Glossary Term

Human Research Subject

A living individual about whom an investigator conducting research obtains data through intervention or interaction with an individual or with his or her identifiable private information, or an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. The U.S. FDA and HHS have different definitions for the term human subject, link to the FDA and HHS human subject definitions: http://www.mayo.edu/research/institutional-review-board/definition-terms (Alliance Terminology & Data Resources May 2021)