In addition to IRB approval, other approvals are necessary before a study may begin. These approvals will vary depending on funding, location of the research, procedures performed, and research area, among other factors. This page will provide you with more information about the additional approvals required for human research.

Ancillary Committees – Required prior to final IRB approval

Ancillary review assists the IRB with matters related to research risk, regulatory requirements, and research compliance. Not all studies require ancillary review. If ancillary review is required, documentation of IRB approval cannot be released until all ancillary reviews are completed.

• Safety Committees
• Scientific/Ethical Committees
• Medical Education approvals to target students/residents as subjects

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Performance Site Approval (PSA) – Required prior to enrolling first research participant at the site

Institutional approval (or PSA) must be obtained before any human research-related activities begin at each applicable site(s). This requirement applies to UT Southwestern and partner hospitals.

When conducting research at an institution, you must also obtain appropriate institutional approvals to ensure support and feasibility of the study. Because performance sites are contributing resources to the protocol, the support and approval of performance sites are vital to the success of a research protocol. Examples of requirements covered during a performance site review are:

• Credentialing
• Pharmacy
• Radiology
• Pathology
• Data requests
• Supplies, equipment, and devices
• Staff resources not on study team (nursing, physician, therapists, and others)