CHIMBRIDS - Chimeras and Hybrids in Comparative European and International Research - Scientific, Ethical, Philosophical and Legal Aspects

von: Jochen Taupitz, Marion Weschka

Springer-Verlag, 2009

ISBN: 9783540938699 , 1039 Seiten

Format: PDF, OL

Kopierschutz: Wasserzeichen

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CHIMBRIDS - Chimeras and Hybrids in Comparative European and International Research - Scientific, Ethical, Philosophical and Legal Aspects


 

Preface

5

Table of Contents

7

Introduction

20

A. General research aspects

22

I. Problems with terminology and definitions

23

II. Etymological background and furtherclarifying remarksconcerning chimeras and hybrids

25

1. Introduction

25

2. Semantic analysis

25

a. Chimera as an archetype

25

b. Etymological background

28

c. Chimera as a metaphor and as a terminus technicus

29

d. Hybrid

30

e. Some further differentiations

32

f. Chimera as a strategy

33

3. Anthropological clarifications

34

a. Chimera and the deeper understanding of humanity

34

b. Should we cross boundaries?

36

c. The art of slowness

37

III. Scientific background

39

1. Introduction

39

2. Intra-species mixtures

42

a. Intra-species chimeras

42

b. Intra-species hybrids

46

3. Inter-species mixtures

46

a. Inter-species chimeras

46

b. Inter-species hybrids

50

c. Examples of inter-species mixtures

53

aa. Xenotransplantation

53

bb. Transgenic animals carrying human genes

57

cc. Nuclear transfer research

61

dd. Transplantation of human embryonic stem cells into animal brain

69

ee. Hamster test: Testing human sperm capacity with hamster ova

70

ff. Mixing of embryos

71

gg. Interspecies gestation

72

hh. Other mixtures

73

IV. Ethics

78

1. Introduction

78

2. The Fundamental Debates on Moral Status: What MakesEntities Morally Significant?

79

a. Preliminary Remarks

79

b. Moral Status Based on Sentience (i.e., on the ability to feel painor suffer)

80

c. Moral Status Based on Agency, Self-Consciousness or Rationality

81

d. Moral Status Based on the Significance of the Human Species

82

e. Moral Status Based on the Intrinsic Value of Animals

83

aa. Applications of Moral Status: Potentiality, Precaution andSymbolic Extensions of Status

84

bb. Applications of Moral Status: Potentiality

84

cc. Applications of Moral Status: Precaution

85

dd. Applications of Moral Status: Symbolic Meanings

85

f. The Moral Status of Human Embryos and Chimbrids

87

3. Specific Moral Considerations in Evaluating Chimbrids: AnEthical Matrix

87

a. Preliminary Remarks

88

b. Moral Considerations in Research Ethics

88

c. Moral Considerations in Animal Ethics

90

V. Law

95

1. Legal tools and strategies for the regulation of chimbrids

95

a. Introduction

95

b. Determining the aims of the regulatory project

96

c. Identifying the appropriate regulator

97

d. The choice of regulatory instruments

97

e. Decision-making in individual cases

100

f. Monitoring and sanctions

100

g. Some challenges in the regulation of chimbrids

101

2. Which Beings Should Be Entitled to Human Rights?

104

a. The General Concept of Personhood

104

b. Human Rights – Their Meaning and Their Foundation

105

c. Human Rights and the Constitution

107

aa. The Paradigm: Born of a Human (the Natural Person)

107

bb. Does the Unborn Human Being Enjoy Constitutionally Protected Human Rights?

108

cc. Indicators of Personhood

110

d. The Status of Chimeras and Chimeric Embryos

111

3. Chimbrids and International Law

114

4. EU Law and Council of Europe Law applicable to chimeraand hybrid research

132

a. Relevant facts

132

b. Research law

132

c. Protection of human-beings by the fundamental rights of theEuropean Union

135

d. Protection of human rights and the dignity of the human beingwithin the Council of Europe’s Legal Framework

