Dual Use Research of Concern (DURC) Institutional Review Entity (IRE)

About the Dual Use Research of Concern (DURC) Institutional Review Entity (IRE)

The Georgia Tech Institutional Review Entity (IRE) is charged with providing institutional oversight for life sciences research that may fall under the definition of Dual Use Research of Concern (DURC) as established by the US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

Background Information on DURC:

  • Despite its value and benefits, certain types of research conducted for legitimate purposes can be utilized for both benevolent and harmful purposes. Such research is called Dual Use Research (DUR).
  • DURC is a subset of DUR and is defined as “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.”
  • On March 29, 2012, the US Government released the US Government Policy for Oversight of Life Sciences Dual Use Research of Concern to establish the requirements for the oversight of DURC by the US Government. On September 24, 2014, the US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern was released to establish the requirements for institutional (i.e., non-US Government) oversight of DURC. The US Government considers these two policies to be complementary.

These definitions could potentially encompass a number of life science research projects at Georgia Tech.  However, the current scope of the US Government Policy has been limited to the following agents/toxins and categories of experiments.  Research must involve both a listed agent/toxin and category of the experiment to be deemed potential DURC.

Agents & Toxins

Categories of Experiments

  • Avian influenza virus (highly pathogenic)
  • 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 strains of Clostridium botulinum
  • Variola major virus
  • Variola minor virus
  • Yersinia pestis
  • 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 in the column to the left

A General Overview on How  DURC is Assessed at Georgia Tech:

  1. Investigators working with biological/infectious agents or experiments involving recombinant/synthetic nucleic acid molecules answer screening questions related to the above-listed agents and types of experiments when they submit registration documents with the Biological Materials Safeguards Committee (BMSC) or Institutional Biosafety Committee (IBC), respectively.
  2. The BMSC and IBC notify the IRE when potential DURC has been identified during the respective review process.
  3. The IRE conducts a Risk Assessment to determine if the research meets the definition of DURC and communicates this with the appropriate funding agency.
  4. The IRE develops a Draft Risk Mitigation Plan and submits it to the appropriate funding agency for review.
  5. Once approved, Georgia Tech implements the Risk Mitigation Plan (which is reviewed annually).

GT Policies and Forms

Federal Policies and Guidance