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Title 42 — The Public Health and Welfare

Part B · Chapter 6A — Public Health Service

§ 284d. Definitions

Statutory text

(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.

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.

  1. 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. 358

    Enacted 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.”.

  2. 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.”.

  3. Pub. L. 106–505 title II § 206 · 114 Stat. 2314

    1. Amended · 42 U.S.C. § 284d

      Pub. L. 106–505 designated existing provisions as subsec. (a)

    2. Inserted · 42 U.S.C. § 284d

      Pub. L. 106–505 inserted heading

    3. 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
  1. 1944July 1, 1944, ch. 373, title IV, § 409, as added Pub. L. 102–321, title I, § 121(b), , 106 Stat. 358
  2. 1993amended Pub. L. 103–43, title XX, § 2016(a), , 107 Stat. 218
  3. 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.)

Parsed from the official OLRC USLM XML in data/usc_all/usc42.xml · release point 119-108 · OLRC build 2026-09-09

USLM identifier /us/usc/t42/s284d