A “human subject” is any living person who is the subject of research or the subject of information gathered about a living person.
“Research” is a systematic investigation designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions or inform policy). Human subject research entails either the collection of data through the researcher’s intervention or interaction with the individual or the collection by the researcher of identifiable private information.
Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction on the other hand, includes communication or interpersonal contact between the investigator and a subject such as by way of interviews or survey questionnaires.
Private information includes data about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual in circumstances or conditions where the individual reasonably expects the information will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order to constitute research involving human subjects.
Oral histories and ethnographic investigations that are intended to produce generalizable knowledge (e.g., that are designed to draw conclusions, inform policy, or collect data to test economic, sociological, or anthropological models and or theories) require IRB review. Investigations that do not generalize beyond a particular place, person or setting, but instead document or report on a specific person’s life or event, are in most instances considered journalism and not subject to IRB review.