“Research” in this context is defined by 45 CFR #46.102(d): “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. “
“Human subject” is defined by 45 CFR #46.102(f): “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.”
Guidance about what classifies as non-human research can be found on the HHS website. In addition, the application form below includes a checklist to help guide researchers in determining if their study meets these criteria.
Investigators may request that an activity be classified as non-research or non-human research, and therefore requiring no IRB oversight, but the final determination will be made by the ORSP/IRB Office.
Also attach, if applicable