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The Basics
- What is CITI Training?
The Collaborative IRB Training Initiative (CITI) was founded in March 2000 through
collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center to develop
a web based training program in human research subjects protections. In spring 2006, the Office of
Human Research worked in partnership with the CITI to create customized, basic training modules to
meet the educational needs of biomedical and social/behavioral researchers at GWU. In addition
to the ”Basic” content, the CITI model provides the opportunity to post additional instructional
materials specific to GW’s institutional needs.Currently, the CITI Program is used by over
600 participating institutions and facilities from around the world with over 125,000 registered
participants.
- Who needs to take it?
GWU offers access to the CITI program to all faculty, staff, and students. All
individuals identified as on the GW IRB Synopsis Form, who will be involved in the design and conduct
of human subjects research, must fulfill this education requirement.By definition, a “human
subject” means a living individual about whom an investigator (whether professional or student)
conducting research obtains: (1) data through intervention or interaction with the individual, or
(2) identifiable private information. (Source: Department of Health and Human Services (HHS), Code
of Federal Regulations, Protection of Human Subjects 45
CFR part 46).
- Does GW’s education requirement apply to researchers that do not involve human subjects?
No, but it is important for all investigators—even those working with
tissues or specimens derived from human sources, to understand when proposed research triggers
regulatory and policy requirements.
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Getting Started
- How do I register?
- Log on to CITI at: www.citiprogram.org
- Click the "Register
for the CITI Course" link. This will take you to the main registration
page.
- Select the GWU from the "ALL OTHERS" pull-down menu and click 'submit'.
- Complete the 'username and password' steps.
- Complete the full registration process (this is the info that will help GW identify you in
the CITI system)
For more detailed instructions, CITI Registration information is available at: http://citiprogram.org/citidocuments/citiinstructions.htm
- I have a username and password from the previous "Blackboard" Course site. Does
this give me access to CITI training?
No. You will need to register with CITI by creating a separate user name
and password at this course site.Follow the link to "Register for the CITI Course" and
choose a username and password that you will remember. If it is easier to remember, you may use old
usernames and/or passwords, but you still must register through CITI to complete GW’s
educational requirements.
Learner Group Definitions
- I need to select a learner group
before I begin the training. What is the difference between SOCIAL/BEHAVIORAL RESEARCH
(SBR) and BIOMEDICAL RESEARCH?
The term “Biomedical research” includes
both studies designed primarily to increase the scientific base of information about normal or
abnormal physiology and development and studies primarily intended to evaluate the safety, effectiveness
or usefulness of a medical product, procedure, or intervention. The terms "behavioral
research" or "the
behavioral sciences" may be used to refer either to studies of the behavior of
individuals, or to studies of the behavior of aggregates such as groups, organizations, or societies.
The broad objective of the behavioral and social sciences is similar to that of the biomedical
sciences: to establish a body of demonstrable, replicable facts and theory that contributes to
knowledge and to the amelioration of human problems.For additional information, see: Office of
Human Research Protect ions IRB Guidebook, Chapter 5, Section A at the following link: http://www.hhs.gov/ohrp/irb/irb_chapter5.htm.
CITI
Technical Support
- What happens if I forget my CITI username and/or Password?
You may utilize the automated username/password retrieval system by clicking
on the "Forgot Username and Password" link
located on the left margin of the CITI home page (https://www.citiprogram.org/default.asp).
If you made an error in providing your email address or there are firewalls to prevent HTML attachments,
your request will not be filled and you will need to contact CITI
Support at (305) 243-7970.
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Completing the Course
- How long will it take to complete the course?
It depends. GWU has specifically customized the training program and each
CITI module has lecture materials to review. The average learner spends approximately 4.5 hrs in
the Basic Course site and uses approximately 5 logins to complete the course, while the average learner
requires approximately 2 hrs to complete the CITI Refresher Course.
- How do I access the quiz for each module?
The links to the quizzes are at the bottom of each module in the footer of the
page. Review the Institutional requirements to determine the course that you are required to complete.
You may access the quiz by logging on to the site and going to the Learners Menu, and clicking on
either the Basic Course or the Refresher Course to access your Grade Book. There are links in the
Grade Book to provide you access to the all modules available at GWU. Please note that you MUST complete
the first module required by GWU before you will be able to access the next module, e.g.,
you will not be allowed to skip around within the Learner Group.As you complete modules, the next
module in the sequence will become available to you. After all required modules are completed the
Optional Modules will become available for you to review. If you experience technical difficulties
when navigating through the course, please contact CITI
Support at (305) 243-7970.
