Human tissue research: a European perspective on the ethical and legal challenges
Gespeichert in:
| Weitere beteiligte Personen: | , , , |
|---|---|
| Format: | Buch |
| Sprache: | Englisch |
| Veröffentlicht: |
Oxford
Oxford Univ. Press
2011
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| Ausgabe: | 1. ed. |
| Schlagwörter: | |
| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=021142481&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| Umfang: | XXIV, 189 S. |
| ISBN: | 0199587558 |
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Datensatz im Suchindex
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Titel: Human tissue research
Autor: Lenk, Christian
Jahr: 2011
Contents
Preface ix
Contributors xxiii
Abbreviations xxv
Part I Key concepts of the ethical debate
1 The biomedical uses of the body: lessons from the history
of human rights and dignity 3
Y. Michael Barilan
1.1 Introduction: the story of the Irish giant 3
1.2 The paradoxical ethics of the human body 4
1.3 Human rights: basic interests and special restrictions on personal autonomy 5
1.4 Anatomy and tissue banking cannot be issues of human rights 9
1.5 Anatomy, tissue banking, and human dignity 11
1.6 The taboo on exploitation and the ethics of responsibility 11
2 Exploring an alternative to informed consent in biobank research 15
Rieke van der Graafand Johannes J. M. van Delden
2.1 Definition of biobanks 16
2.2 Informed consent and biobank research 16
2.3 Interim evaluation of informed consent and biobank research 19
2.4 Interpretations of not using people merely as a means 19
2.5 Merely as a means and biobank research 20
2.6 Conclusion 22
3 Respect as a precondition for use of human tissue for research purposes 25
Austen Garwood-Gowers
3.1 Introduction 25
3.2 Normative standards 25
3.3 Defending a respect-based approach 27
3.4 Respect as a basis for a robust approach to information- and consent-related
standards 27
3.5 Respect as a basis for prohibiting commodification 31
3.6 Conclusion 32
4 Risky business: re-evaluating participant risk in biobanking 35
Nils Hoppe
4.1 Introduction 35
4.2 Risk as a concept 36
4.3 Contributory parameters 38
4.4 Approaches in ethics and law 39
4.5 Conclusion 42
5 Reciprocity, trust, and public interest in research biobanking: in
search of a balance 45
Nadja K. Kanellopoulou
5.1 Introduction 45
5.2 Major UK initiatives 46
5.3 Ethical principles 47
5.4 Public expectations and anxieties 48
5.5 Assumptions and ambiguities 50
5.6 Envisaging reciprocity 51
6 Taking solidarity seriously: do biobank institutions have a moral obligation to
inform their patients about incidental health findings? 55
Christian Lenk
6.1 Introduction 55
6.2 Why should anyone take part in a biobank research project? 56
6.3 The meaning of solidarity in the context of biomedical and genetic research 58
6.4 Solidarity: mutual or one-sided ethical duty? 61
6.5 Conclusions 62
7 Beyond the dichotomy of individualism and solidarity: participation in biobank
research in Sweden and Norway 65
Katharina Beier
7.1 Introduction 65
7.2 Biobanking in Sweden and Norway 66
7.3 Explaining biobank participation in Sweden and Norway 70
7.4 Conclusion 72
Part II The legal regulation of human tissue research
8 Law, ethics, and human tissue research: integration or competition? 79
José Miola
8.1 Introduction 79
8.2 Ethical regulation in England 79
8.3 Background to the Human Tissue Act 2004 80
8.4 The provisions ofthe Human Tissue Act 2004 81
8.5 The Human Tissue Authority 83
8.6 Integration, not competition? 84
8.7 Conclusion 85
9 Legal paradigms of human tissues 87
Remigius N. Nwabueze
9.1 Introduction 87
9.2 Traditional approach 87
9.3 Critical approach 89
9.4 Modem approach 92
9.5 Convergence of approaches: non-proprietary remedies 95
9.6 Conclusion 96
10 Research with human biological material and personal data in biobanks:
legal and regulatory framework in Switzerland 99
Bianka S. Dörr
10.1 Introduction 99
10.2 Biobanks and networks in Switzerland 99
10.3 Research with biological materials and personal data in biobanks 100
10.4 Discussion and outlook 104
11 Legal issues surrounding French research-focused biobanks 109
Virginie Commin
11.1 A continuously evolving legal framework 110
11.2 Major (outstanding) legal issues 113
11.3 Conclusion 116
