• About the HRPP Department
• Metrics
• HRPPO Satisfaction Survey
• UTSW ETHOS Updates

About the HRPP Department 

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.

All human subject research conducted by UT Southwestern faculty, staff, or students on behalf of UT Southwestern is overseen by the Human Research Protection Program (HRPP) Department. The HRPP responsibilities are carried out by the following offices:

• IRB Office (IRBO) – Responsibilities include: 
  • UTSW IRB review - Research reviewed by one of four UT Southwestern IRBs or by a UTSW IRB Expedited Reviewer
  • Non-UTSW IRB Review (sIRB/Reliance) – Collaborative research reviewed by a single IRB (either UTSW IRB or a non-UT Southwestern IRB)
• Quality Assurance and Monitoring (QAM) Responsibilities include:
  • Routine and for cause monitoring 
  • Support to investigators before, during, and after regulatory audits 
• Regulatory Support Office (RSO) - Responsibilities include support for investigators with:
  • Clinicaltrials.gov registration and reporting requirements.
  • FDA sponsor investigator submission and reporting requirements for an IND or IDE

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 Health℠, Parkland Health & Hospital System, Texas Health Resources, and Scottish Rite for Children

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Metrics

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

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HRPPO Satisfaction Survey

We want to hear from you. Please take our HRPPO Satisfaction Survey.

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UTSW ETHOS Updates

We are excited to announce the new electronic IRB system “UTSW ETHOS” will be live for new study submissions in late December! You may read about the new system, features, training opportunities, and keep up with latest developments on the UTSW ETHOS SharePoint site.

1. The IRB Office will not have any downtime during the migration. IRB reviews will continue to be accepted and reviewed during the phased study migration.
2. There will be limited functionality in the current eIRB system for some study types (details described below in Study Migration Plan).
3. The new UTSW ETHOS will accept all types of new study submissions on December 23, 2024.
4. Studies expiring during the migration should submit continuing reviews prior to the transition. The IRB Office will notify you if your studies are expiring to ensure the approval does not lapse.
5. Please refer only to communication about the new UTSW ETHOS that has been generated by the UTSW Human Research Protection Program. This is necessary to ensure accurate information about the transition plan.

Study Migration Plan

• No full board electronic submissions (new studies, continuing reviews, and/or modifications) will be accepted in the current eIRB system from November 24 – December 23, 2024.**
• This allows the IRB committees to complete all Full Board submissions by December 18, 2024 (the final convened IRB meeting before system go-live).
• Electronic submissions for Full Board review will need to be submitted into the old eIRB system by November 24, 2024.
• Study migration phases for activated studies are prioritized as follows:
• Full Board studies – open and not closed to enrollment
• Full Board studies otherwise active
• Expedited and External IRB (Reliance) studies
• All other studies that were not active during initial migration phases
• The studies migration will be completed by the HRPP staff with the assistance of the Research and Academic Services (RAS) Office. There is no additional work expected from study teams to migrate active studies.

**The IRB Office will receive and review any urgent Full Board items during this time. While study teams will not be able to make electronic changes or submissions to existing Full Board studies at the start of December, the IRB Office staff will be able to make changes on your behalf, review, and approve any urgent submissions.\ 

We planned this transition carefully to ensure there is no downtime in the IRB and that research will not be adversely affected. 

If you have any questions about the new UTSW ETHOS system, the migration plan, or how it may impact you, please send an email to the eIRB@utsouthwestern.edu.