Dual Use Research of Concern (DURC)

Principal Investigators are responsible for assessing whether their research is DURC, reporting this assessment to the DURC Institutional Review Entity (IRE), and, if applicable, implementing a risk mitigation plan.

Assessment

Before commencing research with DURC Agents, the Principal Investigator (“PI”) must first make a determination about whether:

1. The research directly involves non-attenuated forms of one or more of the potential DURC Agents; or
2. The research with non-attenuated forms of one or more of the potential DURC Agents also produces, aims to produce or can reasonably be anticipated to produce one or more Experimental Effects of Concern; or
3. The PI concludes that his/her research may meet the definition of DURC. If research is determined not to meet the DURC criteria, it is the responsibility of the principal investigator to monitor his other research on an ongoing basis and notify the Institutional Review Entity (IRE) if anything changes that may alter the initial IRE determination.

Submit summary

The PI’s assessment in regarding the above should be summarized in writing and this summary shall be registered and retained with the UCSD DURC Institutional Review Entity (IRE) via the Institutional Contact for Dual Use Research (ICDUR) through the existing Biohazard Use Authorization program.

The PI will provide the ICDUR with documentation in accordance with local campus policies and procedures, indicating the reasons for concluding that his/her research involves, or does not involve potential DURC, along with sufficient data to permit the IRE to complete the review required.

Implement risk mitigation

If the IRE determines that the proposed research is DURC, the PI will be expected to:

1. Collaborate with the IRE to develop the Risk Mitigation Plan.
2. Conduct DURC in accordance with the final Risk Mitigation Plan;
3. Notify the ICDUR of any substantive change in the on-going conduct of the DURC;
4. Notify the ICDUR if for whatever reason (e.g., changes in the research, new discoveries), he/she feels that the research should no longer be considered DURC;
5. Ensure that laboratory personnel (i.e., those under the supervision of laboratory leadership, including graduate students, postdoctoral fellows, research technicians, laboratory staff and visiting scientists) conducting research with one of more of DURC Agents have received appropriate education and training on DURC;
6. Be knowledgeable about and comply with all UC and federal policies and requirements for oversight of DURC; and
7. Communicate about the DURC in a responsible manner and in compliance with the approved risk mitigation plan.

1. Avian influenza virus (highly pathogenic)
2. Bacillus anthracis
3. Botulinum neurotoxin (For purposes of this Policy, there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin should be evaluated for DURC potential.)
4. Burkholderia mallei
5. Burkholderia pseudomallei
6. Ebola virus
7. Foot-and-mouth disease virus
8. Francisella tularensis
9. Marburg virus
10. Reconstructed 1918 Influenza virus
11. Rinderpest virus
12. Toxin-producing strains of Clostridium botulinum
13. Variola major virus
14. Variola minor virus
15. Yersinia pestis

1. Enhances the harmful consequences of the agent or toxin.
2. Disrupts immunity or effectiveness of an immunization against the agent or toxin, without clinical and/or agricultural justification.
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.
4. Increases the stability, transmissibility or the ability to disseminate the agent or toxin.
5. Alters the host range or tropism of the agent or toxin.
6. Enhances the susceptibility of a host population to the agent or toxin.
7. Generates or reconstitutes an eradicated or extinct agent or toxin listed in the definition of DURC Agents.

The UCSD DURC Institutional Review Entity (IRE) evaluates research that involves one or more of the fifteen DURC agents and/or toxins and which produces, aims to produce or can be reasonably anticipated to produce one or more of the 7 experimental effects of concern.

IRE is administratively managed and supported by Environmental Health and Safety. For questions related to the IRE, contact DURC-IRE@ucsd.edu.

UC San Diego’s Vice Chancellor for Research has designated Angela McMahill, Assistant Vice Chancellor for Research Compliance and Integrity, to serve as UC San Diego’s internal resource for issues regarding compliance with and implementation of the requirements for oversight of Dual Use Research of Concern (DURC) as well as the liaison between the University and the relevant Federal funding agencies. 

For guidance or assistance with DURC related matters, please email Angela McMahill at amcmahill@ucsd.edu.

Initial review

If the IRE determines the research meets the definition of DURC, it will promptly so notify the PI and within 30 calendar days, the applicable US Funding Agency, and shall proceed to develop a Risk Mitigation Plan. This process is outlined in detail in the UC DURC policy (PDF). Upon approval of the draft Plan by the U.S. Funding Agency, the IRE will present the final Risk Mitigation Plan to the PI and the ICDUR will collaborate with the PI to ensure its implementation.

Continuing research

For research determined to be DURC, the IRE shall review, at least annually, all active Risk Mitigation Plans at the University. The IRE, working with the PI, shall modify the applicable Risk Mitigation Plan as needed to ensure that the Plan still adequately mitigates the risks associated with the DURC.

Identification of research as DURC has no direct bearing on whether or not an export license is required. However, certain risk mitigation measures (e.g., the imposition or acceptance of restrictions on publication) MAY affect whether the research is subject to the Export Control Regulations such as the Commerce Export Administration Regulations (EAR) or the State International Traffic in Arms Regulations (ITAR). Export Control will advise researchers on any export licensing obligations, required control plans and file export license applications related to research identified as DURC.

Under certain circumstances, the International Traffic in Arms Regulations (ITAR) may apply to DURC items (including materials and information). For information on these controls, see Title 22, Code of Federal Regulations, Parts 120 through 130 (ITAR) - including but not limited to: Part 121.1 Category XIV “Toxicological Agents, Including Chemical

Agents, Biological Agents and Associated Equipment,” and, Part 120.11 “Public Domain.” See https://www.pmddtc.state.gov/ under “Regulations”, United States Munitions List and definitions. Note that the order of precedence for export controls first requires a determination of whether an item is ITAR-controlled. If it is not ITAR-controlled, DURC may be subject to the Commerce Export Administration Regulations (EAR). Export Control will work with the researchers to determine jurisdiction between ITAR and EAR and identify licensing requirements.

Export licenses are required for any exports of DURC Agents and in certain cases export licenses may be required for foreign person access to confidential, proprietary or information restricted from publication. The fifteen agents listed in the USG DURC Oversight policies are all included in Category 1 of the Commerce Control List (For the complete list, see Part 774 of the EAR available under the “Regulations” tab on the Bureau of Industry and Security homepage at www.bis.doc.gov.) Licensing takes a minimum of 6 weeks and must be in place prior to export.

• Federal Government DURC Policy & Guidance
• United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012, PDF)
• United States Government Policy for Institutional Oversight of Dual Use Research of Concern (September 2014, PDF)
• FAQ on USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (PDF)
• National Institutes of Health – Office of Science Policy: Dual Use Research of Concern
• Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern: A Companion Guide to the United States Government Policies for Oversight of Life Sciences Dual Use Research of Concern (PDF)
• Training Slide Set: Training on the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (PDF)