Learn about Dual Use Research of Concern (DURC)
Dual Use Research of Concern 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.
The United States Government has published several policies relevant to Dual Use Research of Concern, with the intention of raising awareness and limiting the potential for misuse of scientific information derived from life sciences research.
Research with one or more of the fifteen DURC agents and/or toxins currently listed in the US Government DURC Policy and which produces, aims to produce or can be reasonably anticipated to produce one or more of the 7 experimental effects of concern listed in the Policy must be evaluated by the VCU Institutional Review Entity (IRE) for its DURC potential.
PIs must notify Susan Robb, the Institutional Contact for Dual Use Research, that they are using DURC agents. See PI Responsibilities below. Review and oversight of DURC are outlined in the VCU policy on DURC.
The Institutional Review Entity (IRE) will conduct a review of the research and make a determination. If the IRE determines the research meets the definition of DURC it will promptly notify the PI, and within 30 calendar days will also notify applicable US Funding Agency. The IRE, PI, and US Funding Agency will work together to develop a Risk Mitigation Plan. This process is outlined in detail in the VCU policy on DURC. 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 Institutional Contact for Dual Use Research (ICDUR) will collaborate with the PI to ensure its implementation.
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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.
Principal Investigators are responsible for assessing whether their research is DURC, reporting this assessment to the VCU DURC Institutional Review Entity (IRE), and, if applicable, implementing a risk mitigation plan.
Before commencing research with DURC Agents, the Principal Investigator (“PI”) must first make a determination about whether:
- The research directly involves non-attenuated forms of one or more of the potential DURC Agents; or
- 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
- 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.
The PI’s assessment in regarding the above should be summarized in writing and this summary shall be registered and retained with the VCU DURC Institutional Review Entity (IRE).
The PI will provide the Institutional Contact for Dual Use Research (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:
- Collaborate with the IRE to develop the Risk Mitigation Plan.
- Conduct DURC in accordance with the final Risk Mitigation Plan;
- Notify the ICDUR of any substantive change in the on-going conduct of the DURC;
- 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;
- 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;
- Be knowledgeable about and comply with all UC and federal policies and requirements for oversight of DURC; and
- Communicate about the DURC in a responsible manner and in compliance with the approved risk mitigation plan.
Federal DURC policy requires that where elements of a potential DURC project are being carried out at multiple institutions through a sub-award with a primary institution that directly receives the grant or contract from the U.S. Funding Agency, (the “Prime Institution”), the Prime Institution will be responsible for notifying the applicable U.S. Funding Agency of research that may constitute DURC and if such research is determined to be DURC, providing copies of each institution’s Risk Mitigation Plan. The Prime Institution should also ensure that DURC oversight is consistently applied by all entities participating in the collaboration. If the Prime Institution’s procedures or standards are less rigorous than the sub-awardee’s, the more rigorous standard will be applied.
Link to additional resources related to Dual Use Research of Concern (DURC).
- Federal Government DURC Policy & Guidance
- United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern (March 2012)
- United States Government Policy for Institutional Oversight of Dual Use Research of Concern (September 2014)
- FAQ on USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
- 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
- Training Slide Set: Training on the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern