Additional Documents and Forms

All applications are online at https://irbis.research.unc.edu/irb/. The system generates consent form templates based on the information provided in your application. Additional information regarding IRBIS related Consent FAQs and Consent Process Requirements are available.

Other Forms

HIPAA-Related Forms for Access to Records at UNC School of Dentistry (not OHRE forms)

• UNC School of Dentistry Guidelines for Release of Protected Health Information (PHI) for Research Purposes

Recruitment

• Social Media Plan Example

Miscellaneous

• Report of Emergency Use of a Test Article to the IRB
• International Research Guidance and Worksheet
• OHRP International Compilation of Human Research Standards
• Lead Site/Coordinating Center Addendum
• Verification of Foreign Language Translation
• Protocol Exception Request Form
• Protocol Deviation Tracking Log
• Perioperative Review Form

Device Related

• HUD Addendum Completion Instructions
• Humanitarian Use Device (HUD) Application Addendum
• Investigational Device Guidance Document
• Investigational Device (IDE) Worksheet
• Expanded Access Drugs/Devices Addendum Instructions
• Expanded Access Devices Addendum
• Expanded Access Devices Informed Consent Form Template

Drug Related

• IND Exemption Checklist
• Expanded Access Drugs/Devices Addendum Instructions
• Expanded Access Drugs Addendum
• Expanded Access Drugs Informed Consent Form Template