PRIA Logo™
Title 42, The Public Health and WelfareRelease 119-110

§289b Office of Research Integrity

Title 42 › CHAPTER 6A — PUBLIC HEALTH SERVICE › SUBCHAPTER III — NATIONAL RESEARCH INSTITUTES › Part H — General Provisions › § 289b

Last updated Sep 22, 2026|Official source

Summary

The Secretary of Health and Human Services must create an Office of Research Integrity as an independent unit in the Department no later than 90 days after June 10, 1993. The Secretary must pick a Director who has research experience, special training, and experience investigating research misconduct. The Secretary must also write a rule that defines “research misconduct” and that says “financial assistance” means a grant, contract, or cooperative agreement. Any group asking for financial assistance for biomedical or behavioral research must promise that it has a system to review reports of research misconduct, that it will tell the Director about any substantial investigations tied to funded projects, and that it will follow the rules. The Secretary must set how the Director will get reports, respond, investigate, and act to fix problems, and must set ways for the Director to watch how institutions handle cases. The Secretary must also set rules to stop and punish retaliation against employees who report or help investigate misconduct, including possible loss or recovery of funding.

Full Legal Text

Title 42, §289b

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

(a)In general
(1)Establishment of Office
Not later than 90 days after June 10, 1993, the Secretary shall establish an office to be known as the Office of Research Integrity (referred to in this section as the “Office”), which shall be established as an independent entity in the Department of Health and Human Services.
(2)Appointment of Director (3) Definitions
The Office shall be headed by a Director, who shall be appointed by the Secretary, be experienced and specially trained in the conduct of research, and have experience in the conduct of investigations of research misconduct. The Secretary shall carry out this section acting through the Director of the Office. The Director shall report to the Secretary.
(b)Existence of administrative processes as condition of funding for research
The Secretary shall by regulation require that each entity that applies for financial assistance under this chapter for any project or program that involves the conduct of biomedical or behavioral research submit in or with its application for such assistance—
(1)assurances satisfactory to the Secretary that such entity has established and has in effect (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of research misconduct in connection with biomedical and behavioral research conducted at or sponsored by such entity;
(2)an agreement that the entity will report to the Director any investigation of alleged research misconduct in connection with projects for which funds have been made available under this chapter that appears substantial; and
(3)an agreement that the entity will comply with regulations issued under this section.
(c)Process for response of Director (d) Monitoring by Director (e) Protection of whistleblowers
The Secretary shall by regulation establish a process to be followed by the Director for the prompt and appropriate—
(1)response to information provided to the Director respecting research misconduct in connection with projects for which funds have been made available under this chapter;
(2)receipt of reports by the Director of such information from recipients of funds under this chapter;
(3)conduct of investigations, when appropriate; and
(4)taking of other actions, including appropriate remedies, with respect to such misconduct.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Codification June 10, 1993, referred to in subsec. (a)(1), was in the original “the date of enactment of this section” which was translated as meaning the date of enactment of Pub. L. 103–43, which amended this section generally, to reflect the probable intent of Congress.

Amendments

1993—Pub. L. 103–43, § 161, amended section generally. Prior to amendment, section read as follows: “(a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that such entity— “(1) has established (in accordance with

Regulations

which the Secretary shall prescribe) an administrative process to review reports of scientific fraud in connection with biomedical and behavioral research conducted at or sponsored by such entity; and “(2) will report to the Secretary any investigation of alleged scientific fraud which appears substantial. “(b) The Director of NIH shall establish a process for the prompt and appropriate response to information provided the Director of NIH respecting scientific fraud in connection with projects for which funds have been made available under this chapter. The process shall include procedures for the receiving of reports of such information from recipients of funds under this chapter and taking appropriate action with respect to such fraud.” Subsec. (e). Pub. L. 103–43, § 163, added subsec. (e).

Statutory Notes and Related Subsidiaries

Regulations

Pub. L. 103–43, title I, § 165,
June 10, 1993, 107 Stat. 143, provided that: “(a) Issuance of Final Rules.—“(1) In general.—Not later than 180 days after the date of the enactment of this Act [
June 10, 1993], the Secretary shall, subject to paragraph (2), issue the final rule for each regulation required in section 493 or 493A of the Public Health Service Act [42 U.S.C. 289b, 289b–1]. “(2) Definition of research misconduct.—Not later than 90 days after the date on which the report required in section 162(e) [107 Stat. 142] is submitted to the Secretary, the Secretary shall issue the final rule for the

Regulations

required in section 493 of the Public Health Service Act with respect to the definition of the term ‘research misconduct’. “(b) Applicability to Ongoing Investigations.—The final rule issued pursuant to subsection (a) for investigations under section 493 of the Public Health Service Act [42 U.S.C. 289b] does not apply to investigations commenced before the date of the enactment of this Act [June 10, 1993] under authority of such section as in effect before such date. “(c) Definitions.—For purposes of this section:“(1) The term ‘section 493 of the Public Health Service Act’ means such section [42 U.S.C. 289b] as amended by section 161 and 163 of this Act, except as indicated otherwise in subsection (b). “(2) The term ‘section 493A of the Public Health Service Act’ means such section [42 U.S.C. 289b–1] as added by section 164 of this Act. “(3) The term ‘Secretary’ means the Secretary of Health and Human Services.”

Reference

Citations & Metadata

Citation

42 U.S.C. § 289b

Title 42, The Public Health and Welfare

Last Updated

Sep 22, 2026

Release point: 119-110