Office of Responsible Research Practices
The Ohio State University

Study Team Requirements

All investigators and key personnel engaged in human subjects research must be appropriately trained in the protection of human subjects. All persons eligible to conduct research must also be trained in the responsible conduct of research.  Additional training in good clinical practice or US export control may also be required by colleges, departments, and/or funding agencies and research sponsors. The university uses the Collaborative Institutional Training Initiative (CITI) web-based courses to provide these trainings to Ohio State researchers.  Requirements and training resources are explained below.

CITI course completions may take up to 2 hours to be reflected in Ohio State systems.

Human Subjects Protection (HSP)

The university requires all those who will participate in the design, conduct, and/or reporting of human subjects research to be trained in human subjects protection. The training requirement can be met by one of two available CITI web-based courses: Human Subjects Protection (Biomedical) or Human Subjects Protection (Social and Behavioral).  Initial and continuing education (every 3 years) are required.

Human Subjects Protection

Responsible Conduct of Research (RCR)

The university requires all individuals eligible to conduct research to be trained in the Responsible Conduct of Research (RCR).  The training requirement can be met by one of seven discipline-specific CITI web-based courses.  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

Good Clinical Practice (GCP)

Individuals seeking training in Good Clinical Practice (GCP) for clinical research may complete one of two available CITI web-based courses:  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 Human Subjects Protection course (Biomedical or Social and Behavioral).

Good Clinical Practice