Human Subject Research Training for North Texas Regional IRB Researchers

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 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. No protocols can be reviewed for new or continuing reviews that are not in compliance with this requirement.

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 through the CITI (Collaborative Institutional Training Initiative) Course in the Protection of Human Subjects, with links located on the IRB web site. This is now the basic standard training requirement for all faculty, staff, employees and students engaged in research involving 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.

NOTE: If other institutions have different requirements, affiliate that institution with your CITI account and take their required course / training. 

CITI Training Requirements

Researchers must take the Basic of the Human Subjects Research Course (not the Refresher Course) found within the Human Research Curriculum. This training is valid for three (3) years.

Additionally, 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 or John Peter Smith Health Network,  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 www.citiprogram.org
  • Once there, simply click on the link “Register for CITI course”.
  • Under institution selection, select “University of North Texas Health Science Center” in the “All others” drop down box.
  • Next, proceed to create your own username and password and select the CITI Human Subjects Research training course.

For any questions, call Ms. Eleanor Knutson at the Office of Research Compliance – North Texas Regional IRB (817)-735-0409; download these CITI instructions (pdf); or visit “CITI Frequently Asked Questions“.

**NEW COVID-19 TRAINING OPTION FOR UNTHSC HUMAN SUBJECT RESEARCHERS**

UNTHSC has added a new CITI course to the UNTHSC training program, titled, “COVID-19: Back to Campus (Fall 2020)”. (Please note that this course is not offered through the NTR IRB CITI program account).

This complementary course has been launched to train researchers/faculty, staff, and students on COVID-19 safety for their return to campus. Please note that this course/training is voluntary, and available to interested individuals at UNTHSC – it is not required that researchers complete this. However, individuals interested in completing this course will need to do so by midnight September 30, 2020 (the course will close October 1, 2020).

A reminder that you must have a UNTHSC CITI Program account to access this course. Please click the following link to access the CITI Website. For additional information/instructions on accessing the course, please click here.

A special shout-out and THANK YOU to our colleague, Dr. Maya Nair (Associate Director, Biosafety/Assistant Professor – MIG) for her authorship and contributions to this effort, and for helping to make this course possible!!

(In addition to UNTHSC, other contributors include: University of Maryland School of Medicine, Vanderbilt University Medical Center, Yale University, and Northwestern University.)

This page was last modified on July 27, 2020