Regulatory Definitions

Research is a systematic investigation—including research development, testing and evaluation—designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that’s considered research for other purposes. [45 CFR 46.102(d)]

Research can also be defined as any experiment that involves a test article (any drug, biologic, medical device, food additive, color additive or electronic product) and one or more human subjects. [21 CFR 50.3(c)]

A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens. [45 CFR 46.102(f)(1),(2)]

A human subject can also be 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 subject may be either a healthy human or a patient. [21 CFR 50.3(g)]

Intervention includes physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between the investigator and the subject.

Identifiable private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

Private information must be individually identifiable (e.g., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. [45 CFR 46.102(f)]