Reproduction and responsibility: the regulation of new biotechnologies
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| Format: | Book |
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| Language: | English |
| Published: |
Washington, D.C.
Bioethics
2004
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XLIX, 252 Seiten |
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MARC
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Record in the Search Index
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| adam_text | v Contents Letter of Transmittal to the President Members of the President’s Council on Bioethics Council Staff and Consultants Preface xv xxi xxv xxvii acknowledgments xxxiii Executive Summary xxxix 1 Introduction I. II. III. IV. V. VI. VII. 1 Background 2 The Domain of Inquiry 3 The Human Goods at Stake 4 Some Specific Issues 5 The American Legal Landscape 8 The Character and Significances of Human Procreation 13 Brief Outline of the Report 18 Endnote 20 PARTI 2 Assisted Reproduction I. Techniques and Practices 23 A. Collection and Preparation of Gametes 24 B. Fertilization 25 C. Transfer 30 D. Pregnancy 31 E. Delivery 33 F. DisposmoN of Unused Embryos 34 G. Projected Techniques/Recent Experiments 34 23
VI II. III. Reproduction and Responsibility Ethical Considerations 36 A. Well-Being of the Child 37 B. Well-Being of Women in the ART Process 42 C. Meaning of Enhanced Control over Procreation 43 D. Use and Destruction of Human Embryos 46 Current Regulation 46 A. Direct Governmental Regulation of Assisted Reproduction 47 1. Federal Oversight. 47 a. Consumer protection and embryo LABORATORY STANDARDS 47 (i) Success rates 47 (ІІ) MODEL CERTIFICATION PROGRAM 50 2. State Oversight. 51 B. Indirect Governmental Regulation of Assisted Reproduction 54 1. Federal Oversight. 54 a. Safety and efficacy of products and . PUBLIC HEALTH 54 b. Quality assurance and control in CLINICAL LABORATORIES 63 C. REGULATION OF UNFAIR TRADE PRACTICES 63 2. State Oversight. 64 a. Regulation of the practice of MEDICINE 64 (i) Informed consent 64 (ii) Licensure 65 (iii) Registration with DEA 66 (iv) Hospital credentialing 66 (v) Board certification 67 (vi) National Practitioners Databank 67 (vii) Facility licensure 67 (viii) Malpractice insurance coverage 68 (ix) Disciplinary proceedings by state licensure board 68
vu Contents b. Litigation as regulation 69 C. Nongovernmental Regulation 71 1. Safety, Efficacy, and Privacy. 71 2. Safeguarding Professional Integrity and Promoting the Ethical Practice of Medicine. 74 IV. Conclusion 75 Endnotes 79 3 Screening and Selection for Genetic Conditions and Traits 89 I. II. III. ГѴ. Uses and Techniques 90 A. Preimplantation Genetic Diagnosis of Embryos 90 B. Genetic Analysis of Gametes 92 1. Preimplantation genetic diagnosis of ova. 93 2. Sperm selection. 93 Ethical Considerations 93 A. IVF-Related Concerns 94 B. Well-Being of Children 94 C. Increased Control over the Characteristics of Children 94 D. PGD FOR LATH-ONSET DISEASE 97 E. Eugenics and Inequality 97 F. Parents and Children 98 Regulation 99 A. Federal Regulation 99 B. State Laws 99 C. Tort Litigation 100 D. Professional Self-Regulation 101 Conclusion 102 Endnotes 104 4 Modification of Traits and Characteristics I. II. Techniques and Practices 105 Ethical Considerations 108 A. Safety of Embryonic Genetic Modification 105 108
viii Reproduction and Responsibility В. Sources of Disquiet Regarding Genetic Modification 109 III. Current Regulation 110 A. Federal Regulation of Gene-Transfer Research 110 1. FDA Oversight, ill 2. NIH/RAC Oversight. 114 B. Tort Litigation as a Regulatory Mechanism C. Nongovernmental Regulation 117 ГѴ. Conclusion 118 Endnotes 120 5 Research Involving In Vitro Human Embryos I. II. m. IV. П. 123 Techniques and Practices 124 A. Present Applications of Human Embryo Research 124 B. Sources of Embryos 124 C. Projected Techniques/Recent Experiments 125 Ethical Considerations 126 Regulaton 127 A. Federal Law 127 1. Secretary s Advisory Council on Human Research Protections (SACHRP). 131 2. Human-subjects protections. 131 B. State Law 136 C. Professional Self-Regulation 138 Conclusion 143 Endnotes 144 6 Commerce I. 116 Gametes and Embryos 147 A. Current Practices 147 B. Ethical Considerations 149 C. Regulation 151 Sale of ART Services 153 A. Current Practices 153 B. Ethical Considerations 153 147
