LEADER 06582nam 2200793Ia 450 001 9910957190103321 005 20250623163716.0 010 $a9786610195732 010 $a9780309176866 010 $a0309176867 010 $a9781280195730 010 $a1280195738 010 $a9780309586504 010 $a030958650X 010 $a9780585137568 010 $a0585137560 035 $a(CKB)110986584751416 035 $a(EBL)3376332 035 $a(SSID)ssj0000398694 035 $a(PQKBManifestationID)12123220 035 $a(PQKBTitleCode)TC0000398694 035 $a(PQKBWorkID)10362922 035 $a(PQKB)10515807 035 $a(Au-PeEL)EBL3376332 035 $a(CaPaEBR)ebr10055460 035 $a(OCoLC)923262981 035 $a(MiAaPQ)EBC3376332 035 $a(Perlego)4736754 035 $a(BIP)1750654 035 $a(EXLCZ)99110986584751416 100 $a19931220d1994 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aWorkshop and commissioned papers $eethical and legal issues of including women in clinical studies /$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 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$d1994 215 $a1 online resource (264 p.) 225 0 $aWomen and health research ;$vv.2 300 $aDescription based upon print version of record. 311 08$a9780309050401 311 08$a0309050405 320 $aIncludes bibliographical references and index. 327 $a""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"" 327 $a""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"" 327 $a""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"" 327 $a""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"" 327 $a""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"" 327 $a""DISPARATE TREATMENT, DISPARATE BENEFITS, AND EQUAL OPPORTUNITY"" 330 $aThere 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. 606 $aHuman experimentation in medicine$xLaw and legislation 606 $aHuman experimentation in medicine$xMoral and ethical aspects 606 $aWomen$xHealth and hygiene$xResearch$xMoral and ethical aspects 615 0$aHuman experimentation in medicine$xLaw and legislation. 615 0$aHuman experimentation in medicine$xMoral and ethical aspects. 615 0$aWomen$xHealth and hygiene$xResearch$xMoral and ethical aspects. 676 $a174/.28 701 $aFaden$b Ruth R$01805688 701 $aFederman$b Daniel D.$f1928-2017.$01828827 701 $aMastroianni$b Anna C$01805690 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910957190103321 996 $aWorkshop and commissioned papers$94397948 997 $aUNINA