Human subject
Also referred to as a participant, subject, or volunteer, a person who voluntarily agrees by giving their Informed Consent (IC) to participate in a research study. Human subject is defined by the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), and the International Council for Harmonisation (ICH) as follows:
Human subject (DHHS): A living individual (also referred to as a subject, participant, or volunteer) about whom an investigator (whether professional or student) conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimen(s). Common Rule, 2018 Requirements: 45 CFR 46.102, Definitions for the Purposes of This Policy
Human Subject (FDA): An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may either be a healthy individual or patient. FDA: 21 CFR 50.3, Definitions
Subject/trial subject (ICH GCP): An individual who participates in a clinical trial, either as a recipient of the Investigational Product (IP) or as a control. ICH GCP, 1.57
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