Women and health research [electronic resource] : ethical and legal issues of including women in clinical studies. Volume I / Anna 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.

Format:

Book

Contributor:

Mastroianni, Anna C.

Faden, Ruth R.

Federman, Daniel D., 1928-2017.

Language:

English

Subjects (All):

United States. National Institutes of Health Revitalization Act of 1993.

United States.

Women--Health and hygiene--Research--Moral and ethical aspects.

Women.

Human experimentation in medicine--Moral and ethical aspects.

Human experimentation in medicine.

Human experimentation in medicine--Law and legislation.

Physical Description:

1 online resource (288 p.)

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1994.

Language Note:

English

Summary:

Women and Health Research 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--while highlighting the limitations of science, legal liabilities, and governmental policies.

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""

""Potential for Exploitation""

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

ISBN:

1-280-19580-0

9786610195800

0-309-58621-6

0-585-02366-2

OCLC:

923260596