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Dual Use Research of Concern (DURC)
Introduction and Definition
Life sciences research improves and saves lives every day. However, in some cases, this research yields materials or knowledge that can be directly misapplied for nefarious purposes. One real-life example of this is experimentally increasing the ability of some influenza viruses to be transmitted among mammals. While this experiment could provide valuable insight in terms of public health (use 1), it could arguably provide a blueprint for creation of a biological weapon (use 2). Thus, these types of experiments are called “dual use research.”
Recommended Video - Dual Use Research: A Dialogue
The National Science Advisory Board for Biosecurity (NSABB) outlined a subset of dual use research which they termed "Dual Use Research of Concern" (DURC) and for which they recommended a formal process for oversight. To qualify as DURC, three conditions must be met.
- Research involves one or more of the following agents or toxins:
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin (any quantity)
- Burkholderia mallei
- Burkholderia pseudomallei
- Ebola virus
- Foot-and-mouth disease virus
- Francisella tularensis
- Marburg virus
- Reconstructed 1918 Influenza virus
- Rinderpest virus
- Toxin-producing strains of Clostridium botulinum
- Variola major virus
- Variola minor virus
- Yersinia pestis
- Research produces, aims to produce, or is reasonably anticipated to produce one of the following effects:
- Enhances the harmful consequences of the agent or toxin
- Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
- 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
- Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
- Alters the host range or tropism of the agent or toxin
- Enhances the susceptibility of a host population to the agent or toxin
- Generates or reconstitutes an eradicated or extinct agent or toxin
- Research meets the following definition: "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, material, or national security."
While these conditions must be met to fully qualify as DURC, investigators should keep in mind the dual use potential of all of their work and responsibly conduct and communicate research accordingly (see Principal Investigator Responsibilities).
In 2012, the US Government initiated a process of DURC review through federal funding agencies. However, many felt like this review process often came too late, after initial experiments had already been performed. In 2014, the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern was released, outlining an oversight process that should begin prior to the initiation of experiments.
Principal Investigator Responsibilities
- Be knowledgeable about and comply with all University of Maryland, Baltimore and US Government policies and requirements for the oversight of DURC.
- Submit an Institutional Biosafety Committee (IBC) protocol for any research involving infectious agents, recombinant or synthetic nucleic acid molecules, or human materials using the online CICERO system. As part of the normal registration process, all protocols are reviewed for dual use potential.
- Remain vigilant for changes in the dual use status of ongoing research projects and communicate with the Biosafety Office (x6-7055) and IBC when a change does occur.
- 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 life sciences research with one or more of the 15 agents listed above have received education and training on DURC.
- If DURC is identified, work with the IBC and the DURC Committee to assess the dual use risks and benefits and to develop a risk mitigation plan.
- Conduct DURC in accordance with the provisions in the approved risk mitigation plan.
- Communicate DURC in a responsible manner. Communication of research and research findings is an essential activity for all researchers, and occurs throughout the research process, not only at the point of publication. Researchers planning to communicate DURC should do so in compliance with the approved risk mitigation plan.
- If changes need to be made to an approved risk mitigation plan, work with the IBC and DURC Committee to revise the plan (which needs to be reviewed and approved by the US Government funding agency or NIH prior to implementation of any changes).
- The Biosafety Team of Environmental Health and Safety will create and maintain dual use training for the UMB community (see Dual Use Training). Personnel working with one or more of the 15 agents or toxins listed above may be required to attend an in-person DURC training session in conjunction with EHS and the Principal Investigator.
- All IBC protocols are screened for dual use potential.
- If the protocol does not involve one or more of the 15 agents or toxins listed above, but does produce, aims to produce, or is reasonably anticipated to produce one or more of the seven listed effects, the IBC may require a risk/benefit analysis and risk mitigation plan as part of its approval process.
- If the protocol does involve one or more of the 15 agents or toxins listed above, the IBC will fulfill the requirements of the Institutional Review Entity for the identification of DURC as detailed in the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern and IBC Charter.
- When DURC is identified, the UMB DURC Committee will work will work with the Principal Investigator to draft a risk/benefit analysis and risk mitigation plan (as detailed in the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern). In addition to scientific subject matter experts, this committee will contain members to provide expertise in areas such as export control, legal counsel, media relations, and publication restriction.
- The Biosafety Officer will act as the Institutional Contact for Dual Use Research (ICDUR) to communicate with the US Government funding agency (or NIH in the case of no USG funding). The ICDUR will chair the UMB DURC Committee.
- The IBC protocol of any project identified as involving DURC, along with the associated risk mitigation plan, will be reviewed by the DURC Committee at least annually.