IRB Announcement Archive

This archive contains documents and information sources provided to the NTR IRB research community via past announcements. 

 

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

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:   

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

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 3rd 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.

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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:

  1. 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).
  2. 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!

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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.

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This page was last modified on February 16, 2022