Clinical Research Law and Legal Definition

Pursuant to 42 USCS § 284d [Title 42. The Public Health and Welfare; Chapter 6a. The Public Health Service Administration and Miscellaneous Provisions Administration], 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 physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.”