Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities (45 CFR 46.102)(d)).

A Human Subject is a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information (45 CFR 46.102(f)).