Human Subject Research Training with CITI

Many, if not all, questions about the CITI Human Research Training are addressed at the CITI website. However, here are responses to anticipated questions from UNTHSC researchers:

Does Everyone on a research project have to take this training?

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 OReC for special interpretation. However, the human research protection program at UNTHSC 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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Why CITI training?

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.

Third, the training on CITI can be tailored to fit certain research disciplines and expectations. For example, social and behavioral science researchers can be required to take those modules only, and leave the biomedical units as options; and the reverse for clinical trials investigators. Of course, anyone can take all the modules if they so desire (IRB members must complete all modules, for example).

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How much time is involved with CITI training?

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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Which CITI training modules do I take…Biomedical-Clinical or Social-Behavioral Science?

Among the many important aspects of CITI training is that it can be tailored to meet specific research interest areas. As a result, everyone can select which group of modules best suits their training needs.

Currently, the CITI program has two main clusters of modules: Social and Behavioral Research (SBR), and Biomedical (Clinical) Research. The CITI website for UNTHSC will list and describe four “Learner Groups”. Simply select the Learner Group most appropriate for your research area and proceed accordingly:

Biomedical-Clinical:Researchers involved with clinical drug or device trials or engaged in integrative physiology and anatomy studies or similar biomedical intensive studies, would select the Biomedical-Clinical Learner Group.

Social-Behavioral:This learner group is most appropriate for key personnel specializing in social and behavioral sciences studies (School of Public Health, School of Health Professions, etc.). This group would select the SBR group of modules.

Interdisciplinary Researchers:This learner group, Interdisciplinary Researchers, provides an array of modules that focus primarily on biomedical issues, but there are additionaloptional modules relevant to social and behavioral sciences. Persons likely to benefit from this training series would be investigators in ORC (Osteopathic Research Center), Epidemiology, Occupational and Environmental Health, Human Genetics Research, and so forth. Given the rapidly expanding overlap of behavioral and biomedical research and the trend toward multidisciplinary studies, research personnel are strongly encouraged to take this Learner Group to have the broadest most effective training program available.

NOTE that this group is required to take the same group of modules as the Biomedical learner group, but the SBR modules are offered as an option.

IRB Members:IRB members, because they must be able to effectively review projects across a wide range of disciplines, are required to complete all modules from both the social- behavioral as well as biomedical-clinical groups.

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Is there a “passing grade requirement” for the CITI training?

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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How often does one have to take CITI training?

At present, initial CITI training for UNTHSC research faculty staff and students is a “one-time” requirement valid for 3 years. However, there is a Refresher Course for CITI trainees that will be required every three (3) years thereafter. This refresher course is primarily a series of updates on changing regulations, findings and case studies that impact human subject researchers. The Refresher Course takes about 1 hour to complete.

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Is CITI training eligible for CME credit?

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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Are there alternatives or substitutes for CITI training?

Yes. The new training policy allows for valid and current certificates of clinical research professionals (CRC, CTI) and IRB professionals (CIP) to serve as evidence of appropriate training in human research protection. In addition, successful registered completion of the UNTHSC course on human subject research (as in BMSC 5203) also qualifies as evidence of required educational knowledge. Note that this specific form of human subject protection training (BMSC 5203) is good for six (6) years. No other on-line tutorials can serve as substitutes for CITI training (see policy for details).

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Record Keeping: Do I have to hand in a certificate of training to verify course completion?

The CITI web site, under ordinary circumstances will automatically forward to the UNTHSC OReC a list of who has completed a CITI training program. Our Office will then update a database (and eventually you will be able to check your CITI status through the UNTHSC web site…more on that later).

But back-up plans are always a good idea, so we encourage everyone to print out and retain your own copy of CITI completion; and also send a copy directly to our office (OReC, CBH-160, Attn: Dr.Gladue). 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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For Additional Information…

Contact the Office of Research Compliance (OReC) at (817) 735-0409.

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This page last updated 15th Jan 2014