06582nam 2200793Ia 450 991095719010332120250623163716.0978661019573297803091768660309176867978128019573012801957389780309586504030958650X97805851375680585137560(CKB)110986584751416(EBL)3376332(SSID)ssj0000398694(PQKBManifestationID)12123220(PQKBTitleCode)TC0000398694(PQKBWorkID)10362922(PQKB)10515807(Au-PeEL)EBL3376332(CaPaEBR)ebr10055460(OCoLC)923262981(MiAaPQ)EBC3376332(Perlego)4736754(BIP)1750654(EXLCZ)9911098658475141619931220d1994 uy 0engur|n|---|||||txtccrWorkshop and commissioned papers 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 Medicine1st ed.Washington, D.C. National Academy Press19941 online resource (264 p.)Women and health research ;v.2Description based upon print version of record.9780309050401 0309050405 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""There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies. Women and Health Research, Volume 2 , addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation. The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.Human experimentation in medicineLaw and legislationHuman experimentation in medicineMoral and ethical aspectsWomenHealth and hygieneResearchMoral and ethical aspectsHuman experimentation in medicineLaw and legislation.Human experimentation in medicineMoral and ethical aspects.WomenHealth and hygieneResearchMoral and ethical aspects.174/.28Faden Ruth R1805688Federman Daniel D.1928-2017.1828827Mastroianni Anna C1805690MiAaPQMiAaPQMiAaPQBOOK9910957190103321Workshop and commissioned papers4397948UNINA