
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: 42USC289a-1]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                       Part H--General Provisions
 
Sec. 289a-1. Certain provisions regarding review and approval of 
        proposals for research
        

(a) Review as precondition to research

              (1) Protection of human research subjects

        (A) In the case of any application submitted to the Secretary 
    for financial assistance to conduct research, the Secretary may not 
    approve or fund any application that is subject to review under 
    section 289(a) of this title by an Institutional Review Board unless 
    the application has undergone review in accordance with such section 
    and has been recommended for approval by a majority of the members 
    of the Board conducting such review.
        (B) In the case of research that is subject to review under 
    procedures established by the Secretary for the protection of human 
    subjects in clinical research conducted by the National Institutes 
    of Health, the Secretary may not authorize the conduct of the 
    research unless the research has, pursuant to such procedures, been 
    recommended for approval.

                           (2) Peer review

        In the case of any proposal for the National Institutes of 
    Health to conduct or support research, the Secretary may not approve 
    or fund any proposal that is subject to technical and scientific 
    peer review under section 289a of this title unless the proposal has 
    undergone such review in accordance with such section and has been 
    recommended for approval by a majority of the members of the entity 
    conducting such review.

(b) Ethical review of research

            (1) Procedures regarding withholding of funds

        If research has been recommended for approval for purposes of 
    subsection (a) of this section, the Secretary may not withhold funds 
    for the research because of ethical considerations unless--
            (A) the Secretary convenes an advisory board in accordance 
        with paragraph (5) to study such considerations; and
            (B)(i) the majority of the advisory board recommends that, 
        because of such considerations, the Secretary withhold funds for 
        the research; or
            (ii) the majority of such board recommends that the 
        Secretary not withhold funds for the research because of such 
        considerations, but the Secretary finds, on the basis of the 
        report submitted under paragraph (5)(B)(ii), that the 
        recommendation is arbitrary and capricious.

                      (2) Rules of construction

        Paragraph (1) may not be construed as prohibiting the Secretary 
    from withholding funds for research on the basis of--
            (A) the inadequacy of the qualifications of the entities 
        that would be involved with the conduct of the research 
        (including the entity that would directly receive the funds from 
        the Secretary), subject to the condition that, with respect to 
        the process of review through which the research was recommended 
        for approval for purposes of subsection (a) of this section, all 
        findings regarding such qualifications made in such process are 
        conclusive; or
            (B) the priorities established by the Secretary for the 
        allocation of funds among projects of research that have been so 
        recommended.

                          (3) Applicability

        The limitation established in paragraph (1) regarding the 
    authority to withhold funds because of ethical considerations shall 
    apply without regard to whether the withholding of funds on such 
    basis is characterized as a disapproval, a moratorium, a 
    prohibition, or other characterization.

         (4) Preliminary matters regarding use of procedures

        (A) If the Secretary makes a determination that an advisory 
    board should be convened for purposes of paragraph (1), the 
    Secretary shall, through a statement published in the Federal 
    Register, announce the intention of the Secretary to convene such a 
    board.
        (B) A statement issued under subparagraph (A) shall include a 
    request that interested individuals submit to the Secretary 
    recommendations specifying the particular individuals who should be 
    appointed to the advisory board involved. The Secretary shall 
    consider such recommendations in making appointments to the board.
        (C) The Secretary may not make appointments to an advisory board 
    under paragraph (1) until the expiration of the 30-day period 
    beginning on the date on which the statement required in 
    subparagraph (A) is made with respect to the board.

                     (5) Ethics advisory boards

        (A) Any advisory board convened for purposes of paragraph (1) 
    shall be known as an ethics advisory board (in this paragraph 
    referred to as an ``ethics board'').
        (B)(i) An ethics board shall advise, consult with, and make 
    recommendations to the Secretary regarding the ethics of the project 
    of biomedical or behavioral research with respect to which the board 
    has been convened.
        (ii) Not later than 180 days after the date on which the 
    statement required in paragraph (4)(A) is made with respect to an 
    ethics board, the board shall submit to the Secretary, and to the 
    Committee on Energy and Commerce of the House of Representatives and 
    the Committee on Labor and Human Resources of the Senate, a report 
    describing the findings of the board regarding the project of 
    research involved and making a recommendation under clause (i) of 
    whether the Secretary should or should not withhold funds for the 
    project. The report shall include the information considered in 
    making the findings.
        (C) An ethics board shall be composed of no fewer than 14, and 
    no more than 20, individuals who are not officers or employees of 
    the United States. The Secretary shall make appointments to the 
    board from among individuals with special qualifications and 
    competence to provide advice and recommendations regarding ethical 
    matters in biomedical and behavioral research. Of the members of the 
    board--
            (i) no fewer than 1 shall be an attorney;
            (ii) no fewer than 1 shall be an ethicist;
            (iii) no fewer than 1 shall be a practicing physician;
            (iv) no fewer than 1 shall be a theologian; and
            (v) no fewer than one-third, and no more than one-half, 
        shall be scientists with substantial accomplishments in 
        biomedical or behavioral research.

        (D) The term of service as a member of an ethics board shall be 
    for the life of the board. If such a member does not serve the full 
    term of such service, the individual appointed to fill the resulting 
    vacancy shall be appointed for the remainder of the term of the 
    predecessor of the individual.
        (E) A member of an ethics board shall be subject to removal from 
    the board by the Secretary for neglect of duty or malfeasance or for 
    other good cause shown.
        (F) The Secretary shall designate an individual from among the 
    members of an ethics board to serve as the chair of the board.
        (G) In carrying out subparagraph (B)(i) with respect to a 
    project of research, an ethics board shall conduct inquiries and 
    hold public hearings.
        (H) In carrying out subparagraph (B)(i) with respect to a 
    project of research, an ethics board shall have access to all 
    relevant information possessed by the Department of Health and Human 
    Services, or available to the Secretary from other agencies.
        (I) Members of an ethics board shall receive compensation for 
    each day engaged in carrying out the duties of the board, including 
    time engaged in traveling for purposes of such duties. Such 
    compensation may not be provided in an amount in excess of the 
    maximum rate of basic pay payable for GS-18 of the General Schedule.
        (J) The Secretary, acting through the Director of the National 
    Institutes of Health, shall provide to each ethics board reasonable 
    staff and assistance to carry out the duties of the board.
        (K) An ethics board shall terminate 30 days after the date on 
    which the report required in subparagraph (B)(ii) is submitted to 
    the Secretary and the congressional committees specified in such 
    subparagraph.

               (6) ``Ethical considerations'' defined

        For purposes of this subsection, the term ``ethical 
    considerations'' means considerations as to whether the nature of 
    the research involved is such that it is unethical to conduct or 
    support the research.

(July 1, 1944, ch. 373, title IV, Sec. 492A, as added Pub. L. 103-43, 
title I, Sec. 101, June 10, 1993, 107 Stat. 126.)

                         Change of Name

    Committee on Energy and Commerce of House of Representatives treated 
as referring to Committee on Commerce of House of Representatives by 
section 1(a) of Pub. L. 104-14, set out as a note preceding section 21 
of Title 2, The Congress.


         References in Other Laws to GS-16, 17, or 18 Pay Rates

    References in laws to the rates of pay for GS-16, 17, or 18, or to 
maximum rates of pay under the General Schedule, to be considered 
references to rates payable under specified sections of Title 5, 
Government Organization and Employees, see section 529 [title I, 
Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note under section 5376 
of Title 5.

                  Section Referred to in Other Sections

    This section is referred to in section 283f of this title.
