Dual Use Research of Concern (DURC)

What is DURC?

Dual Use Research of Concern (DURC) is life sciences research that can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a threat to public health and safety, plants, animals, the environment, materiel, or national security. More detail is provided in the DURC Policy provided by the National Institutes of Health Office of Science Policy.

Research with any amount of one or more of the 15 DURC agents and/or toxins currently listed in the Policy and which produces, aims to produce or can be reasonably anticipated to produce one or more of the seven experimental effects of concern listed in the Policy must be evaluated by the Institutional Review Entity (IRE) for its DURC potential.

What is the difference between Biosafety and Biosecurity?

Biosafety is the discipline that addresses the safe handling and containment of infectious microorganisms to protect workers, the public, agriculture, and the environment from exposure to biological agents or materials that may cause disease or other detrimental effects in humans, plants, or animals. Biosecurity pertains to the measures in place to stop the spread or introduction of harmful organisms to human, animal and plant life. The Institutional Biosafety Committee (IBC) regularly reviews projects with regard to ensuring safe handling of pathogens to limit accidental exposure. DURC review includes additional focus regarding the biosecurity of those projects. For DURC projects, the Principal Investigator (PI) must provide details about proposed measures for preventing nefarious use of the pathogens or technologies involved. Projects determined to be DURC will require a risk mitigation plan that must be approved by the USG funding agency.

Do I have to submit a DURC application?

A Principal Investigator (PI) must submit a DURC application (Listed Agent Use Authorization form) whenever the research project involves any amount of at least one of the above agents or toxins.

Research involving any of the following is not currently intended for DURC oversight:

The use of any of the listed agents in attenuated forms.
The use of genes from any of the listed agents.
In silico experiments (e.g. modeling experiments, bioinformatics approaches) involving the biology of the listed agents.
Research related to the public, animal, and agricultural health impact of any of the listed agents (e.g. modeling the effects of a toxin, developing new methods to deliver a vaccine, developing surveillance mechanism for a listed agent.

Are there different levels of review for DURC projects?

No, there is only full committee review for DURC projects. Although normal biological research studies can qualify for different levels of review, those identified as DURC projects must undergo full review by UCR’s Institutional Review Entity (IRE), which meets periodically. Also, keep in mind that the project may require review and approval by additional UCR research compliance committees (e.g., IBC, IRB-Clin, IACUC, SCRO, PRO).

What is the process for reviewing DURC projects?

This diagram shows the steps involved in the DURC review process.

When completing a DURC application (Listed Agent Use Authorization Form), the PI is responsible for reviewing the research protocol and including information about any aspects of the project that may constitute DURC. The application should explain in detail what strategies the PI proposes to mitigate the associated risks in the research project.

DURC applications are reviewed at convened meetings of the IRE. Within 30 calendar days of IRE review of the research for DURC potential, the committee is responsible for notifying the funding agency (or NIH for non-federally funded research) about whether the research meets the definition of DURC.

The IRE works with the funding agency to establish a risk mitigation plan for the project and then checks in periodically to ensure that the research is being conducted according to the plan.