Additional Forms

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All applications are online at http://irbis.unc.edu.  There are a few ADDITIONAL FORMS that are not provided online and may be accessed below.  As needed, these should be completed and uploaded to your IRB application.

foreign language Consent FORMS

Templates for Standard Consent Documents

Biomedical

Non-Biomedical

Consent to Participate in a Research Study
Adult Subjects
Parental Permission for a Minor Child to Participate in a Research Study
Assent to Participate in a Research Study
Adolescent Subjects (15-17 yrs)
Assent to Participate in a Research Study
Minor Subjects (7-14 yrs–use for Biomed and Soc/Beh)
SSN Collection Forms
1. Use with subject to obtain permission to collect Social Security Number for payment
2. Use with subject to obtain permission to collect Social Security Number to use as an identifier
(see SSN guidance for details)
 

HIPAA Addendum to Consent Form

HIPAA Authorization Template

Alternatives to Full Consent Forms; Examples

Short Consent Form (for a single subject who may be illiterate, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject; updated November 10, 2016).

consent form addenda

Addendum English

Other Forms

HIPAA-Related Forms for Access to Records at UNC-CH (not OHRE forms)

UNC School of Dentistry Request for Access to Protected Health Information (PHI) for Research Purposes Word
UNC School of Dentistry Guidelines for Release of Protected Health Information (PHI) for Research Purposes Word

Miscellaneous

Report of Emergency Use of a Test Article to the IRB Word
Verification of Foreign Language Translation Word
IND Exemption Checklist Word
HUD Addendum Completion Instructions
Humanitarian Use Device (HUD) Application Addendum
Word
Word
Investigational Device Guidance Document
Investigational Device (IDE) Worksheet
PDF
PDF
Expanded Access Drugs/Devices Addendum Instructions
Expanded Access Drugs Addendum
Expanded Access Drugs Informed Consent From Template
Word
Word
Word
Expanded Access Drugs/Devices Addendum Instructions
Expanded Access Devices Addendum
Expanded Access Devices Informed Consent From Template
Word
Word
Word