Contents III. IV. C. Current Regulation 155 Patenting Human Organisms 157 A. Current Practices 157 B. Ethical Considerations 158 C. Current Regulation 159 1. Patenting living things. 159 2. Patenting of human organisms. Conclusion 163 Endnotes 164 ix 161 7 Diagnostic Survey: Summary and Conclusion I. II. 167 Conclusion 170 Summary 8 Findings I. II. 167 173 Domain of inquiry 173 General Conclusions 174 A. Assisted Reproduction 174 1. Institutional Governance. 174 a. Governmental oversight 174 b. Professional oversight 175 2. Substantive Areas of Concern. 175 a. The well-being of children, egg donors, AND GESTATIONAL MOTHERS 175 b. Access to services and consumer PROTECTION 176 c. Movement of techniques and practices FROM EXPERIMENTAL TO CLINICAL USE 176 d. Public discussion and deliberation Regarding the ethical significance of new technologies and PRACTICES 177 B. Preimplantation Genetic Diagnosis 177 C. Gene Transfer Research 177 D. Use and disposition of Human Embryos in Research 178 E. Commerce 178
x Reproduction and Responsibility PARTII 9 Policy Options I. II. 183 Institutional Options 185 A. A New Regulatory Agency 186 B. Augmentation of Existing agencies 188 C. Particular Legislative Action 189 D. Federal Funding as a Regulatory Lever 190 E. Increased Oversight and Self-Regulation by Practitioners and Professional Societies 192 Substantive Options 193 A. Safety and Well-Being of Children Born Using ART 193 1. Improved Annual Monitoring of ART Techniques and Outcomes. 194 2. Long- Term Longitudinal Studies. 194 3. Improved/Expanded Decision-Making. 195 4. Requirements for Higher Standardsand More Substantial Animal Research before Moving Experimental Procedures into Clinical Practice. 195 5. Enforcement Mechanism if Studies Show That Certain Procedures Are Insufficient ly Safe. 195 6. Expanded/Publicly Funded Research with a View to improving ART Procedures. 196 B. Equal and Improved Access to IVF/ART 196 C. Genetic Screening and Selection of Embryos for Non-Disease-Related Traits 197 1. Increased Monitoring. 197 2. Review Mechanisms. 197 3. Limits on Non-Disease Uses. 198 D. Intentional Germ-Line Modification of Embryos or Gametes to Produce Children 198 E. New Reproductive Possibilities That Alter the Biological Relationships between Children and Parents 199 F. Commercialization of Elements of Human Reproduction 200
Contents III. í. Limits or Restrictions on the Buying and Selling of Gametes. 200 2. Limits or Restrictions on the Buying and Selling of Human Embryos. 200 3. Prohibition on the Patenting of Human Embryos or Gametes. 200 G. Biomedical Research Involving Early-Stage Human Embryos/Blastocysts 201 1. Expanded Restrictions. 202 2. Expanded Funding. 202 3. Expanded Regulation/Public Licensure under Certain Guidelines. 203 H. Implantation of Human Embryos into Human or Non-Human Uteri for Biomedical Research 203 1. Restrictions on Embryo Transfer for Research. 203 2. Time Limit on Embryo Use. 204 Conclusion 204 10 Recommendations I. xi 205 Federal Studies, Data Collection, Reporting, and Monitoring Regarding the Uses and Effects of These Technologies 208 A. Undertake a Federally Funded Longitudinal Study of the Impact of ARTs on the Health and Development of Children Born with Their Aid 208 B. Undertake Federally Funded Studies on the Impact of ARTs on the Health and Well-Being of Women 209 C. Undertake Federally Funded Comprehensive Studies on the Uses of Reproductive Genetic Technologies, and on Their Effects on Children Born with Their Aid 210 D. Strengthen and Augment the Fertility Clinic Success Rate and Certification Act 210 1. Enhance Reporting Requirements. 210 a. Efficacy. Provide more user-friendly REPORTING OF DATA, INCLUDING ADDING
XII Reproduction and Responsibility PATIENTS AS AN ADDITIONAL UNIT OF MEASURE 210 b. Risks and side effects. Require the PUBLICATION OF ALL REPORTED ADVERSE HEALTHEFFECTS 211 c. Costs to the patients. Require the re porting AND PUBLICATION OF THE AVERAGE PRICES OF THE PROCEDURESAND THE AVER AGE COST (TO PATIENTS) OF A SUCCESSFUL ASSISTED PREGNANCY 212 d. Innovative techniques. Include inform ation ON NOVEL AND EXPERIMENTAL PROCEDURES 212 e. Adjunct technologies. Require more SPECIFIC REPORTING AND PUBLICATION OF THE FREQUENCY OF, AND REASONS FOR, USES OF SPECIALIZED TECHNIQUES SUCH AS ICSI, PGD, AND SPERM SORTING FOR SEX SELECTION 213 2. Enhance Patient Protections, informed Decision-Making. 214 a. Provide model forms for decisionmaking 214 3. Improve Implementation. 214 a. Enforcement. Provide stronger penalt ies to enhance compliance with the Act’s reporting requirements 214 b. Funding. Increase funding for imple mentation of the Act 214 Increased Oversight by Professional Societies and Practitioners 215 A. Strengthen Informed Patient DecisionMaking 215 B. Treat the Child Born with the Aid of Assisted Reproductive Procedures as a patient 215 C. Improve Enforcement of Existing Guidelines 216 D. Improve Procedures for Movement of Experimental Procedures into Clinical Practice 216 E. Create and Enforce Minimum Uniform Standards II.
