Women and Health Research

Women and Health Research

Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1

  • Author: Federman, Daniel; Faden, Ruth; Mastroianni, Anna C.
  • Publisher: National Academies Press
  • ISBN: 9780309049924
  • eISBN Pdf: 9780309586214
  • Place of publication:  United States
  • Year of digital publication: 1994
  • Month: January
  • Pages: 286
  • Language: English

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.

  • WOMEN AND HEALTH RESEARCH
  • Copyright
  • Preface
  • Acknowledgments
  • Contents
  • Executive Summary
    • WOMEN'S PARTICIPATION IN CLINICAL STUDIES
    • JUSTICE IN CLINICAL STUDIES: GUIDING PRINCIPLES
    • SCIENTIFIC CONSIDERATIONS
    • SOCIAL AND ETHICAL CONSIDERATIONS
    • LEGAL CONSIDERATIONS
    • RISKS TO REPRODUCTION AND OFFSPRING
    • IMPLEMENTATION
      • The Investigator
        • Immediate Actions
        • As Soon as Feasible
      • The IRB
        • Immediate Actions
        • As Soon as Feasible
      • IRGs and TEGs
        • Immediate Actions
        • As Soon as Feasible
      • Scientific Advisory Councils
        • As Soon as Feasible
      • NIH
        • Immediate Actions
        • As Soon as Feasible
  • 1 Introduction
    • MANDATE AND SCOPE OF STUDY
    • STRUCTURE OF REPORT
    • DEFINITIONS
    • THE DRUG DEVELOPMENT PROCESS
    • REFERENCES
  • 2 Women's Participation in Clinical Studies
    • HISTORICAL BACKGROUND
      • Evolution of Protectionist Policies
        • Research Abuses
        • Responses to Fetal Injury
      • Advent of Inclusionary Policies
      • NIH Office of Research on Women's Health and Recent Changes
    • CURRENT STATUS
      • Studies of Heart Disease and AIDS
        • Heart Disease
        • AIDS
      • Women of Childbearing Age in Early Phases of Drug Trials
      • Clinical Trial Registries
    • CONCLUSIONS AND RECOMMENDATIONS
    • NOTES
    • REFERENCES
  • 3 Justice in Clinical Studies: Guiding Principles
    • CONCEPTIONS OF JUSTICE
      • The Distributive Paradigm
        • Application to Clinical Studies
      • Justice and the Research Agenda: Oppression and Power
    • LIMITS TO THE REQUIREMENTS OF JUSTICE
    • STATEMENT OF GUIDING PRINCIPLES
    • REFERENCES
  • 4 Scientific Considerations
    • EVIDENCE OF GENDER DIFFERENCES
      • Body Size, Composition, and Metabolism
      • Gender and Aging
      • Behavioral and Psychosocial Differences
      • Endogenous Hormones
      • Pregnancy and Lactation
      • Exogenous Hormones
        • Hormonal Contraceptives
        • Menopause and Hormone Replacement
    • METHODOLOGICAL IMPLICATIONS
      • Clinical Studies
      • Clinical Trials
        • External and Internal Validity
        • Homogeneity Versus Heterogeneity
        • Exclusions from Trials
        • Subgroup Analysis
        • Alternatives to Clinical Trials
    • CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 5 Social and Ethical Considerations
    • SCIENCE AND OBJECTIVITY
    • QUESTIONS OF GENDER
      • Male Bias
      • Male Norm
    • QUESTIONS OF RACE AND ETHNICITY
      • The Diversity of Women
      • Constructions of Race and Ethnicity
        • Biology or Sociology?
        • Faulty Constructions of Ethnicity
        • One Model of Health Does Not Fit All Groups
      • Context and Meaning of Research in Different Communities
    • RECRUITMENT AND RETENTION ISSUES
      • Feasibility, Logistics, and Cost
      • Outreach and Access
      • Community Attitudes Towards Research
      • Appropriateness of Participation
    • PROTECTION OF RESEARCH PARTICIPANTS
      • Potential for Exploitation
      • Informed Consent Process
    • CONCLUSIONS AND RECOMMENDATIONS
    • REFERENCES
  • 6 Legal Considerations
