42 U.S.C. · The Public Health and Welfare
42 U.S.C. § 284d

Definitions

Ch. 6A — PUBLIC HEALTH SERVICE
Title 42 U.S.C. ● ACTIVE Primary Source Ch. 6A
Statutory Text

42 U.S.C. § 284d — Definitions

U.S.C. Title 42 - THE PUBLIC HEALTH AND WELFARE 42 U.S.C. United States Code, 2023 Edition Title 42 - THE PUBLIC HEALTH AND WELFARE CHAPTER 6A - PUBLIC HEALTH SERVICE SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES Part B - General Provisions Respecting National Research Institutes Sec. 284d - Definitions From the U.S. Government Publishing Office, www.gpo.gov

§284d. Definitions

(a) Health service research For purposes of this subchapter, the term "health services research" means research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care. Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions. (b) Clinical research As used in this subchapter, 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.

(July 1, 1944, ch. 373, title IV, §409, as added Pub. L. 102–321, title I, §121(b), July 10, 1992, 106 Stat. 358; amended Pub. L. 103–43, title XX, §2016(a), June 10, 1993, 107 Stat. 218; Pub. L. 106–505, title II, §206, Nov. 13, 2000, 114 Stat. 2329.)

Editorial Notes

Amendments 2000—Pub. L. 106–505 designated existing provisions as subsec. (a), inserted heading, and added subsec. (b). 1993—Pub. L. 103–43 inserted at end "Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions."

Statutory Notes and Related Subsidiaries

Effective Date Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102–321, set out as an Effective Date of 1992 Amendment note under section 236 of this title.

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