Training Requirements
All investigators and key personnel who participate in the design, conduct, or reporting of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects. Trainees supported by certain NIH grants must receive specified education in the responsible conduct of research. In some cases, sponsors or funding agencies require researchers to demonstrate knowledge of good clinical practices. There are several courses available to meet these requirements, depending on the kind of education desired. These courses are explained below.
Human Subjects Protection - CITI
The University uses the Collaborative Institutional Training Initiative (CITI) web-based human research course to satisfy the requirement for OSU researchers for training in human research subjects protection. Initial and continuing education (every 3 years) in human subjects protection are required.
Responsible Conduct of Research - RCR
All trainees supported by National Institutes of Health (NIH) Institutional National Research Service Award (NRSA) Research Training Grants (T32, T34) must receive instruction in the Responsible Conduct of Research (RCR). Trainees and others seeking RCR education may use the web-based CITI RCR modules or attend the OSU workshop to fulfill these requirements.
Good Clinical Practice - GCP
Individuals seeking training in Good Clinical Practice (GCP) for clinical research may access a web-based program on the CITI website. The course contains 15 modules that include GCP and ICH requirements, investigator responsibilities in drug and device studies, safety monitoring, and adverse event reporting. Prerequisite: Completion of the CITI basic course in human subjects protection.
Additional Training (Optional)
The following optional CITI Courses are also available:
- Good Clinical Practice and ICH
- Health Information Privacy and Security
- International Research (some content available in Simplified Chinese, French, Portuguese, and Spanish)
- Responsible Conduct of Research
These courses can be used to supplement required training, but may not be used to satisfy OSU requirements for training in human research subjects protection.
