What is the definition of a Human Subject for research purposes?
45 CFR ยง46.102 defines a human subject as: “A living individual(s) about whom an investigator (whether professional or student) conducting research obtains: data through intervention or interaction with the individual, or identifiable private information.” Intervention includes both physical procedures by which data are gathered (for example, electrodes, venipuncture, collection of saliva) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifia
