IRB Forms

The list below provides guidance for the initial IRB submission. The forms are accessible by clicking on the link and are available as Microsoft Word documents. All other IRB forms for special submissions are listed as well.

Name of Form Exempt Submission Expedited Submission Full IRB Submission
Application for the Initial Review (IRB Approval Form) FRM-301   X X
Research Description Form FRM-801 X X X
Exempt Research Checklist and Form FRM-305 X    
Expedited Research Categories FRM-304   X  
Research Proposal Submission Checklist FRM-901     X
Protocol  (no form; this is a written presentation of the proposed study) X X X
Sponsor's Investigator Brochure     when applicable
Copy of Device Designation and Number     when applicable
Affiliated Investigator Agreement FRM-1001 X X X
Unaffiliated Investigator Agreement FRM-1002 X X X
Copy of form FDA-1572     when applicable
HIPAA Authorization with Study Title TMP-509   X X
Informed Consent Template TMP-502   X X

Special Submission Forms

Reportable New Information (Unanticipated Problems and Protocol Deviations) FRM-601

Modification (Amendment) of Approved Research FRM-501

Continuing Review Progress Report FRM-401

Pediatric Research

Assent Form Template TMP-512

Emergency Use

Emergency Use Submission Form FRM-303

Informed Consent Template for Emergency Use TMP-506

Informed Consent Template for Emergency Device Use TMP-511

Compassionate Use

Compassionate Use Submission Form FRM-302

Informed Consent Template for Compassionate Device Use TMP-510