IRB Application Forms
Important Information
COVID-19 IRB Resource Page: Learn about its impact on human subject research projects. View the COVID-19 IRB Resource Page.
Single IRB Requirement: All federally funded cooperative research projects receiving initial IRB approval on or after January 20, 2020 will be required to utilize a Single IRB Review. Learn about the new Single IRB Review requirement.
Online TOPAZ Electronic Forms
The following IRB application forms are available for online electronic submission within the TOPAZ system. Investigators should first review the Obtaining Approval instructions and/or Managing Your Approval instructions prior to using these online forms.
Original Form | Description |
---|---|
IRB Approval Form | For Expedited / Full Board Review Submissions |
IRB Exemption Form | For Exempt Review Submissions |
IRB HSR Determination Form | For Human Subject Research Determinations (Determining if IRB approval is applicable) |
IRB Reliance Request Form | For Requesting to have FIU to Rely Upon an External IRB |
Amendment Form | Description |
---|---|
IRB Amendment Form | For Expedited / Full Board Review Amendments |
IRB Exempt Amendment Form | For Exempt Review Amendments |
IRB Reliance Amendment Form | For Reliance Request Amendments |
Renewal Form | Description |
---|---|
IRB Renewal Form | For Expedited / Full Board Review Renewals |
IRB Reliance Renewal Form | For Reliance Request Renewals |
Interim Review Forms | Description |
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IRB Event Report Form | For Expedited / Full Board Review Adverse Event or Deviation Reports |
IRB Exempt Event Report Form | For Exempt Review Adverse Event or Deviation Reports |
IRB Reliance Event Report Form | For Reliance Request Adverse Event or Deviation Reports |
IRB Exempt Project Completion Form | For Exempt Review Completions |
IRB Project Completion Form | For Expedited / Full Board Review Completions |
Offline Paper-Based Forms
The following IRB forms are available for download in a paper-based format for the purposes outlined below.
Form | Description |
---|---|
Adverse Event Table Form | For tracking and logging adverse events in a project |
Event Report Form | For reporting adverse events or protocol deviations (only when the event cannot be submitted electronically via the TOPAZ system) |
Consent Translation Form | For translating Informed Consent documents into a non-English language |
Informed Consent Templates | For developing Informed Consent Forms (investigators are required to use the FIU-formatted templates) |
HIPAA Authorization Form Templates | For developing HIPAA Authorization Forms when (required when using identifiable medical records) |
WCG IRB Pre-Submission Eligibility Form | For determining eligibility for submitting a clinical trial to WCG IRB (formerly WIRB) |
Individual Investigator Agreement | For covering an external individual under the FIU IRB when the individual will be engaged in conducting FIU research with human subjects (and the individual is not from an institution that has a Federal Wide Assurance) |
External Site IRB Reliance Request Form | For covering an external site under the FIU IRB when an individual from the external site will be engaged in conducting FIU research with human subjects (and the institution has a Federal Wide Assurance) |
Request for Access to Educational Records for Research | For requesting student academic records for research projects |