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The Ohio State University

Office of Responsible Research Practices



 



 
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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. 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

Ohio State uses the Collaborative Institutional Training Initiative (CITI) web-based human research courses to satisfy the requirement for Ohio State 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.
CITI Information

Responsible Conduct of Research - RCR

Sponsor Requirements
Researchers should verify and address all sponsor requirements for responsible conduct of research training. Federal funding agency requirements for RCR training are not uniform.
NIH RCR Requirements
NSF RCR Requirements

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.

Instructors may also access discipline specific case studies for use within their courses.
CITI RCR

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 course contains 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.
GCP Information

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. The course contains modules providing a basic overview of export controls. Also provided is information specific to the various federal agencies that oversee export controls including the State Department’s International Traffic in Arms Regulations (ITAR), the Commerce Department’s Export Administration Regulations (EAR) and the Treasury Department’s Office of Foreign Assets Control (OFAC).

The CITI course can be used to fulfill the export control training requirement for University staff, students and/or employees that may be required by certain Colleges or Departments. Additional training and educational programs related to export controls are also available. Contact exportcontrol@osu.edu for more information on other training opportunities.

Additional Training

The following CITI course is also available:
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.
CITI Information

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Last Modified: January 26, 2012
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