Is it Research?
Because study methods used in non-medical research often do not involve direct contact between
researchers and human subjects, the question "Does my research involve human subjects?" is often asked.
Federal Regulations (45 CFR 46: HHS Policy for the Protection of Human Research Subjects) provide
the following definitions on which to base an initial decision.
- Research: "A systematic investigation including research development, testing and evaluation,
designed to develop or contribute to generalizable knowledge." Some "demonstration" and "service"
programs may include research activities.
- Human Subject: A living individual about whom an investigator (whether professional or student) conducting
research obtains (i) data through intervention or interaction with the individual, or (ii) identifiable private
information. The definition of human subject also includes research involving previously collected data or
tissue specimens.
- Intervention: "...includes both physical procedures by which data is gathered (for example,
venipuncture) 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 or school record)."