Human Subjects Research (HSR)

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l), definition of research) that involves a living individual about whom an investigator: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; and/or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (45 CFR 46.102(e)(1)), definition of human subject). Common Rule, 2018 Requirements: 45 CFR 46.102, Definitions for the Purposes of This Policy