Research involving human subjects requires approval by the Institutional Review Board (IRB) of UT Southwestern Medical Center.  In addition to UTSWMC, our IRB reviews research for the Dallas VA, Scottish Rite Hospital for Children, Children's Medical Center of Dallas, Parkland Hospital and Richardson Regional Medical Center.

Getting started with your research project involves understanding what human subject protection (HSP) means and how the IRB reviews, approves and monitors all HSP research.  There are local university rules as well as federal laws that govern human subject research.  These are found in the Investigator's Manual and the Rules, Policies and Procedures guide.

You need specific training in order to work on human subject research projects whether your own or assisting others.  Once submitted, the IRB keeps your training record on file for all your future research work. There are three main training components, Human Subject Protection, Advanced HIPAA Research, and  Good Clinical Practices (for industry sponsored projects).

Human Subject Protections training is required for all personnel who are listed on the NR1 form, working with human research participants or their personal health information. This on-line tutorial is offered through the National Cancer Institute (NCI) and fulfills the requirement for education in the area of human subject protection. 

The HIPAA Research module is required for all UT Southwestern Medical Center at Dallas (including Zale Lipshy and St Paul hospitals), Parkland and Children's Hospital's research personnel. It is a web-based tutorial offered through the UT Southwestern (UTSW) Medelearn system and can be accessed with a Southwestern user ID and password. Topics covered include access and use of protected health information for research purposes, authorization and waiver of authorization, and data security.

Good Clinical Practices training is required for all industry sponsored clinical trials.  The GCP training is offered by the Clinical Trials Office (CTO) and takes about one hour to complete.   A certificate of completion is issued by the CTO upon successful completion of the test. 

There are many forms to submit to the IRB: initial submission, yearly review, modifications and closing documents just to name a few. 

For departmental assistance with these forms or other questions please contact Betty Loy, Clinical Research Manager for Otolaryngology/Head and Neck Surgery, or, Barb Staves, Clinical Research Coordinator.