UW-Madison Collaborative
Institutional Training Initiative (CITI)
Frequently Asked Questions about Human
Subjects Training
Ÿ Why do I need to take research training courses offered through CITI?
Ÿ What if I already have human subjects protection certification from UW-Madison?
Ÿ Who are "personnel engaged in human subjects research"
Ÿ What if I already have certification from the VA or an outside institution?
Ÿ Do I need to take CITI to submit change of protocol or continuing review applications?
Ÿ How will the IRB know that I have completed the required training?
Ÿ How long will it take to complete the course?
Ÿ How often do I need to take human subjects education?
Ÿ How do I check my certification expiration date?
Ÿ How do I print a copy of my certification form?
What is CITI?
CITI (Collaborative Institutional Training Initiative) is an online
research education program developed and hosted by the University of Miami and
currently used by more than 800 institutions.
Why do I need to take human
subjects training through CITI?
UW-Madison requires human subjects training for all “personnel
engaged in human subjects research” who are listed on a human subjects
protocol submitted to a UW-Madison IRB before the protocol can be approved by
the IRB. The CITI program has replaced the previously offered UW-Madison Human
Subjects Tutorial. Mandatory training in human subjects protection is one
method UW-Madison uses to assure that those involved in human subjects research
understand the applicable federal regulations and ethical principles that must
be applied in conducting such research.
After December 31, 2008, an IRB WILL NOT REVIEW OR APPROVE any protocol application (Initial Application, Continuing Review, Change of Protocol, etc.) until all persons listed on that application as principal or co-investigator or key personnel have completed the required CITI human subjects protection training course. This includes applications for exempt research.
What if I already have human
subjects protection certification from UW-Madison?
If you have taken the previous UW-Madison Human Subects Tutorial, you
have until December 31, 2008 to complete the CITI Human Subjects Protection
training. After December 31, 2008, the IRB will not review or approve any IRB
protocol application (Initial Application, Continuing Review, Change of
Protocol, etc.) if study personnel listed on that application have not
completed the new CITI human subjects protection training.
Which courses are required?
Once you access the CITI training website, you will be asked to select
the specific Human Subjects Protection training module(s) applicable to you.
See, How to Access and
Complete CITI Training.
All UW-Madison “personnel engaged in human subjects research” who are listed on a human subjects protocol submitted to a UW-Madison IRB must complete one of the following three CITI human subjects protection training courses before the protocol can be approved:
Ÿ Human Subjects Protection for Biomedical Researchers (if you are listed only on protocols submitted to the HS IRB or MR IRB)
Ÿ Human Subjects Protection for Education, Social and Behavioral Science Researchers (if you are listed only on protocols submitted to the ED IRB or SBS IRB)
Ÿ Combined Course - Human Subjects Protection for Biomedical, Education, Social and Behavioral Researchers (if you are listed on protocols submitted to the HS IRB or MR IRB and ED IRB or SBS IRB)
UW Comprehensive Cancer Center (UWCCC) affiliates (e.g., researchers, members and staff) must also take the CITI Good Clinical Practice training course.
Who are "personnel engaged in
human subjects research?"
“Personnel engaged in
human subjects research,” for purposes of the human subjects training
requirement, means all individuals who:
Ÿ design research,
Ÿ direct research or serve as the principal investigator,
Ÿ enroll research subjects (including obtaining subjects’ informed consent or screening potential subjects) or make decisions related to eligibility to participate in research,
Ÿ conduct study procedures,
Ÿ analyze or report research data,
Ÿ analyze or report adverse events, or
Ÿ author manuscripts concerning the research for publication.
These include, but are not limited to: Investigators, faculty advisors, graduate and undergraduate students, study coordinators, recruitment staff, and anyone else performing study procedures or interventions. If you are unsure whether or not you or someone on your study team needs to take the required CITI human subjects protection training, please contact the Human Research Protection Program (HRPP) Manager at hrpp@bascom.wisc.edu or 608-262-1224.
What if I already have certification from the VA or an
outside institution?
All UW-Madison
research personnel must take the new CITI training by December 31, 2008. For personnel at other
institutions collaborating with UW-Madison researchers, UW-Madison IRBs may
accept certification of the completion of a comparable human research training
program as a substitute for completion of UW-Madison’s required training.
UW-Madison IRBs accept the following substitutes:
Ÿ the Veterans Affairs Good Clinical Practice & Human Subjects Protection training,
Ÿ training taken at another institution that uses the CITI Course in The Protection of Human Research Subjects,
Ÿ the National Institutes of Health training, and
Ÿ training from other institutions holding a Federalwide Assurance.
