42 U.S. Code § 289b - Office of Research Integrity

(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
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.
(3) Definitions
(A) The Secretary shall by regulation establish a definition for the term “research misconduct” for purposes of this section.
(B) For purposes of this section, the term “financial assistance” means a grant, contract, or cooperative agreement.
(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
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.
(d) Monitoring by Director
The Secretary shall by regulation establish procedures for the Director to monitor administrative processes and investigations that have been established or carried out under this section.
(e) Protection of whistleblowers
(1) In general
In the case of any entity required to establish administrative processes under subsection (b) of this section, the Secretary shall by regulation establish standards for preventing, and for responding to the occurrence of retaliation by such entity, its officials or agents, against an employee in the terms and conditions of employment in response to the employee having in good faith—
(A) made an allegation that the entity, its officials or agents, has engaged in or failed to adequately respond to an allegation of research misconduct; or
(B) cooperated with an investigation of such an allegation.
(2) Monitoring by Secretary
The Secretary shall by regulation establish procedures for the Director to monitor the implementation of the standards established by an entity under paragraph (1) for the purpose of determining whether the procedures have been established, and are being utilized, in accordance with the standards established under such paragraph.
(3) Noncompliance
The Secretary shall by regulation establish remedies for noncompliance by an entity, its officials or agents, which has engaged in retaliation in violation of the standards established under paragraph (1). Such remedies may include termination of funding provided by the Secretary for such project or recovery of funding being provided by the Secretary for such project, or other actions as appropriate.

Source

(July 1, 1944, ch. 373, title IV, § 493, as added Pub. L. 99–158, § 2,Nov. 20, 1985, 99 Stat. 874; amended Pub. L. 103–43, title I, §§ 161, 163,June 10, 1993, 107 Stat. 140, 142.)
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).
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 sections 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.”

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42 CFR - Public Health

42 CFR Part 93 - PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

 

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