Human Subjects Education
The University of North Texas Institutional Review Board (IRB) requires that all individuals working with human subjects in research complete an instructional program before the IRB will review an application. This policy reflects UNT’s commitment to the protection of the rights and welfare of human subjects in research and incorporates the requirements of the National Institutes of Health (NIH).
This training requirement covers not only Investigators, but also all individuals identified as “key personnel” who are responsible for the design, conduct, and reporting of the study. The Investigator will submit a copy of the training completion certificate for each of the “key personnel.”
This policy also applies to external collaborators; these personnel will be required to provide a certificate of human subjects education and the IRB will accept any training provided. External collaborators do not have to take the same CITI courses as UNT personnel, per se, but do have to present a training certificate that would be considered equivalent to the UNT IRB training requirements.
Human subject training must be renewed every 3 years.
(Required for all researchers)
- Researchers will need to create an account through the CITI program and affiliate with the University of North Texas.CITI courses can be accessed by following these steps.
- Go to https://www.citiprogram.org
- Click “Register” (top right hand corner of website)
- Under “Select Your Organization Affiliation” begin typing University of North Texas and when the list is presented, click “University of North Texas (Denton, TX)
- Click the checkbox “I affirm that I am an affiliate of the University of North Texas (Denton, TX). *NOTE: If you are unaffiliated with UNT, do NOT click this option. Call the Office of Research Integrity and Compliance at 940-565-3941 or e-mail firstname.lastname@example.org for further instructions.*
- Click “Continue To Create Your CITI Program Username/Password"
- Fill our the Personal Information (*Important Note: Use your University issued e-mail address. The Secondary email address can be a personal email account.*)
- Create your Username and Password
- Enter your Country of Residence
- Are you interested in the option of receiving Continuing Education Unit (CEU) credit for completed CITI Program courses? Answer Yes or No.
- Please provide the following information requested by University of North Texas (Denton, TX) *Note: You must provide your EUID.
- For Question 3, you must choose Social & Behavioral Research - Basic/Refresher or Biomedical Research - Basic/Refresher depending on which is applicable to your study.
- If you are conducting a biomedical study, you may be required to take both courses.
- Completing UNT RCR Basic course only or the UNT RCR Refresher course only will NOT satisfy human subjects training requirements for IRB submissions.
- Answer “No” to the other course offerings unless you have been instructed to register for other courses or would like to complete other courses.
- After all questions to Step 7 are completed, click “Complete Registration”
- After registration is complete, select “Finalize Registration” on the next page to continue
- The UNT Social & Behavioral Research - Basic/Refresher course and/or Biomedical Research - Basic/Refresher you selected should now appear on your “Main Menu” page. You may need to expand the drop-down box for them to appear. You may enter the course (by clicking the name of the course) and complete individual modules at your convenience, re-entering the course as needed. You will receive a “Completion Certificate” upon successful completion of all required modules.
- The CITI program offers several courses, however, all UNT study personnel working with human subjects are required to complete the course titled, “Social & Behavioral Research Investigators” if you are engaged in Social Behavioral Research. If you are engaged in Clinical/Biomedical Research, the course requirement is "Biomedical Research." Additional trainings may be required, depending on your study and funding. Please see “Additional Trainings” below to see if you are required to complete additional CITI courses.
- The Social & Behavioral Research and Biomedical Research courses can be completed in approximately three hours. The courses consists of video and reading modules, all of which are followed by quizzes.
- Upon successful completion of either course, a “certificate of completion” may be printed and retained by the researcher. Copies of the certificates must be submitted for all study personnel to the UNT IRB as part of the researcher’s human subjects research proposal.
Please note, the NIH no longer offers Protecting Human Research Participants (PHRP) course. The IRB will accept NIH/PHRP training certificates if they adhere to the above requirements.
(May be required depending on your study and funding)
Other courses are offered through the CITI program and will be optional for most researchers; however, some courses are required depending on the type of study that is being conducted.
- All key study personnel (PI, Co-PI, and Study Coordinators) that are working on clinical trials must take the “Good Clinical Practice (GCP)” training modules.
- For studies funded by the National Science Foundation (NSF), all key study personnel are required to take the “UNT Responsible Conduct of Research (RCR) Basic” training in the CITI program.
- Additionally, the IRB performs in person training on a regular basis. Please note upcoming trainings here.
The IRB staff are willing to perform one-on-one training by request. If you would like to schedule personalized training, please contact our team at email@example.com.