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)


Questions?

For questions about training and education contact:

COMIRB at COMIRB@ucdenver.edu | 303-724-1055

Clinical Research Support Center at clinicalresearchsupportcenter@ucdenver.edu | 303-724-1111

FAQs