Format:
Online-Ressource (288 p)
ISBN:
9780309049924
Content:
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.
Note:
Description based upon print version of record
,
""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""
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""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 ""
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""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""
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""Potential for Exploitation""
Additional Edition:
ISBN 9780309586214
Additional Edition:
ISBN 9780309049924
Additional Edition:
Print version Women and Health Research, Volume 1 : Ethical and Legal Issues of Including Women in Clinical Studies
Language:
English
Keywords:
Electronic books
URL:
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