Office of Research Regulatory Affairs
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ProtocolBuilder - Now Available
What is ProtocolBuilder?
- A secure, cloud-based application that helps researchers create high-quality, consistent human subject research protocols. It supports the internal and IRB review process by guiding you through each section of your protocol.
Login:
- Access the ProtocolBuilder link
- Use your UTSW credentials and password to login
- Click Submit
Who can use it?
- All individuals with UTSW username
Where to find tutorials?
- Tutorials are located within the ProtocolBuilder system under New Features & Tutorials.
Support contact:
Human Research Protection Program
IRB Office
UT Southwestern Medical Center
Office: 214-648-3060
Email: [email protected]
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UTSW RedCap 21 CFR Part 11 Project
UTSW 21 CFR Part 11 Compliant REDCap system is live! For more information on how to create a RedCap project, training, and resources, please visit the REDCap SharePoint site.
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UTSW ETHOS Updates
**Important Notice**
As of Monday, December 23, 2024, all new submissions must be created in UTSW ETHOS.
eIRB is no longer accepting new submissions.
Access to existing studies
Exempt and existing studies not yet migrated will continue to be managed in eIRB. These will be prioritized and merged into UTSW ETHOS in waves, based on study type and activity status.
Researchers will be notified once their study has been migrated and can begin initiating IRB requests in the UTSW ETHOS system.
Urgent Requests: While study teams will not be able to make electronic changes to studies during migration, the IRB Office staff will assist with any urgent updates or submissions. Please submit urgent requests via Urgent Requests Form
If you have any questions, please contact [email protected].
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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 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 HRPP Satisfaction Survey.