135

e. Protection of biotechnological inventions

137

f. Protection of personal data

138

g. Protection of Health

139

h. Protection of animals in the case of animal experiments

145

i. Genetics in the non-human domain

147

5. National law

148

a. EU member states

148

aa. Austria

148

bb. France

152

cc. Germany

156

dd. Sweden

161

ee. Spain

166

ff. United Kingdom

167

b. Other Countries

174

aa. Switzerland

174

bb. Israel

181

cc. United States

185

dd. Canada

189

ee. China

194

ff. Japan

196

B. Key Cases in chimbrids research

200

I. Case 1 - Muotri: Transfer of human embryonic stem cell-derived neurons in mouse brain

201

1. Scientific considerations

201

2. Ethical considerations

204

3. Legal regulation in different countries

210

II. Case 2 - Chen: Interspecies somatic cell nuclear transfer

215

1. Scientific considerations

215

2. Ethical considerations

219

3. Legal regulation in different countries

223

III. Case 3 - Bailey: Animal-Human Xenotransplantation

245

1. Scientific considerations

245

2. Ethical considerations

249

3. Legal regualtions in different countries

251

IV. Case 4 - Fink: Porcine Xenografts in Parkinson's Disease and Huntington's Disease patients

276

1. Scientific considerations

276

2. Ethical considerations

280

3. Legal regulation in different countries

284

V. Case 5 - McCune: The SCID-hu Mouse

299

1. Scientific considerations

299

2. Ethical considerations

302

3. Legal regualtion in different countries

305

VI. Case 6 - EMEA: Transgenic goat producing human antithrombin

328

1. Scientific considerations

328

2. Ethical considerations

331

3. Legal regulation in different countries

335

VII. Case 7 - O'Doherty: Mouse with human chromosome

363

1. Scientific considerations

363

2. Ethical considerations

366

3. Legal regulation in different countries

370

VIII. Case 8 - Yanagimachi: Hamster egg penetration test

371

1. Scientific considerations

371

2. Ethical considerations

374

3. Legal regulation in different countries

377

IX. Case 9 - Fehilly: Human-animal embryo mixing

389

1. Scientific considerations

389

2. Ethical considerations

391

3. Legal regulation in different countries

395

X. Case 10 - Nan et al.: Interspecies gestation

414

1. Scientific considerations

414

2. Ethical considerations

416

3. Legal regulation in different countries

419

XI. Short Remarks to the cases 1-10 in the light of European legal order

435

C. Summary, Conclusions and Recommendations

440

I. General remarks

441

II. Scientific overview of human-animal mixtures

443

III. Ethical Aspects

447

1. Moral status

447

2. Human research ethics

449

3. Animal ethics

450

4. Appearance and Symbolic Meaning

451

5. Plurality of ethical theories and legal regulations

452

IV. Legal Aspects

454

1. The regulatory needs and challenges

454

2. Regulatory tools and strategies applied

455

3. Concluding remarks

457

V. Recommendations

460

Annex

463

Annex - A. Chimbrids – Scientific, Ethicaland Legal Reports

464

I. Science

465

1. Transgenic animals carrying human genes: Methods and Ethical Aspects

465

2. Xenotransplantation - Aspects of Chimerism

477

3. Nuclear Transfer, Chimeras and Hybrids Activities and legal aspects of research in Hungary

503

4. Interspecies Nuclear Transfer Research in China

526

5. Developing Human-Nonhuman Chimeras in Human Stem Cell Research Ethical Issues and Boundries

537

6. Chimeras in developmental biology: scientific objectives and ethical issues

558

II. Ethics

573

1. Man-made chimeras, hybrids and mosaics--ethical perspectives

573

2. Ethical Issues in Transgenesis: Biopharming, Xenotransplantation & Recreational Transgenesis

594

III. Law

605

1. These concerning chimerisation and hybridisation from an ethical and legal perspective

605

2. The Regulation of Hybrids and Chimeras in the UK

647

3. Providing a legal framwork for chimeras - French Report

669

4. Legal Aspects of Human-Animal Chimeras and Hybrids: Country Report Sweden

691

5. Chimeras and Other Human-Animal Mixtures in Relation to the Swiss

708

6. Die rechtliche Regelung von Chimaren und Hybridwesenein osterreichischer Landesbericht

718

7. New types of Chimeras and Hybrids: a challenge for Biolaw

736

8. The legislation on Chimeras and Hybrids in Spain

743

9. Discussing the European Union Competences to Legislate on Chimbrids Research

745

10. Legal Issues involving Hybrids and Chimeras United States Country Report

756

11. Legal Aspects of Human-Animal Combinations in Canada

780

12. Legal and Ethical Aspects of Chimera and Hybrid Research in Israel: Country Report with Comparative Observations

800

13. Bioethical Discussions on Specified Embryos in Japan

811

14. The Law Concerning Regulations Relating to Human Cloning Techniques, Handling of a Specified Embryo and Animal experiment in Japan

