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Responsible research : a systems approach to protecting research participants / / Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, editors ; Committee on Assessing the System for Protecting Human Research Participants
| Responsible research : a systems approach to protecting research participants / / Daniel D. Federman, Kathi E. Hanna, and Laura Lyman Rodriguez, editors ; Committee on Assessing the System for Protecting Human Research Participants |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academies Press, c2003 |
| Descrizione fisica | 1 online resource (312 p.) |
| Disciplina | 174/.28 |
| Altri autori (Persone) |
FedermanDaniel D. <1928-2017.>
HannaKathi E RodriguezLaura Lyman |
| Soggetto topico |
Human experimentation in medicine - Moral and ethical aspects
Medical ethics Medical protocols Patients - Legal status, laws, etc |
| ISBN |
9786610209392
9780309169035 0309169038 9781280209390 1280209399 9780309500463 030950046X |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front Matter -- Preface -- Reviewers -- Acknowledgments -- Acronyms -- Contents -- List of Tables, Figures, and Boxes -- Executive Summary -- 1 Introduction -- 2 A Systemic Approach to Human Research Participant Protection Programs -- 3 Back to Basics: Scientific, Conflict of Interest, and Ethical Review of Research Protocols -- 4 The Participant-Investigator Interface -- 5 Improving Protection Through Oversight and Data and Safety Monitoring -- 6 Improving Human Research Participant Protection Program Performance and Clarifying Roles -- 7 Improving an Evolving National Human Research Participant Protection System -- References -- Appendix A Data Sources and Methods -- Appendix B -- Appendix C Clarifying Protocol Accountability -- Appendix D Committee Biographies -- Index. |
| Record Nr. | UNINA-9910960617003321 |
| Washington, D.C., : National Academies Press, c2003 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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
| 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 |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1994 |
| Descrizione fisica | 1 online resource (288 p.) |
| Disciplina | 174/.28 |
| Altri autori (Persone) |
MastroianniAnna C
FadenRuth R FedermanDaniel D. <1928-2017.> |
| Soggetto topico |
Women - Health and hygiene - Research - Moral and ethical aspects
Human experimentation in medicine - Moral and ethical aspects Human experimentation in medicine - Law and legislation |
| ISBN |
1-280-19580-0
9786610195800 0-309-58621-6 0-585-02366-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""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"" |
| Record Nr. | UNINA-9910961685903321 |
| Washington, D.C., : National Academy Press, 1994 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Workshop 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 Medicine
| Workshop 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 Medicine |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1994 |
| Descrizione fisica | 1 online resource (264 p.) |
| Disciplina | 174/.28 |
| Altri autori (Persone) |
FadenRuth R
FedermanDaniel D. <1928-2017.> MastroianniAnna C |
| Collana | Women and health research |
| Soggetto topico |
Human experimentation in medicine - Law and legislation
Human experimentation in medicine - Moral and ethical aspects Women - Health and hygiene - Research - Moral and ethical aspects |
| ISBN |
9786610195732
9780309176866 0309176867 9781280195730 1280195738 9780309586504 030958650X 9780585137568 0585137560 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""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"" |
| Record Nr. | UNINA-9910957190103321 |
| Washington, D.C., : National Academy Press, 1994 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||