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COVID-19 in Human Research Resources 

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IRB/HRPP Fee Change Announcement

September 22, 2021

The HRPP will institute a new IRB and HRPP Administrative Fee schedule for any study where the contract is submitted on or after October 15, 2021. Most of the fees will remain the same with the addition of a new modification review fee for sponsor-initiated modifications. See the below table for a summary of the fee schedule. The HRPP will be working with Sponsored Programs Administration and Department Administrators to ensure a smooth transition for newly submitted contracts. 

If you have any questions or need additional information, please contact Joshua Fedewa (IRB Director). 

Comparing Current and New Fees (changes highlighted)

Study type

Submission type

Fee expiring October 14, 2021

Fee Effective October 15, 2021

UTSW IRB Reviews

(IRB Review Fees)

New Study

$3,000

$3,000

Continuing Review

$1,500

$1,500

Modifications

$0

$750

External IRB Reviews

(HRPP Administrative Review Fees)

New Study

$3,000

$3,000

Continuing Review

$1,500

$1,500

Modifications

$0

$250

UTSW Serving as sIRB

(sIRB Review Fees)

New Study - Relying Site

$1,500

$1,500

Continuing Review – Relying Site

$1,500

$1,500

Modifications

$0

$0

HRPP Virtual Open Office Hours

August 6, 2020

Due to the COVID-19 pandemic, HRPP Open Office Hours has gone virtual and added a partner, the Office of Clinical Trial Management (OCTM). Join us weekly to obtain answers to your study-related questions and receive guidance on regulation-based aspects of your research.

Unsure which documents you need to upload with your study submission? Have questions regarding participant recruitment and informed consent? Need guidance on obtaining performance site approval?

HRPP & OCTM staff have the expertise to answer these questions and many more. To better serve the UTSW research community, HRPP-OCTM Virtual Open Office Hours is held weekly. No appointment necessary.

Zoom links for Tuesday and Thursday OOHs sessions are provided in a weekly HRPP Events Listserv* announcement.

HRPP-OCTM Virtual Open Office Hours

Tuesdays & Thursdays

10:00 am-11:00 am held via virtual Zoom Sessions

* Register for HRPP Listserv to receive these announcements (link below)  

Enrollment and Consent of Non-English Speaking Subjects Guidance

January 28, 2020

Effective January 21, 2020, the UTSW HRPP released a guidance document titled, "Enrollment and Consent of Non-English Speaking Subjects." This document was created to clarify when non-English speaking subjects should be enrolled on studies, how the UTSW IRB will review and approve the use of short forms during initial and modification reviews, and provide clarity regarding the documentation processes when utilizing a short form or fully translated document. Below is the executive summary from the guidance:

  • Study teams should consider whether inclusion of non-English speaking subjects is appropriate for each study
  • Short forms will be approved for new studies to enroll an occasional* non-English speaking subject
  • If more than an occasional* non-English speaking subject will be enrolled, a short form may be approved for new studies while the full translation is pending
  • The UTSW HRPP will confirm short forms are used appropriately at annual review
  • Using short forms with more than occasional subject may require a fully translated consent be IRB approved and may be considered non-compliance

*generally meaning three or less over the course of the study

To request a quote to obtain a fully translated version of any research study document, see the HRPP Translation Support Service guidance.

If you have any questions or need additional information, please contact Joshua.Fedewa@utsouthwestern.edu (HRPP Associate Director).

eIRB Update: Simplified Annual Updates Available for Some Studies
December 27, 2019

eIRB was updated on Friday, December 27, 2019 to allow for submission of simple Annual Updates (AU) in lieu of existing Continuing Reviews (CR) for some studies. This update was made in response to Revised Common Rule which no longer requires continuing review for some minimal risk research. In addition, studies relying on non-UT Southwestern IRBs will also be able to utilize this simplified Annual Update form.

If your study qualifies for an Annual Update, you will receive notifications requesting submission of an “Annual Update” or a notification that your “Annual Update is Overdue.” In addition, the “My Activities” section of eIRB will allow you to create a “New Annual Update” instead of a “New Continuing Review”. The eIRB submission and review process for AUs mirrors that of the CRs process. However, AUs will not be reviewed by the IRB. Instead, AUs will receive an administrative review within the HRPP office. 

For additional information, refer to the Annual Update - Frequently Asked Questions (FAQs).

Archived News

Enhancing Transparency of Study Activation - Greenlight - December 10, 2019 
AAHRPP Accreditation Awarded June 17, 2019 
The Revised Common Rule became effective January 21, 2019