819

15. Human embryonic stem cell research in China

821

Annex - B. Country Reports on the 10 Cases

828

I. Germany: Case 1-10 according to German Law

829

1. Case 1 -- Muotri Case

829

2. Case 2 -- Chen Case (interspecies SCNT human into rabbit)

833

3. Case 3 -- Animal-Human Xenotransplantation

835

4. Case 4 -- Fink

837

5. Case 5 -- McCune

838

6. Case 6 -- EMEA

841

7. Case 7 -- O'Doherty

842

8. Case 8 -- Golden Hamster test

843

9. Case 9 -- Mixing of embryos

844

10. Case 10 -- Interspecies gestation

844

II. UK: Case 1-10 according to UK law

846

1. Muotri case

846

2. Chen Case

847

3. Bailey Case. Baboon to Human Cardiac Xenotransplant in Neonates

848

4. Fink Case Porcine Xenografts for Huntington's

849

5. McCune Case: SCID

849

6. Transgenic Goat Case

850

7. Mice with Down's Syndrome Phenotypes

850

8. Golden Hamster Test

850

9. Mixing of Embryos

851

10. Interspecies Gestation

851

III. France legal Issues in French Law: the case studies

853

1. Case 1 -- Muotri

853

2. Case 2 -- Chen

858

3. Case 3 -- Chen (alternative)

861

4. Case 4 -- Fink

865

5. Case 5 -- McCune

866

6. Case 6 -- EMEA

870

7. Case 7 -- O'Doherty

873

8. Case 8 -- Golden Hamster test

874

9. Case 9 -- Mixing of Embryos

876

10. Case 10 -- Interspecies gestation

878

IV. Sweden -- Case 1-10 according to Swedish law

881

1. Case 1 -- Muotri, A.R. et al. (2005)

881

2. Case 2 -- Chen, Y. et al. (2003)

882

3. Case 3 -- Bailey Leonard L. et al. (1985)

884

4. Case 4 -- Fink, J.S. et al. (2000)

885

5. Case 5 -- McCune et al. (1988)

886

6. Case 6 -- EMEA

888

7. Case 7 -- O'Doherty, A. et al. (2005)

888

8. Case 8 -- Lee M. Ho et al. (2007)

889

9. Case 9 -- Mixing of embryos

890

10. Case 10 -- Interspecies gestation

892

V. Spain -- Case 1-10 according to Spanish law

894

1. Case 1

894

2. Case 2

895

3. Case 3

898

4. Case 4

900

5. Case 5

902

6. Case 6

905

7. Case 7

906

8. Case 8 -- Golden Hamster test

909

9. Case 9 -- Mixing of embryos

909

10. Case 10 -- Interspecies gestation

911

VI. Austria -- Case 1-10 according to Austrian Law

914

1. Case 1 -- Muotri case

914

2. Case 2 -- Chen case

914

3. Case 3 -- Bailey case

915

4. Case 4 -- Fink case

915

5. Case 5 -- McCune case

916

6. Case 6 -- Transgenic goat case

916

7. Case 7 -- O;Doherty case

916

8. Case 8 -- Hoo Lee case

917

9. Case 9 -- Fehilly case

917

10. Case 10 -- Nan case

918

VII. Switzerland Case 1 to 10 according to Swiss Law

919

1. Case 1 -- Muotri

919

2. Case 2 -- Chen

927

3. Case 3 -- Bailey

929

4. Case 4 -- Fink

933

5. Case 5 -- McCune

935

6. Case 6 -- EMEA

936

7. Case 7 -- O'Doherty

941

8. Case 8 -- Yanagimachi

943

9. Case 9 -- Fehily

943

10. Case 10 -- Nan et al.

947

11. Alternative to Case 10 -- Zavos and Illmensee

947

VIII. USA -- Case comments

950

1. Case 1: Human embryonic stem cells into brain of mouse embryo/foetus at day 14

950

2. Case 2, Chen, Y. et al. (2003):Embryonic stem cells generated by nuclear transfer of humansomatic nuclei into rabbit oocytes

953

3. Case 3: Solid organ xenotransplantation of xenograft intohuman being

954

4. Case 4:Porcine xenografts (porcine foetal neuronal cells) inParkinson’s Disease and Huntington’s Disease Patients

958

5. Case 5: Human foetal cells into adult mice.

961

6. Case 6:Transgenic goats that secrete human antithrombine into theirmilk; transfer of human DNA into goat zygotes.

963

7. Case 7:Aneuploid mouse strain carrying human chromosome 21 withDown’s syndrome phenotypes; transfer of almost full humanchromosome 21 into mouse embryonic stem cells; afterwardsinjection into mouse blastocysts.

965

8. Case 8: Golden Hamster Test

966

9. Case 9:Mixing embryos of non-human species with embryos ofhuman species

967

10. Case 10: Interspecies Gestation

970

IX. Canada

972

A. Introduction

972

1. Case Study No. 1

978

2. Case Study No. 2

986

3. Case Study No. 3

989

4. Case study No. 4

997

5. Case Study No. 5

998

6. Case Study No. 6

1001

7. Case Study No. 7

1003

8. Case Study No. 8

1005

9. Case Study No. 9

1008

10. Case Study No. 10

1011

X. Israel – Case 1-10 according to Israeli law

1014

1. Case 1 – Muotri

1014

2. Case 2 – Chen

1014

3. Case 3 – Chen (alternative)

1015

4. Case 4 – Fink

1016

5. Case 5 – McCune

1017

6. Case 6 – EMEA

1018

7. Case 7 – O'Doherty

1018

8. Case 8 – Golden Hamster Test

1019

9. Case 9 – Mixing of Embryos

1020

10. Case 10 – Interspecies Gestation:Transfer of an Animal Embryo into the Uterus of a Womanand Transfer of a Human Embryo into the Uterus of anAnimal

1021

XI. Japan – Case 1-10 according to JapaneseLaw

1023

Table of Authors

1025

Index

1030