New Study Submission

All research involving human subjects must be submitted for review and approval by the Institutional Review Board (IRB). This page provides information and links to guidelines and policies regarding new study submission process. This page is designed to help the UT Southwestern Medical Center clinical research community prepare for initial study application submission.

Prior to starting a new application, please see specific “Review Types” to determine level of review the research study requires. This will also help during completion of the application.   

Basic components of initial study submission process to UT Southwestern IRB include:

In addition, all new study submissions require to have a written study protocol/project summary. Please review the protocol writing guidelines and Data and Safety Monitoring Plan (DSMP) guidelines. A sponsor-written protocol may be used in lieu.

For additional IRB forms and templates (i.e. consent form, Health Insurance Portability and Accountability Act (HIPAA) form, etc.), please refer to Forms.

Note: UT Southwestern-affiliated researchers may serve as a study Principal Investigator (PI). The Principal Investigator Eligibility (PI Eligibility) and Responsibilities policy provides specific information to this regard. If a PI does not meet institution’s criteria to serve as a PI as described in the policy, a Faculty Sponsor may be required.