Biohazards: Institutional Biosafety Committee (IBC)
Dual Use Research of Concern (DURC)
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.
All research, regardless of funding, using one or more of the agents or toxins listed below may be subject to the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (the “2014 Policy”).
The following 15 agents and toxins referred to in the 2014 Policy:
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin (For purposes of this Program, there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin should be evaluated for DURC potential.)
- Burkholderia mallei
- Burkholderia pesudomallei
- 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
Experimental Effects of Concern: the following 7 categories of experiments referred to in the 2014 Policy:
- Enhances the harmful consequences of the agent or toxin.
- Disrupts immunity or 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 definition of DURC Agents above.
Process at ISU
ISU Researchers must identify and register research involving any of the listed agents or toxins with EH&S. Then the researcher must submit either a new IBC submission or an IBC amendment to the IBC committee. In the event that a DURC determination is made, the Institutional Review Entity (IRE) will work with the researcher to create the federally-mandated mitigation plan.
Additional information is available in the Iowa State University Program Guidelines on Dual Use Research of Concern.
Researchers who are conducting studies that involve DURC are also required to complete DURC training every three years. If an individual has completed the “NIH Guidelines” training through EH&S, additional training is not required. If an individual has completed the CITI training, s/he must complete the additional training module entitled “Dual Use Research of Concern (DURC).”
- Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern (the “Companion Guide”)
- Implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences DURC: Case Studies
- Training on the US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
- National Institutes of Health (NIH) Notice NOT-CD-15-017: NIH Implementation of the US Government Policy on Institutional Oversight of Life Sciences Dual Use Research of Concern, issued on November 21, 2014