Does Your Research Project Require IRB Review?
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; or (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. 46.102 (l)