§ 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.)

Amendments

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.”

Effective Date

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.