The University of Wisconsin–Madison will meet the requirements stated in the United States Government (USG) Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. This policy requires Principal Investigators (PI) to notify the Institutional Review Entity (IRE) as soon as their research, both USG - or privately funded, meets any of the following criteria:
- Research directly involves non-attenuated forms of one or more of the listed agents*.
- Research with non-attenuated forms of one or more of the agents also produces, aims to produce, or can be reasonably anticipated to produce one or more of the seven listed experimental effects**.
- PI concludes that his or her research with non-attenuated 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.
The Dual Use Research of Concern (DURC) Subcommittee, described in detail in the DURC Subcommittee Policy, will serve as the IRE for the University of Wisconsin–Madison.
PIs at the University of Wisconsin–Madison will comply with the USG Policy as follows:
- PI will conduct an assessment of the DURC potential of their research by filling out the Notification of Potential DURC Form located on the Office of Biological Safety’s website on the DURC page.
- Immediately notify the Institutional Contact for Dual Use Research (ICDUR) when his or her research meets one of the three criteria described above by using the form listed above.
- Work cooperatively with the DURC Subcommittee to assess the risks of his or her research and aid in the development of risk mitigation plans as needed.
- Conduct DURC in accordance with the risk mitigation plan.
- Provide the DURC Subcommittee with updates in regards to the progress and results of DUR and DURC research as requested by the Subcommittee.
- Submit all manuscripts and presentations associated with DUR or DURC research to the ICDUR for review.
- Comply with all institutional and USG policies regarding DURC.
- Ensure his or her researchers have received the appropriate DURC training.
- Communicate DURC in a responsible manner.
- Report any instances of noncompliance with institutional and/or USG policies to the ICDUR.
* Agents covered by USG Policy
- Avian influenza virus (highly pathogenic)
- Bacillus anthracis
- Botulinum neurotoxin (all amounts)
- 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
** Categories of Experimental Effects
- Enhance the harmful consequences of a biological agent or toxin
- Disrupt immunity or the effectiveness of an immunization without clinical and/or agricultural justification
- Confer to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate their ability to evade detection methodologies
- Increase the stability, transmissibility, or the ability to disseminate a biological agent or toxin
- Alter the host range or tropism of a biological agent or toxin
- Enhance the susceptibility of a host population
- Generate a novel pathogenic agent or toxin or reconstitute an eradicated or extinct biological agent