For purposes of determining which projects require IRB review, Franklin University adheres to the definitions of ‘research’ and ‘human subject’ presented in the Department of Health and Human Services (DHHS) Code of Federal Regulations (45 CFR part 46):
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(l)].
Human subject means a living individual about whom an investigator (whether professional or student) conducts research and (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. [45 CFR 46.102(e)(1)].
See also the guidance on Determining If an Activity Requires IRB Review and Approval.