DUAL USE RESEARCH
OF CONCERN
Environment, Health & Safety
University of North Carolina @ Chapel Hill
Overview – The Fink Report
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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
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“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
USG Policy on
Dual Use Research of Concern (1)
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 new
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.
oba.od.nih.gov/oba/biosecurity/pdf/united_states_government_policy_for_o
versight_of_durc_final_version_032812.pdf
USG Policy on
Dual Use Research of Concern (2)
Although all life sciences research has the potential to
meet NSABB’s definition of DURC, this new USG policy
on DURC applies only to research with certain infectious
agents and toxins.
In the future, the policy is likely to be broadened to
other life sciences research, and will likely require
academic institutions to review their research for DURC
locally.
oba.od.nih.gov/oba/biosecurity/pdf/united_states_government_policy_for_o
versight_of_durc_final_version_032812.pdf
Dual Use Research Concern Policy
Under the new policy, review will focus on research that involves one or more of
the following select agents or toxins:
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Avian influenza virus (highly
pathogenic)
Bacillus anthracis
Botulinum neurotoxin
Burkholderia mallei
Burkholderia pseudomallei
Ebola virus
Foot-and-mouth disease virus
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Francisella tularensis
Marburg virus
Reconstructed 1918 Influenza
virus
Rinderpest virus
Toxin-producing strains of
Clostridium botulinium
Variola major virus
Variola minor virus
Yersinia pestis
Experiments of Concern
NSABB identified 7 categories of experiments that may meet the definition of DURC. Such experiments
are not “prohibited” but their risks vs. benefits, and how to communicate the results, should be carefully
considered before starting the research.
Note that these are not
restricted to select agents and toxins.
1. Enhances the harmful consequences of an agent or toxin.
Example: Information on how to make a seasonal strain of the influenza virus as deadly as the 1918 pandemic
strain.
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: Information on how to confer doxycycline resistance to Vibrio vulnificus or antibiotic resistance to
agriculturally relevant microbes, such as rendering Erwinia amylovora resistant to streptomycin.
Experiments of Concern
4. Increases the stability, transmissibility, or the ability to disseminate a biological agent or toxin.
Example: Information on changing genetic factors to increase transmissibility & altering the route of
transmission or vector to increase the ease & effectiveness by which an agent may be transmitted.
5. Alter the host range or tropism of the agent or toxin
Example: Knowledge of how to convert nonzoonotic agents into zoonotic agents, altering the tropism of
viruses& expanding the varieties of the same plant that an altered pathogenic agent could infect.
6. Enhance the susceptibility of a host population to an agent or toxin.
Example: Information on how to create a stable recombinant Lactobacillus casei that could effectively block
the host’s ability to synthesize an important immune signal, such as a tumor necrosis factor alpha, which may
directly facilitate the evasion of normal host defenses.
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.
Case Study #1
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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
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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.
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
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UNC’s Institutional Biosafety Committee (IBC) and
Environment, Health & Safety (EHS) Biological Safety
section currently reviews research proposals (Schedule
G) & determines if they might meet the NSABB
definition of DURC.
If a protocol meets the criteria for DURC, a risk
assessment is done and a mitigation plan is developed.
Further safety measures may be taken or if necessary
the protocol may be revised or retracted.
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)
4. Could this research yield information that could potentially
benefit the life sciences and/or public health, safety or
national security?
5. DoFramework
the potential
outweigh
the potential
forrisks
assessing
& managing
risk:benefits??
If potential risks outweigh the
potential benefits, determine
whether research should be
modified, delayed or
discontinued.
Hypothetical Cases
- Although the new USG policy on DURC that was issued in March
2012 calls for review and oversight only of research involving
certain select agents and toxins, the NSABB and others have made
it clear that DURC is not restricted only to such research but can
exist in other types of life sciences research.
- The NSABB has highlighted the need to broadly educate life science
researchers about DURC and to increase their awareness of the
issue. Such efforts could enhance public confidence in research, and
possibly forestall additional draconian regulation or oversight
measures.
- To aid in these efforts, the NSABB has prepared a series of
hypothetical cases and related questions for discussion.
http://oba.od.nih.gov/oba/biosecurity/documents/B_Dual_Use_Educational_Module_FINAL.pdf
Hypothetical Case #1*
Ann, a post-doctoral fellow, is working with Peter, a senior
researcher, on a study of antimicrobial resistance in gram-positive
pathogenic bacteria. Ann is studying recently isolated strains of
Streptococcus pneumoniae that have developed antibiotic
resistance & cause significantly increased pneumonia morbidity &
mortality. She has identified a gene that she believes is
responsible for the resistance, one that encodes part of a
membrane-bound pump that removes materials from bacterial
cells. With that gene, she has created a variant with increased
capacity and heightened resistance.
* http://oba.od.nih.gov/oba/biosecurity/documents/B_Dual_Use_Educational_Module_FINAL.pdf
Questions
-This research has the clear potential to yield public health
benefits, but it could also be used for malevolent
purposes. What, if anything, should Ann & Peter do to
minimize the risks of misuse of the research? They should
contact their local IBC for an evaluation of their research & if
necessary risk mitigation procedures should be established.
-Should Ann & Peter be held responsible if the findings of
their research are maliciously misused? No, not if they have
gone through the proper channels of having their research
reviewed and approved by the IBC.
Hypothetical Case #2*
Clostridium botulinum produces a toxin that causes ~150 cases of food
poisoning a year in the U.S. Bioterrorists could exploit several of the
bacterium’s properties as it is accessible & easy to prepare in large
quantities. To counteract the effects of such an attack, a research
team screened a library of compounds with the potential to inhibit the
activity of botulinum toxin to determine if they could be used
therapeutically after an attack. During the studies, a small molecule
scaffold that strongly enhances the catalytic activity through an
apparent increase in binding affinity was discovered. This finding
could yield both benefits & harms. In small doses, botulinum toxin is
used to treat cerebral palsy. This finding could allow for it to be used
therapeutically for other conditions. However, this discovery could also
be used malevolently.
* http://oba.od.nih.gov/oba/biosecurity/documents/B_Dual_Use_Educational_Module_FINAL.pdf
Questions
-Should these researchers share the results of their
research at a scientific conference? What
considerations should they take into account when
making a decision on whether to share the findings?
Yes. If they have been evaluated by the IBC & a researcher who
specializes in dual use research.
-Are there ways to share findings while minimizing the
risks of misuse? Yes, the findings can be shared however, the
details should be limited.
Fink Committee of the National Research Council
of the National Academies, USA (2003):
“Even experiments that have the greatest potential
for diversion to offensive applications or terrorist purposes
may also have potentially beneficial uses for public health
promotion and defense”.
If you have any questions regarding your research
and its dual use research potential, please contact
UNC’s Institutional Biosafety Committee
dmhoward@ehs.unc.edu