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 four 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 four (4) 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. Christine Keas at the Office of Research Compliance – North Texas Regional IRB (817)-735-0409; download these CITI instructions (pdf); or visit “CITI Frequently Asked Questions“.