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 a Dual Use Research of Concern (DURC) Application via the TOPAZ system. 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 |
|
|
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.