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 WCG IRB (formerly WIRB) approval process. Separate instructions for WCG IRB submissions are available on our WCG IRB 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:
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.
Step 3: Determine the Review Type
All research protocols involving human subjects will fall under one of the following three categories of review:
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.
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).
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):
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:
Step 7: Application Review Process