Human Research Protection Program

To make this determination, the following questions should be answered: 

1. 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)

2. 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)

If the answer to both questions is yes, IRB review is required.

If the answer to one or both questions is no, a Not Human Subjects Research (NHSR) application needs to be submitted to the IRB for a formal determination, prior to initiating any study activities. Retroactive determinations will not be made. Many journals require a determination from the IRB. Submitting NHSR applications is strongly encouraged.