Training Requirements for Conducting Human Subjects Research
All personnel involved in the conduct of human subjects research must complete human subjects training and must renew that training every three years. Additional training is necessary depending on the type of research you are conducting and how your research is funded. The University of Colorado Denver | Anschutz Medical Campus uses the Collaborative Institutional Training Initiative (CITI Program) to deliver and record human subjects training.
When you log into CITI, and affiliate with the University of Colorado Denver, you will find available courses listed below.
Human Subjects Training:
- If you are conducting biomedical research, select Group 1 Biomedical Investigators.
- If you are conducting Social/Behavioral Research, select Group 2 Social and Behavioral Research.
HIPAA: If your research involves access to Protected Health Information, you must also complete training related to the Health Information Portability and Accessibility Act (HIPAA) every three years.
- Select CITI Health Information Privacy and Security (HIPS) for Clinical Investigators.
Good Clinical Practice (GCP): All NIH-funded clinical investigators and clinical trial staff who are involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).
- Select Group 4: ICH/GCP – meets NIH Requirements, or
- Select GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
How do I access these CITI courses?
- Log into CITI. Create an account if you do not have one.
- Add an affiliation with the University of Colorado Denver.
- Add your University of Colorado Denver | Anschutz Medical Campus Employee ID number, or your POI number, on your institutional profile.
- Select from the list of courses provided.
I don’t have a University of Colorado employee ID number. How do I get a POI number?
- Submit a Person of Interest (POI) Request Form. Once your request is processed, you will receive your POI number and be granted access to the COMIRB eRA(InfoEd) system.
Will COMIRB accept UCHealth or VA CITI training?
- Yes, please upload your completion certificate to InfoEd with your next submission.
Will COMIRB accept courses taken with another institution?
- If you are a new faculty at the University of Colorado, Denver | Anschutz Medical Campus, for the first year COMIRB will accept a completion certificate for human subjects training from your previous institution. Your training must have been completed within the last three years. Within your first year here, please affiliate with our University on CITI and update your training.
How do I renew my training?
- CITI will email you reminders about renewing your training. Follow the instructions on CITI to complete a refresher course.
Will GCP training satisfy either Group 1 or 2 Human Subjects training?
- At this time, yes, COMIRB will accept GCP training as fulfilling human subjects training requirements.
Do co-investigators from other institutions need to complete University of Colorado Denver CITI training?
If I am conducting community engagement research, do my community partners need to complete CITI training?
- Although you can ask your community partners to complete CITI training, the Clinical Research Support Center provides an Education Consultation Service to tailor training based on your study and the community you are working with.
Who is responsible for making sure study staff complete training?
- The PI. COMIRB will make sure human subjects and HIPAA training is up-to-date for the PI, co-investigators, and primary contact during our reviews of the research. However, other study staff are not required to be identified in eRA(InfoEd) and COMIRB does not review their training.
Do I need to take training about Responsible Conduct of Research (RCR)?
I completed the CITI courses but they are not reflected accurately in InfoEd.
- Make sure you have added an affiliation with the University of Colorado Denver.
- Make sure your University of Colorado Denver employee ID number, or your POI number, is accurately listed on your CITI profile for the university. If you do not have a University of Colorado Employee ID number, request a POI number here.
- Make sure you completed and passed every module within the course.
- Please wait 48 hours after completing a course for course completion to be reflected in InfoEd.
I completed the CITI courses under two different CITI accounts.
- Please call CITI support at 888.529.5929 to merge your accounts.
I’m still having trouble.
- Please call COMIRB at 303.724.1055
- Attach your completion certificate to your COMIRB submission.
Additional Training and Educational Resources:
COMIRB and the Clinical Research Support Center offer ongoing training opportunities for investigators to expand their knowledge about research involving human subjects.
See the Clinical Research Training and Education page for more information.
To schedule training and education contact:
COMIRB at COMIRB@ucdenver.edu | 303-724-1055
Clinical Research Support Center at firstname.lastname@example.org | 303-724-1111