Dual Use Research of Concern
The purpose of this guidance is to outline NDSU's institutional oversight of Dual Use Research of Concern (DURC) according to the "United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern" released on September 24, 2014. NDSU Policy 347 establishes regular review processes for United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC) in order to:
(a) mitigate risks where appropriate; and
(b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC.
The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
For more information, please see the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern.
Scope of Research Requiring DURC Oversight
Agents and Toxins
DURC policy focuses on researc that involves one or more of the agents or toxins listed below.
Agents and toxins:
- 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
Note: These agents and toxins are regulated by the Select Agent Program under Federal Law (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121), which set forth the requirements for possession, use, and transfer of select agents and toxins, and have the potential to pose a severe threat to human, animal, or plant health, or to animal or plant products.
Categories of Experiments
- Enhances the harmful consequences of the agent or toxin;
- Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification;
- 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;
- 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; or
- Generates or reconstitutes an eradicated or extinct agent or toxin listed above.
Researchers shall consider whether their research requires review under the DURC policy throughout the lifecycle of the research. Review of research for DURC potential shall be initiated whenever any of the following criteria are met:
- The research directly involves nonattenuated forms of one or more of the listed agents or toxins; or
- The research produces, aims to produce, or can be reasonably anticipated to produce one or more of the listed experimental effects; or
- The research may meet the definition of DURC and should be considered for DURC potential.
DURC Review and Risk Mitigation
Institutional Contact for Dual Use Research (ICDUR)
The ICDUR is designated by the University to serve as an institutional point of contact for questions regarding compliance with, and implementation of the requirements for the oversight of DURC as well as the liaison (as necessary) between the institution and the relevant US Federal funding agency. The Vice President for Research and Creative Activity or their designee serves as the ICDUR.
Institutional Review Entity (IRE)
The purpose of the IRE is to determine if life science research meets the federal definition of Dual Use Research of Concern and to, as needed, work with the PI and others to draft a Risk Mitigation Plan. The IRE shall be an ad hoc subcommittee of the IBC comprised of five (5) members from the Institutional Biosafety Committee (IBC) with the ICDUR acting as a consultant. On a case by case basis, other individuals with specific expertise may be added to the IRE as members or called on to act as consultants.