Office of Responsible Research Practices
The Ohio State University

Study Team 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. 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 (HSP)

The university uses the Collaborative Institutional Training Initiative (CITI) web-based human research courses to satisfy the requirement for Ohio State researchers to be trained in human research subjects protection. The coursework is available in two versions, both of which meet the training requirement: Biomedical Human Research or Social and Behavioral Human Research.  Initial and continuing education (every 3 years) are required. Additional training and educational programs related to human subjects research protections are available.

Human Subjects Protection training

Responsible Conduct of Research (RCR)

The university requires all individuals eligible to conduct research to be trained in the Responsible Conduct of Research (RCR).  All research eligible individuals must take the CITI RCR course.  Researchers should verify and address all sponsor requirements for responsible conduct of research training. Federal funding agency requirements for RCR training are not uniform.

Responsible Conduct of Research training

Good Clinical Practice (GCP)

Individuals seeking training in Good Clinical Practice (GCP) for clinical research may complete one of two available web-based courses on the CITI website:  Good Clinical Practice (US FDA Focus) or Good Clinical Practice (Social and Behavioral Focus). 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 a CITI basic human research course (Biomedical or Social and Behavioral).

Good Clinical Practice training

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.

US Export Control Regulation training