COVID-19 Update: Information and resources can be found here.

Human Research Protection Program Office

COVID-19 Updates - Impacts to Human Research

The following links will be updated regularly. Please refer to them for the most up-to-date information:

HRPP Announcement (this link will be updated as new announcements are sent out on the Listserv)

HRPP COVID-19 FAQs for Human Research

COVID-19 in Human Research Resources 

Office of Clinical Research website for resources and other tools for conducting research during the

COVID-19 outbreak (COVID-19 screening surveys in English and Spanish can be phone under "Quick Links" on the OCR webpage)

UTSW COVID-19 website for updates regarding UTSW operations and guidance during the

COVID-19 outbreak

 

About the Office 

The UT Southwestern Medical Center Human Research Protection Program is responsible for ensuring that all human-subject research conducted by faculty, staff, or students for UTSW is conducted ethically and in compliance with federal regulations and policies that promote ethical research in human subjects according to the Federalwide Assurance on file with the U.S. Department of Health and Human Services, Office of Human Research Protection.

Seal of Full Accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc.

All human subject research conducted by UT Southwestern faculty, staff, or students on behalf of UT Southwestern must be reviewed by the Human Research Protection Program Office (HRPPO). The following responsibilities are within the scope of the HRPPO:

  • IRB Review – Research reviewed by one of four UT Southwestern IRBs or by a UTSW IRB Expedited Reviewer
  • Reliance Review – Research reviewed by a non-UT Southwestern IRB will undergo an abbreviated review
  • Training –The HRPPO offers both required and optional training opportunities in a multitude of formats.
  • Quality Assurance/Reportable Event Review – The HRPPO QA Program works closely with the Education, Compliance, and Privacy Programs at UTSW and its affiliates to identify educational opportunities, implement best practices, and institute systemic improvement.

UT Southwestern IRBs routinely review research involving human subjects which is conducted at UT Southwestern and/or several affiliated partner hospitals. UTSW has standing partnerships with Children’s Healthâ„ , Parkland Health & Hospital System, Texas Health Resources, and Texas Scottish Rite Hospital

Metrics

The HRPPO monitors the submission volume and turnaround times routinely. See the most current HRPPO metrics.

News

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 

Stay Informed! Subscribe to the Listservs!

The following Listservs provide subscribers with important announcements. The Listservs are available to anyone at UT Southwestern or affiliates. Please use the following links to sign up:

  • HRPP Researchers Events – Receive information about HRPP events such as training opportunities, Open Office Hours and the Research Matters Lecture Series.
  • HRPP News – Receive important HRPP announcements, information related to HRPP procedures, changes in policies, forms and processes, and updates on regulatory issues
  • Research Administration – Important research systems announcements and funding opportunities distributed by Research Administration.
  • eResearchSystems – eResearch Systems.

Research Matters Lecture Series

The Research Matters lectures is presented by the Human Research Protection Program Office (HRPPO) at UT Southwestern Medical Center.

See upcoming events, and view past sessions and slides.

Contact Us

Phone: 214-648-3060
Fax: 214-648-2171
hrpp@utsouthwestern.edu
Mail Code: 8843