
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-2]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                       Part H--General Provisions
 
Sec. 289a-2. Inclusion of women and minorities in clinical 
        research
        

(a) Requirement of inclusion

                           (1) In general

        In conducting or supporting clinical research for purposes of 
    this subchapter, the Director of NIH shall, subject to subsection 
    (b) of this section, ensure that--
            (A) women are included as subjects in each project of such 
        research; and
            (B) members of minority groups are included as subjects in 
        such research.

          (2) Outreach regarding participation as subjects

        The Director of NIH, in consultation with the Director of the 
    Office of Research on Women's Health and the Director of the Office 
    of Research on Minority Health, shall conduct or support outreach 
    programs for the recruitment of women and members of minority groups 
    as subjects in projects of clinical research.

(b) Inapplicability of requirement

    The requirement established in subsection (a) of this section 
regarding women and members of minority groups shall not apply to a 
project of clinical research if the inclusion, as subjects in the 
project, of women and members of minority groups, respectively--
        (1) is inappropriate with respect to the health of the subjects;
        (2) is inappropriate with respect to the purpose of the 
    research; or
        (3) is inappropriate under such other circumstances as the 
    Director of NIH may designate.

(c) Design of clinical trials

    In the case of any clinical trial in which women or members of 
minority groups will under subsection (a) of this section be included as 
subjects, the Director of NIH shall ensure that the trial is designed 
and carried out in a manner sufficient to provide for a valid analysis 
of whether the variables being studied in the trial affect women or 
members of minority groups, as the case may be, differently than other 
subjects in the trial.

(d) Guidelines

                           (1) In general

        Subject to paragraph (2), the Director of NIH, in consultation 
    with the Director of the Office of Research on Women's Health and 
    the Director of the Office of Research on Minority Health, shall 
    establish guidelines regarding the requirements of this section. The 
    guidelines shall include guidelines regarding--
            (A) the circumstances under which the inclusion of women and 
        minorities as subjects in projects of clinical research is 
        inappropriate for purposes of subsection (b) of this section;
            (B) the manner in which clinical trials are required to be 
        designed and carried out for purposes of subsection (c) of this 
        section; and
            (C) the operation of outreach programs under subsection (a) 
        of this section.

                       (2) Certain provisions

        With respect to the circumstances under which the inclusion of 
    women or members of minority groups (as the case may be) as subjects 
    in a project of clinical research is inappropriate for purposes of 
    subsection (b) of this section, the following applies to guidelines 
    under paragraph (1):
            (A)(i) In the case of a clinical trial, the guidelines shall 
        provide that the costs of such inclusion in the trial is not a 
        permissible consideration in determining whether such inclusion 
        is inappropriate.
            (ii) In the case of other projects of clinical research, the 
        guidelines shall provide that the costs of such inclusion in the 
        project is not a permissible consideration in determining 
        whether such inclusion is inappropriate unless the data 
        regarding women or members of minority groups, respectively, 
        that would be obtained in such project (in the event that such 
        inclusion were required) have been or are being obtained through 
        other means that provide data of comparable quality.
            (B) In the case of a clinical trial, the guidelines may 
        provide that such inclusion in the trial is not required if 
        there is substantial scientific data demonstrating that there is 
        no significant difference between--
                (i) the effects that the variables to be studied in the 
            trial have on women or members of minority groups, 
            respectively; and
                (ii) the effects that the variables have on the 
            individuals who would serve as subjects in the trial in the 
            event that such inclusion were not required.

(e) Date certain for guidelines; applicability

                          (1) Date certain

        The guidelines required in subsection (d) of this section shall 
    be established and published in the Federal Register not later than 
    180 days after June 10, 1993.

                          (2) Applicability

        For fiscal year 1995 and subsequent fiscal years, the Director 
    of NIH may not approve any proposal of clinical research to be 
    conducted or supported by any agency of the National Institutes of 
    Health unless the proposal specifies the manner in which the 
    research will comply with this section.

(f) Reports by advisory councils

    The advisory council of each national research institute shall 
prepare biennial reports describing the manner in which the institute 
has complied with this section. Each such report shall be submitted to 
the Director of the institute involved for inclusion in the biennial 
report under section 283 of this title.

(g) Definitions

    For purposes of this section:
        (1) The term ``project of clinical research'' includes a 
    clinical trial.
        (2) The term ``minority group'' includes subpopulations of 
    minority groups. The Director of NIH shall, through the guidelines 
    established under subsection (d) of this section, define the terms 
    ``minority group'' and ``subpopulation'' for purposes of the 
    preceding sentence.

(July 1, 1944, ch. 373, title IV, Sec. 492B, as added Pub. L. 103-43, 
title I, Sec. 131, June 10, 1993, 107 Stat. 133.)


                   Inapplicability to Current Projects

    Section 133 of Pub. L. 103-43 provided that: ``Section 492B of the 
Public Health Service Act, as added by section 131 of this Act [this 
section], shall not apply with respect to projects of clinical research 
for which initial funding was provided prior to the date of the 
enactment of this Act [June 10, 1993]. With respect to the inclusion of 
women and minorities as subjects in clinical research conducted or 
supported by the National Institutes of Health, any policies of the 
Secretary of Health and Human Services regarding such inclusion that are 
in effect on the day before the date of the enactment of this Act shall 
continue to apply to the projects referred to in the preceding 
sentence.''

                  Section Referred to in Other Sections

    This section is referred to in sections 283b, 287d, 289a of this 
title; title 38 sections 317, 318.
