Collaborative Institutional Training Initiative (CITI) is a web-based training package on issues relating to human subjects research. The program contains modules on topics like informed consent, vulnerable populations, ethical principles, and IRB regulations. The CITI programs can be found at https://www.citiprogram.org/?pageID=668
Human Subjects Protection (“HSP”) Modules
All researchers who are engaged in the planning, conduct, or analysis of human subjects research must complete this training.
As of June 1, 2020, all investigators must renew HSP training every three years.
Your training will expire in the month that you last completed HSP initial or renewal training. So, if you completed your training in September of 2014, your expiration date is September 1, 2020.
For new submissions or to be added to an existing study, your training will need to be current (completed within the last three years). For example, even though your training expires September 1, 2020, you will need to complete the renewal training in order to be added to a new study or as new personnel on an existing study.
Good Clinical Practice (GCP) Modules
GCP training is required for investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects where the study includes a drug, device, or biologic.
The GCP requirement can be satisfied by either:
- GCP for Clinical Trials with Investigational Drugs, Biologics and Devices, or
- GCP for Social and Behavioral Research Best Practices.
The GCP course at CITI has two additional modules available. These courses do not fulfill the GCP requirement for UNC:
- Elective Modules for Clinical Trials with Investigational Medical Devices
- Supplemental Modules for Clinical Trials with Investigational Medical Devices
Similar to HSP training, GCP must be renewed every three years.
Please visit the OHRE website for additional information on CITI training and our FAQ’s.
https://research.unc.edu/human-research-ethics/getting-started/training/
If you have questions about the IRB or need any assistance with your submission, email the IRB at irb_questions@unc.edu
To submit a topic or question for a future DYK, email Celeste Cantrell