Additional 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.
While you should use IRBIS to generate consent forms specific to your project, sample consent forms are available for review.
Other Forms
HIPAA-Related Forms for Access to Records at UNC School of Dentistry (not OHRE forms)
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