Dual Use Research of Concern (DURC)

What is DURC?

Dual Use Research of Concern (DURC), under the United States Government Policy, 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.

Dual Use Research vs Dual Use Research of Concern

Research yielding new technologies or information with the potential for both benevolent and malevolent applications is referred to as "dual use research." Some degree of dual use potential may be inherent in a significant portion of life sciences research. However, the small subset of life sciences research with the highest potential for yielding knowledge, products, or technology that could be misapplied to threaten public health or national security is referred to as "dual use research of concern." 



DURC Policy

The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. There are two USG policies that address the oversight of life sciences DURC:

• The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (September 2014) - Describes the policies, practices, and procedures required to ensure DURC is identified and risk mitigation measures are implemented at the institutional level
• The United States Government Policy for Oversight of Life Sciences Dual use Research of Concern (March 2012) - Establishes regular review by Federal agencies of USG-funded or conducted research with certain high-consequence pathogens and toxins for its DURC potential and to mitigate risks where appropriate

Separately, review and oversight of DURC are outlined in the University of California policy on DURC.

DURC Agents/Toxins

Agents and toxins specified by the U.S. Government as governed by its DURC policy. The below list of agents and toxins will be subject to revision to reflect future changes in federal DURC policy, but as currently defined, the following 15 agents and toxins, in any quantity, are governed by federal and University policy on DURC:

1. Avian influenza virus (highly pathogenic)
2. Bacillus anthracis
3. Botulinum neurotoxin (any quantity)
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

Experimental Effects of Concern

Research that produces, aims to produce, or can be reasonably anticipated to produce one or more of the following experimental effects:

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.

Procedures for DURC Research

Initial review

To begin the IRE approval process, please contact the Institutional Contact for Dual Use Research (ICDUR), Anju Subba, at asubba@uci.edu to complete the identification and assessment form. The research must involve one of the 15 DURC agents/toxins AND involve one of the experimental effects of concern to meet the definition of DURC. If the IRE determines the research meets the definition of DURC, it will promptly 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. 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.

Training

Before research can begin, Principal Investigators must ensure that they, and all the personnel conducting research with one or more of the DURC agents have received DURC training. At this time, DURC training can be accomplished by reviewing and understanding the following slides prepared by the Program on Biosecurity and Biosafety Policy at NIH.

• DURC Training and Certification

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.

Questions? Contact:

Anju Subba, Institutional Contact for Dual Use Research (ICDUR)

(949) 824-4365

asubba@uci.edu

Amy Green, Research Compliance & Policy Administrator/DURC Administrator

(949) 824-9015

acgreen1@uci.edu