Institutional Review Board Forms and Templates
Completed 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.
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.
- 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.*
Consult
| File Name | Document Description | Category | Version Date |
|---|---|---|---|
| Initial Consult Form | The purpose of this form is to provide the North Texas Regional Institutional Review Board (NTR IRB) with specific information about a potential new study submission and to request a consultation with an NTR IRB staff member before submitting a project for review. | Form | 05.2022 |
Protocol Synopsis
| File Name | Document Description | Category | Version Date |
|---|---|---|---|
| Master Protocol Synopsis Guidance Sheet | This document provides general guidance and tips on how to complete the General Protocol Synopsis template. The General Protocol Synopsis provides relevant study information for an effective IRB review, as required by the federal regulations. | Guidance | 02.2022 |
| Protocol Synopsis Template (General) | For all research projects involving human subjects, provide information about the project using this template. Note that a clear and complete protocol description facilitates a timely and effective review of protocols. Prior to completing this form, please consult the NTR IRB Master Protocol Synopsis Guidance Sheet, which includes guidance/instructions for developing your specific research project (e.g., Focus Groups/Interviews, Surveys, Registries/Repositories, Existing Materials, etc.). | Template | 03.2024 |
| Protocol Synopsis Template (Chart Reviews) - Not to be used for Data Registry Projects | To assist with timely and appropriate reviews of projects involving analysis of (more than one patient’s) medical records and/or charts, please fill out this document. Note that this protocol must list a full-time faculty member (not adjunct), staff member, or employee (not part-time) as the Principal Investigator. | Template | 11.2019 |
Consent / HIPAA Authorization
| File Name | Document Description | Category | Version Date |
|---|---|---|---|
| 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). | Template | 04.2024 |
| 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. | Template | 04.2024 |
| Consent Form "Key Information" Section Template | A “Key Information” section is required for Expedited and Full Board projects but not for Exempt category projects. | Template | 04.2019 |
| Short Form Template - English | 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. | Template | 04.2024 |
| Short Form Template - Spanish | 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. | Template | 04.2024 |
| HIPAA Authorization Template (HSC version) | The purpose of this template is to create the HIPAA Authorization form that human subjects, parents, and/or legally-authorized representatives of human subjects sign to give you permission to obtain, use and disclose protected health information for research purposes. | Template | 12.2023 |
| HIPAA Authorization Template (JPS Version) | The purpose of this template is to create the HIPAA Authorization form that human subjects, parents, and/or legally-authorized representatives of human subjects sign to give you permission to obtain, use and disclose protected health information for research purposes. | Template | 12.2023 |
| Waiver of Informed Consent | Federal regulations require that investigators obtain the informed consent of each research participant (or the participant’s legally authorized representative) and document consent with a written consent form. This requirement must be met in all cases, except in very specific circumstances in which the North Texas Regional Institutional Review Board (IRB) is authorized to grant a “waiver.” | Forms | 01.2019 |
| Waiver of Documentation of Informed Consent | Federal regulations require that investigators obtain the informed consent of each research participant (or the participant’s legally authorized representative) and document consent with a written consent form. This requirement must be met in all cases, except in very specific circumstances in which the North Texas Regional Institutional Review Board (IRB) is authorized to grant a “waiver.” | Forms | 01.2019 |
| Waiver of HIPAA Authorization | In certain situations, researchers may request to waive (or alter) the requirement to obtain HIPAA Authorization when involving individually identifiable health information. Specific criteria must be met to grant a HIPAA waiver of alteration. It is important to note that a HIPAA waiver is not the same as a waiver of informed consent. An investigator must request either separately. Please access this document to request said waiver. | Form | 01.2019 |
Key Personnel
| File Name | Document Description | Category | Version Date |
|---|---|---|---|
| Change of Key Personnel Form | Use this form to request changes in study personnel, including personnel. This applies to co-investigators, study staff, students, and trainees. DO NOT USE THIS FORM TO REPORT CHANGES IN PRINCIPAL INVESTIGATOR. For Principal Investigator (PI) change, you must revise the protocol synopsis to reflect the new PI. | Form | 01.2018 |
| Conflict of Interest (COI) Form | Each protocol submitted to the IRB for review must be accompanied by a Conflict of Interest (COI) Disclosure Statement for each investigator/key personnel who is involved in the research activities and/or interacting with research subjects in the covered study. | Form | 01.2018 |
Continuing Review and Close Outs
| File Name | Document Description | Category | Version Date |
|---|---|---|---|
| Continuing Review Form | Please use this form to provide information about your research project; the responses you provide will be the basis for the re-review of your project. Federal regulations require an IRB to conduct a Continuing Review of all research projects involving the use of human subjects at least annually, or more frequently, appropriate to the degree of risk. | Form | 04.2024 |
| Conflict of Interest (COI) Form | Each protocol submitted to the IRB for review must be accompanied by a Conflict of Interest (COI) Disclosure Statement for each investigator/key personnel who is involved in the research activities and/or interacting with research subjects in the covered study. | Form | 01.2018 |
| Final Report / Close-Out Form (INVESTIGATOR initiated projects ONLY) | As a condition of project approval, the North Texas Regional Institutional Review Board (IRB) requires a Final Report (close-out) of all research projects involving the use of human subjects. Use this form to provide information about your research project. Your responses will be the basis for review of your request to formally terminate IRB oversight of this research activity. | Form | 11.2019 |
| Final Report / Close-Out Form (SPONSORED CLINICAL TRIALS ONLY) | As a condition of project approval, the North Texas Regional Institutional Review Board (IRB) requires a Final Report (close-out) of all research projects involving the use of human subjects. Use this form to provide information about your research project. Your responses will be the basis for review of your request to formally terminate IRB oversight of this research activity. | Form | 11.2019 |
IRBNet / Electronic Submission
| File Name | Document Description | Category | Version Date |
|---|---|---|---|
| IRBNet User Manual | This user manual is designed to assist investigators and study teams in the use of IRBNet. You will find step by step instructions for registration, initial project submission and amendments. | Guidance | 08.2022 |
| IRBNet’s electronic Wizard Application Form Guidance Document | The guidance in this document is intended to help you navigate through completing the IRBNet Wizard/SMART application form (i.e., the IRB application form for a new study). | Guidance | 04.2019 |
Reportable Events
| File Name | Document Description | Category | Version Date |
|---|---|---|---|
| Serious Adverse Event (SAE) Guidance Document | This document provides guidance on SAE reporting. | Guidance | 11.2019 |
| Serious Adverse Event (SAE) Form - ON-SITE | A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution. Researchers must report a SAE within 10 working days of notification of the event by providing a detailed written summary of the event. Please use this SAE Onsite application for this written summary of events occurring onsite (i.e. NTR IRB affiliated research projects). | Form | 12.2019 |
| Serious Adverse Event (SAE) Form - OFF-SITE | A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution. Researchers must report a SAE within 10 working days of notification of the event by providing a detailed written summary of the event. For multi-site research projects, please use this SAE Offsite application for this written summary of events occurring offsite (i.e. non-NTR IRB affiliated research projects). | Form | 11.2019 |
| Protocol Violation Report Form | Protocol Violations/Deviations are considered to be any change or departure from the IRB-approved study design, study procedures, or study materials of a research project. A violations/deviations must be reported within 10 working days of discovery. This form prompts researchers to provide all the necessary information needed by the IRB to assess the violation/deviation.
| Form | 01. 2024 |
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.
This page was last modified on July 23, 2024