Important Notice Regarding Collaborative IRB Training Initiative (CITI) Modules
A recently approved NSU-IRB policy applies to all involved in research activities that include human subjects including students, dissertation chairs and members, research staff and FSEHS faculty.
As stated in the attached memo, after April 1, 2005, all students submitting their IRB protocol for review will be required to have completed the course BEFORE their protocol is sent to the IRB office.
This NSU-IRB requirement is known as Collaborative IRB Training Initiative (CITI) and covers a range of topics that extend from the history of regulatory procedures to current issues with human subjects involved in social and behavioral research. These online training modules are a growing national trend as many universities are quickly adopting these courses as mandated training sessions. Effective Fall 2005, all NSU doctoral students will be required to complete the CITI training during their required research and evaluation coursework, and, although students will not be "graded" on CITI, it will be a course component which must be successfully completed prior to submission of a final course grade. In summary, only those students that start their doctoral program in Fall 2005 or after will have their CITI requirement included in one of their courses; all other students must complete it prior to IRB submission.
The online CITI modules typically require approximately 3 to 5 hours to complete. After reading each module you will be required to complete a short quiz on the content just covered. You will be allowed to complete each module as many times as you wish. In addition, the course is set up in a way that allows participants to start and stop sessions and to retake quizzes as many times as necessary in order to achieve the required overall passing score of 90%. Training will provide a three year renewable certification. Also, if you completed the CITI certification previously, you will be required to provide documentation in lieu of completing the online CITI modules/quizzes. Once you successfully complete the training (and achieve an overall score of at least 90%) you will receive an e-mail confirmation, which will also be forwarded to NSU's IRB Administrator who will then notify the ARC. These procedures will apply to students as they get ready to submit their IRB protocols. Those protocols that have a PI or a Co-PI that did not complete the CITI certification will be deemed non-reviewable until this requirement is completed.
Students who have not submitted their IRB by April 1st will have to complete the CITI certification. Several scenarios are addressed as follows:
a) a student's applied dissertation proposal was approved
by the applied dissertation committee and his IRB was approved
as an exempt protocol before April 1st, 2005; the student
in this case does not need to complete the CITI course;
b) a student's proposal was approved by the applied dissertation
committee and her IRB approved (as expedited or full review)
prior to April 1st, 2005, for a one-year period of time (as
is the case for expedited and full reviews). For the student
to obtain reauthorization after the one-year period passes
in order to continue with the research project, she would
have to complete the CITI certification;
c) a student's proposal was approved and his IRB protocol
was received in the ARC on March 29th, 2005; again, this student
will not have to complete the CITI certification (this case
is similar to case a) but it may have a slight variation in
that the protocol might have to be reviewed by the IRB chair
(i.e., expedited) or by the entire board (i.e., full review)
and there might be the requirement that the student completes
the CITI certification as an additional safeguard);
d) a student's proposal was approved, she sends her IRB protocol
for her AD Chair to review on March 28th, 2005, then mails
the paperwork to the ARC on March 31st; the ARC receives it
and logs it on April 2nd, 2005; she will have to complete
the CITI certification.
