What is CITI?

CITI is a web-based training package on issues relating to human subjects research. The CITI website is maintained by the University of Miami, with content developed by a national consortium. CITI contains modules on such topics as informed consent, vulnerable populations, ethical principles, and IRB regulations. Each module includes a short quiz at the end to assess understanding. Over 400 institutions are using CITI as part of their training program.

Who is required to complete the CITI Modules, and when?

This training will be required of all physicians, faculty members, staff members, and students who are engaged in planning, conducting, or analyzing research at Mount Carmel that involves human subjects. The following implementation schedule has been adopted:

• Effective June 1, 2005, completion of the CITI Basic Course will be required of all study personnel. Until then, other training previously completed in satisfaction of the Mount Carmel requirements (e.g., NIH tutorials) will continue to be accepted.
• New study personnel who have not completed previous training are encouraged to complete the CITI Basic Course new, instead of other options. This will avoid the need to redo training within a short period of time.

How often do I have to take the Modules?

Once you have taken the Basic Modules, you will be required to take the Refresher Course every two years. The Human Subject Protection Office will notify you when your certification is about to expire.

Which Modules are required?

Modules have been grouped for (1) Biomedical Research, (2) Social and Behavioral Research, and (3) IRB Members. Select the group that best describes your area of research. 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.

How long does it take to complete the training?

The time required to complete each unit within the module varies between 10 and 20 minutes. The total time required is estimated to be 3 hours or less. The course does not have to be completed in one sitting, and personnel may enter the course at any time. Units are designed to be taken sequentially, but you may take them in any order.

How will the Human Subject Protection Office know training is complete?

Once you have completed the selected modules, print a hard copy of the Grade Book for your records. The Human Subject Protection Office is automatically notified once you have completed the CITI Course.

Where are the test data maintained and what about confidentiality?

Your individual quiz scores are confidential. The webmaster and staff supporting the distance learning software at the University of Miami where the data are processed and stored have access to individually identifiable quiz scores. However, each of the staff members has signed confidentiality statements and will not disclose individually identifiable quiz results or aggregate institutionally identifiable results. Anonymous aggregate quiz data will be used by the course facility to help improve course content and quiz questions. No one in the Human Subject Protection Office has access to individually identifiable quiz scores. Absolute confidentiality will be maintained.

Why am I required to do this?

Human subject research presents many challenges. As with any complex and evolving area, continuing education is vital. Inadequate training in these issues has been recognized as one reason some institutions and their researchers have experienced problems. Mount Carmel is committed to upholding the highest standards of ethical conduct and regulatory compliance regarding research. This training program through CITI will increase the level of awareness and understanding about these issues across our research community, and help us fulfill an important obligation.

Is there a fee?

Mount Carmel pays an annual fee for all Mount Carmel users. Individual users are not assessed a fee unless continuing education credit is requested (see below).

Can I obtain Continuing Medical Education Credits?

The University of Miami Office of Continuing Medical Education will provide 6 Category 1 Continuing Medical Education (CME) credits for Physicians, Physician Assistants, Nurse Practitioners, and Psychologists. You must complete the first 14 Core Biomedical training modules to be eligible. The cost for the 6 CMEs is $60. This must be handled directly with the University of Miami, and not through the Human Subject Protection Office.