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

Preface

Table of Contents

Introduction

A. General research aspects

I. Problems with terminology and definitions

II. Etymological background and furtherclarifying remarksconcerning chimeras and hybrids

1. Introduction

2. Semantic analysis

a. Chimera as an archetype

b. Etymological background

c. Chimera as a metaphor and as a terminus technicus

d. Hybrid

e. Some further differentiations

f. Chimera as a strategy

3. Anthropological clarifications

a. Chimera and the deeper understanding of humanity

b. Should we cross boundaries?

c. The art of slowness

III. Scientific background

1. Introduction

2. Intra-species mixtures

a. Intra-species chimeras

b. Intra-species hybrids

3. Inter-species mixtures

a. Inter-species chimeras

b. Inter-species hybrids

c. Examples of inter-species mixtures

aa. Xenotransplantation

bb. Transgenic animals carrying human genes

cc. Nuclear transfer research

dd. Transplantation of human embryonic stem cells into animal brain

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

ff. Mixing of embryos

gg. Interspecies gestation

hh. Other mixtures

IV. Ethics

1. Introduction

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

a. Preliminary Remarks

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

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

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

e. Moral Status Based on the Intrinsic Value of Animals

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

bb. Applications of Moral Status: Potentiality

cc. Applications of Moral Status: Precaution

dd. Applications of Moral Status: Symbolic Meanings

f. The Moral Status of Human Embryos and Chimbrids

3. Specific Moral Considerations in Evaluating Chimbrids: AnEthical Matrix

a. Preliminary Remarks

b. Moral Considerations in Research Ethics

c. Moral Considerations in Animal Ethics

V. Law

1. Legal tools and strategies for the regulation of chimbrids

a. Introduction

b. Determining the aims of the regulatory project

c. Identifying the appropriate regulator

d. The choice of regulatory instruments

e. Decision-making in individual cases

f. Monitoring and sanctions

g. Some challenges in the regulation of chimbrids

2. Which Beings Should Be Entitled to Human Rights?

a. The General Concept of Personhood

b. Human Rights – Their Meaning and Their Foundation

c. Human Rights and the Constitution

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

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

cc. Indicators of Personhood

d. The Status of Chimeras and Chimeric Embryos

3. Chimbrids and International Law

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

a. Relevant facts

b. Research law

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

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

e. Protection of biotechnological inventions

f. Protection of personal data

g. Protection of Health

h. Protection of animals in the case of animal experiments

i. Genetics in the non-human domain

5. National law

a. EU member states

aa. Austria

bb. France

cc. Germany

dd. Sweden

ee. Spain

ff. United Kingdom

b. Other Countries

aa. Switzerland

bb. Israel

cc. United States

dd. Canada

ee. China

ff. Japan

B. Key Cases in chimbrids research

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

1. Scientific considerations

2. Ethical considerations

3. Legal regulation in different countries

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

1. Scientific considerations

2. Ethical considerations

3. Legal regulation in different countries

III. Case 3 - Bailey: Animal-Human Xenotransplantation

1. Scientific considerations

2. Ethical considerations

3. Legal regualtions in different countries

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

1. Scientific considerations

2. Ethical considerations

3. Legal regulation in different countries

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

1. Scientific considerations

2. Ethical considerations

3. Legal regualtion in different countries

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

1. Scientific considerations

2. Ethical considerations

3. Legal regulation in different countries

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

1. Scientific considerations

2. Ethical considerations

3. Legal regulation in different countries

VIII. Case 8 - Yanagimachi: Hamster egg penetration test

1. Scientific considerations

2. Ethical considerations

3. Legal regulation in different countries

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

1. Scientific considerations

2. Ethical considerations

3. Legal regulation in different countries

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

1. Scientific considerations

2. Ethical considerations

3. Legal regulation in different countries

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

C. Summary, Conclusions and Recommendations

I. General remarks

II. Scientific overview of human-animal mixtures

III. Ethical Aspects

1. Moral status

2. Human research ethics

3. Animal ethics

4. Appearance and Symbolic Meaning

5. Plurality of ethical theories and legal regulations

