Human Subject

Human Subject means:

  • OHRP: “A living individual about whom an investigation conducting research obtains (1) Data through intervention or interaction with the individual or (2) identifiable private information.” 45 CFR 46.102 (f)
  • FDA: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  A subject may be either a healthy human or a patient.”   21 CFR 50.3 (g) and 21 CFR 56.102 (e)