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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?"  Completing this form will let you know if your project meets the definition of human subjects research, and therefore must be reviewed and authorized by the IRB before it is conducted, and if so, which kind of IRB protocol to submit.  Some programs to require students to submit this form even if their project does not meet the definition, in order to obtain a letter showing that the IRB is aware of their project.

"Key personnel" in research projects involving human subjects or data containing personal identifiers 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, or have access to data with personal identifiers.