CITI Web-Based Course for the Protection of Human Research Subjects at Stony Brook University

The Collaborative IRB Training Initiative (CITI) Course on the Protection of Human Research Subjects is offered as an alternative to the lecture series coordinated through the Office of Research Compliance as a means to satisfy Stony Brook University's (SBU's) education requirement for investigators engaging in research involving human subjects.

What is SBU's Education Requirement for Investigators involved with human subjects?

SBU's Education Requirement was initially implemented in response to the NIH's requirement (effective with October 2000 awards) of training, prior to grant award, for all key personnel involved with human subjects. Our Federalwide Assurance (FWA), on file with the federal oversight agency called the Office for Human Research Protections (OHRP), mandates that all investigators conducting research involving human subjects, or data or biological specimens derived therefrom, regardless of funding source or status, be trained in the protection of human subjects in research activities. This requirement has been in effect since early 2001. The Vice President for Research has determined that this requirement may be met by one of two means:

a) successful completion of the lecture series (which concludes with a test) conducted by the Office of Research Compliance OR

b) successful completion of the CITI Web-based training program (which includes quizzes after each module)

AS REQUIRED BY OUR FWA: ALL INDIVIDUALS WHO ARE INVOLVED IN HUMAN SUBJECTS RESEARCH, AND WHO WORK EITHER DIRECTLY WITH THE SUBJECT, OR WITH DATA OR BIOLOGICAL SPECIMENS DERIVED FROM SUBJECTS OR PATIENTS, WILL BE REQUIRED TO SUCCESSFULLY COMPLETE ONE OF THESE 2 PROGRAMS. IF ALL SUCH INDIVIDUALS ARE NOT TRAINED, IRB APPROVAL FOR PENDING PROJECTS WILL BE WITHHELD UNTIL SUCH TIME AS ALL INDIVIDUALS ARE IDENTIFIED, AND TRAINING VERIFIED, BY THE OFFICE OF RESEARCH COMPLIANCE.

What does 'successful completion' mean?

Successful completion means that the individual scores a 70% or above on the examination at the end of the lecture, or a composite score of 70% on all the quizzes that must be taken at the end of each CITI module.

What if you fail?

If you fail the examination at the end of the lecture, you will be asked to take the CITI web-based training modules discussed below. 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 take the quizzes again.

What is the CITI Program?

The current CITI Program consists of two research tracks: Biomedical and Social/Behavioral. There are 15 modules (with quizzes) plus one module (Section 16) entitled Hot Topics (no quiz).

NOTE: All researchers are required to complete appropriate modules within the BIOMEDICAL section rather than the Social / Behavioral section. (If you are a social behavioral researcher at Stony Brook, you may review the Social / Behavioral tracks, but it is not required.)

Choose the appropriate category based on the following activities:

For Category 1 research: you work directly with human subjects in research activities that do not involve drugs, biologics, or devices. You are required to take Modules 1-11 of the Biomedical section ONLY.

For Category 2 research: you work directly with human subjects in research activities that do involve drugs, biologics or devices. You are required to take Modules 1-12 of the Biomedical section ONLY.

For Category 3 research: you do not, and will not ever, work directly with human subjects. Rather, the only research activities with which you are involved include analysis of data and/or biological specimens obtained from subjects or patients. (Note that if you are the individual who takes down the data, or is responsible for taking the biological specimens, from the subject or patient, you do not qualify as a category 3 researcher). Category 3 researchers are required to take Modules 1, 2, 5 and 6 of the Biomedical section ONLY.

Module 13 addresses specific requirements for human subjects research conducted at Veterans Administration facilities. If you have faculty status at a VA site or are involved in collaborative research at a VA site, you are encouraged to review this module, but it is not required.

Modules 14 and 15 address HIPAA & Human Subjects Research and Workers as Vulnerable Subjects. Although these two sections are not required, you are encouraged to review the information.

If all 13 modules and quizzes are completed, total time would be approximately 4-6 hours. One of the major benefits of the CITI program is that you can complete the coursework at your leisure. You can complete a few modules and their associated quizzes and come back at a later time to complete a few more, etc. The program will record your responses and track which modules have not been completed. You will have 60 days to complete all modules before your registration expires. Note that approval will not be granted until you successfully complete all of the necessary quizzes.

Who can use the CITI program?

• SBU offers access to the CITI program to all SBU faculty, staff, or students.
• Non-SBU investigators can use the CITI program if they are on file with CORIHS as an investigator on an IRB application (approved or pending).
• SBU and Non-SBU investigators, who are now due for their tri-annual recertification, may use the program as detailed in the section below.

Unauthorized use of the CITI program is prohibited.

CITI is an Ongoing Educational Resource:

The CITI program is available to all investigators (as detailed above), whether they completed the CITI or lecture program. CITI is a valuable resource on human subject protections for use anytime; in particular, the 'hot topics' module is a site where you can review information on important issues impacting researchers and research involving human subjects.

OK! HOW DO YOU REGISTER FOR CITI?

You may register for CITI by proceeding to the following registration webpage: http://www.miami.edu/citireg/

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Scroll down to the bottom and click on the link for Basic modules for biomedical or social and behavioral researchers

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Click on the link for SUNY Core Course (NOTE: If a runtime error box pops up, click No.)

Fill-in the registration form and click Submit when finished.

Within 24 hours (weekends and holidays excluded), you will receive a notification e-mail from sunyreg@jaguar.it.miami.edu followed by a second email with your username and password. The second email will include instructions on how to access the CITI site to begin your initial training. Once you are logged on to the site, follow the instructions to complete the necessary modules in the Biomedical section ONLY.

Contact Laura Wessels in the Office of Research Compliance with any questions you may have (631-632-9036; lwessels@notes.cc.sunysb.edu

Tri-Annual Recertification Requirement:

At this institution, certification in human subject protections must be renewed every three years. The continuing education requirement must be satisfied via the web-based CITI program (regardless of whether or not you obtained your initial certification via the live lecture, or on-line via the CITI 'Core' Course).

To register for the continuing education program:

Proceed to www.miami.edu/citireg

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Scroll down to the bottom and click on the link for Continuing Education Modules

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Click on the link for SUNY CE Course Site (NOTE: If a runtime error box pops up, click No.)

Fill-in the form and click Submit when finished.

Within 24 hours (weekends and holidays excluded), you will receive a notification e-mail from sunyreg@jaguar.it.miami.edu followed by a second email with your username and password. The second email will include instructions on how to access the CITI site to begin the Continuing Education Course. Once you are logged on to the site, follow the instructions to complete the necessary modules. When you are finished, remember to submit a C.E. Course Completion Notice.

Questions regarding this process may be sent to Ms. Laura Wessels, Office of Research Compliance, Tel. 631-632-9036, email: lwessels@notes.cc.sunysb.edu.