A human subject is "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" (45 CFR 46.102(f).
Within this definition, a human subject is a living person about whom the researcher conducts research and gathers:
- data through interaction or intervention with the subject, and/or
- identifiable private information
- this definition includes pilot studies, feasibility studies and other preliminary research