LEADER 05414nam 2200685Ia 450 001 9910455937803321 005 20200520144314.0 010 $a1-280-19573-8 010 $a9786610195732 010 $a0-309-58650-X 010 $a0-585-13756-0 035 $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(MiAaPQ)EBC3376332 035 $a(Au-PeEL)EBL3376332 035 $a(CaPaEBR)ebr10055460 035 $a(OCoLC)923262981 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$b[electronic resource] $eethical and legal issues of including women in clinical studies /$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 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 $a0-309-05040-5 320 $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"" 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 608 $aElectronic books. 615 0$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$0930475 701 $aFederman$b Daniel D.$f1928-$0930476 701 $aMastroianni$b Anna C$0930477 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910455937803321 996 $aWorkshop and commissioned papers$92092914 997 $aUNINA