All KUMC research personnel, KUMC staff and affiliated staff who have any role in research involving human subjects must pass and maintain current training in human subjects protection. The requirement to maintain current training also applies to collaborators from other institutions who are working on KUMC projects. KUMC is now using CITI (Collaborative Institutional Training Initiative, housed at the University of Miami) for the Human Subjects Protection Training and some training required by other compliance areas. Investigators who are transferring to KUMC from another institution may email their current certification to firstname.lastname@example.org if they have already completed the appropriate CITI Basic Course through a previous institution.
WHO NEEDS TO TAKE THE HUMAN SUBJECTS PROTECTION BASIC COURSE?
IS YOUR TRAINING CURRENT? The KUMC IRB honors human subjects protection basic or refresher training completed within a three-year cycle based on the fiscal year. Your training is current if it was completed after July 1, 2012.
As of July 14, 2014, KUMC uses CITI for all human subjects protection training. For new studies or new personnel, training must be current (completed after July 1, 2012) for all study team members before IRB approval is granted. The compliance window closes on September 17, 2014 at which time all researchers must have current training.
HOW TO CHECK YOUR TRAINING DATES: If you have completed your human subjects training through KUMC, log into eCompliance, click on your name in the upper right hand corner. On your Properties tab, select the view "Research Profile." Refer to "2. Training data" where you will find the title of the course and the date on which you passed it. Current training must be maintained by persons who have any role in the review, design, and/or conduct of human subjects research at KUMC.
HOW DO YOU FIND CITI? Use the "Log in via SSO" button with your KUMC user name and password at www.citiprogram.org For initial instructions, view our screen shot user guide for Setting up your Coursework or view our instructional video.
WHAT COURSES DO YOU NEED TO PASS? All KUMC researchers should complete either the Biomedical Basic Course or the Social Behavioral Basic Course, depending on the type of research in which you typically engage. Advanced courses may be required if your research involves vulnerable populations. Investigators who conduct FDA-regulated research must complete the Biomedical Course. For investigators who previously completed Social/Behavioral training and are now involved in FDA-regulated research, an additional course "FDA Research for Social-Behavioral Investigators" will satisfy this requirement.
HOW MUCH TIME SHOULD YOU ALLOW? Completing either of the CITI Basic Courses could take up to 3 hours. You can complete it in stages if necessary.
AFFILIATES OR COLLABORATORS: The requirement to maintain current training (within the past three years) also applies to collaborators from other institutions who are working on KUMC projects. Collaborators may demonstrate human subjects training from their home institution, CITI, or NIH by emailing their completion certificate to email@example.com Alternatively, collaborators may obtain a KUMC affiliate account to complete the CITI course.
Obtaining an Affiliate Account: If you do not have a KUMC network account and are affiliated with human subjects research at KUMC, you'll need an affiliate account. Ask the account requestor from your sponsoring department at KUMC to create an appropriate account for you. (It could take up to three days to create an account.) If you are unable to successfully log into CITI, please make sure you have authenticated your affiliate account at myKUMC. If you are still unable to access it, call University Customer Support at 913-588-7995.
The Good Clinical Practice (GCP) modules are available for your use in CITI. GCP modules offer a comprehensive resource for personnel who are involved in the conduct of clinical trials. Please note: GCP modules are optional training for KUMC research personnel unless required by your study sponsor. The GCP modules do not substitute for the Basic Biomedical Human Subjects Protection curriculum.
If you have any questions or comments regarding the Human Subjects Protection and other courses in CITI, please contact Diane Etzel-Wise at 913-588-1390 or email firstname.lastname@example.org