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Is My Project Human Subjects Research?

 

The Code of Federal Regulations: Title 45, Public Welfare, Part 46, Protection of Human Subjects, specifies that human subjects research may not begin until it has been authorized by the university IRB. These pages contain the instructions and materials you need to prepare and submit  your IRB protocol for review.

It is strongly suggested that you begin with "Is My Project Human Subjects Research?"

"Key personnel" in research projects involving human subjects must be certified in Human Subjects Protection Training (HSPT) for IRB authorization of their protocols. Key personnel are the principal investigator and any other people -- co-investigators and research assistants -- who would interact with human subjects in data collection or obtaining informed consent.