12 Biobanks: ethical and legal aspects of the collection and storage of human
biological material in Italy 119
Antonio G. Spagnolo, Viviana Daloiso, andPaola Parente
12.1 Introduction 119
12.2 Overview of the Italian approach to biobanks 119
12.3 The definition of biobanks and stored samples 120
12.4 Informed consent and information form 121
12.5 Privacy and confidentiality regarding data and results 123
12.6 Ownership of samples 123
12.7 Conclusion 124
13 How to achieve 'free movement of tissue' in the EU research area 127
Jasper Bovenberg
13.1 Prologue 127
13.2 Introduction 127
13.3 Anxiety over tissue flows results from concerns over abuse 128
13.4 How to address national concerns 129
13.5 How to address institutional concerns 130
13.6 How to address donor concerns 131
13.7 EU law on international transfer of personal data 133
13.8 Donor as third-party beneficiary 134
13.9 Combining MTA and EU standard contractual clauses 135
13.10 Conclusion 136
Part III Practices-disciplinary perspectives
14 Ethical recommendations for the use of human biological material stored in
pathology archives for research purposes 139
Christoph Brochhausen, Nabila Ahmed, Nicolas Roßricker, and C. James Kirkpatrick
14.1 The need for human tissue 139
14.2 The use of archived tissue 140
14.3 European recommendations 141
14.4 German regulations 143
14.5 Suggestions for a formalized informed consent procedure 144
14.6 Conclusion 145
15 Informed consent when donating cells for the production of human tissue
engineered products 149
Leen Trommelmans, Joseph Selling, and Kris Dierickx
15.1 Introduction 149
15.2 Scope of tissue engineering 150
15.3 Regulation of tissue engineering 151
15.4 Features of tissue engineering 151
15.5 Value of cells 152
15.6 Conclusion 156
16 The regulation of autologous stem cells in heart repair: comparing the
UK and Germany 159
Susanne Weber, Dana Wilson-Kovacs, and Christine Hauskeller
16.1 Analysing national regulatory contexts in clinical stem cell research 159
16.2 Background and regulatory setting of stem cell clinical trials in heart repair 160
16.3 The EU framework: regulating novel cell therapies 161
16.4 The UK framework: assemblage 163
16.5 The German framework: streamlining 164
16.6 Conclusion 165
17 Discovering informed consent: a case study on the practices of informed
consent to tissue donation in Austria 169
Milena D. Bister
17.1 Introduction 169
17.2 Methods 170
17.3 Readiness of address: informed consent before undergoing surgery 171
17.4 Managing uncertainties: informed consent before performing research 173
17.5 Discussion 174
17.6 Implications 175
Epilogue 179
Index 183 |
| any_adam_object | 1 |
| author2 | Lenk, Christian 1971-2022 Hoppe, Nils 1977- Beier, Katharina Wiesemann, Claudia 1958- |
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| dewey-ones | 610 - Medicine and health |
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| dewey-tens | 610 - Medicine and health |
| discipline | Biologie Philosophie Medizin |
| edition | 1. ed. |
| format | Book |
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| title | Human tissue research a European perspective on the ethical and legal challenges |
| title_auth | Human tissue research a European perspective on the ethical and legal challenges |
| title_exact_search | Human tissue research a European perspective on the ethical and legal challenges |
| title_full | Human tissue research a European perspective on the ethical and legal challenges ed. by Christian Lenk ... |
| title_fullStr | Human tissue research a European perspective on the ethical and legal challenges ed. by Christian Lenk ... |
| title_full_unstemmed | Human tissue research a European perspective on the ethical and legal challenges ed. by Christian Lenk ... |
| title_short | Human tissue research |
| title_sort | human tissue research a european perspective on the ethical and legal challenges |
| title_sub | a European perspective on the ethical and legal challenges |
| topic | Gewebebank (DE-588)4333665-6 gnd Medizin (DE-588)4038243-6 gnd Tissue Engineering (DE-588)4646061-5 gnd Ethik (DE-588)4015602-3 gnd Forschung (DE-588)4017894-8 gnd |
| topic_facet | Gewebebank Medizin Tissue Engineering Ethik Forschung Europa Aufsatzsammlung |
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