IRB Question and Answer
Human Subject Educational Training Requirement
What is CITI training?
In accordance with federal regulations, it is necessary for all individuals identified as "key personnel" on a research project involving human subjects to complete educational training on the protection of human research subjects.
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 has successfully completed the appropriate educational tutorial/program designated by the UNTHSC Office of Research Compliance (OReC) through the CITI (Collaborative Institutional Training Initiative) Course in the Protection of Human Subjects, with links located on the UNTHSC IRB web site. For CITI training log-in instructions, please click here.>
Does CITI training expire?
Current UNTHSC IRB Policy upholds CITI certification for three years. Key personnel should renew their certification in order to maintain research studies active. This can be done through a refresher course on the CITI website every three years. If you are also subject to other IRB reviews (at different institutions), please check with them regarding their policy on educational training for human subject research as it may differ from ours.
If you encounter any problems with CITI, contact CITI help desk for assistance found on their "contact us" page. UNTHSC does not maintain the CITI website.>
How do I register on the CITI website to complete CITI training (for first time users)?
If you are a first time CITI trainee, you must complete the BASIC CITI course, which is a series of short modules regarding human subject protection. This certification is valid for 3 years.
To do this, visit the CITI main page at https://www.citiprogram.org/default.asp and create a new CITI Username and Password. For additional instructions on how to log into CITI and take the Basic CITI training course, please click here.>
How do I log into CITI and take the REFRESHER course (for NON-first time CITI trainees)?
Recall that CITI (Basic) training is valid for only three years. After three years, a brief "refresher" course can be taken through the CITI website to renew CITI certification. This "refresher" course will need to occur every three years.
To log on, go to the CITI main page...log in using your CITI User ID and Password you set up for your initial CITI training, then click on
Add a course or update your learner groups for University of North Texas Health Science Center
Once in there, scroll down to "Question 2" which references the Refresher course options...Select an Option (Biomedical, Social Behavioral, etc.) and follow the instructions from there.
For additional instructions on how to log into CITI and take the REFRESHER CITI training course, please click here.
What documentation of human subject education training do I need to submit for collaborating non-UNTHSC or UNT Health investigators?
Acceptable training for outside investigators and study personnel includes CITI, NIH, and institutionally based "research with human subjects" programs. Please submit hard copy documentation with your IRB application or Application for Change in Study Personnel. OReC will not be able to verify completion of CITI training online for investigators that are not affiliated with UNTHSC. If you are having trouble acquiring a hard copy of the training certificate from the investigator, please contact us to discuss.