Definitions: Human Subject (FDA)

U.S. Food and Drug Administration

Human subject means 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)

For a clinical investigation involving drugs: “Subject means a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease.” 21 CFR 312(b)

For a clinical investigation involving devices: “Subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease." 21 CFR 812.3(p)