August 2015 (version 1)
Dual Use Research of Concern (DURC) Application
Dual Use Research of Concern (DURC) is defined as 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, or national security.
Complete questions 1 through 13 (until you reach the “DURC Institutional Review Entity Assessment” section). Fields
will expand as needed. Consult the DURC Companion Guide, DURC Case Studies, and UW EH&S DURC website for help
completing the application.
Submit your completed document to:
EH&S Research and Occupational Safety
[email protected] · box 357165 · phone 206.221.7770 · fax 206.221.3068
Electronic submissions are preferred.
General Project Information
Project Title
Name
Principal
Investigator
Lab Contact
Phone
206.
.
206.
Email
UW NetID
Advanced
Degree(s)
Box
.
if different than PI
Department
Division if applicable
Anticipated Start Date
eGC-1 Number(s)
Agent or Toxin Involved in Project
1.
Check all that apply. Include all research that directly involves non-attenuated forms of the listed
agents. Strains are considered to be “attenuated” and do not need to be listed on this form only if they
appear on the Select Agent and Toxins Exclusions list. However, if a listed attenuated agent will be
subjected to any manipulation that restores or enhances its virulence or toxic activity, the resulting
agent or toxin needs to be described on this form.
Avian influenza virus (highly pathogenic)
Rinderpest virus
Bacillus anthracis
Toxin-producing strains of Clostridium botulinum
Botulinum neurotoxin (any quantity)
Yersinia pestis
**Risk Group 4 agents are not permitted at UW.**
Burkholderia mallei
Burkholderia pseudomallei
Ebola virus
Foot-and-mouth disease virus
Marburg virus
Francisella tularensis
Variola major virus
Reconstructed 1918 influenza virus
Variola minor virus
For DURC Institutional Review Entity (IRE) Use Only:
The research has been verified to directly involve non-attenuated strains as indicated above.
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August 2015 (version 1)
Research Description
In language scientific colleagues outside of your discipline would understand, please provide a narrative answer
to the questions below. Describe your research only as it relates to the agents & toxins listed above.
2. Describe the goals or aims of your research.
3. Describe the experimental manipulations you will perform.
4. Describe the anticipated outcome of your research.
Assessment of Experimental Effects
Please indicate whether the research produces, aims to produce, or can be reasonably anticipated to produce
any of the experimental effects listed below. Check all that apply. Visit the DURC Companion Guide for help.
Yes
No
5.
Enhances the harmful consequences of the agent or toxin. Explain your answer.
6.
Disrupts immunity or the effectiveness of an immunization against the agent or toxin without
clinical or agricultural justification. Explain your answer.
7.
Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin or facilitates its ability to evade
detection methodologies. Explain your answer.
8.
Alters properties of the agent or toxin in a manner that would enhance its stability,
transmissibility, or ability to be disseminated. Explain your answer.
9.
Alters the host range or tropism of the agent or toxin. Explain your answer.
10.
11.
Enhances the susceptibility of a host population to the agent or toxin. Explain your answer.
Generates or reconstitutes an eradicated or extinct agent or toxin listed in question 1.
Explain your answer.
For DURC IRE Use Only
None of the experimental effects apply to this research.
One or more of the experimental effects applies to this research.
Funding Source(s)
12.
Funding Agency
Grant / Contract Number
(or other project identifier)
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Funding Agency
Point of Contact
August 2015 (version 1)
Training of Laboratory Personnel
The Policy for Institutional DURC Oversight requires that all laboratory personnel conducting research with any of
the 15 agents listed above have received education and training on DURC. Please indicate below the names of
all laboratory personnel involved in this project and the date that UW DURC training was completed.
Use My EH&S Training to help you find the relevant training dates.
Name
Title/Role
UW Net ID
Completion Dates
13.
To the best of my knowledge, the information reported on this form is correct and accurately reflects my
proposed research. I will notify the DURC IRE if the scope of my research changes or I initiate work with any
of the agents listed on the first page of this form. I will ensure that any laboratory personnel working with any
DURC agent will complete the UW DURC training online course.
Principal Investigator Name (printed or typed)
Principal Investigator Signature/Electronic Signature
Date
Submit your completed form to
EH&S Research and Occupational Safety
[email protected] · box 357165 · phone 206.221.7770 · fax 206.221.3068
Electronic submissions are preferred.
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August 2015 (version 1)
DURC Institutional Review Entity (IRE) Assessment:
Person Preparing this Document
Name:
Email:
Phone:
Fax:
Previous Review(s) of PI’s Research
Please list prior dates of reviews or assessments for DURC potential. For each date, please include a copy
of the review or assessment.
Date:
Risk Assessment
This section is completed if (1) the research directly involves work with nonattenuated strains of one or more
of the DURC agents or toxins and (2) one or more of the experimental categories applies.
