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What Training is Required?


MCW HRPP requires the completion of the online Collaborative IRB Training Initiative (CITI) program.    In 2004 MCW announced the requirement to all individuals involved in the design, conduct or review of human subjects research to have been certified under a new educational program.  If an Investigator has completed CITI modules at a previous institution, they are able to transfer that work within CITI by opting to change their institutional affiliation to MCW. See the FAQ below for more specific instructions.

Initial


Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must obtain CITI certification. CITI certification is obtained by completing the required on-line modules with an overall score of 80%. The initial CITI course can be completed in four to six hours. Six CME credits are available from CITI.

  • New employees must complete the required modules and obtain CITI certification within 90 days from date of hire.
  • An investigator may not be a Principal Investigator until initial certification is complete.

The required modules depend on the type of research and your role in that research.

  • Biomedical Research involves any type of clinical research studies, including those that involve investigational drugs and/or devices.
  • Social/Behavioral Research involves observational and survey research, work with population and/or epidemiological studies. This type of research does not involve any drugs or devices (investigational or marketed).
  • Please refer to the HRPP Certification Program web page - Requirements for help in determining the modules required for your role in a study.
     

Annual


Additional human subject protection education is required each year for investigators and coordinators.

  • MCW investigators and coordinators must obtain three hours of human subject protection education annually.
  • Non MCW members of the research team must obtain one hour of human subject protection education annually.

     

CITI Refresher


In order to maintain CITI certification, everyone is required to complete the CITI Refresher course every three (3) years after initial certification is obtained. Completion of the refresher modules can usually be completed in less than two hours.

 

Frequently Asked Questions


For these and additional FAQs, and for comprehensive information on CITI certification, please visit the HRPP Certification Program web page

Who must complete requirements of the MCW Human Research Protections Certification Program?
Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must be certified.

Will my training that I completed at another institution be accepted?
If you are involved in human subject research at either Children’s Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and are current in your human subject protection training, MCW will accept this training.

If you have completed human subject protection training at an institution other than Children’s Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and request MCW acceptance of the training, please contact _citihelpdesk@mcw.edu .

How long will it take to complete the certification program?
The total time is approximately 4 to 6 hours for the basic course and less than 2 hours for the refresher course. You may complete it multiple sittings. The certification program is web-based and can be accessed from any computer via the internet.

What are some available options for the required annual education/training?

  • Annual Research Conference
  • MCW program, clinical research workshop or seminar regarding human research
  • Human Research Professionals Meeting
  • CITI Core Course module not done for initial certification CITI Refresher Course module not required for biennial recertification
  • Clinical Research Scholars Program
  • Non-MCW sponsored courses regarding human subject research
  • NIH computer based training
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