Institutional Review Entity (IRE)

PI identifies research that involves any of the 15 listed agents

Institutional Review Entity (IRE):

  • Determines whether the research involves any of the 7 experimental effects;
  • If so, conducts a risk assessment to determine whether the research is DURC; and
  • If so, weighs the risk and benefits and develops a draft risk mitigation plan

USG funding agency finalizes and approves risk mitigation plan

Institution implements approved risk mitigation plan and provides ongoing oversight

PI conducts and communicates research according to risk mitigation plan

The IRE is charged with oversight of, and education on, life sciences research involving the use of potential DURC agents. The Committee advises and reports to the Chancellor through the Vice Chancellor for Research.

Initial review

To begin the IRE approval process, please contact the DURC Administrator to complete the identification and assessment form. If the IRE determines the research meets the definition of DURC, it will promptly notify the PI and within 30 calendar days, the applicable US Funding Agency, and shall proceed to develop a Risk Mitigation Plan. This process is outlined in detail in the UC DURC policy. Upon approval of the draft Plan by the U.S. Funding Agency, the IRE will present the final Risk Mitigation Plan to the PI and the Institutional Contact for Dual Use Research will collaborate with the PI to ensure its implementation. 

Training

Before research can begin, Principal Investigators must ensure that they, and all the personnel conducting research with one or more of the DURC agents have received DURC training. At this time, DURC training can be accomplished by reviewing and understanding the following slides prepared by the Program on Biosecurity and Biosafety Policy at NIH.

Continuing Research

For research determined to be DURC, the IRE shall review, at least annually, all active Risk Mitigation Plans at the University. The IRE, working with the PI, shall modify the applicable Risk Mitigation Plan as needed to ensure that the Plan still adequately mitigates the risks associated with the DURC.