Human Subject Research Training for North Texas Regional IRB Researchers

Training Links

Background to human subject protection training for researchers

In accordance with federal regulations, it is necessary for all individuals identified as “key / research personnel” on a research project involving human subjects to complete required educational training on the protection of human research subjects.

Current North Texas Regional IRB Policy (as well as all partnering institutions) requires that, when submitting a protocol for IRB review (both new and continuing review), the Principal Investigator must include written verification that each of the key personnel on that project has successfully completed the online educational tutorial (i.e., provide documentation of the completed training, such as a completion certificate or transcript of modules complete).

Educational requirement for human subject research

When submitting a protocol for IRB review (both new and continuing review), the Principal Investigator must include written verification that each of the key / research personnel has successfully completed the appropriate educational tutorial/program designated by the North Texas Regional IRB (and partnering institutions) through the CITI (Collaborative Institutional Training Initiative) Course in the Protection of Human Subjects.

CITI training for the North Texas Regional IRB is valid for three years. Expiration of this educational training requirement can jeopardize any current or newly submitted research protocol.

CITI Training Requirements

For UNTHSC:

Researchers should affiliate with the “University of North Texas Health Science Center” and must take the Basic of the Human Subjects Research Course (not the Refresher Course) found within the Human Research Curriculum. This is the basic standard training requirement for all faculty, staff, employees and students engaged in research involving human subjects. This training is valid for three (3) years.

For JPS:

Researchers should affiliate with the “North Texas Regional IRB” and must take the Biomedical Research Basic Course. Note: For any questions regarding this any of the other trainings that may be needed for JPS-specific researchers, please reach out the JPS Office of Clinical Research at ResearchSubmissions@jpshealth.org.

For UNT Dallas:

Researchers should affiliate with the “University of North Texas at Dallas” and must take the “Social and Behavioral Research (SBE)” Basic Course. Note: For any questions regarding this or any of the other trainings that may be needed for UNT Dallas-specific researchers, please reach out the Director Alicia Brossette (Executive Director, Office of Sponsored Projects at UNT Dallas) at Alicia.Brossette@UNTDallas.edu.

Other Institutions:

If you are affiliated with another institution that has different requirements, affiliate that institution with your CITI account and take their required course / training. If any of your key study personnel have completed training from a different institution, please include a copy of the full transcript of modules completed (for that individual) in your submission to the NTR IRB.

NOTE FOR ALL RESEARCHERS SUBMITTING TO THE NTR IRB:

Completion of the CITI Good Clinical Practice (GCP) Course or any other CITI course (such as Responsible Conduct of Research – RCR) is NOT a substitute for the HUMAN SUBJECTS RESEARCH Training Course. While completion of the GCP and/or RCR courses may be required by the funding agency (e.g., National Institute of Health), or other departments at the UNT Health Science Center, John Peter Smith Health Network, University of North Texas at Dallas, etc., these courses do not meet the basic “entry level” requirement of the North Texas Regional IRB for human subjects research.

Please note that selecting and completing an inappropriate CITI training course may delay IRB review and approval of the protocol/application.

How to log in to CITI Human Subjects Research training course

Go to the CITI website at citiprogram.org.
Once there, simply click on the link “Register” button (if you do not yet have a CITI account; you can also click on the “Guide to Getting Started” at the bottom of the page for additional assistance).
From there, you will need to “Select Your Organization Affiliation” (by entering your organization’s name in the box, and choosing from the selections that appear) (Note: If you are not affiliated with an organization, you will need to check the “Independent Learner Registration” and complete the appropriate steps.)
Next, proceed to create your own username and password and select the CITI Human Subjects Research training course.
For detailed directions on how to register and affiliate your CITI account, download these instructions for UNTHSC personnel or these instructions for North Texas Regional IRB affiliates.

For any questions, call the Office of Research Compliance at (817)-735-0409, or visit “CITI Frequently Asked Questions“.

This page was last modified on May 25, 2023