IRE Assessment Process

FIU IRE Assessment and Approval Process

1. Notification

Principal investigators must notify the FIU IRE as soon as a research project is anticipated to involve one of the listed agents or toxins by submitting an IRE Assessment Application via TOPAZ. Additional registration and review may be required by the FIU IRE. For more information, please visit the IRE tools and resources page.

2. Assessment

Agents/Toxins

Categories of Experiments

  • Avian influenza virus (highly pathogenic)
  • Bacillus anthracis
  • Botulinum neurotoxin (no exempt quantities)
  • Burkholderia mallei
  • Burkholderia pseudomallei
  • Ebola virus
  • Marburg virus
  • Reconstructed 1918 Influenza virus
  • Rinderpest virus
  • Toxin-producing strains of Clostridium botulinum
  • Foot-and-mouth disease virus
  • Francisella tularensis
  • Variola major virus
  • Variola minor virus
  • Yersinia pestis
  • Enhances the harmful consequences of the agent or toxin.
  • Disrupts the 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.
  • Generates or reconstitutes an eradicated or extinct agent or toxin listed above.

Upon receipt of a notification of potential DURC, the IRE Chair will review and verify that the proposed research uses one of the listed agents and/or toxins and perform a review of the PI’s assessment regarding whether the proposed research will or is anticipated to achieve any of the listed categories of experiments and/or their effects.

If the IRE Chair determines that the research in question does not involve one or more of the categories of experiments detailed above, the research will not be subject to additional review or oversight, but shall continue to be assessed by the PI going forward.

3. Mitigation Plan

If the IRE Chair determines the research falls within the scope of DURC the IRE Coordinator will notify the US Government funding agency within 30 days of review. The IRE will review the application and will work with the PI to develop and a draft risk mitigation plan and submit to the US Government funding agency within 90 days for review and approval.

4. Annual Review

Once a risk mitigation plan is approved, the IRE and PI will implement the plan and the IRE will review the plan and research at least annually.

5. Amendment

Any change in the status of a DURC project or risk mitigation plan must be communicated to the IRE as soon as possible and the IRE will notify the US Government funding agency within 30 calendar days.