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 U.S. 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 training to Ohio State researchers.
Requirements for All Studies
Human Subjects Protection (HSP)
All investigators and key personnel who participate in the design, conduct, and/or reporting of human subjects research (including exempt research) and all IRB members and IRB staff must be appropriately trained in the protection of human subjects. The training requirement can be met by one of two available Collaborative Institutional Training Initiative (CITI) web-based courses: Human Subjects Protection (Biomedical) or Human Subjects Protection (Social and Behavioral).
- Training must be completed prior to receiving the initial or continuing IRB review of research.
- Initial and continuing education (every 3 years) is required.
- CITI course completions may take up to 2 hours to be reflected in Ohio State systems.
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 RCR training as federal funding agency requirements are not uniform.
Requirement Determined by Sponsor
Good Clinical Practice (GCP)
All investigators should confirm what training courses an individual sponsor may require prior to funding or beginning research. Sponsors or funding agencies can require researchers who conduct clinical research to demonstrate knowledge of good clinical practices. 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).
- Formal GCP training for clinical investigators is not currently required by the university.
- The Good Clinical Practice courses may not be used to satisfy Ohio State requirements for training in human subjects protection.
- The GCP basic and refresher courses align with the Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.
- CITI course completions may take up to 2 hours to be reflected in Ohio State systems.