retracted. The IRE approved risk mitigation
plan must be approved by the funding agency before
the research can commence.
Framework for assessing & managing risk:*5 Key Questions:
1. Could this research yield information that could be
intentionally misused to threaten public health, safety and
security?
2. What is the nature of the threat that could be posed from
intentional misapplication of the information & what are the
potential consequences?
3. Based on questions 2&3, how reasonably anticipated
is it that the information could be used to pose a threat
to public health, safety and/or security?
*http://oba.od.nih.gov/oba/biosecurity/documents/B_Dual_Use_Educational_Module_FINAL.pdf
Framework for assessing & managing risk:5 key questions (cont’d)
If potential risks outweigh the
potential benefits, determine
whether research should be
modified, delayed or
discontinued.
Framework for assessing & managing risk:
4. Could this research yield information that could potentially
benefit the life sciences and/or public health, safety or
national security?
5. Do the potential risks outweigh the potential benefits??
Process Overview
DURC?
Notify Funding
Agency (30 days)
Assessed as DURC,
IRE Review
No
Yes
• Notify Funding
Agency (30 days)
• Provide Risk
Mitigation Plan
(90 days)
End
Funding Agency
provides initial
response (30 days)
and finalizes plan
(60 days)
Start
PI’s Initial
DURC
Assessment
Not DURCStandard grant
submission
process
End
Conduct Research in
accordance with plan
Annual IRE
Review
Notify
Funding
Agency
When
Project Ends
Initial DURC Assessment
i. Research involves one or more of the agents or toxins listed in the DURC policy;
And
ii. Research with one or more of the agents or toxins listed in the DURC policy also
produces, aims to produce, or can be reasonably anticipated to produce one or more of
the seven experimental effects listed the policy;
Or
iii. Research that may meet the definition of DURC.
Fink Committee of the National Research Councilof the National Academies, USA (2003):
“Even experiments that have the greatest potentialfor diversion to offensive applications or terrorist purposesmay also have potentially beneficial uses for public healthpromotion and defense”.
Case Study #1
Reconstruction of the 1918 Spanish Flu (2005)
Dual use concern: The information obtained could be
misused and the virus could be bioweaponized
Biosecurity/Biosafety issues: Were appropriate
precautions taken for containment & security? Were
the results communicated in a way to enhance public
understanding of the need for the research?
Case Study #2
Mousepox Experiment - A strain of ectromelia virus
(mousepox) was bioengineered in an effort to sterilize
mice in Australia. The strain killed 60% of the infected
mice. (2001)
Dual use concern: Many feared that publication of this
research would provide a blueprint for those with
malevolent intentions and a more virulent strain of
smallpox could be created to infect humans.
If you have any questions regarding your research
and its dual use research potential, please contact
UNC’s Biological Safety Officer and Institutional
Contact for Dual Use Research
Dan Eisenman, PhD, CBSP