Dual Use Research of Concern (DURC)


Dual use research of concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misused to pose a significant threat with broad consequences to public health and safety, agricultural crops and other plants, animals, the environment, or national security.

DURC Policy

The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, effective September 24, 2015, describes the policies, practices, and procedures required to ensure DURC is identified and risk mitigation measures are implemented. EH&S and the Institutional Biosafety Committee (IBC), with assistance from the UW Office of Research, are responsible for developing and implementing the University's DURC policy.

Research involving botulinum neurotoxins in any quantity and a subset of select agents must be reviewed for DURC. If research with these agents is anticipated to create any of the below categories of experimental effects of concern, it can be DURC.

Agents and toxins subject to DURC policy:

  1. Botulinum neurotoxins (any quantity)
  2. Avian influenza virus (highly pathogenic)
  3. Bacillus anthracis
  4. Burkholderia pseudomallei
  5. Burkholderia mallei
  6. Foot-and-mouth disease virus
  7. Francisella tularensis
  8. Reconstructed 1918 influenza virus
  9. Rinderpest virus
  10. Toxin-producing strains of Clostridium botulinum
  11. Yersinia pestis
  12. Risk Group 4 agents not permitted at UW (Ebola virus, Marburg virus, Variola major and minor viruses)

Experimental categories of concern:

  1. Enhances the harmful consequences of the agent or toxin
  2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification
  3. Confers to the agent or toxin resistance to clinically 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 susceptibility of a host population to the agent or toxin
  7. Generates or reconstitutes an eradicated or extinct agent or toxin listed above

UW DURC Policy and Procedures

  1. Training: EH&S online DURC training is required for Principal investigators (PIs) and research personnel if their research involves the agents covered in DURC policy. Training is required initially and then every three years.
  2. DURC Application: PIs are required to complete and submit a DURC application to EH&S if research involves any agents subject to DURC policy. This is required initially and then every three years or more frequently if there is a change in agents or experimental effects. The three year renewal will be made concurrent with the Biological Use Authorization (BUA) renewal date when applicable.
  3. DURC Institutional Review Entity (IRE): A DURC IRE is required to assess all research with agents subject to DURC policy. The DURC IRE will be a standing subcommittee of the IBC comprised of faculty, staff, and consultants with expertise in select agent research and regulations, biomedical and infectious disease research, biosafety, bioethics, animal research, environmental health and safety, export control, and UW policies and procedures.
  4. Risk Mitigation Plan: If research with the listed agents is anticipated to involve any experimental effects of concern and is considered DURC, the IRE will work with the PI and the funding sponsor to develop a risk mitigation plan that will be updated annually or more frequently as needed.

UW DURC Review Process Summary


Regulations and Resources

Regulations

Resources


Questions?

Questions about DURC can be directed to the Institutional Contact for Dual Use Research: