About the IRB

What’s an IRB?

An Institutional Review Board (IRB) is a committee of physicians, scientists, non-scientists, and community members who serve to protect the rights and welfare of human research subjects in accordance with U.S. Department of Health and Human Services (HHS) (45 CFR 46), and U.S. Food and Drug Administration (FDA) (21 CFR 50 and 21 CFR 56) regulations.

All research projects conducted by faculty, students, or employees of UT Southwestern Medical Center, which involve living humans, or identifiable data about living humans require prior review and approval by the IRB.

What constitutes Human Subject research?

HHS regulations define research as a systematic investigation, including research development, testing, and evaluation designed to develop or contribute to generalizable knowledge (45 CFR 46.102).

FDA regulations define research as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA...or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit, according to the FDA (21 CFR 56.102).

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains according to HHS regulations (45 CFR 46.102):

1. Data through intervention or interaction* with the individual
2. Identifiable private information

*Intervention includes both physical procedures by which data is gathered (i.e., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

According to the FDA regulations, human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient (21 CFR 56.102).

Investigators should err on the side of caution and consult with the IRB when uncertain about whether a study meets the definition of human subjects research.