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.