Contents III. xiii for the Protection of Human Subjects Affected by Assisted Reproduction 217 F. Develop Additional Self-Imposed Ethical Boundaries 217 Targeted Legislative Measures 218 A. Preserving a Reasonable Boundary between the Human and the Nonhuman (or, between the Hu man and the Animal) in Human Procreation 220 B. Respect for Women and Human Pregnancy, Pre venting Certain Exploitative and Degrading Practices 221 C. Respect for Children Conceived with the Aid of Assisted Reproductive Technologies, Securing for Them the Same Rights and Human Attach ments Naturally Available to Children Con ceived In Vivo 222 D. Setting Some Agreed-Upon Boundaries on How Embryos May Be Used and Treated 223 Appendix: Personal Statements 229 Rebecca S. Dresser, Mary Ann Glendon, Charles Krauthammer, and James Q. Wilson 230 Rebecca S. Dresser 231 Daniel W. Foster, Michael S. Gazzaniga, Janet D. Rowley, Michael J. Sandel, and James Q. Wilson 233 Francis Fukuyama and James Q. Wilson 236 Michael S. Gazzaniga 237 Robert P. George, Mary Ann Glendon, Alfonso GÓMEZ-LOBO, William В. Hurlbut, and Gilbert C. Meilaender 240 Robert p. George and Alfonso Gómez-Lobo 243 Leon R. Kass 245 Paul McHugh 247 Janet D. Rowley 249
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| spelling | Reproduction and responsibility the regulation of new biotechnologies report of the President's Council on Bioethics Washington, D.C. Bioethics 2004 XLIX, 252 Seiten txt rdacontent n rdamedia nc rdacarrier Bioethik (DE-588)4006791-9 gnd rswk-swf Biotechnologie (DE-588)4069491-4 gnd rswk-swf USA (DE-588)4078704-7 gnd rswk-swf USA (DE-588)4078704-7 g Biotechnologie (DE-588)4069491-4 s Bioethik (DE-588)4006791-9 s DE-604 USA Council on Bioethics Sonstige (DE-588)3056471-2 oth Digitalisierung UB Bamberg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=019986767&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Reproduction and responsibility the regulation of new biotechnologies Bioethik (DE-588)4006791-9 gnd Biotechnologie (DE-588)4069491-4 gnd |
| subject_GND | (DE-588)4006791-9 (DE-588)4069491-4 (DE-588)4078704-7 |
| title | Reproduction and responsibility the regulation of new biotechnologies |
| title_auth | Reproduction and responsibility the regulation of new biotechnologies |
| title_exact_search | Reproduction and responsibility the regulation of new biotechnologies |
| title_full | Reproduction and responsibility the regulation of new biotechnologies report of the President's Council on Bioethics |
| title_fullStr | Reproduction and responsibility the regulation of new biotechnologies report of the President's Council on Bioethics |
| title_full_unstemmed | Reproduction and responsibility the regulation of new biotechnologies report of the President's Council on Bioethics |
| title_short | Reproduction and responsibility |
| title_sort | reproduction and responsibility the regulation of new biotechnologies |
| title_sub | the regulation of new biotechnologies |
| topic | Bioethik (DE-588)4006791-9 gnd Biotechnologie (DE-588)4069491-4 gnd |
| topic_facet | Bioethik Biotechnologie USA |
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