
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC289b]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                       Part H--General Provisions
 
Sec. 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.

(July 1, 1944, ch. 373, title IV, Sec. 493, as added Pub. L. 99-158, 
Sec. 2, Nov. 20, 1985, 99 Stat. 874; amended Pub. L. 103-43, title I, 
Secs. 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, Sec. 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, Sec. 163, added subsec. (e).


                               Regulations

    Section 165 of Pub. L. 103-43 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 [this 
    section and section 289b-1 of this title].
        ``(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 [this section] 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 as amended by sections 161 and 163 of this Act 
    [this section], except as indicated otherwise in subsection (b).
        ``(2) The term `section 493A of the Public Health Service Act' 
    means such section as added by section 164 of this Act [section 
    289b-1 of this title].
        ``(3) The term `Secretary' means the Secretary of Health and 
    Human Services.''
