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Required Education
Collaborative Investigator Training Initiative (CITI) –
Required human subjects protection education
VCU requires that investigators and key personnel complete the Collaborative IRB Training Initiative (CITI) Basic Course in either Biomedical or Social-Behavioral Research. The course and exam are web-based and can be accessed at www.citiprogram.org.
New protocols (including ‘exempt’), continuing reviews, and change to research submissions will be forwarded for IRB review only after the principal investigator’s completion of the CITI Biomedical or Social-Behavioral Course has been verified. The CITI Refresher course does not qualify as one of the Basic courses. Make sure you take the Basic course. If the system will not 'allow' you to do so, please contact Zena Bailey (see contact information below). IRB members and staff are expected to take both Basic Courses.
All key study personnel, including the principal investigator, sub- and co-investigators, study coordinators, and students, are required to complete Basic CITI human subjects protection education in either Biomedical or Social-Behavioral Research. Key personnel are viewed as persons involved with the research protocol through interacting or intervening with research participants or their identifiable data. Those obtaining informed consent from a study participant are key personnel. The principal investigator confirms on the IRB application that all key personnel have completed the CITI course. CITI completion by key personnel is subject to random verification. The IRB may consider alternate training arrangements for certain kinds of research involving key personnel. The requirement for CITI BASIC course completion also applies to all investigators and research personnel who took a past VCU-required human subjects protection exam from the Dunn & Chadwick paperback text. Those individuals are required to take the CITI Basic course in Biomedical or Social-Behavioral research.
What is CITI?
The CITI program consists of on-line tutorials with on-line exams and is offered through the University of Miami. It was developed by experts in the IRB community and focuses on different aspects of bioethics and human subjects research. There is a basic course for the protection of human subjects in either biomedical or social/behavioral research. Choose the basic course that best describes your research. The courses have some content overlap. Students should ask for guidance from their departments about which course to take.
The Basic CITI training takes approximately 4-6 hours to complete, usually far less if the material is not completely unfamiliar. This training does not need to be completed in one sitting. However, it is suggested to start and finish a quiz without taking a break. The modules are completed in succession. You may repeat a quiz to improve your score. VCU requires an 80% passing rate for faculty and staff. The Biomedical or Social-Behavioral Basic Course is required for new investigators and key personnel or those who are new to VCU and did not take a CITI course at their previous institution.
Several hundred institutions require the CITI course as human subjects protection training. CEU’s and CME’s are available (for a fee) and can be directly obtained through the CITI program. You will receive immediate on-line verification of CITI course completion. This verification can be submitted with your IRB application and MUST be retained for your records. VCU may accept CITI completion from another institution. The investigator is responsible for obtaining the verification from the former institution.
Registration for CITI
CITI can be accessed at www.citiprogram.org. Closely follow the directions for registration. Remember your user name and password for future access into the CITI program. In order for VCU to obtain your record, indicate your institution as Virginia Commonwealth University only. When completing the Registration Profile as a first-time CITI participant, DO NOT indicate prior completion of another human subjects protection course. If the program indicates completion of the CITI Basic course, DO NOT take the Refresher course if you have not previously taken the Basic course.
For additional information contact Zena Bailey in the Office of Education and Compliance Oversight at zbailey@vcu.edu or 804-827-2156. |
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