- Will CITI provide me with proof of completion after I have completed the CITI computer-based
training module on Protection of Human Subjects?
Yes. The software will track your progress through the course. The Grade Book
will provide a list of the modules you have completed and those remaining to be completed in your
required course of instruction.When all required modules have been completed with a "passing" aggregate
score of at least 75%, a link to the Completion Report will appear at the bottom of the Grade
Book Page. Simply click the link and print a copy of the completion report for you records.In addition,
the Office of Human Research (OHR) automatically receives a copy of the Completion Report by email.
- When will my certification (completion report) expire?
The Basic Course completion report is good for two (2) years from the date in which you completed
the training. A Refresher Course must be taken every two (2) years.
- Can my certificate of completion report be used for more than one study or proposal
that I submit to the IRB?
Yes. As long as your educational requirements have been met and have not yet
expired, the same certificate may be submitted to IRB/OHR.
- What if I fail the quiz?
If you fail the examination at the end of the lecture, you will be asked to
take the CITI web-based training modules. If you fail the CITI program, you will be informed of the
modules that you failed and be given the opportunity to review them and to take the quizzes again.
Continuing
Medical Education (CME) and Continuing Education Units (CEU)
- How do I know if I am eligible for CME/CEU Credits
You must complete a minimum of 12 modules from the Basic Course with an aggregate
score of 70% correct on the quizzes to be eligible for 6 Credits. For the Refresher Course you
must complete a minimum of 20 modules with an aggregate score of 70% correct on the quizzes to
be eligible for 2 Credits. Follow the link for further details regarding the CITI CME/CEU
policy, which is available at the following link: https://www.citiprogram.org/citidocuments/cme/index.htm
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Other
Human Subject Research Training Programs
- I completed CITI Protection of Human Subjects on-line training through
another institution. Can my credits be transferred?
Yes. Credits taken at other institutions through CITI are eligible for transfer. However,
there is no guarantee that those courses taken will satisfy the educational requirement at
GWU.Through CITI, each institution creates their own training program specific to the types of research
being conducted and the associated needs. Because the training programs are uniquely customized
for each institution, it is almost impossible to guarantee 100% rollover credit acceptance of ALL
the individual modules within each training program.
- I have completed other types of training programs for human subject research (e.g.,
NCI, NIH, etc.). Can I substitute these instead?
No. The GWU human research educational program has been customized for
the GWU research environment and therefore, substitutions and/or grandfathering of other human
research training certificates are not authorized options at this time.
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Transfer/Rollover of Completion
Reports
- How do I request transfer or rollover of credits from another institution?
To have credits transferred, you must contact CITI Office at citisupport@med.miami.edu or
at 305 243-7970. Please keep in mind rollover of credits or transfer of credits does not guarantee
satisfaction of the GW training requirement. You still may need to complete those modules that
were not eligible for transfer. (Their status will appear as “Incomplete” in your
grade book.)
- I registered as a member of the Social/Behavioral Research (SBR) Learner Group by mistake. I
had completed a few of the modules before I realized my error. When I changed my Learner
Group to Biomedical, none of the modules I completed appear. Why?
The content of the lectures and quizzes in the modules are customized by learner
groups. For example, the Biomedical learner group lectures/quizzes relate to topics most
frequently associated with biomedical or clinical research. The only way to assure that you receive
credit for the modules taken (whether in error or just for fun), is to complete the entire training
requirement for the learner group (i.e., all lectures and quizzes) before you decide to change your learner
group.
Active Research Projects
- I was told that my research activities are EXEMPT from IRB review. Do I still
have to complete GWU training requirement?
Yes. Investigators who conduct human subjects research that is exempt from IRB
review and approval (as defined by 45
CFR part 46.101(b)) must also comply with the education requirement.
- Will IRB approval
be delayed until proof of the required education is provided?Yes. The IRB approval
process will be delayed.
Questions
- Questions?
For questions regarding completions
reports or the GWU training program content or completion reports, contact the Office of
Human Research at 202.994.2715.For questions regarding CITI technical support, contact the CITI
Office at citisupport@med.miami.edu or at 305 243-7970.
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