The Office of
There are a variety of forms available, and their use depends on the nature of the study and where it is in its life cycle. People new to the IRB process might benefit from the Guide to the IRB Process.
See Submission Instructions for number of copies and where to send the application. See also meeting deadlines and schedules, important for studies that must be reviewed by the convened IRB ("full board" studies).
Forms may change without notice, and old forms will not be accepted after some period of time. You are strongly advised to go to this web page and download a current form each time you need to submit to the IRB.
Most forms are in Microsoft Word; some are Adobe Acrobat PDF.
| Forms | |
|---|---|
| Application for IRB Approval of Human Subjects Research (updated 23-Apr-2008) |
MS Word |
| Addendum for Multi-Site Studies Where UNC-CH is the Lead Coordinating Center | MS Word |
| Determination Whether Research or Similar Activities Require IRB Approval (see instructions on form for when to use this) (updated 19-Feb-2008) |
MS Word |
Templates for Standard Consent Documents (English documents revised 2-Oct-2007; Spanish, 7-Sep-2005, unless otherwise indicated) |
Biomedical
|
Social Behavioral
|
|---|---|---|
|
Consent to Participate in a Research Study Adult Subjects |
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Parental Permission for a Minor Child to Participate in a
Research Study |
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Assent to Participate in a Research Study Adolescent Subjects (15-17 yrs) |
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Assent to Participate in a Research Study Minor Subjects (7-14 yrs--use for Biomed and Soc/Beh) |
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| Consent for Stored Specimens, Identified Consent for Stored Specimens, Unidentified Use for Biomedical and Social/Behavioral (instructions for applications that include use of specimens) |
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SSN Collection Forms 1. Use with subject to obtain permission to collect Social Security Number for payment (updated 28-Sep-2007) 2. Use with subject to obtain permission to collect Social Security Number to use as an identifier (updated 28-Sep-2007) (see SSN guidance (PDF) for details) |
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HIPAA Addendum to Consent Form |
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HIPAA Authorization Template (English version updated 14-Sep-2007; Spanish 16-Sep-2005) |
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Alternatives to Full Consent Forms; Examples |
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Short Consent Form (for a single subject who may be illiterate, blind, or otherwise unable to read the consent form — used when full consent form has to be read or translated for subject; updated 12-May-2008) |
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Telephone Consent Script (example) |
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Postal or Email Letter for Anonymous Questionnaire (example) |
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Information or Fact Sheet (example) |
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Focus Group (example) |
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Important note for studies that were approved before March 15, 2005: If you used one of the initial application forms current before the formation of OHRE, these are usually grandfathered for renewals and modifications. However, if the IRB finds that the information on the old initial application form is inadequate, you may be requested to update to the new initial application form. Use the new (and brief) submission sheets below for modifications or renewals, but you may attach the existing approved description of the study (IRB application) and consent forms. Application and consent forms may be reformatted if the investigator prefers to use the new templates, but this is not required for previously approved studies. See the IRB Changes FAQ for additional information.
| Form | |
|---|---|
| Request for Renewal of IRB Approval or Study Closure (updated 23-Apr-2008) |
MS Word |
| Modification of Approved Human
Subjects Research (updated 29-Apr-2008) |
MS Word |
| Adverse Event | MS Word |
| HIPAA-Related Forms for Access to Records at UNC-CH (not OHRE forms) | |
|---|---|
| UNC HCS Form HD974: Request for Access to PHI or Aggregate Data for Research Purposes (UNC Hospitals medical records) (updated 7-Feb-2006) | |
| UNC School of Dentistry Request for Access to Protected Health Information (PHI) for Research Purposes | MS Word |
| UNC School of Dentistry Guidelines for Release of Protected Health Information (PHI) for Research Purposes | MS Word |
| Miscellaneous | |
| Responsibilities of Staff in Human Subjects Research | MS Word |
| Statement of Compliance | |
| Report of Emergency Use of a Test Article to the IRB (updated 20-Feb-2008) | MS Word |
| Other UNC-CH Guidance and Forms (primarily links to other web sites) | |
|---|---|
| General Clinical Research Center (GCRC) Guidance and Forms | |
| Environment, Health and Safety | |
| Oncology Protocol Review Committee | |
| Investigational Drug Service (IDS) | |
| Conflict of Interest Policy | |
| Request to Conduct Research with UNC Hospitals Staff | (coming soon) |