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Book Cover
E-book
Author Staff, Institute of Medicine

Title Women and Health Research, Volume 1 : Ethical and Legal Issues of Including Women in Clinical Studies
Published Washington : National Academies Press, 1900

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Description 1 online resource (288 pages)
Contents ""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""
Notes ""Potential for Exploitation""
Print version record
Subject United States. National Institutes of Health Revitalization Act of 1993.
SUBJECT National Institutes of Health Revitalization Act of 1993 (United States) fast
Subject Women -- Health and hygiene -- Research -- Moral and ethical aspects
Human experimentation in medicine -- Moral and ethical aspects
Human experimentation in medicine -- Law and legislation.
Human experimentation in medicine -- Law and legislation
Human experimentation in medicine -- Moral and ethical aspects
Form Electronic book
Author Mastroianni, Anne C
Faden, Ruth
ISBN 9780309586214
0309586216