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Guidelines on Using Cells from Established Human Embryonic

Stem Cell Lines for Research

 

 

Acknowledgements........v
How to Have your Say........vi
Executive Summary........vii
Structure of the discussion document........vii
1 What are Embryonic Stem Cells?........1
1.1 Embryonic stem cells are found in early embryos........1
1.2. Embryonic stem cell lines are not embryos........1
1.3 Embryonic stem cell lines can give rise to cells from a large range of cell types........2
1.4 Embryonic stem cell lines can be cultured for very long periods of time without differentiating........3
1.5 Other stem cells do not have the same properties as embryonic stem cells........3
1.6 When embryonic stem cells are obtained from an embryo, that embryo cannot go on to develop into a fetus........4
1.7 Embryonic stem cells must be obtained from embryos in vitro........4
1.8 It may one day be possible to create human pluripotent stem cell lines without using human embryos........6
2 Research Using Cells from Established Human Embryonic Stem Cell Lines........8
2.1 The potential benefits of human embryonic stem cell research........8
2.2 Types of human embryonic stem cell research........10
2.3 The current state of knowledge of human embryonic stem cells........11
3 Existing Regulation in New Zealand........15
3.1 The Human Assisted Reproductive Technology (HART) Act 2004........15
3.2 The Human Tissue Act 1964, and associated review........15
3.3 The Hazardous Substances and New Organisms (HSNO) Act 1996........16
3.4 The New Zealand Public Health and Disability Act 2000........16
3.5 The Medicines Act 1981, and associated review........17
4 Ethical Issues Associated with Research Using Established Human Embryonic Stem Cells........18
4.1 Ethical issues associated with the way in which human embryonic stem cell lines were established........18
4.2 Ethical issues associated with the proposed research use of cells from established human embryonic stem cell lines........22
4.3 Ensuring that the ethical issues are dealt with appropriately........23

5 Overview of International Regulations of Research Using Human Embryos and Human Embryonic Stem Cells........25
5.1 Italy (position 1)........25
5.2 Germany (position 2)........25
5.3 Australia (position 3)........26
5.4 France (position 3)........27
5.5 Switzerland (position 3)........28
5.6 United Kingdom (position 4)........29
5.7 Belgium (position 4)........31
5.8 The Netherlands (position 4)........32
5.9 United States (various positions)........33
5.10 Summary table........34
References........35
Legislation and Regulations........38
Glossary........39
Proposed Guidelines for Using Cells from Established Human Embryonic Stem Cells Lines for Research........42
Part One – Ethical review and other requirements........42
Part Two – Provisions associated with the way in which the human embryonic stem cell lines have been established 42
Part Three – Provisions relating to proposed use of the established human embryonic stem cell lines........43
Part Four – Duties of ethics committees........43
Submission Booklet........45
Part One........46
Part Two........46
Part Three........47
Part Four........48
General questions........50
Further comments........51