Research that involves collecting or analyzing information obtained from an individual person whose responses about themselves are the object of the study is considered human subject research. Some examples of human subject research, common to NIJ-funded research, include when participants complete questionnaires about themselves; they participate in interviews designed to collect information about themselves; their behavior is observed; and their opinions of their activities are studied. The use of identifiable data about individuals and studies that involve human tissues and DNA for research purposes may also qualify.
The regulations at 28 CFR 46.102 (d) define research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
Human subject is defined in section 46.102(f) as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) 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 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 identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”