42 U.S.C. § 289b — Office of Research Integrity

submitted 82 years ago by Pub. L. 99-158 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 633 words · no verdicts yet

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HHS must create an independent Office of Research Integrity, led by a director experienced in research and in investigating research misconduct. Any group applying for biomedical or behavioral research funding must promise it has a process to review misconduct reports and must agree to report substantial misconduct investigations to the Office. The Secretary sets rules for the Office to respond to misconduct reports, monitor institutions' processes, and protect whistleblowers who report misconduct in good faith, including penalties for institutions that retaliate against them.

(a) Setting up the Office. (1) Establishment. Within 90 days of June 10, 1993, the Secretary must set up an independent office within the Department of Health and Human Services called the Office of Research Integrity. (2) Director. The Office is led by a Director, appointed by the Secretary, who must have research experience and experience investigating research misconduct. The Secretary carries out this section through the Director, who reports to the Secretary. (3) Definitions. The Secretary must define "research misconduct" by regulation for this section. "Financial assistance" means a grant, contract, or cooperative agreement. (b) Requiring a misconduct-review process as a funding condition. The Secretary must, by regulation, require any entity applying for financial assistance under this chapter, for a biomedical or behavioral research project or program, to submit with its application: assurances that it has an administrative process, following the Secretary's regulations, to review reports of research misconduct connected to its biomedical or behavioral research; an agreement to report to the Director any investigation of alleged misconduct, connected to chapter-funded projects, that appears substantial; and an agreement to follow this section's regulations. (c) The Director's response process. The Secretary must, by regulation, set up a process for the Director to promptly and properly: respond to information about research misconduct connected to chapter-funded projects; receive reports of such information from funding recipients; conduct investigations when appropriate; and take other actions, including remedies, about such misconduct. (d) Monitoring. The Secretary must, by regulation, set up procedures for the Director to monitor the administrative processes and investigations set up under this section. (e) Protecting whistleblowers. For entities required to set up processes under subsection (b), the Secretary must, by regulation, set standards to prevent and respond to retaliation against an employee for having, in good faith, alleged that the entity mishandled or failed to properly respond to a research misconduct allegation, or for cooperating with an investigation of such an allegation. The Secretary must set up procedures for the Director to monitor whether entities have actually put these standards into practice, and must set remedies for entities that retaliate in violation of these standards, which can include ending or clawing back the entity's project funding, or other appropriate action.

the actual law source: uscode.house.gov ↗public domain

(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.

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), 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 credit: (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.)

history & why it existsrecord from the source credit

1944Enacted · Pub. L. 99-158 · 99 Stat. 874
1993Amended · Pub. L. 103-43 · 107 Stat. 140, 142

A history note hasn’t been published yet. The record shows enactment by Pub. L. 99-158 on 1944-07-01.

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