05414nam 2200685Ia 450 991045593780332120200520144314.01-280-19573-897866101957320-309-58650-X0-585-13756-0(CKB)110986584751416(EBL)3376332(SSID)ssj0000398694(PQKBManifestationID)12123220(PQKBTitleCode)TC0000398694(PQKBWorkID)10362922(PQKB)10515807(MiAaPQ)EBC3376332(Au-PeEL)EBL3376332(CaPaEBR)ebr10055460(OCoLC)923262981(EXLCZ)9911098658475141619931220d1994 uy 0engur|n|---|||||txtccrWorkshop and commissioned papers[electronic resource] ethical and legal issues of including women in clinical studies /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 MedicineWashington, D.C. National Academy Press19941 online resource (264 p.)Women and health research ;v.2Description based upon print version of record.0-309-05040-5 Includes bibliographical references and index.""WOMEN AND HEALTH RESEARCH""; ""Copyright""; ""Preface""; ""Contents""; ""Women's Participation in Clinical Research: From Protectionism to Access""; ""CURRENT FEDERAL POLICY""; ""PROTECTIONIST POLICIES""; ""ADVENT OF INCLUSIONARY POLICIES""; ""CONCLUSION""; ""NOTES""; ""Women in Clinical Studies: A Feminist View""; ""NOTES""; ""Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (I)""; ""THE PREGNANT WOMAN AS SUBJECT""; ""Therapeutic: To Meet the Health Needs of the Mother""; ""Nontherapeutic Research: Not Meeting the Health Needs of the Pregnant Woman""""THE FETUS AS SUBJECT""""Therapeutic: To Meet the Health Needs of the Fetus""; ""Nontherapeutic Fetal Research: Not to Meet the Fetus's Health Needs""; ""NOTES""; ""Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (II)""; ""REFERENCES""; ""Ethical Issues Related to the Inclusion of Women of Childbearing Age in Clinical Trials""; ""NOTES""; ""Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (I)""; ""TYPES OF INFORMATION DEFICITS""; ""TYPES OF CONSEQUENCES""; ""Morbidity and Mortality""; ""Diagnosis and Treatment Patterns""""Treatment Outcomes""""Provider Perceptions""; ""CONCLUSIONS""; ""NOTES""; ""Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (II)""; ""Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations""; ""THE DYNAMICS OF RECRUITMENT AND RETENTION""; ""CROSS-CULTURAL DIFFERENCES: MEN VS. WOMEN""; ""GENDER DIFFERENCES: IMPLICATIONS FOR RESEARCH""; ""METHODOLOGICAL CONSIDERATIONS FOR RESEARCHERS""; ""REFERENCES""; ""Recruitment and Retention of Women of Color in Clinical Studies""; ""NOTES""""Recruitment and Retention of Women in Clinical Studies: Ethical Considerations""""INCENTIVES TO ENROLL AND TO CONTINUE PARTICIPATION""; ""FREE ABORTION AS AN INCENTIVE""; ""DEALING WITH DROPOUTS""; ""COSTS OF INVOLVING WOMEN AS RESEARCH SUBJECTS""; ""TWO SEPARATE AGENDAS ON THE INCLUSION OF WOMEN""; ""WOMEN IN (SOME) DEVELOPING COUNTRIES""; ""REFERENCES""; ""Impact of Current Federal Regulations on the Inclusion of Female Subjects in Clinical Studies""; ""THE IMPACT OF PRESENT LAW""; ""Regulations that Appear to Limit Women's Participation in Clinical Research""""FDA Definition of ""Childbearing Potential"" and Required Prior Reproductive Studies""""DHHS Limitations on Research with Pregnant Women""; ""Federal Requirements that Support the Inclusion of Women in Clinical Research""; ""FDA Premarketing Testing""; ""DHHS Regulations on Research with Children""; ""RECOMMENDED CHANGES IN THE FEDERAL LAW""; ""Amendment of FDA Regulations""; ""Amendment of DHHS Regulations""; ""National Institutes of Health Policy""; ""CONCLUSION""; ""NOTES""; ""Brief Overview of Constitutional Issues Raised by the Exclusion of Women from Research Trials""""DISPARATE TREATMENT, DISPARATE BENEFITS, AND EQUAL OPPORTUNITY""Human experimentation in medicineLaw and legislationHuman experimentation in medicineMoral and ethical aspectsWomenHealth and hygieneResearchMoral and ethical aspectsElectronic books.Human experimentation in medicineLaw and legislation.Human experimentation in medicineMoral and ethical aspects.WomenHealth and hygieneResearchMoral and ethical aspects.174/.28Faden Ruth R930475Federman Daniel D.1928-930476Mastroianni Anna C930477MiAaPQMiAaPQMiAaPQBOOK9910455937803321Workshop and commissioned papers2092914UNINA