Obtaining Initial FIU IRB Approval

The following steps are provided to assist investigators with submitting applications to the FIU IRB for review and approval.

Special Note: Studies involving a clinical trial and/or FDA-regulated drugs or significant risk devices need to be submitted through the Western IRB (WIRB) approval process (not the FIU IRB approval process). Separate instructions for WIRB submissions are available on our WIRB web page.

Step 1:  Determine if You Need IRB Review

IRB approval is required for all “research” that involves “human subjects”.

      • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge.
      • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains 1) Data through intervention or interaction with the individual, or 2) Identifiable private information.

Information on Determining if IRB Review is Needed

Step 2:  Complete the CITI Online IRB Training Course

All research personnel that will be engaged in conducting research with human subjects (including analysis of data) are required to complete the CITI Online IRB Training Course.

Instructions to Sign Up for CITI Online IRB Training

Step 3:  Determine the Review Type

All research protocols involving human subjects will fall under one of the following three categories of review:

      • Exempt Review Minimal risk research. Must fall under a specific exemption number. Review process averages 2 weeks.
      • Expedited Review Minimal risk research. Must fall under a specific expedited number. Review process averages 3 weeks.
      • Full-Board Review More than minimal risk. Not eligible under an Exempt or Expedited category of review. Review process takes at least 4 weeks.

Information on Determining the Review Type

Step 4:  Prepare an Informed Consent Document

All protocols undergoing an Expedited Review or Full Board Review are required to use an Informed Consent document. Researchers are required to use the FIU formatted Informed Consent Templates.

Information on Obtaining Informed Consent
Access the FIU Informed Consent Templates

Step 5:  Review the Guidelines and Policies

Additional IRB requirements may be required depending on the type of research you are conducting (e.g., using vulnerable populations).

Access the IRB Guidelines and Policies

Step 6:  Submit an Application

FIU IRB applications need to be submitted through the online TOPAZ Electronic Protocol Application System. Investigators should complete one of the following two forms, which are both accessible within the TOPAZ system (review “step 3” above to determine the type of submission you need):

      • IRB Exemption Form (For Exempt Review Submissions)
      • IRB Approval Form (For Expedited / Full Board Review Submissions)

Only those investigators that need a written determination that a project does not require IRB review (see step 1 above) should complete the following “optional” form, which is accessible within the TOPAZ system:

      • IRB HSR Determination Form (For Human Subject Research Determinations)

Information on the TOPAZ Electronic Protocol Application System
IRB Application Checklist

Step 7:  Application Review Process
      • Pre-Review: Your submission is first pre-evaluated by the IRB Coordinator for completeness. This pre-review will normally take at least 5 business days, but can vary depending on the complexity of the submission and the current workload of submissions. Please note that incomplete and/or poorly written applications will delay the review process.
      • IRB Member Review: After the Pre-Review has occurred (and all applicable revisions have been addressed by the PI), the protocol will be assigned to a reviewer. This review will normally take at least 5 business days, but can vary depending on the complexity of the submission and the current workload of submissions. Please note that incomplete and/or poorly written applications will delay the review process.
      • Full Board Review: If it is determined that Full Board Review is necessary, the protocol will be placed on a meeting agenda. You should expect the Full Board process to take at least 1 month.
      • Final Approval: You will need to wait until you receive an email containing the final approval letter and the stamped consent form(s) before you can begin your research.