§284d — Title 42 The Public Health and Welfare | U.S. Code

Summary

Defines two research terms used in this part of the law. Health services research studies how the way health care is organized, paid for, and run affects quality, cost, access, and results; it does not include studies that test whether services prevent, diagnose, or treat medical conditions. Clinical research means patient-focused studies with people or human samples where researchers meet patients in clinics or hospitals; it covers studies of disease causes and effects, group-level (population) studies, outcomes research, and work to develop new tests, treatments, or clinical trials.

Title 42, §284d

The Public Health and Welfare — Source: USLM XML via OLRC

(a)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)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.

Notes & Related Subsidiaries

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.

§284d Definitions

Summary

Title 42, §284d

Notes & Related Subsidiaries

Editorial Notes

Amendments

Statutory Notes and Related Subsidiaries

Effective Date

Effective Date

Citations & Metadata