Human Subject Research Training with CITI
FREQUENTLY
ASKED QUESTIONS:
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?
How much time is involved with CITI training?
Which CITI training modules do I
take…Biomedical-Clinical or Social-Behavioral Science?
Is there a “passing grade requirement” for the
CITI training?
How often does one have to take CITI training?
Is CITI training eligible for CME credit?
Are there alternatives or substitutes for
CITI training?
Record Keeping: Do I have to hand in a certificate of training
to verify course completion?
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 OPHS 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.
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).
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.
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 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 additional optional 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.
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.
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 two (2) 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.
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.
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 5400) also qualifies as evidence of required educational knowledge.
No other on-line tutorials can serve as substitutes for CITI training (see
policy for details).
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
OPHS 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 (OPHS, 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.
Contact
the Office for the Protection of Human Subjects (OPHS) at (817) 735-0409.