IRB Training and Disclosure Requirements

The University of Texas at Austin (University) requires faculty, staff, and students who are or will be involved in the conduct of human subjects research to complete human subjects research training, financial conflicts of interest training, and to submit a financial interest disclosure form. IRB approval will not be provided if these requirements are not met.

These requirements apply to all persons with a significant 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, or
  • Analyze identifiable research data

Human subjects research training is required every three (3) years and must be completed through The Collaborative Institutional Training Initiative (CITI) Program.

To complete the required training, select which of the following applies to you and follow the provided instructions at the webpage to which you are guided:

Questions? Visit the Human Subjects Research Training FAQ.

Effective February 6, 2017, FCOI training is now housed within the FID form via the electronic submission system, eProtocol. The FCOI training is built in to the FID form, such that when researchers complete the FID form, they will have also completed FCOI training.

This means that the FCOI training module is no longer available through the University Compliance Services Compliance Training System (CTS). Prior CTS completion records will be maintained and researchers are not required to re-take the FCOI training as a result of this change. FCOI training will only need to be re-taken when the record expires or when the FID form expires, whichever occurs first. Over time, the expiration date of FCOI training and the FID form will be one and the same.

To complete the FCOI/FID requirements, select which of the following applies to you and follow the provided instructions at the webpage to which you are guided:

  • Do you need to complete FCOI Training/FID for the first time? 
    Follow the instructions here.
  • Do you need to submit a FID form that you partially completed and saved?
    Follow the instructions here for submitting a FID form that you previously edited and saved.
  • Do you need to update your FCOI Training Record or FID form because it will expire or has expired? 
    Follow the instructions here to update your FID form.
  • Are you a Non-University Researcher who needs to comply with FCOI requirements?
    If you are working on University research, but you are not a University affiliated faculty, student, or staff, you will need to comply with the instructions outlined for Non-University Researchers at the Investigators and Collaborators.

Questions about Training History? 

If you have any questions, visit the FCOI Training FAQ or contact the Office of Research Support and Compliance at coi@austin.utexas.edu or (512) 471-8871.

The University requires that NIH-funded investigators and staff complete Good Clinical Practice (GCP) Training every three (3) years through the Collaborative Institutional Training Initiative (CITI) Program. This is to comply with the NIH Policy, effective as of January 1, 2017.

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.

If you are an Investigator or staff working on an NIH-funded clinical trial, follow the Instructions for Completing Good Clinical Practices (GCP) Training.