UTSW IRB
Overview
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.
UT Southwestern has four Institutional Review Boards (IRBs). Each IRB meets twice per month and is properly constituted to review all submissions and types of research.
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.
The Institutional Review Board is charged with the responsibility of reviewing, prior to its initiation, research involving human participants. The IRB is primarily concerned with ensuring that the rights, welfare, and privacy of human participants are protected.
The IRB has the authority to approve, require modifications in order to approve, disapprove, suspend, terminate, and observe the consent process for research that falls within its jurisdiction as specified by both the federal regulations and institutional policy. Each IRB must have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its safety, institutional, legal, scientific, and social implications. Each Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist. The UT Southwestern IRBs have several consultants who advise the Board and are periodically involved in protocol review as necessary.
Jurisdiction
The UT Southwestern IRBs routinely review and approve research when UTSW or Partner Hospitals are engaged in human subjects’ research. UT Southwestern IRBs serve as the IRBs of record for the following partner hospitals:
Review Types
All review types require Performance Site Approval.
Non-Human Research (No IRB Review after PI submits application in UTSW ETHOS)
- Deceased subject research
- Leftover, de-identified specimens
- Commercial cell lines
- Data/specimens from a repository (received de-identified)
Non-Regulated Research (HRPPO Staff/IRB Member Review Only)
- Quality Improvement
- Quality Assurance
- Health Surveillance
- Program Evaluation
Exempt (HRPPO Staff/IRB Member Review Only)
- Comparing/evaluating educational methods
- Benign behavioral interventions
- Secondary research with biospecimens and/or information
- Surveys of adults
Expedited (Designated IRB-Member Review)
- Prospective clinical data and biospecimens
- Non-invasive procedures
- Surveys of children
- Chart reviews not eligible for exemption
Full Board (IRB Committee Review)
- Greater than minimal risk research
- Clinical trials
- Any research use of: radiation, anesthesia, or invasive procedures
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
eIRB@UTSouthwestern.edu
Note: UTSW has not adopted use of InformedConsentBuilder
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.
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 eIRB@UTSouthwestern.edu.
Metrics
The HRPP monitors the submission volume and turnaround times routinely. See the most current HRPP metrics.
Satisfaction Survey
We want to hear from you. Please take our HRPP Satisfaction Survey.