Under the Policy for Institutional DURC Oversight, the identification of DURC-related risks and the management of those risks begin with the identification, by PIs, of research that directly involves nonattenuated forms of 1 or more of the 15 listed agents. Any such research that is identified must then be assessed for whether the research produces, aims to produce, or can be reasonably anticipated to produce one or more of seven listed experimental effects.
Identification and Assessment by PIs of Research That Requires Institutional Review
As noted above, PIs are required to submit research for Institutional review as soon as any of the following three criteria are met:
- The PI's research directly involves nonattenuated forms of one or more of the listed agents; or
- The PI's research with nonattenuated forms of one or more of the listed agents also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects; or
- The PI concludes that his or her research with nonattenuated forms of one or more of the listed agents that also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects may meet the definition of DURC and should be considered (or reconsidered) by the IRE for its DURC potential.
Research Involving the Listed Agents
To initiate the institutional review process, PIs are to notify the IRE if they are conducting research that directly uses nonattenuated forms of one or more of the following agents:
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin (in any quantity)
- 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
When a PI determines that his or her research does directly involve nonattenuated forms of one or more of these listed agents, he or she must also assess whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the experimental effects listed below, and this assessment should be provided to the institution for its consideration during the review of the research.
The categories of experimental effects are as follows:
- 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; and
- Generates or reconstitutes an eradicated or extinct listed agent or toxin.
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