Human Subject: According to 45 CFR 46 , a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:

•    Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

•    Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Research: A clinical investigation or systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Generalizable Knowledge: Knowledge from which general conclusions will be drawn. A study that is designed to develop or contribute to Generalizable Knowledge is one that is designed and intended to draw conclusions, inform policy or generate generalizable findings.

Quality Improvement (QI) is the scenario where an activity is specifically initiated with the goal of improving and established standard. QI projects involve systematic, data-guided initiatives or processes designed to improve clinical care, patient safety, health care operations, services and programs or for developing new programs or services (e.g. teaching evaluations, patient/employee service surveys). QI is intended to use experience to identify effective methods, implement the methods broadly, and evaluate the immediate impact or effect of the implemented changes.