All research personnel who are actively involved with the project (principal investigator, co-investigators, study physician, research assistants, coordinators, etc.), and anyone who will be interacting with human subjects from a research perspective is considered a key personnel and must complete this training. When in doubt about your own, or a staff person’s involvement in a project, call the North Texas Regional IRB for special interpretation. However, the human research protection program at UNTHSC and JPS is a campus wide endeavor. CITI training is a good thing for anyone, and we encourage staff members who think they may be only marginally involved in a project to go ahead and take the training at their own pace. It’s educational, informative (and free!) and broadens awareness of what human subject research is all about.

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First, CITI it is the most diverse, effective, and comprehensive on-line training and educational approach for the subject matter in use by over hundreds of institutions worldwide (as of Aug 2008). The CITI system offers broad training across both biomedical and social/behavioral science areas and is updated regularly to be current with federal guidelines and regulations. Second, investigators can log on and go at their own pace…the program is eligible for CME credits for those seeking them, and many institutions already use CITI allowing for “reciprocity” of training requirements for collaborative research projects…thus our researchers (or our partners) won’t have to prove their training or undergo off-site training to satisfy another IRBs requirements. Typically, the full set of required modules takes a total of about 2 – 3 hrs of on-line reading and quiz responding time. Again, since this is an open-access internet training system, anyone can log on from anywhere and do one or more modules at their leisure at any time.

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Typically, completing a required series of modules will take about 2 – 3 hours. However, the CITI training program is set up as a series of short (5-15 minute) modules that can be taken at any time from any place with internet access.

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Each required module has a short quiz of a few relatively straight-forward questions. In order to successfully complete the CITI training program, an overall average score of 80% is required. Note that the goal of CITI training is for researchers to have an awareness and understanding of the issues associated with human research protection. Thus, anyone may take the CITI training as many times as needed to obtain this level of education and training.

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CITI training for North Texas Regional IRB researchers is valid for 4 years.

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Yes. The University of Miami Miller School of Medicine Division of Continuing Medical Education will provide up to 6 AMA PRA Category 1 credits™ for Physicians, Physician’s Assistants, Nurses, Psychologists and other health care providers. The current fee associated with the Basic Course is through the University of Miami Miller School of Medicine Division of Continuing Medical Education. Details are at the CITI web site.

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Yes. (1) Another institution’s CITI training is acceptable if the training is comparable to the North Texas Regional IRB’s CITI training curriculum. A valid CITI certificate from that institution is required indicating that the training date has not expired. The North Texas Regional IRB will decide if the training is acceptable as a substitute. (2) The National Institutes of Health (NIH) training course in the protection of human research participants is also acceptable as a substitute for CITI training. The NIH training course is valid four years from date of completion. The appropriate NIH Protection of Human Research Participants certificate of completion is required and must be submitted to the North Texas Regional IRB. (3) Documentation of current, active certification as a clinical research professional (e.g., CRC, CTI) or as a Certified IRB Professional (CIP) also serves as evidence of appropriate training in human research protection. Again, appropriate documentation is required and must be submitted to the North Texas Regional IRB prior to involvement in any research project involving human subjects.

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The CITI web site, under ordinary circumstances will automatically forward to the Office of Research Compliance – North Texas Regional IRB a list of who has completed a CITI training program through UNTHSC. Those who have taken the training through another institution (external, John Peter Smith, etc.) will need to submit a copy with their new protocol submission.

However, we encourage everyone to print out and retain your own copy of CITI completion for appropriate record keeping (i.e. good back up plan); and also send a copy directly to our office (Office of Research Compliance – North Texas Regional IRB at UNTHSC located within CBH-160). Once we have it “on file”, your status will be noted for current and all future research protocols involving human subjects.

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Contact the Office of Research Compliance – North Texas Regional IRB at (817) 735-0409.

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