    • INSTITUTIONAL FRAMEWORK
    • CURRENT FEDERAL POLICIES
      • National Institutes of Health
        • The 1991 NIH Policy
      • Food and Drug Administration Policies
        • 1977 Guidelines
        • 1993 Guideline
      • Other DHHS Policies
        • DHHS Policy on Pregnant Women as Research Subjects
      • Policies of Other Federal Agencies and Departments
    • CONSTITUTIONAL ISSUES
      • Liberty, Privacy, and Bodily Self-Determination
        • Privacy vs. Fetal Protection
      • Equal Protection
        • Policies That Exclude Pregnant Women
        • Exclusion of Women of Childbearing Potential
        • Policies That Favor Inclusion of Women
    • LIABILITY
      • Potential Liability for Inclusion
        • Incidence of Research Injuries and Subsequent Legal Actions
        • Theories of Liability for Inclusion
        • Informed Consent
        • Liability of Potential Defendants
        • Liability for Injuries to Offspring
        • Is Johnson Controls Relevant?
      • Liability for Exclusion
    • CONCLUSIONS AND RECOMMENDATIONS
    • NOTES
    • REFERENCES
    • STATUTES AND REGULATIONS
    • CASE REFERENCES
  • 7 Risks to Reproduction and Offspring
    • SCIENTIFIC ISSUES: RISK ASSESSMENT
      • Identifying Reproductive and Developmental Toxicants
        • Hazard Identification
        • Hazard Characterization
        • Exposure Definition
        • Risk Characterization
      • Challenges to Identification of Reproductive and Developmental Toxicants
      • Male-Mediated Developmental Toxicity
      • Evaluating Drugs for Use in Men and Women of Reproductive Age
        • Use of Toxicity Testing Data
        • Subjects' Understanding of Developmental and Reproductive Risks
        • Contraception in Clinical Trials
      • Evaluating Drugs for Use in Lactating Women
      • Evaluating Drugs for Use in Pregnant Women
        • Surveillance for Developmental Effects
    • ETHICAL ISSUES: RISK-BENEFIT ANALYSIS
      • Women (Not Pregnant or Lactating) and Men of Reproductive Age
      • Lactating Women
      • Pregnant Women
        • Adequate Information
        • Paternal Consent
        • Scientific Criteria for Exclusion
        • Other Criteria for Exclusion
        • Documentation and Monitoring of Exclusions
        • Conclusion
    • NOTE
    • REFERENCES
  • 8 Implementation
    • RECOMMENDATIONS
      • The Investigator
        • Immediate Actions
        • As Soon as Feasible
      • The IRB
        • Immediate Actions
        • As Soon as Feasible
      • IRGs and TEGs
        • Immediate Actions
        • As Soon as Feasible
      • Scientific Advisory Councils
        • As Soon as Feasible
      • NIH
        • Immediate Actions
        • As Soon as Feasible
  • Appendixes
    • A Reports on Women's Participation in Clinical Studies, 1977-1993
    • B NIH Revitalization Act of 1993 Public Law 103-43
      • SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH
        • SEC. 132. PEER REVIEW
        • SEC. 133. INAPPLICABILITY TO CURRENT PROJECTS
    • C DES Case Study
      • HISTORY OF DEVELOPMENT AND TESTING OF DES
      • DES-RELATED INJURIES
      • LIABILITY
      • REFERENCES
      • CASE REFERENCES
    • D Compensation Systems for Research Injuries
      • EXISTING COMPENSATION SYSTEMS
      • EFFORTS TO DEVELOP A NATIONAL SYSTEM
      • ISSUES IN DEVELOPING A NATIONAL COMPENSATION SYSTEM
      • EXAMPLES OF COMPENSATION SYSTEMSIN THE AREA OF MEDICAL MALPRACTICE
        • Virginia and Florida
        • National Childhood Vaccine Injury Act
      • NOTES
      • REFERENCES
      • STATUTORY AND REGULATORY REFERENCES
    • E Committee Biographies
  • Index

Subjects

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