IRB Announcement Archive

This archive contains documents and information sources provided to the NTR IRB research community via past announcements. Please Note: all forms, webpages, and documents that were linked in the original announcements have been removed from the announcement archive, in order to reduce the potential number of broken or outdated links on our website.

If you have any questions about these resources/updates, please contact the NTR IRB office at 817-735-0409 or NorthTexRegIRB@unthsc.edu.

NTR IRB Announcement and Reminders – July 31, 2023

We hope you are all enjoying your summer! The North Texas Regional Institutional Review Board would like to provide our researchers with some updates, reminders, and announcements. As you continue to contemplate and plan your research endeavors, please keep the following in mind:

1. Update to Reliance Agreement process:

We have created a form for submitting Reliance Agreement requests, titled “NTR IRB Reliance Agreement”. Investigators who are engaged in a collaborative study can use this form to request for another IRB to be the “IRB of record” for a multi-site human subject research study, or vice versa (request the NTR IRB to be the IRB of record for a multi-site human subject research study). Researchers requesting reliance should first complete this form, which will request an explanation of the situation/request, the reason for the reliance agreement, and any required documents.

2. General reminders for NTR IRB Researchers:

- Please ensure all research personnel remain current with their IRB training requirements. If a researcher’s training lapses, please halt all engagement in ANY research activity (for that specific researcher) until their training has been renewed. Continued engagement in research under lapsed training is considered a violation of IRB processes and procedures and should only continue IF the researcher’s role/responsibility is critical to subject welfare and safety. For more information regarding IRB training requirements, please click here. If you would like general guidance on tracking training records, please contact our office.
- For any IRB-regulated research project in which research activities have ended, please remember to close it out with the IRB. Study closure can occur once study recruitment/enrollment and the intervention have been completed, and all data have been de-identified (no direct, indirect or HIPAA identifiers remain). To close out a project, please complete and submit within IRBNet the applicable study close-out form (investigator-initiated or sponsored clinical trials). Note: For HSC projects only, any open, active project is subject to our Post-Approval Monitoring Program.
- For multi-site / external research collaborations (i.e., reliance agreements), we highly encourage researchers to seek our guidance before initiating any research activities (see above for an update to this process). Ultimately, when multiple institutions are engaged in research, a decision should be made whether each IRB involved in the collaboration should do their own independent review of the research, or if one institution/IRB will assume regulatory oversight of the research being conducted by all collaborating institutions. This decision is made (on a case-by-case basis) by institutional leadership after extensive discussions between the partnering regulatory offices and the collaborating researchers.

Please never hesitate to contact us should you have any questions. We find that opening the line of communication facilitates the submission and review process. You may reach us through the Office of Research Compliance main phone line (817-735-0409) or at NorthTexRegIRB@unthsc.edu.

Announcing New NTR IRB Resources and Guidance – March 13, 2023

We hope the start of 2023 has brought a lot of new exciting research endeavors, opportunities and successes. As you embark upon this new year, the North Texas Regional Institutional Review Board (NTR IRB) would like to highlight specific guidance, resources, and tools – all available to you on our website!

IRB Resources/Tools/Templates:

Request a New Study/Initial Consultation: Meet with an IRB Compliance Manager to discuss your project!
IRB Concepts and Resources Video: This 15-minute video provides a general overview of main IRB ethical concepts and the NTR IRB’s resources.
IRBNet Tutorial Video: This 15-minute video covers the basics of how to navigate the IRBNet system.
Investigator Guidebook: This is intended to facilitate investigators with the creation and submission of IRB projects.
Instructional Guidance and Sources for Human Subject Investigators: Visit our page for specific guidance and information about the following topics:
Survey Guidance document
Focus Group and Interview Guidance document
Existing Materials Guidance document
Guidance for Research and Repository Protocols
Data Storage and Security Guidance
Research using Human Biological Materials/Samples
Re-contacting Subjects from Existing Research Studies
Recruitment Guidance
IRB Guidance for Students
IRB Forms and Templates: A few of the forms found on this page include the following:
General Protocol Synopsis Template (Companion Document: Master Protocol Synopsis Guidance Sheet)
Consent Form Template
Consent Statement/Cover Letter Template
HIPAA Authorization Templates
Waiver Documents (for Informed Consent and HIPAA Authorization)
Other Helpful Items:
Not Human Subject Research Determinations
IRB Announcement Archives: Check out past IRB announcements and guidance information.
Office of Research Compliance Newsletter Archives: Review previous newsletters containing helpful updates, guidance tips and news items for Investigators, Coordinators, Students and other Research team members.

We highly encourage you to review and utilize these resources as you develop your research protocol and submission. Please stay tuned to the NTR IRB website for important updates and announcements.

Announcing New NTR IRB Resource and Guidance Tutorial Videos- July 22, 2022

The North Texas Regional IRB Premieres Two New Resource Videos:

(Click the below thumbnail to watch each video direct on YouTube.)

As part of our ongoing efforts to provide detailed and helpful guidance to our NTR IRB researchers, the NTR IRB Office has created two short 15-minute training videos with researchers like YOU in mind, and invite you to watch the exclusive premiere at this time!

The first video, Institutional Review Board Concepts and Resources, provides the historical background of IRBs, a brief overview of IRB concepts, and NTR IRB specific Resources and Guidance materials.

