FIU Research

Human Research Forms

IRB FORMS

IRB Proposal Template - Proposal Outline that Must be Submitted with Form A

IRB Application (Form A) - For Initial IRB Approval Submission Only

IRB Application (Form A-1) - Assists in Determining if IRB Review is Applicable

IRB Application (Form B-1) - For Research Amendments or Modifications

IRB Application (Form B-2) - For Annual Renewal or Project Completion Report

IRB Application (Form C) - For Projects Requiring Data and Safety Monitoring

IRB Application (Form D) - For Reporting Protocol Deviations

IRB Application (Form E) - For Determining if Eligible for WIRB Submission

IRB Application (Form H) - For Requesting Waiver of HIPAA Authorization

Consent Translation - Affirmation Form for Translated Consent Documents

Non-Serious Adverse Event Form – For Non-Serious and/or Expected Adverse Events

Serious Adverse Event Form – For Serious and Unexpected Adverse Events