IRB Training and Education
The UT Southwestern Institutional Review Board (IRB) office staff provides training and education on the ethical and regulatory standards for human subject protection. IRB policy requires all study team members listed on a UT Southwestern IRB protocol application (including offsite collaborators) to complete training before conducting research involving human subjects.
Successful completion of training is required prior to granting final approval of a new protocol. Human Subject Protection (HSP), Health Insurance Portability and Accountability Act (HIPAA) Research, and Conflict of Interest (COI) are required for all research personnel listed on the eIRB study. Good Clinical Practices (GCP) is also required for study personnel involved in a Clinical Trial.
What is a clinical trial?
www.clinicaltrials.gov defines a Clinical Trial as: “A clinical study in which participants are assigned to receive one or more interventions (or no intervention [i.e., placebo]) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.”
New study personnel cannot be added to an approved protocol until they have completed all the required training. Information about the required training and answers to frequently asked questions is listed below.