The second video, IRBNet Tutorial Video for NTR IRB Researchers, is a “How To” video where we cover the basics of how to use IRBNet – which is the electronic submission system used by the NTR IRB.

You may watch these short videos from start to finish, or select the specific chapter(s) that pertain to your questions. These videos will also be housed on the NTR IRB website.

Because your human subject research is important to us, we hope to provide other tutorial videos in the future as well as additional guidance/resource materials. Please continue to stay tuned!

In the meantime, we hope you find these videos to be helpful in your HSR research endeavors!

Announcing New NTR IRB Resources and Updates – February 10th, 2022

In continuing our endeavors to streamline and enhance processes for our human subject researchers, the North Texas Regional IRB is excited to share the following new resources for investigators as well as some important updates:

Update Regarding Protocol Synopsis Templates and New Resources:

As part of the streamlining efforts, the NTR IRB is proud to announce the release of our revised General Protocol Synopsis Template, and the accompanying Master Protocol Synopsis Guidance Sheet. Additionally, the NTR IRB has also created several project-specific guidance documents – please see links and descriptions below.

These resources have been created as part of the NTR IRB’s commitment to providing researchers with valuable tools needed for their research successes.

PLEASE NOTE: The revised General Protocol Synopsis Template should now be used for ALL human subject research studies, with the exception of Chart Review studies. Studies that only involve chart reviews will continue to use the Protocol Synopsis for Research Involving Chart Reviews.

In order to complete a human subject research protocol using the General Protocol Synopsis Template, researchers should refer to the Master Protocol Synopsis Guidance Sheet, as well as the appropriate project-specific guidance document(s) (as needed). Each project-specific guidance document below lists required elements for IRB submission in addition to the basic protocol elements that are outlined in the main Protocol Synopsis template:

Survey Guidance Document
Existing Materials Guidance Document
Focus Group and Interview Guidance Document
Guidance for Research Registry and Repository Protocols Document

In addition to the above, guidance documents regarding specific elements of a protocol are also now available for reference/use:

NTR IRB Recruitment Guidance
Guidance Document on Data Storage and Security

Updates to NTR IRB Investigator Guidebook:

The Investigator Guidebook was introduced in July 2021 with the goal of helping investigators create and submit IRB projects. A 3^rd chapter was recently added:

Chapter 3 offers tips and tricks for developing and submitting a new project to the IRB. The first subsection in this chapter focuses on how researchers can respond to the NTR IRB’s feedback via a signed memo or in a tabular format. The chapter also includes guidance regarding how to access IRB-related documents in IRBNet and how to access IRBNet training resources.

NTR IRB Website Update:

Website Update: A new “IRB Announcement Archive” page has been added to the NTR IRB’s website, which includes all past announcements sent out regarding all new resources and updates for NTR IRB Investigators.

If you have any questions about these new/revised resources and updates, please contact the NTR IRB office at 817-735-0409 or NorthTexRegIRB@unthsc.edu.

Announcing New NTR IRB Resources and Updates – August 10th, 2021

New Consent Form Templates for Human Subject Investigators:

In continuing the North Texas Regional Institutional Review Board’s (NTR IRB’s) commitment to providing researchers with valuable tools needed for their research successes, the NTR IRB is excited to announce the release of two new consent form templates for investigators:

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).
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. Please note that this template replaces the NTR IRB’s previous versions of the “Research Statement/Consent Cover Letter” templates.

Please note that each template includes general guidance as well as instructions to investigators on how to draft an appropriate consent form/template. Investigators should carefully read through the information provided in each template, and ensure that all information included in the final draft submitted to the NTR IRB is appropriate to the conduct of their specific research study.

Recent Updates to NTR IRB Standard Operating Principles and Procedures (SOPs):

The NTR IRB recently made some administrative updates to the NTR IRB SOPs. Among these updates (which are outlined on pages 5-6 of the SOPs), include a change in the timeline of Administrative Closures of new projects (in which there has been no response to IRB comments) from 6 months to 2 months.

The goal of this change is to ensure timely IRB review and approval of projects. Investigators should always communicate to the IRB staff/office, as soon as possible, any questions/concerns they have regarding IRB comments, or if there are any project-related issues that arise during the course of the review. Remember – we are always here to help you so please don’t hesitate to reach out!

Announcing New Resources for Investigators – July 30th, 2021

As part of the North Texas Regional IRB’s commitment to provide researchers with valuable tools needed for their research successes, the NTR IRB is proud to announce two exciting resources for investigators and an important website update:

Initial Consultation for Investigators about new projects
- The purpose of these consultations is to provide the NTR IRB with specific information about a potential study submission. These consultations are intended to be an opportunity for the investigator to ask any questions and for the NTR IRB provide guidance as needed. Investigators should fill out the Consultation Request Form to provide details and timelines about their project to request a meeting.
Investigator Guidebook
- The Investigator Guidebook is intended to provide information about various types of projects in order to assist investigators with the creation and submission of IRB projects. Currently, this manual consists of 2 chapters:
  - Chapter 1 outlines the definition of human subjects research and how to submit to the IRB if you believe your project is Not Human Subjects Research
  - Chapter 2 provides guidance on projects that use clinically derived data for secondary use (such as chart reviews, registries, and repositories)

This guidebook will be a “living” document and updated regularly in order to ensure that all information remains current and accurate.

New “IRB Forms” page, which has updated formatting for easier navigation as well as links to the most current versions of the IRB forms.

This page was last modified on August 1, 2023