Required Ethics Training
To access the CITI Program Online course, please choose one of two options:
If you are currently affiliated with UNC, please select this option and login with your Onyen.
If you are listed as research personnel on a UNC IRB but do not have an active UNC Onyen:
- Create a username and password to log-on to CITI using the “Guest or CITI Login” option.
- Select University of North Carolina at Chapel Hill as your Participating Institution.
- Note: It is important that the email address that you entered into the CITI website match the email address entered into the IRB application.
After you have completed the CITI Program Online course, your training course completion history will be added to the UNC Human Research Ethics Training Database. UNC affiliated staff can go there to generate a completion certificate.
- What is CITI?
The Collaborative Institutional Training Initiative (CITI) is a web-based training package on issues relating to human subjects research. The CITI web site is maintained by the University of Miami, with content developed by a national consortium. CITI contains modules on topics like informed consent, vulnerable populations, ethical principles and IRB regulations. Each module has a short quiz at the end to assess understanding. Over 1300 institutions are using CITI for their mandatory training.
- Which CITI modules are required?
The modules are grouped by categories of research. You only need to complete one group of modules. You should choose the group that best fits the type of research you normally conduct. If in doubt, ask your IRB.
- Group 1: Biomedical Research: Medical, physiological or pharmacological studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices or other interventions.
- Group 2: Social and Behavioral Research: Studies on sociological, psychological, anthropological or educational phenomena that typically involve direct contact with subjects. Does not include drug or device studies.
- Group 3: Data and Specimens ONLY: No direct contact with human subjects. Research limited to use of records, data (including secondary data sets), or biological samples.
- In addition to the required modules, you should complete any “OPTIONAL” modules that apply to your research projects.
Effective March 15, 2005, completion of the CITI Basic Course is required of all study personnel who are engaged in the planning, conduct or analysis of research at UNC-Chapel Hill that involves human subjects. Other training previously completed in satisfaction of UNC-Chapel Hill requirements (e.g., NIH tutorials, campus lectures) is no longer accepted or valid.
Effective January 1, 2017, CITI Good Clinical Practice (GCP) training is additionally required of all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects. A refresher course will be required every three years. The GCP training requirement is in addition to the OHRE requirement for Human Research Ethics Training (CITI Human Subjects Research Protection modules). If you have further questions regarding the required GCP training, please contact the Office of Clinical Trials at firstname.lastname@example.org or call 919-843-2698.
- If you login using the UNC CITI Login or if the team member’s original CITI registration record included a PID (the University’s personal identifier number for faculty, staff, students, and some other associates of UNC-Chapel Hill), the CITI completion record will be linked automatically to the IRB’s information system.
- If the team member does not have a UNC-CH PID, please use the Guest or CITI Login option above. Once complete, attach a copy of the training certificate to the IRB application. To do this, go to the Attachments section and choose Document Type ‘Research Ethics Training’. To generate a certificate for your research team, go to the Human Research Ethics Training Database.
- Please note: It is not necessary to forward your completed CITI course information to the UNC-Chapel Hill office in order to be entered in to the database. UNC-Chapel Hill is automatically notified once you have completed the CITI Course. Your name will appear in the Human Research Ethics Training Database within 48 business hours. Send a hard copy of the training certificate only for personnel listed on application forms who do not have a UNC-CH PID.
Human subjects research presents many challenges. As with any complex and evolving area, continuing education is critical. Inadequate training in these issues is recognized as one reason that some researchers and their institutions have experienced problems. UNC-Chapel Hill is committed to upholding the highest standards of ethical conduct and regulatory compliance in research. The enhanced training available through CITI will increase the level of awareness and understanding about these issues across our research community, and help us fulfill these important obligations.
If you are listed as research personnel on a UNC based study, and have completed CITI training at another institution, (1) log-on to CITI using your existing CITI username and password, (2) click “affiliate with another institution,” (3) select University of North Carolina at Chapel Hill as your Participating Institution. If you have not previously completed all of the training modules required by UNC-CH, you may be prompted to complete additional modules.
This will depend on your experience with human research issues. Most modules will take about 10-20 minutes to complete. Researchers familiar with these topics may require three hours or less to complete all of the required modules. You do not have to complete all the modules at once. CITI is designed for you to work at your own pace, and allows you to exit and return at a later date to where you left off.
You must receive a total passing score of 75% after completing all the required modules. You can track your progress on-line by clicking on the GRADE BOOK. If you do not obtain a total passing score of at least 75%, you can return to the modules and retake the quizzes.
The University pays an annual fee for all UNC-Chapel Hill users. Individual UNC-Chapel Hill users are not assessed a fee for the CITI training unless continuing medical education credit is requested (see below).
The University of Miami Office of Continuing Medical Education will provide Continuing Medical Education (CME) credits. This is handled directly with the University of Miami, and not through any offices at UNC-Chapel Hill. For questions regarding Continuing Education Credit please contact:
University of Miami Leonard M. Miller School of Medicine
Division of Continuing Medical Education
Continuing education is not required at this time. Note: Disregard any statements about training expiration; certification does not currently expire. When in the future an annual refresher course is required, ample notice will be provided on the OHRE website.
Please contact the UNC-Chapel Hill IRB CITI Training Coordinator.