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 Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations.

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

What Constitutes Human Subjects Research?
According to federal regulations, research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, 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.

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.

Who may serve as a Principal Investigator (PI)?
UT Southwestern faculty and academic administrators may serve as PI of protocols.  Other UT Southwestern-affiliated individuals (e.g., staff, students, residents, fellows, and volunteer faculty members credentialed to practice at one of the affiliated hospitals) may serve as PI on research protocols only with a faculty sponsor.

What Kind of Training Is Required?
All PIs and research personnel are required to complete training in Human Subjects Protections, Health Insurance Portability and Accountability Act (HIPAA) and Research, and-- for industry sponsored trials--Good Clinical Practices.  To complete on-line training, go to http://www8.utsouthwestern.edu/utsw/cda/dept27777/files/68335.html.

Where Can I Go for More Information?
Please visit the IRB website at: www.utsouthwestern.edu/irb  or call the IRB Office at 214-648-3060.