Section 1: The ways in which knowledge, information, technologies, or products from the
research could be misused.
a. What types of knowledge, information, technology, or products are anticipated to be generated through
the research?
b. How will the results or products of the research in question be shared or distributed?
o Knowledge, information, technology, or products that are freely available and widely distributed may be
more easily accessed by individuals with harmful intent.
c.
 Who will have access to the knowledge, information, technology, or final products?
 Will it be shared openly or remain within the laboratory?
What is the novelty of the information provided by the research or of the research methods?
o Research that adds novel information or consolidates information in novel ways may be of greater
concern, whereas information that is already widely available is generally of lower concern.
 Have the results of the research been previously described or shared?
 If so, at what venues and in what detail?
 How readily available are these results?
d. Are the products of the research under consideration applicable to other more common or less
pathogenic agents?
o Knowledge, information, technology, or products generated from research that could be applied to more
commonly available organisms to increase their associated risks may be of greater concern.
e.  Does the research highlight weaknesses in the ability to prepare for and respond to disease outbreaks
that could impact public, agricultural, or environmental health?
 Does the research consolidate existing information in ways that highlight vulnerabilities in public
health and/or safety preparedness?
Considering the above questions, discuss Section 1 (the ways in which knowledge, information,
technologies, or products from the research could be misused) as it relates to the risk assessment of
this project.
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August 2015 (version 1)
Section 2: The ease with which the knowledge, information, technologies, or products might
be directly misused and the feasibility of such misuse.
a. Consider the technical expertise and/or physical resources that would be needed to apply the
knowledge, information, technology, or product for malevolent purposes.
o The risk of misuse may be lower for knowledge, information, technologies, or products that would be
expensive, difficult to procure, or that require a high degree of technical skill to facilitate such misuse.
 Would it require a low or high degree of technical skill and sophistication to use the information from
dual use research for harmful purposes?
 Would its misuse require materials, equipment, or reagents that are expensive or difficult to procure?
b. Consider whether the products of the research in question could be directly misused to pose a threat to
public health and safety, agriculture, plants, animals, the environment, or national security.
o The risk of misuse may be higher for research information that can be directly misused than for research
information that requires significant additional scientific advances to facilitate its misapplication.
c.
 Can the products, information, or technologies generated from the research be directly misapplied? If
so, how?
 If not, do these outcomes of the research need to be combined with other knowledge, information,
technology, or products in order to pose a threat? If so, is that other information already available?
Consider the time frame in which information from the research might be misused.
o Information that can be misused in the near term may be of greater concern.
 Is there concern about immediate or near-future potential use, or is the concern about misuse in the
distant future?
d.  Given your responses to the preceding questions, how readily could the knowledge, information,
technology, or products from the research be used to threaten public health and safety, agricultural
crops and other plants, animals, the environment, or national security?
Considering the above questions, discuss Section 2 (the ease with which the knowledge, information,
technologies, or products might be directly misused and the feasibility of such misuse) as it relates to
the risk assessment of this project.
Section 3: Potential consequences of misuse.
a. Consider the nature of the potential consequences (e.g., harm to the economy, the environment,
agriculture, or public health; public terror) that might result from misuse of the research results in
question.
o Information that could be misused to harm numerous sectors of society or the environment may be of
greater concern.
b. Consider the scope and magnitude of the potential consequences.
o Research or research information that could be misused to cause severe harm, disease, or
consequences is generally considered to be of greater concern.
c.
 Could the impact on people, plants, and/or animals be considered minor, moderate, or major?
Consider the available countermeasures.
o Adequate countermeasures may help to decrease concern about the consequences of misuse.
Countermeasures may include drugs, biological products, public health practices, pesticides, or devices
intended for diagnosis, detection, mitigation, prevention, or treatment.
 Are there currently any countermeasures to help mitigate the potential consequences?
 Are they readily available?
Considering the above questions, discuss Section 3 (potential consequences of misuse) as it relates to
the risk assessment of this project.
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August 2015 (version 1)
Outcome of IRE Review
Your research does not meet the scope of the Policy for Institutional DURC Oversight, and the IRE
does not need to continue with this assessment.
You have approval to proceed with your research involving
.
After you receive Biological Use Authorization from the UW IBC, you may proceed with your
research involving
.
IBC Chair Signature
Date
Your research does meet the DURC definition as defined in the Policy for Institutional DURC Oversight,
and requires a risk mitigation plan and notification to the appropriate funding sponsor.
As Principal Investigator for this project I will:
 Conduct DURC in accordance with the attached risk mitigation plan
 Be knowledgeable about and comply with all institutional and Federal policies and requirements
for oversight of DURC
 Ensure that DURC training is provided to all laboratory personnel (e.g. graduate students,
postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) conducting
research with any of the 15 listed agents
 Communicate DURC in a responsible manner throughout the research process, not only at the
point of publication
 Ensure that communication is in compliance with the risk mitigation plan approved by the
appropriate federal funding agency
Principal Investigator Signature/Electronic Signature
You have approval to proceed with your research involving
IBC Chair Signature
Date
.
Date
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