Institutional Review Board Forms

writingphdCompleted IRB forms and documents submitted for North Texas Regional Institutional Review Board review and approval must be submitted in IRBNet. Additionally, the Principal Investigator (PI) must electronically sign the IRBNet package before submitting to the IRB for review. 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.

*As a general reminder, Full Board submissions MUST be received by CLOSE OF BUSINESS (5:00 PM CT) on the day of the submission deadline in order to be considered for the upcoming IRB Meeting.*

Guidance Materials

Version MS Word Doc Adobe Acrobat PDF
Initial Consult Form 07/2021 adobe logo
“Read Me First” Document 11/2018 ms word icon
IRBNet User Manual 08/2019 adobe logo
Guidance on IRBNet’s electronic Wizard Application Form (for new protocol submissions) 04/2019 adobe logo
Investigator Guidebook 07/2021 adobe logo

Change of Key Personnel Form

07/2018 ms word icon

Conflict of Interest (COI) Form

07/2018 adobe logo

Consent Templates:

Consent Form Template (General). This template includes all of the required elements of informed consent (per the federal regulations, with regard to human subjects research), and can be used to develop a consent form for any category of research project (Exempt, Expedited, or Full Board). ms word icon
Consent Statement/Cover Letter Template.  This template should ONLY be used for studies in which the principal investigator is requesting a Waiver of Documentation of Informed Consent, as the subjects will not be signing (documenting) their agreement to participate by signing a consent form. ms word icon
Template for the “Key Information” section of the consent form. NOTE: A “Key Information” section is required for Expedited and Full Board projects but not for Exempt category projects. ms word icon
Short Form Templates (Informed Consent for Use with Non-English Speaking Subjects). Please contact the NTR IRB for guidance if you are unsure when to use a short form.
Short Form- English version 02/2018 ms word icon
Short Form- Spanish version 02/2018 ms word icon

Continuing Review Form

12/2019 ms word icon

FDA Checklist

07/2018 ms word icon

Final Report / Close-Out Forms:

Final Report / Close-Out Form (INVESTIGATOR-initiated projects ONLY) 12/2019 ms word icon
Final Report / Close-Out Form (SPONSORED CLINICAL TRIALS ONLY) 12/2019 ms word icon

HIPAA Templates:

HIPAA Authorization template (UNTHSC version) 07/2018 ms word icon
HIPAA Authorization template (JPS Version) 03/2019 ms word icon

Involvement of Other Institutional Review Boards (IRBs):

IRB Authorization Agreement 2019 adobe logo
SMART IRB Agreement Template 2018 adobe logo

Protocol Synopsis:

Protocol Synopsis Template (General) 11/2018 ms word icon
Protocol Synopsis Template (Biospecimens) 11/2019 ms word icon
Protocol Synopsis Template (Chart Reviews) – Not to be used for Data Registry projects 11/2019 ms word icon
Protocol Synopsis Template (Publicly-Available Dataset) 07/2021 ms word icon
Protocol Synopsis Template (Existing Materials or Data)                                                                                                             (for use with projects that involve materials and/or data that were originally collected for non-research purposes) 10/2019 ms word icon
Protocol Synopsis Template (Survey Research) 12/2019 ms word icon
Sponsored Clinical Trials (Site-Specific Protocol Synopsis and Guidance) 04/2019 ms word icon

Serious Adverse Event (SAE):

SAE Form – OFF-SITE 11/2019 adobe logo
SAE Form – ON-SITE 12/2019 adobe logo
SAE Guidance Document 11/2019 adobe logo

Waiver Forms:

Waiver of Informed Consent 01/2019 ms word icon
Waiver of Documentation of Informed Consent 01/2019 ms word icon
Waiver of HIPAA Authorization 01/2019 ms word icon

This page was last modified on August 13, 2021