Human Tissue Research A European perspective on the ethical and legal challenges

by Lenk, Christian; Hoppe, Nils; Beier, Katharina; Wiesemann, Claudia

• ISBN13: 9780199587551
• ISBN10: 0199587558
• Edition: 1st
• Format: Hardcover
• Copyright: 2011-03-22
• Publisher: Oxford University Press

Summary

Goettingen Univ. Medical Center, Germany. Explores issues concerning biobank-related research and provides answers to urgent questions by means of ethical, philosophical, and legal investigation. Topics include the biomedical uses of the body, legal paradigms of human tissues, and discovering informed consent. For researchers and policy makers. Expanded-outline format.

Table of Contents

Preface	p. ix
Contributors	p. xxiii
Abbreviations	p. xxv
Key concepts of the ethical debate
The biomedical uses of the body: lessons from the history of human rights and dignity	p. 3
Introduction: the story of the Irish giant	p. 3
The paradoxical ethics of the human body	p. 4
Human rights: basic interests and special restrictions on personal autonomy	p. 5
Anatomy and tissue banking cannot be issues of human rights	p. 9
Anatomy, tissue banking, and human dignity	p. 11
The taboo on exploitation and the ethics of responsibility	p. 11
Exploring an alternative to informed consent in biobank research	p. 15
Definition of biobanks	p. 16
Informed consent and biobank research	p. 16
Interim evaluation of informed consent and biobank research	p. 19
Interpretations of not using people merely as a means	p. 19
Merely as a means and biobank research	p. 20
Conclusion	p. 22
Respect as a precondition for use of human tissue for research purposes	p. 25
Introduction	p. 25
Normative standards	p. 25
Defending a respect-based approach	p. 27
Respect as a basis for a robust approach to information- and consent-related standards	p. 27
Respect as a basis for prohibiting commodification	p. 31
Conclusion	p. 32
Risky business: re-evaluating participant risk in biobanking	p. 35
Introduction	p. 35
Risk as a concept	p. 36
Contributory parameters	p. 38
Approaches in ethics and law	p. 39
Conclusion	p. 42
Reciprocity, trust, and public interest in research biobanking: in search of a balance	p. 45
Introduction	p. 45
Major UK initiatives	p. 46
Ethical principles	p. 47
Public expectations and anxieties	p. 48
Assumptions and ambiguities	p. 50
Envisaging reciprocity	p. 51
Taking solidarity seriously: do biobank institutions have a moral obligation to inform their patients about incidental health findings?	p. 55
Introduction	p. 55
Why should anyone take part in a biobank research project?	p. 56
The meaning of solidarity in the context of biomedical and genetic research	p. 58
Solidarity, mutual or one-sided ethical duty?	p. 61
Conclusions	p. 62
Beyond the dichotomy of individualism and solidarity: participation in biobank research in Sweden and Norway	p. 65
Introduction	p. 65
Biobanking in Sweden and Norway	p. 66
Explaining biobank participation in Sweden and Norway	p. 70
Conclusion	p. 72
The legal regulation of human tissue research
Law, ethics, and human tissue research: integration or competition?	p. 79
Introduction	p. 79
Ethical regulation in England	p. 79
Background to the Human Tissue Act 2004	p. 80
The provisions of the Human Tissue Act 2004	p. 81
The Human Tissue Authority	p. 83
Integration, not competition?	p. 84
Conclusion	p. 85
Legal paradigms of human tissues	p. 87
Introduction	p. 87
Traditional approach	p. 87
Critical approach	p. 89
Modern approach	p. 92
Convergence of approaches: non-proprietary remedies	p. 95
Conclusion	p. 96
Research with human biological material and personal data in biobanks: legal and regulatory framework in Switzerland	p. 99
Introduction	p. 99
Biobanks and networks in Switzerland	p. 99
Research with biological materials and personal data in biobanks	p. 100
Discussion and outlook	p. 104
Legal issues surrounding French research-focused biobanks	p. 109
A continuously evolving legal framework	p. 110
Major (outstanding) legal issues	p. 113
Conclusion	p. 116
Biobanks: ethical and legal aspects of the collection and storage of human biological material in Italy	p. 119
Introduction	p. 119
Overview of the Italian approach to biobanks	p. 119
The definition of biobanks and stored samples	p. 120
Informed consent and information form	p. 121
Privacy and confidentiality regarding data and results	p. 123
Ownership of samples	p. 123
Conclusion	p. 124
How to achieve 'free movement of tissueÆ in the EU research area	p. 127
Prologue	p. 127
Introduction	p. 127
Anxiety over tissue flows results from concerns over abuse	p. 128
How to address national concerns	p. 129
How to address institutional concerns	p. 130
How to address donor concerns	p. 131
Eu law on international transfer of personal data	p. 133
Donor as third-party beneficiary	p. 134
Combining MTA and EU standard contractual clauses	p. 135
Conclusion	p. 136
Practicesùdisciplinary perspectives
Ethical recommendations for the use of human biological material stored in pathology archives for research purposes	p. 139
The need for human tissue	p. 139
The use of archived tissue	p. 140
European recommendations	p. 141
German regulations	p. 143
Suggestions for a formalized informed consent procedure	p. 144
Conclusion	p. 145
Informed consent when donating cells for the production of human tissue engineered products	p. 149
Introduction	p. 149
Scope of tissue engineering	p. 150
Regulation of tissue engineering	p. 152
Features of tissue engineering	p. 151
Value of cells	p. 152
Conclusion	p. 156
The regulation of autologous stem cells in heart repair: comparing the UK and Germany	p. 159
Analysing national regulatory contexts in clinical stem cell research	p. 159
Background and regulatory setting of stem cell clinical trials in heart repair	p. 160
The EU framework: regulating novel cell therapies	p. 161
The UK framework: assemblage	p. 163
The German framework: streamlining	p. 164
Conclusion	p. 165
Discovering informed consent: a case study on the practices of informed consent to tissue donation in Austria	p. 169
Introduction	p. 169
Methods	p. 170
Readiness of address: informed consent before undergoing surgery	p. 171
Managing uncertainties: informed consent before performing research	p. 173
Discussion	p. 174
Implications	p. 175
Epilogue	p. 179
Index	p. 133
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