IRB Application Forms

Important Update

The U.S. Department of Health and Human Services (HHS) announced on June 18, 2018 that the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) will be delayed until January 21, 2019.

Please visit the following web page for more information:

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
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)
WIRB Pre-Submission Eligibility Form For determining eligibility for submitting a clinical trial to Western IRB (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)
Request for Access to Educational Records for Research For requesting student academic records for research projects