Pub. L. 106-505, tit. II, sec. 206
DEFINITION.
SEC. 206. DEFINITION. Section 409 of the Public Health Service Act (42 U.S.C. 284d) is amended— (1) by striking “For purposes” and inserting “(a) Health Service Research.—For purposes”; and (2) by adding at the end the following: “(b) Clinical Research.—As used in this title, the term ‘clinical research’ means patient oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human 114 STAT. 2330physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.”.