IV. Legal Aspects

1. The regulatory needs and challenges

2. Regulatory tools and strategies applied

3. Concluding remarks

V. Recommendations

Annex

Annex - A. Chimbrids – Scientific, Ethicaland Legal Reports

I. Science

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

2. Xenotransplantation - Aspects of Chimerism

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

4. Interspecies Nuclear Transfer Research in China

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

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

II. Ethics

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

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

III. Law

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

2. The Regulation of Hybrids and Chimeras in the UK

3. Providing a legal framwork for chimeras - French Report

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

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

6. Die rechtliche Regelung von Chimaren und Hybridwesenein osterreichischer Landesbericht

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

8. The legislation on Chimeras and Hybrids in Spain

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

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

11. Legal Aspects of Human-Animal Combinations in Canada

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

13. Bioethical Discussions on Specified Embryos in Japan

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

15. Human embryonic stem cell research in China

Annex - B. Country Reports on the 10 Cases

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

1. Case 1 -- Muotri Case

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

3. Case 3 -- Animal-Human Xenotransplantation

4. Case 4 -- Fink

5. Case 5 -- McCune

6. Case 6 -- EMEA

7. Case 7 -- O'Doherty

8. Case 8 -- Golden Hamster test

9. Case 9 -- Mixing of embryos

10. Case 10 -- Interspecies gestation

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

1. Muotri case

2. Chen Case

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

4. Fink Case Porcine Xenografts for Huntington's

5. McCune Case: SCID

6. Transgenic Goat Case

7. Mice with Down's Syndrome Phenotypes

8. Golden Hamster Test

9. Mixing of Embryos

10. Interspecies Gestation

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

1. Case 1 -- Muotri

2. Case 2 -- Chen

3. Case 3 -- Chen (alternative)

4. Case 4 -- Fink

5. Case 5 -- McCune

6. Case 6 -- EMEA

7. Case 7 -- O'Doherty

8. Case 8 -- Golden Hamster test

9. Case 9 -- Mixing of Embryos

10. Case 10 -- Interspecies gestation

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

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

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

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

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

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

6. Case 6 -- EMEA

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

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

9. Case 9 -- Mixing of embryos

10. Case 10 -- Interspecies gestation

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

1. Case 1

2. Case 2

3. Case 3

4. Case 4

5. Case 5

6. Case 6

7. Case 7

8. Case 8 -- Golden Hamster test

9. Case 9 -- Mixing of embryos

10. Case 10 -- Interspecies gestation

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

1. Case 1 -- Muotri case

2. Case 2 -- Chen case

3. Case 3 -- Bailey case

4. Case 4 -- Fink case

5. Case 5 -- McCune case

6. Case 6 -- Transgenic goat case

7. Case 7 -- O;Doherty case

8. Case 8 -- Hoo Lee case

9. Case 9 -- Fehilly case

10. Case 10 -- Nan case

VII. Switzerland Case 1 to 10 according to Swiss Law

1. Case 1 -- Muotri

2. Case 2 -- Chen

3. Case 3 -- Bailey

4. Case 4 -- Fink

5. Case 5 -- McCune

6. Case 6 -- EMEA

7. Case 7 -- O'Doherty

8. Case 8 -- Yanagimachi

9. Case 9 -- Fehily

10. Case 10 -- Nan et al.

11. Alternative to Case 10 -- Zavos and Illmensee

VIII. USA -- Case comments

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

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

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

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

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

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

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.

8. Case 8: Golden Hamster Test

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

10. Case 10: Interspecies Gestation

IX. Canada

A. Introduction

1. Case Study No. 1

2. Case Study No. 2

3. Case Study No. 3

4. Case study No. 4

5. Case Study No. 5

6. Case Study No. 6

7. Case Study No. 7

8. Case Study No. 8

9. Case Study No. 9

10. Case Study No. 10

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

1. Case 1 – Muotri

2. Case 2 – Chen

3. Case 3 – Chen (alternative)

4. Case 4 – Fink

5. Case 5 – McCune

6. Case 6 – EMEA

7. Case 7 – O'Doherty

8. Case 8 – Golden Hamster Test

9. Case 9 – Mixing of Embryos

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

XI. Japan – Case 1-10 according to JapaneseLaw

Table of Authors

Index