The University of Texas at Austin requires faculty, staff and students who are or will be involved in the conduct of human subjects research to complete human subjects research training. IRB approval will not be provided if these requirements are not met.
These requirements apply to all persons with a role in the research (e.g., Principal Investigators, Co-Investigators, Project Managers or Research Assistants) and who are designated to:
- Recruit potential research participants
- Obtain informed consent from prospective research participants
- Interact or intervene with participants to collect research data
- Analyze identifiable research data
Human Subjects Research Training
Human subjects research training is required every three years and must be completed through The Collaborative Institutional Training Initiative (CITI) Program.
To complete the required training, select from the following:
New to Human Subjects Research Training (PDF)
Human Subjects Research Training Refresher Course (PDF)
Affiliate with The University of Texas at Austin from an Existing CITI Account (PDF)
Questions?
Visit the CITI Training FAQ for Human Subjects Research (PDF).
Good Clinical Practices (GCP) Training
To comply with NIH Policy, the University requires that NIH-funded investigators and staff conducting a clinical trial complete Good Clinical Practice (GCP) training every three years through the Collaborative Institutional Training Initiative (CITI) Program.
Clinical Trial
Defined by NIH 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 those interventions on health-related biomedical or behavioral outcomes.
Investigator
The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
Clinical Trial Staff
Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements.
These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.
The instructions apply to investigators and research staff who are involved in the conduct, oversight or management of NIH-funded clinical trials. Before beginning the training, be sure to read all of the steps. Download the guide on GCP training.
Conflict of Interest Disclosure
For financial conflict of interest disclosure requirements for covered individuals, visit the Conflicts of Interest Program webpage.
See IRB Policies and Procedures 3.8 Conflict of Interest, 3.8.4 Principal Investigator and Research Staff for additional information regarding COI disclosure requirements for research staff engaged in human subjects research.
Revised Common Rule
The revised Common Rule applying to research supported by DHHS and many other federal agencies (excluding FDA and DOJ), went into effect on January 21, 2019. This Revised Common Rule guide provides an overview of the major changes and how the UT IRB will implement them. Other information on recent related regulation is also provided.
Forms and Templates
To access the most recent versions submission forms and templates, please download them from the UTRMS-IRB Library, “Templates” tab.