The term research includes studies in which any substance or stimulus is administered to a subject by any means. 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. Part I, C, 2. 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 the normal relationships 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. If doubt exists as to whether the procedures to be employed are within accepted and established practice or whether the purpose is only for the personal needs of the client, the activity should be considered to involve subjects whose rights and welfare are to be protected in accord with this policy statement.