Collaborators who do not have certification of the completion of comparable human research training, as described above, must take the UW-Madison CITI course. Please review How to Access and Complete CITI Training.
If you completed the CITI Training for the Madison VA in 2007, you have satisfied the new UW-Madison CITI human subjects training requirement.
If you have completed the training for another institution that uses CITI, please log on to the CITI home page using the username and password you created to do the training for that institution, and add UW-Madison by clicking "Affiliate with another Institution" on the Learner's Main Page. You may need to complete additional modules because different institutions have different training requirements. However, CITI modules that you have completed for another institution will count as completed for UW-Madison.
Investigators must apply to the IRB Offices for approval to substitute other training programs for research personnel not otherwise affiliated with the UW-Madison when circumstances warrant. For example, a different substitute training program might be approved if other personnel would have difficulty accessing one of the training programs listed above because they are not located in the U.S.
Do I need to take CITI to submit
change of protocol or continuing review applications?
Beginning January 1, 2009, to submit an application for a change of
protocol or for continuing review, you and everyone listed on the application
will need to be certified as having completed the new CITI human subjects
protection training course.
Before January 1, 2009, if you submit a change of protocol that adds "key personnel" to a previously approved study, each of the new personnel added to the protocol must have completed human subjects training. If the individual has not previously taken the UW-Madison Human Subjects Tutorial, then that person must complete the new CITI Human Subjects Protection Training course before the IRB will review and approve the change of protocol.
How will the IRB know that I have
completed the required training?
Once you have completed all the required and elective modules as part of
a course and achieved a score of 85% averaged across all required and elective
modules, your information will be automatically entered into the UW-Madison
Researcher Certificate of Completion database. The IRB office will be able to
use the database to verify your training. If you are submitting a protocol
electronically and have completed the training, but your training date does not
show up in the electronic protocol submission software, please contact the IRB
office for assistance.
How long will it take to
complete the course?
Each CITI human subjects protection training module has a short lesson
to read and a quiz to complete. The average learner spends approximately 2
hours to complete one of the CITI Human Subjects Protection training courses.
To be certified, you must complete several "required" modules and
your choice of one "elective" module. Users can log in as many times
as necessary to complete the course. CITI will track which modules you have
completed and which remain uncompleted.
If you select the Combined Course - Human Subjects
Protection for Biomedical, Education, Social and Behavioral Science
Researchers, as you complete a module for Biomedical researchers, the same
module will appear completed for Education, Social and Behavioral Science
Researchers. You do not have to repeat the module.
If you have completed the training for another institution that also uses CITI, the modules you have completed for one institution will also count as completed for another institution.
How often do I need to take human
subjects education?
Study personnel listed on IRB applications are required to complete the
CITI Basic Course (or CITI Refresher equivalent) every three (3) years.
How do I check my
certification expiration date?
CITI will notify you by email 90, 30 and 7 days before your
certification expires.
To check the expiration date of your human subjects education certificate do the following:
Ÿ Log into the UW-Madison Researcher Certificate of Completion Database (this requires UW-Madison NetID authentication).
Ÿ Type in the last name of the person you are looking for.
Ÿ Click on the name.
Ÿ The Certificate of Completion will have the completion and expiration dates.
How do I print a copy of
my certification form?
To print a copy of the completion certificate from CITI:
Ÿ Log in into CITI (How do I access the CITI course?).
Ÿ From the "Learners Menu" page, click on the "Previous Coursework Completed" link.
Ÿ The "Completion Reports" page will list all the CITI courses you have completed.
Ÿ Click "Print Completion Report" after the training for which you want to print a Certificate of Completion.
To print a copy of the completion certificate from the UW-Madison Researcher Certificate of Completion Database:
Ÿ Log into the UW-Madison Researcher Certificate of Completion Database (this requires UW-Madison NetID authentication).
Ÿ Type in the last name of the person you are looking up.
Ÿ Click on the name.
Ÿ Print the Certificate of Completion using your browser’s print feature.
Ÿ The Certificate of Completion will have the completion and expiration dates.
Problems or questions about
accessing the CITI courses;
Contact UW-Madison CITI Help Desk at researchpolicy@bascom.wisc.edu
Contact the Human Research Protection Program Manager at hrpp@bascom.wisc.edu or 608-262-1224.
CITI FAQs
To see FAQs provided by CITI please click on the following link
http://www.citiprogram.org/citidocuments/faq.htm