VCU fulfills the federal mandate to ensure all researchers involved in human subjects research are trained by requiring initial and continuing education through the Collaborative IRB Training Initiative.
Complete CITI Basic Human Subjects Protection online training in either:
Select the most appropriate module based on the majority of research you conduct.
Every two years, individuals who have completed the CITI Basic Human Subjects Protection course must complete the CITI Refresher Human Subjects Protection course. After three refresher courses, individuals should take the basic course again.
Instructions for using CITI:
Effective Oct. 1, 2017, VCU no longer accepts CITI courses taken at other universities. All research personnel must officially be affiliated with VCU and have their CITI training from VCU. VCU will only accept CITI course credit that is linked to a VCU CITI account (basic and refresher courses).
All research personnel must complete VCU’s Human Subjects Protection basic course.
Submissions of all types (initial, continuing review, etc.) will not receive IRB approval until research personnel CITI accounts are current.
VCU requires all research personnel on a study to complete the Collaborative IRB Training Initiative Human Subjects Protection basic course before beginning human subjects research.
IMPORTANT NOTE: The CITI Human Subjects Protection refresher course does not qualify as a basic course. Make sure you take the basic course first.
IMPORTANT NOTE: In addition, CITI’s Responsible Conduct of Research and Good Clinical Practice courses do not meet the IRB’s requirement; please ensure you complete the Human Subjects Protection basic course.
The CITI course and exam are web-based and can be accessed at www.citiprogram.org. All the modules listed for VCU must be completed. Most modules include a short quiz. An aggregate passing score of 80% is required. CMEs and CEUs are available for CITI completion.
Occasionally, the CITI database has errors. Thus, it is important to print off a copy of the completion verification and retain in your files should future verification be required.
Every two years, individuals who have completed the CITI Human Subjects Protection basic course must complete the CITI refresher course Human Subjects Protection. After three refresher courses, individuals should take the basic course again.
You should be automatically prompted to retake the basic course after three refreshers. However, if you are not prompted, please contact CITI (firstname.lastname@example.org) or the Human Research Protection Program (email@example.com).
To maintain current CITI training, all research personnel must complete the CITI refresher training before the expiration date of the basic course. The basic course expires 2 years after the original completion date. CITI sends an email reminder to the email address you used to register.
All individuals must formally affiliate their CITI account with VCU. Directions to do that can be found here: Associating your account with multiple institutions.
IMPORTANT NOTE: Courses from previous institutions will automatically link to your VCU account when you affiliate and “add a course” (10 years back) ONLY if you have not yet taken the Human Subjects Protection courses at VCU.
If you have already taken Human Subjects Protection courses at VCU, courses from previous institutions will NOT automatically link to your VCU account. You must call CITI and ask them to manually link the course to your VCU account.
Any courses you’ve taken in the past 10 years can be linked to your VCU CITI account. Once you affiliate with VCU and link your courses, you may be prompted to complete additional VCU modules to meet the VCU education requirements. Any courses taken over 10 years ago must be retaken.
Man looking at laptop screen sitting in office [View Image]Effective Feb. 1, 2015, VCU began requiring Good Clinical Practice training for all clinical trial study personnel listed on a VCU IRB-approved clinical trial. NIH defines a clinical trial as “a research study in which one or more humans are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” This applies to all new AND existing studies. The VCU GCP training must be renewed every three years.
VCU’s GCP training program meets the National Institutes of Health GCP training requirements for all NIH-funded investigators and staff involved in the conduct, oversight or management of clinical trials (NOT-OD-16-148 published Sept. 16, 2016).
This GCP requirement can be met by completing one of the following trainings. Please refer to the following PDF guidance on adding a course:
Depending on your experience with human subjects research, the basic CITI course can take four to six hours to complete. It does not have to be completed in one sitting. Verification of completion is sent to you immediately. Occasionally, the CITI database has errors. Thus, it is important to print off a copy of the completion verification and retain in your files.
The refresher course takes about two hours to complete. It does not have to be completed in one sitting. Verification of completion is sent to you immediately. Print off a completion certificate and retain in your files.
When you enter CITI using the same username and password used for the basic course, you will be automatically routed to the refresher course. Take the refresher course in the learner group most relevant to your research activities — biomedical or social-behavioral research. Note that you can change your learner group. Depending on the learner group, some modules are required for everyone. In addition, you can choose from a selection of elective modules. The required total number for the refresher course must be completed before any optional courses are available. CMEs and CEUs are available for CITI completion.
The basic course expires two years after the month/date it was taken. For example, if you completed the course on Oct. 15, 2010, it expires on Oct. 16, 2012. You will need to take the CITI refresher course to keep your human research protections training current. Use the same username and password for the refresher as was used for the basic course.
The refresher course expires two years after the month/date it was taken. For example, if you completed the refresher on Feb. 15, 2010, it expires on Feb. 16, 2012. You will need to take the refresher course by that date to keep your human research protections training current.
If you do not know your username and password, contact CITI directly using the “Forgot username or password” retrieval tool on CITI’s homepage (www.citiprogram.org).
New protocols (including exempt), continuing reviews and amendments will be forwarded for IRB review ONLY after the principal investigator’s current completion of the CITI biomedical or social-behavioral refresher course has been verified. Investigators and key personnel must have taken the basic course before qualifying for the refresher course.
The optional modules become available after the required number of modules are completed.