Human tissue research : a European perspective on the ethical and legal challenges / edited by Christian Lenk ... [and others].

Format:

Book

Contributor:

Lenk, Christian.

Language:

English

Subjects (All):

Biomedical Research--ethics.

Biomedical engineering.

Tissue engineering--Law and legislation.

Tissue engineering.

Research.

Europe.

Biomedical Research--legislation & jurisprudence.

Bioethical Issues--legislation & jurisprudence.

Tissue Banks.

Tissue engineering--Research.

Tissue engineering--Moral and ethical aspects.

Tissue engineering--Law and legislation--Europe.

Biomedical engineering--Moral and ethical aspects.

Biomedical engineering--Law and legislation--Europe.

Medical Subjects:

Biomedical Research--ethics.

Europe.

Biomedical Research--legislation & jurisprudence.

Bioethical Issues--legislation & jurisprudence.

Tissue Banks.

Physical Description:

xxiv, 189 pages : illustrations ; 25 cm

Edition:

First edition.

Place of Publication:

Oxford ; New York : Oxford University Press, 2011.

Summary:

The use of human tissue for medical-research and scientific progress raises many ethical and legal challenges. The procurement; storage, and transfer of human tissue for research purposes have posed significant questions over recent years, and a number of high profile scandals in the UK prompted the publication of the Madden Report on Post Mortem Practice and Procedures in Irish hospitals in 2006. Additionally, tissue-related research tends to be most promising if samples and information are shared across national borders, but the heterogeneity of current rules and guidelines within the member states of the European Union calls all the more for clarification.

This multi-authored interdisciplinary text, edited by four experienced researchers, explores. many of the issues concerning biobank-related research and aims to provide answers to the most urgent questions by means of ethical, philosophical, and legal-investigation. It provides a fascinating insight into a wide range of interlinking research perspectives and serves as a comprehensive reference to the state of play ethically and legally in Europe.

It will be of value to medics and social scientists, human tissue researchers, policy makers, and members of the general public who have an interest in ethical and legal issues of human tissue research. Book jacket.

Contents:

PartI Key concepts of the ethical debate

1 The biomedical uses of the body: lessons from the history of human rights and dignity / Y. Michael Barilan Barilan, Y. Michael 3

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 / Rieke van der Graaf Graaf, Rieke van der, Johannes J. M. van Delden Delden, Johannes J. M. van 15

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 / Austen Garwood-Gowers Garwood-Gowers, Austen 25

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 / Nils Hoppe Hoppe, Nils 35

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 / Nadja K. Kanellopoulou Kanellopoulou, Nadja K. 45

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? / Christian Lenk Lenk, Christian 55

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 / Katharina Beier Beier, Katharina 65

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? / José Miola Miola, José 79

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 of the 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 / Remigius N. Nwabueze Nwabueze, Remigius N. 87

9.1 Introduction 87

9.2 Traditional approach 87

9.3 Critical approach 89

9.4 Modern 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 / Bianka S. Dörr Dörr, Bianka S. 99

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 / Virginie Commin Commin, Virginie 109

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 / Antonio G. Spagnolo Spagnolo, Antonio G., Viviana Daloiso Daloiso, Viviana, Paola Parente Parente, Paola 119

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 / Jasper Bovenberg Bovenberg, Jasper 127

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 / Christoph Brochhausen Brochhausen, Christoph, Nabila Ahmed Ahmed, Nabila, Nicolas Robricker Robricker, Nicolas, C. James Kirkpatrick Kirkpatrick, C. James 139

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 / Leen Trommelmans Trommelmans, Leen, Joseph Selling Selling, Joseph, Kris Dienckx Dienckx, Kris 149

15.1 Introduction 149

15.2 Scope of tissue engineering 150

15.3 Regulation of tissue engineering 152

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 / Susanne Weber Weber, Susanne, Dana Wilson-Kovacs Wilson-Kovacs, Dana, Chritstine Hauskeller Hauskeller, Chritstine 159

161 Analysing national regulatory contexts in clinical stem cell research 159

162 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 / Milena D. Bister Bister, Milena D. 169

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.

Notes:

Includes bibliographical references and index.

ISBN:

9780199587551

0199587558

OCLC:

687700458