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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994)

Chapter: Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt

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Suggested Citation:"Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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B
NIH Revitalization Act of 1993 Public Law 103-43

Suggested Citation:"Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

Subtitle B—Clinical Research Equity Regarding Women and Minorities

PART I—WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH

SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.

Part G of title IV of the Public Health Service Act, as amended by section 101 of this Act, is amended by inserting after section 492A the following section:

"INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH

"SEC. 492B. (a) REQUIREMENT OF INCLUSION.—

"(1) IN GENERAL.—In conducting or supporting clinical research for purposes of this title, the Director of NIH shall, subject to subsection (b), 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) 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) 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

Suggested Citation:"Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

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),

"(B) the manner in which clinical trials are required to be designed and carried out for purposes of subsection (c); and

"(C) the operation of outreach programs under subsection (a).

"(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), 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 deter mining 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) shall be established and published in the Federal Register not later than 180 days after the date of the enactment of the National Institutes of Health Revitalization Act of 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

Suggested Citation:"Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

of the institute involved for inclusion in the biennial report under section 403.

"(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), define the terms 'minority group' and 'subpopulation' for purposes of the preceding sentence.".

SEC. 132. PEER REVIEW.

Section 492 of the Public Health Service Act (42 U.S.C. 289a) is amended by adding at the end the following subsection:

"(c)(1) In technical and scientific peer review under this section of proposals for clinical research, the consideration of any such proposal (including the initial consideration) shall, except as provided in paragraph (2), include an evaluation of the technical and scientific merit of the proposal regarding compliance with section 492B.

"(2) Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of section 492B, is not subject to the requirement of subsection (a) of such section regarding the inclusion of women and members of minority groups as subjects in clinical research.".

SEC. 133. INAPPLICABILITY TO CURRENT PROJECTS.

Section 492B of the Public Health Service Act, as added by section 131 of this Act, 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. 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.

Suggested Citation:"Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×
Page 233
Suggested Citation:"Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×
Page 234
Suggested Citation:"Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×
Page 235
Suggested Citation:"Appendix B: NIH Revitalization Act of 1993, Public Law 103-43 (June 10, 1993), Excerpt." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×
Page 236
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 Get This Book
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In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues.

Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies.

Leading experts present general principles for the ethical conduct of research on women--principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research.

Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research.

The book addresses present-day challenges to equity in four areas:

  • Scientific--Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics.
  • Social and Ethical--The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants.
  • Legal--Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases.
  • Risk--The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed.

This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

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