The following sections attempt to explain these terms and to provide some guidance for the borderline cases. As used in this document, the word research is defined as any systematic gathering and analysis of information, usually made under conditions determined by the investigator, that aims to test a hypothesis, to discover some unknown principle, or effect, or to re-examine some known or suggested principle. Activities that meet this definition constitute research even if they are supported or funded under a program that serves other purposes. For example, some demonstration and service programs may include research activities. The term human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains identifiable private information.
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. Information is individually identifiable if the identity of the subject is associated with the information or can be readily ascertained by the investigator. The definition of subject excludes all accepted and established service relationships, such as normal relationship of patients to physicians, students to instructors, and other clients to professionals in which the patient, student, or client is receiving aid or services consistent with accepted and established practice, that is intended only to meet her or his own personal needs . This difference may not be fully understood by the subject who is also a client, and can result in the investigator's gaining consent without free decision. The normal employer-employee relationship is also excluded from the definition of subject.