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Human Research Protection Program

Does Your Research Project Require IRB Review?Ìý

In order to determine whether an activity is research that requires review by the IRB the following questions should be answered:

A. Does the study meet the federal definition for involvement of human subjects?

Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;Ìýor (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 46.102 (e)(1)

B. Does the study meet the federal definition of research?

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.Ìý 46.102 (l)

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is it research