IRB Forms

Form Topics

Expedited or Full Board Review Applications
Exempt Protocol Review Application
Informed Consent Templates
Appendices
Collaborative Studies (IRB and Investigator Agreements)
Other Forms

Expedited or Full Board Review

• New Protocol Application: Social/Behavioral/Educational Research
• New Protocol Application: Biomedical Research
• Application for Continuing Review/Renewal of IRB Protocol
• Application for Modifications to an Approved IRB Protocol

Exempt Protocol Review

• Application for Exempt Protocol Determination

Informed Consent Templates

• Informed Consent For Participation in Research Study:
  Social/Behavioral/Educational Research
• Informed Consent For Participation in Research Study:  
  Biomedical Research
• Assent Form - Minors Participating in a Research Study
• Parental Permission for Minor Participating in Research Study
• Information Sheet - Consent For Research Participation (Exempt Research Studies only)
• Authorization to Disclose Protected Health Information (PHI) for Research Purposes

Appendices 

• Appendix P - Use of Protected Health Information
• Appendix V-B Vulnerable Population - Pregnant Persons Neonates Fetuses
• Appendix V-C Vulnerable Population - Prisoners
• Appendix V-D Vulnerable Population - Children
• Appendix W - Waivers Regarding Informed Consent Process
• Appendix T - Tissue and Biological Sample Use
• Appendix F1  FDA-Drug
• Appendix F2  FDA-Devices
• Appendix E:  Electronic Data Security

Collaborative Studies (IRB and Investigator Agreements)

• Individual Investigator Agreement RFU
• IRB Authorization Agreement1 RFUMS as IRB of record
• IRB Authorization Agreement 2 RFUMS Not the IRB of record
• SMART IRB (single IRB application from relying institution)

Other Forms

• Post-Approval Problem Report Form
• Addition or Deletion to Research Team 
• Voluntary Closure of IRB Protocol Form
• Supplement:  Progress Report Form (only for 7 Year de novo Applications)
• Not Human Research (NHR) Guidance and Determination Form (includes QA_QI)