Human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains individually identifiable private information. 

  • Intervention includes both physical procedures by which data are gathered and manipulations of the research participant or the participant's environment that are performed for research purposes. 
  • Interaction includes communication or interpersonal contact between the investigator and research participant. 
  • 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 which the individual can reasonably expect will not be made public.

Thus, human subject research includes investigations that use human tissue, human subject's records, or secondary data collected from human subjects (e.g., medical records, service records, etc.).