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. Additional training in the responsible conduct of research and good clinical practices may also be required by funding agencies and other research sponsors. Requirements and training resources are explained below.
Human Subjects Protection – CITI
The University uses the Collaborative Institutional Training Initiative (CITI) web-based human research courses to satisfy the requirement for OSU researchers for training in human research subjects protection. Initial and continuing education (every 3 years) are required. Additional training and educational programs related to human subjects research protections are available.
Good Clinical Practice – GCP
Individuals seeking training in Good Clinical Practice (GCP) for clinical research may access the Good Clinical Practice (US FDA Focus) web-based program on the CITI website. The Basic and Refresher courses contain modules that include GCP and International Conference on Harmonisation (ICH) requirements, investigator responsibilities in drug and device studies, safety monitoring, and adverse event reporting. Prerequisite: Completion of the CITI basic human research course.
Responsible Conduct of Research – RCR
Researchers should verify and address all sponsor requirements for responsible conduct of research training. Federal funding agency requirements for RCR training are not uniform.
CITI RCR Resources
Individuals seeking training in Responsible Conduct of Research (RCR) may access a web-based program on the CITI web site. The course is available in five disciplines: biomedical research, social and behavioral research, physical science, humanities, and engineering. Each course contains modules in recommended areas of RCR instruction, including data acquisition and management, human and animal research, conflicts of interest, research misconduct, and mentoring.
University instructors may also access discipline-specific case studies for use within their courses.
US Export Control Regulation Course
Individuals seeking training in Export Control Regulations as they relate to University research may access the US Export Control Regulation web-based program on the CITI website.
CITI International Research Course
International Research Course (available in Chinese, English, French, Portuguese, and Spanish). This course can be used to supplement required training, but may not be used to satisfy Ohio State requirements for training in human subjects protection.