Dual Use Research of Concern (DURC)

It is the policy of Georgia Southern University that all research projects involving biological agents or toxins specified in the US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (“Policy for Institutional DURC Oversight”) are subject to review and approval by the institution through the Institutional Biosafety Committee prior to project initiation.  The Institutional Biosafety Committee must be notified the time of sponsored proposal submission of the intent to conduct sponsored DURC research if awarded.

Dual Use Research of Concern (DURC) means 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 Researcher must adequately demonstrate the ability to safely conduct the DURC project at Georgia Southern University.  The Institutional Official may elect to disapprove any DURC research even after IBC approval buy may not approve research disapproved by the IBC.

Definitions

Dual Use Research of Concern means 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. DURC is research that involves one of the agents/toxins below that is also used in one of the stated Experiments of Concern.

Non-attenuated Agents and Toxins of Concern are those so defined by federal policy, which may be updated periodically; including, but not limited to:

  • Avian influenza virus,
  • Bacillus anthracis,
  • Botulinum neurotoxin,
  • Burkholderia mallei,
  • Burkholderia pseudomallei,
  • Ebola Virus,
  • Foot-and-mouth disease virus,
  • Francisella tularensis,
  • Marburg virus,
  • Reconstructed 1918 Influenza virus,
  • Rinderpest virus,
  • Toxin-producing strain of Clostridium botulinum,
  • Variola major virus,
  • Variola minor virus, and
  • Yersinia pestis.

Experiments of Concern are research that produces, aims to produce, or can be reasonably anticipated to produce one or more of the following experimental 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 listed under agents and toxins of concern.

Obligation of Researchers to Identify Research that May Constitute DURC

A Principal Investigator (PI) must identify research that involves Nonattenuated Agents and Toxins of Concern that could meet the definition of an Experiment of Concern. Dual Use Research of Concern falls into both of these categories. The PI is directed to address these categories by notifying the IBC to register the intended field of study and the potential for DURC to be reviewed by the Institutional Biosafety Committee (IBC).    Notification may be made by email to irb@georgiasouthern.edu.

Dual Use Research of Concern Review

The IBC shall review the research plan and register the researchers lab if: (i) any work involving Non-attenuated Agents and Toxins of Concern that may involve an Experiment of Concern, or (ii) similar work is contemplated in the foreseeable future. The IBC may provide input and/or make recommendations for lab controls that require capitol improvement requiring significant lead time to accomplish.  The IBC may, at its disgression, convene a subcommittee to review the DURC project, develop a risk mitigation plan with the PI and manage oversight needs.  The risk mitigation plan and associated IBC registration must be reviewed at least annually.

Last updated: 5/24/2018

Office of Research Integrity • PO Box 8005, Statesboro, GA 30460 • General Inquiries: (912) 478-2359 • irb@georgiasouthern.edu