Institutional Review Board Forms
Completed IRB forms and documents submitted for North Texas Regional Institutional Review Board review and approval must be accompanied with a signed memo from the Principal Investigator (PI) indicating their request. The memo should also include the protocol name and IRB number (if activity or request is post-approval). An IRB number will be generated for new protocols upon initial submission / review. Documents should be submitted in a timely manner for proper review and approval.
Your computer must have Microsoft Word and/or Adobe Acrobat to access and read the following forms, samples and templates. If you need to download Adobe Acrobat, please follow this link.
Important Note:
- Please submit all documents in IRBNet by selecting “Create New Project” in the left-hand navigation bar.
- Please note the following:
- THE PRINCIPAL INVESTIGATOR MUST HAVE FULL ACCESS TO THE IRBNET PROTOCOL PACKAGE IN ORDER FOR IT TO BE REVIEWED BY THE IRB.
- Please be sure to use a very descriptive file name for each document submitted as a pdf or word.doc file. Example: “MMSE scale” is much better than “Scale 1”. . . “Recruiting flyer” is better than “Ad 1”, and so forth.
- Refer to the “Read Me First” document located in IRBNet under “Forms and Templates” for more guidance.
- For Progress Reports/Continuing Reviews:
- Please submit all documents in IRBNet by entering the project you wish to update through “My Projects.” Then select “Create a New Package” in the left-hand navigation bar.
IRB Application Forms
| General Institutional Review Board Forms | Version | MS Word Doc | Adobe Acrobat PDF |
|---|---|---|---|
| IRB New Protocol Application (Full Board Review) ***REVISED*** |
11/2018 |  |
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| IRB Protocol Synopsis Template ***REVISED*** | 11/2018 | |
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| Exempt Review Application ***REVISED*** | 11/2018 | |
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| Expedited Review Application ***REVISED*** | 11/2018 |  |
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| Progress Report ***REVISED*** | 11/2018 | |
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| Sponsored-Initiated Close Out Form ***NEW*** | 11/2018 | |
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| Investigator-Initiated Close Out Form***NEW*** | 11/2018 | |
IRB Reportable Events Forms
| General Institutional Review Board Forms | Version | Adobe Acrobat PDF | MS Word Doc |
|---|---|---|---|
| Serious Adverse Event Report for SAE’s at UNTHSC or JPS (ON-SITE) ***REVISED*** | 01/2018 | |
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| Guidance on ON-SITE SAE reporting ***REVISED*** | 01/2018 | |
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| Serious Adverse Event Report for SAE’s at Other Sites (OFF-SITE) ***REVISED*** | 01/2018 | |
Involving Other IRBs
| General Institutional Review Board Forms | Version | Adobe Acrobat PDF |
|---|---|---|
| IRB Authorization Agreement |
2018 | |
| SMART IRB Agreement Template | 2018 | |
Additional IRB Research-Related Forms
| General Institutional Review Board Forms | Version | MS Word Doc | Adobe Acrobat PDF |
|---|---|---|---|
| Conflict of Interest (COI) Form ***REVISED*** | 01/2018 | |
|
| Existing Database Form (research involving existing data that are publicly available without restriction or require a “responsible use statement”) ***REVISED*** | 11/2018 | |
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| Single Subject Case Study Form (research involving single subject chart/record review) ***REVISED*** | 11/2018 | |
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| Chart Review Protocol Application (bundles protocol synopsis with IRB application, and Waivers of Informed Consent and HIPAA) ***REVISED*** | 11/2018 | |
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| Protocol Template for Research Involving Materials (data, records) Already Collected ***REVISED*** | 11/2018 | |
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| Protocol Template for Research Involving Human Biological Material ***REVISED*** | 11/2018 | |
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| Protocol Template for Survey Research ***REVISED*** | 11/2018 | |
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| Application for Change of Key Personnel ***REVISED*** | 01/2018 | |
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| Waiver of Informed Consent ***REVISED*** | 11/2018 | |
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| Waiver of Documentation of Informed Consent ***REVISED*** | 11/2018 | |
HIPAA Forms
| General Institutional Review Board Forms | Version | MS Word Doc | Adobe Acrobat PDF |
|---|---|---|---|
| HIPAA Research Waiver Application ***REVISED*** | 01/2018 | |
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| HIPAA Authorization Template ***REVISED*** | 01/2018 | |
Consent Templates
| General Institutional Review Board Forms | Version | MS Word Doc | Adobe Acrobat PDF |
|---|---|---|---|
| Study Consent Cover Letter (in lieu of Documentation of Informed Consent) ***REVISED*** | 01/2018 | |
|
| Research/Consent Statement for On-line Survey ***REVISED*** | 01/2018 | |
Short Form Templates
Informed Consent for Use with Non-English Speaking Subjects
| General Institutional Review Board Forms | Version | MS Word Doc | Adobe Acrobat PDF |
|---|---|---|---|
| Short Form- English version ***REVISED*** | 02/2018 | |
|
| Short Form- Spanish version ***REVISED*** | 02/2018 | |