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The existing University Policy on Education and Certification of Investigators Involved in Human Subjects Research has been revised to reflect changes. See the policy for additional information on new web-base training, continuing education, alternative training under special circumstances, and other matters relating to human subjects education and certification.
We have adopted new modules (CITI) for web-based training. The NIH/NCI training is no longer valid (it expired March 15, 2005). UNC-CH human subjects researchers must complete new human research ethics training based on the CITI course; details follow below.
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 400 institutions are using CITI for their mandatory training.
This training is required of all faculty, staff and students who are engaged in the planning, conduct or analysis of research at UNC-Chapel Hill that involves human subjects.
Modules have been grouped for (1) Biomedical Research, (2) Social and Behavioral Research, and (3) Research Involving Data and Specimens Only. Select the group that best describes your area of research (further defined below). You only need to complete one group of modules. In addition to the required modules, you should complete any “OPTIONAL” modules that apply to your research projects.
When you have completed the selected modules, print a hard copy of the completed Grade Book for your own records. 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. If your CITI record includes your 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 automatically linked to the IRB's information system. Send a hard copy of the training certificate only for personnel listed on application forms who do not have a UNC-CH PID.
To generate a certificate for your research team, go to the Human Research Ethics Training Database.
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.
This training is now required of all faculty, staff and students who are engaged in the planning, conduct or analysis of research at UNC-Chapel Hill that involves human subjects. CITI replaces earlier requirements, and the following implementation schedule was adopted:
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.
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 CITI Course site is best viewed with Microsoft Internet Explorer 5.0 or later.
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 6 Category 1 Continuing Medical Education (CME) credits for Physicians, Physician's Assistants, Nurse Practitioners and Psychologists. You must complete the first 14 Core Biomedical training modules to be eligible. The cost for 6 CME’s is $60 through the U of Miami Office of Continuing Medical Education. This must be handled directly with the U of Miami, and not through any offices at UNC-Chapel Hill.
Annual continuing education in human subjects research issues must be completed by the one year anniversary of the initial CITI Basic training, with the first renewals due August 1, 2005. More information on continuing education requirements is forthcoming. Note: Implementation of the renewal requirement has been postponed.
Yes, all researchers completing CITI training are required to complete the UNC-Chapel Hill "HIPAA and Research" module, which is included as the last module. This includes faculty, staff and students involved with human subjects research, regardless of what other HIPAA training you might have received at UNC or elsewhere. This module on "HIPAA and Research" is in addition to, but does not replace, any HIPAA training required by health care providers and/or covered entities (e.g., UNC Health Care and other covered units at UNC-Chapel Hill).
When you have completed the selected modules, print a hard copy of the completed Grade Book for your own records. 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. If your CITI record includes your 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 automatically linked to the IRB's information system. Send a hard copy of the training certificate only for personnel listed on IRB application forms who do not have a UNC-CH PID.
To generate a certificate for your research team, go to the Human Research Ethics Training Database.
Please contact the UNC-Chapel Hill Training Coordinator at
See the University policy for additional information on continuing education, alternative training under special circumstances, and other matters relating to human research ethics training and certification.