What is the scope of research requiring DURC oversight?

DURC policy focuses on research 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.

• 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 life cycle of the research.  Review of research for DURC potential shall be initiated whenever any of the following criteria are met:

• The research directly involves non-attenuated 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.