Human Research Protection Program
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?
- Personnel who have never been certified in human subjects protection at KUMC, or
- Personnel whose certification through KUMC was completed prior to July 1, 2014
- Persons affiliated with research at KUMC, but not employed or enrolled at KUMC (See Affiliates or Collaborators section below for details.)
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:
- If you have completed your human subjects training through KUMC Chalk or CITI through KUMC sign on, log into eCompliance and 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.
- If you have completed your human subjects training through CITI prior to your KUMC position, log into CITI through your previous affiliation and go to My Reports page. Click the "View" link under Completion Report. You may also view your expirations and scores from this page. If you prefer, you may be able to transfer your modules for credit to KUMC on the CITI website or request assistance from CITI staff.
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?
Go to www.citiprogram.org, click on the "Log In" button, then click on "Log in through my institution." Find University of Kansas Medical Center on the list, then log in with your KUMC credentials.
For initial instructions, view our screen shot user guide for Setting up your Coursework.
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.
Responsible Conduct of Research and Good Clinical Practice Training
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.
Responsible Conduct of Research (RCR) Training
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:
- Complete the designated RCR modules in CITI by Jan. 1, 2017, and once every four years after that
- Attend or view two live seminars or conferences on RCR every four years
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.
Good Clinical Practice (GCP) 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:
- Complete the designated GCP modules in CITI by Jan. 1, 2017, and once every three years after that
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.