Title 42 — The Public Health and Welfare
Part B · Chapter 6A — Public Health Service
§ 284d. Definitions
Statutory text
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.
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.
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
ADAMHA Reorganization Act
Pub. L. 102–321 title I § 121(b) · 106 Stat. 323
Enacted · 42 U.S.C. § 284d
July 1, 1944, ch. 373, title IV, § 409, as added Pub. L. 102–321, title I, § 121(b), July 10, 1992, 106 Stat. 358
Source evidence
Code source credit
July 1, 1944, ch. 373, title IV, § 409, as added Pub. L. 102–321, title I, § 121(b), July 10, 1992, 106 Stat. 358Enacted provision · exact public law section
(b) Definition.— Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end thereof the following new section: “Sec. 409. “definitions For purposes of this title, 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.”.National Institutes of Health Revitalization Act of 1993
Pub. L. 103–43 title XX § 2016(a) · 107 Stat. 122
Inserted · 42 U.S.C. § 284d
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.”
Source evidence
Code amendment note
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.”Enacted provision · exact public law section
(a) Definition.— Section 409 of the Public Health Service Act (42 U.S.C. 284d), as added by section 121(b) of Public Law 102–321 (106 Stat. 358), is amended by adding at the end the following sentence: “Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions.”.Pub. L. 106–505 title II § 206 · 114 Stat. 2314
Amended · 42 U.S.C. § 284d
Pub. L. 106–505 designated existing provisions as subsec. (a)
Inserted · 42 U.S.C. § 284d
Pub. L. 106–505 inserted heading
Added · 42 U.S.C. § 284d
Pub. L. 106–505 added subsec. (b)
Source evidence
Code amendment note
Pub. L. 106–505 designated existing provisions as subsec. (a), inserted heading, and added subsec. (b).Enacted provision · exact public law section
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 physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.”.
5 of 5 references resolved to an enrolled provision
Editorial Notes
Amendments1993–2000 · 2 rounds
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 , 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.
Credits
1944–2000 · 3 acts
- 1944July 1, 1944, ch. 373, title IV, § 409, as added Pub. L. 102–321, title I, § 121(b), , 106 Stat. 358
- 1993amended Pub. L. 103–43, title XX, § 2016(a), , 107 Stat. 218
- 2000Pub. L. 106–505, title II, § 206, , 114 Stat. 2329.
Show as published
(July 1, 1944, ch. 373, title IV, § 409, as added Pub. L. 102–321, title I, § 121(b), , 106 Stat. 358; amended Pub. L. 103–43, title XX, § 2016(a), , 107 Stat. 218; Pub. L. 106–505, title II, § 206, , 114 Stat. 2329.)