Human subject

A human subject can be a healthy person or a patient. Being a subject triggers the US rules on informed consent and IRB review.

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 individual or a patient.

21 CFR, 56.102

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