Page may be out of date
This page has not been updated in the last 5 years. The content on this page may be incorrect. If you have any questions please contact the web team.

What is human subject research?

Return to “Where Do I Begin?”

Activities are human subject research under U.S. Department of Health and Human Services (DHHS) regulations when they meet the DHHS definition of “research” (45 CFR §46.102(l)) and involve a “subject” as defined in DHHS regulations (45 CFR §46.102(e)).

Activities are human subject research under U.S. Food and Drug Administration (FDA) regulations when they meet the FDA definition of “research” (21 CFR §50.3(c), 21 CFR §56.103(c), 21 CFR §312.3(b) or 21 CFR §812.3(h)) and involve a “subject” as defined in FDA regulations (21 CFR §50.3(g), 21 CFR §56.103(e), 21 CFR §312.3(b) or 21 CFR §812.3(p)).

Under DHHS regulations (45 CFR §46.102(l)), research is defined as:  A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Under FDA regulations (21 CFR §50.3(c)), research is defined as:  Any experiment that involves a test article and one or more human subjects, and that either is subject to requirements for prior submission to the Food and Drug Administration.

Human Subject
Under DHHS Regulations (45 CFR §46.102(e)), a human subject is defined as:  A living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Under FDA regulations (21 CFR §50.3(g), a human subject is defined as:

An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient.

Or in the case of a medical device: 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 participant may be in normal health or may have a medical condition or disease.