Dual Use Research of Concern

Dual Use Research of Concern

 

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 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’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.

DURC Policy

The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (PDF), effective September 24, 2015, describes the policies, practices, and procedures required to ensure DURC is identified and risk mitigation measures are implemented. The Institutional Biosafety Committee (IBC) and the Executive Vice President for Research and Innovations are responsible for developing and implementing the University's DURC policy.

Agents and toxins subject to DURC policy:

  1. Avian influenza virus (highly pathogenic)
  2. Bacillus anthracis
  3. Botulinum neurotoxin (there are no exempt quantities of botulinum neurotoxin)
  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 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 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 susceptibility of a host population to the agent or toxin
  7. Generates or reconstitutes an eradicated or extinct agent or toxin listed above

 

U of L DURC Policy and Procedures

  1. DURC Application: PIs are required to complete and submit a DURC application[HA1] to Biosafety Office if research involves any agents subject to DURC policy. This is required initially and all active risk mitigation plans at the institution will be reviewed at least annually.

 

  1. DURC Institutional Review Entity (IRE): A DURC IRE (Institutional Dual Use Research of Concern Committee (IDURCC)) is required to assess all research with agents subject to DURC policy. The IDURCC 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 U of L policies and procedures.

 

  1. Risk Mitigation Plan: If research with the listed agents is anticipated to involve any experimental effects of concern and is considered DURC, the IDURCC 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.

 

 

Department of Environmental Health And Safety

Main Office

1800 Arthur Street

Louisville, Kentucky 40208

Phone

tel (502) 852-6670

fax (502) 852-0880

Department of Environmental Health And Safety

Radiation Safety Office

319 Abraham Flexner Way

Louisville, Kentucky 40202

Phone

tel (502) 852-5231

fax (502) 852-8911

Office Hours

M-F 8:00 am to 4:30 pm

No holiday hours

IH Service Account

dehsih@louisville.edu

IBC Service Account

biosafe@louisville.edu