- To assure the rights and well-being of human subjects participating in research are protected
- To educate researchers about how to improve study conduct
- To provide resources to the Research Community
Initial CITI Certification
The Office for Human Subject Protection (OHSP) at the University of Rochester requires all study team members to successfully complete human subjects training through an on-line program called the Collaborative Institutional Training Initiative (CITI Program) prior to conducting any human subject research. This program was developed as a collaborative effort among various universities and organizations (including the University of Rochester) to provide comprehensive training in the protection of human research subjects and is administered by the University of Miami. The program consists of several short learning modules with a brief quiz after each module.
Instructions for registering and completing the training modules through CITI are provided below. Once you have successfully completed the program, OHSP will automatically receive a completion report from CITI via email. You will then be sent e-letter certification documenting your training. This letter will also provide your expiration date. You are required to renew certification every 3 years in order to continue conducting human subjects research at the University of Rochester.
Instructions for Registering and Completing Initial Human Subjects Training Certification
Initial Certification Courses
Once you complete registration in CITI, you will be directed to select 1 of 4 training courses. The course you complete should correspond to the type of research you will conduct:
- Greater Than Minimal Risk Biomedical - Select this course if you will conduct research that involves drugs, devices, biologics, or medical procedures that involve greater than minimal risk (e.g., biopsies, x-rays, etc.).
- Greater Than Minimal Risk Behavioral - Select this course if you will conduct social/behavioral research that involves sensitive or illegal behaviors (e.g., sexual behaviors, domestic violence, drug abuse, etc.).
- Minimal Risk - Select this course if you will conduct research using minimal risk procedures only (e.g., collection of small amounts of blood or other biological materials, surveys, record reviews, etc.). Please note that if you obtain certification for minimal risk research, but then become involved in a greater than minimal risk study, you will be required to complete one of the greater than minimal risk research training modules.
- IRB - Select this course only if you are OHSP staff or are currently a voting member of 1 of the 5 RSRB boards.
Are you unsure of which course to take?
If you are not sure which course to complete, please contact the OHSP office (contact information is provided below). Alternatively, completing one of the greater than minimal risk courses will generally ensure that you have the proper training for all levels of research. In general, faculty/staff/students working in a healthcare setting should complete the Greater than Minimal Risk Biomedical course, while all other faculty/staff/students should complete the Greater than Minimal Risk Behavioral course.
Tips on Completing the Training
- You may leave the course as many times as necessary and come back to it at a later time.
- You must score at least 85% to successfully obtain certification for human subjects research. In order to reach this goal, you may go back into each module to review the information and re-take the quiz as many times as necessary.
- Continuing education credits are available for physicians and other healthcare professionals through CITI for course completion. Please visit the CE Credits page on CITI's website or contact them directly at (305) 243-7970 for more information.
Have you Completed CITI Training at Another Institution?
If you are new faculty or staff at the University of Rochester and completed CITI training through another institution you still need to complete the UR-required training in CITI, however modules you completed previously should transfer to your UR course. To change your affiliated institution within CITI, select "Click here to affiliate with another institution" from the Main Menu once you've logged into CITI. Follow the prompts and answer all required questions. Once you've successfully changed your affiliated institution, select "Add a Course or Update Learner Group" from the Main Menu and then "Human Subject Protection". You'll then be asked to select one of the training courses described above. Note that all new faculty/staff must complete one of the initial certification courses, as opposed to a recertification course, as this is the first time you will complete the University of Rochester's version of CITI training.
If you have any questions about registering for CITI or completing this training, please contact Kelly Unsworth at (585) 275-5244 or by email.
Human Subjects Training
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