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 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 Training Basic Course?
Is your human subjects protection 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, 2014.
KUMC now uses CITI for all human subjects training. For new studies or new personnel, training must be current (completed after July 1, 2014) for all study team members before IRB approval is granted.
How to check your training dates:
How do you obtain a completion report from CITI?
Download instructions for obtaining a copy of your completion report here.
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 training in Human Research Protection?
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 biomedical research (research related to physical health) must complete the Biomedical Course. For investigators who previously completed Social/Behavioral training and are now involved in biomedical 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 & Collaborators
The requirement to maintain current training (within the past three years, based on fiscal year) 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. Complete the account request form. It may take up to 3 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 Jamie Ryan at 316-293-2610.
The CITI system is also used for training in Good Clinical Practice (GCP) and Responsible Conduct of Research (RCR). Please note these requirements for GCP and RCR are separate from the requirements for training in human subjects protection.
All faculty and staff engaged in research (for this purpose defined as all investigators and other research personnel, regardless of title or position, who are involved in the design, conduct, or reporting of research, regardless of funding) will be required to complete RCR training. The new RCR training requirements are as follows:
For those who have previously completed the CITI RCR training, you will not need to repeat the CITI training prior to Jan. 17, 2017, unless it has been four years since that prior training.
Effective Jan. 2017, KUMC requires GCP training for all investigators and clinical research coordinators engaged in the execution of a clinical trial. This includes principal investigators, co-investigators, and study coordinators formally listed as members of the study team (most commonly, on the basis of the IRB application).
The new GCP training requirement is as follows:
Because this GCP training is required by certain sponsors and has already been a requirement in certain areas of KUMC, some individuals involved in clinical research at KUMC have already taken this training. If you have already taken the GCP training, you will not need to retake it until the three-year expiration of the current training.
Additional information on RCR and CGP training can be found at myKUMC and by contacting Mary Hindle, 913-588-1242 or firstname.lastname@example.org.
If you have any questions or comments regarding the Human Subjects Protection and other courses in CITI, please contact Jamie Ryan at 316-293-2610 or email@example.com.