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010   $a9786610195800
010   $a0-309-58621-6
010   $a0-585-02366-2
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100   $a19931220d1994      uy             0
101 0 $aeng
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181   $ctxt
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183   $acr
200 00$aWomen and health research$b[electronic resource] $eethical and legal issues of including women in clinical studies$hVolume I /$fAnna C. Mastroianni, Ruth Faden, and Daniel Federman, editors ; Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies, Division of Health Sciences Policy, Institute of Medicine
210   $aWashington, D.C. $cNational Academy Press$d1994
215   $a1 online resource (288 p.)
300   $aDescription based upon print version of record.
311   $a0-309-04992-X 
320   $aIncludes bibliographical references and index.
327   $a""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""
327   $a""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""
327   $a""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""
327   $a""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 ""
327   $a""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""
327   $a""Potential for Exploitation""
606   $aWomen$xHealth and hygiene$xResearch$xMoral and ethical aspects
606   $aHuman experimentation in medicine$xMoral and ethical aspects
606   $aHuman experimentation in medicine$xLaw and legislation
608   $aElectronic books.
615  0$aWomen$xHealth and hygiene$xResearch$xMoral and ethical aspects.
615  0$aHuman experimentation in medicine$xMoral and ethical aspects.
615  0$aHuman experimentation in medicine$xLaw and legislation.
676   $a174/.28
701   $aMastroianni$b Anna C$0930477
701   $aFaden$b Ruth R$0930475
701   $aFederman$b Daniel D.$f1928-$0930476
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910455372303321
996   $aWomen and health research$92277475
997   $aUNINA