Training and Resources
The Human Research Protection Program Office (HRPPO) offers both required and optional training opportunities in a multitude of formats.
- Required ethics education training is offered online by CITI Program.
- Face-to-face educational classes are scheduled each month for research teams in collaboration with the Center for Translational Medicine (CTM) and the Office of Clinical Research Personnel (OCRP).
- In addition, the HRPPO offers monthly educational forums intended to bring the research community together around numerous ethical and regulatory issues.
The UT Southwestern HRPPO 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.
What CITI training do I need to take, and how often must it be renewed?
|Course(s)||Required For||Refresher Required|
|(HSP) – Human Subject Protection||All research personnel engaged in human research||Every 3 years|
(HIPAA) – Health Insurance Portability and Accountability Act in Research
|All research personnel engaged in human research||N/A – this is completed one time only|
(GCP) – Good Clinical Practices
|Research personnel involved in a Clinical Trial*||Every 3 years|
*What is a clinical trial?
The revised common rule (45 CFR 46.102(b)) defines a Clinical Trial as: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”
www.clinicaltrials.gov goes beyond the common rule definition to add: “The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.”
Additional training may be required by various institutions or safety committees.