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UTSW IRB

Overview

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.

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-Research (No IRB Review Required)

    • Quality Improvement
    • Quality Assurance
    • Health Surveillance
    • Program Evaluation

Download Form Y2 – Non-Regulated Research Request Form and HRPP@utsouthwestern.edu it to HRPP.

Non-Human Research (No IRB Review Required)

    • Deceased subject research
    • Leftover, de-identified specimens
    • Commercial cell lines
    • Data/specimens from a repository (received de-identified)

Download Form Y1 – Non-Human Request Form and HRPP@utsouthwestern.edu it to HRPP.

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