Ethical Issues in Cancer Genetics

Human Embryo Research – informing regulatory policy Professor Neva Haites Vice Principal of University of Aberdeen Member of the Human Fertilisation and Embryology Authority Human Embryos The human embryo research debate Not a fetus or a person or property but has ‘Special status’  Can be used as a means to achieve certain ends Regulation by HFEA of use of Human Embryos  For use in Clinical purposes – both Private Clinics and in the National Health Service For Research purposes  History of UK approach to regulating Embryo Research         1st IVF baby – UK Warnock enquiry into Human Fertilisation and Embryology reports HFEA established Dolly the sheep cloned CMO report into stem cell research Legislation amended to allow use of embryos for stem cell research UK ban on reproductive cloning UK stem cell bank launched 1978 1984 1991 1997 2000 2001 2001 2004 Purposes for which a human embryo research licence may be granted      Promoting advances in the treatment of infertility, Increasing knowledge about the causes of congenital disease, Increasing knowledge about the causes of miscarriages, Developing more effective techniques of contraception, or Developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation……. Sched. 2, para. 3(2) Additional HF&E (Research Purposes) Regulations 2001    increasing knowledge about the development of embryos; increasing knowledge about serious disease, or enabling any such knowledge to be applied in developing treatments for serious disease s.2(2) Preventing: prohibitions of the HFE Act    No person can use/store a human embryo after the appearance of the primitive streak and/or fourteen days after fertilisation No person can introduce a human embryo into an animal No person can introduce animal eggs, sperm or embryos into a woman’s body Alter the genetic structure of an embryo  Recent Potential Developments     Sex selection for Social reasons PGD with HLA typing Stem cell derivation Hybrid embryos  Single embryo replacement policy Public consultations International Debate S Korea cloning research was fake Embryo cloning cheat resigns in disgrace Clone human embryo creator admits ethical lapses in work Stem-cell scientist faces new questions over egg use Cloning crisis goes from bad to worse Sex Selection  Technically possible to select male and female sperm and hence choose sex of embryo apparently safely using laser sorting HFEA decision, following Public consultation, informed British Government decision to prohibit sex selection from non-medical reasons  PGD and HLA Typing  Saviour sibling possibilities Testing of embryos for unaffected and HLA matched with living affected child HFEA agreed to licence under appropriate clinical circumstances   Stem cell sources: what is permitted in UK • Adult stem cells (e.g. bone marrow) • Foetal cells (foetal tissue or cord blood) • Embryonic stem cells (pre-implantation embryos) (i) ‘spare’ IVF embryos (ii) embryos created from donated gametes (iii) somatic cell nucleus transfer from donated oocytes Human Hybrid Embryo Consultation  Cytoplasmic hybrids (human somatic nucleus into an enucleated animal ova) True hybrids Chimeras Transgenic embryos    Hybrid Embryos  Legally HFEA advised that cytoplasmic hybrids fall within its jurisdiction. HFEA licence committees therefore able to consider individual applications for research licences to create human/animal hybrid embryos  Hybrid Embryos Consultation  The scientific community felt confident that the creation of cytoplasmic hybrids is an avenue of research worth exploring… and an alternative to using human eggs, to investigate the mechanisms of creating patient matched embryonic stem cells. Public consultation showed that the majority of those consulted would support the creation of these embryos if they were to be used to research improved understanding and treatment of disease.  Joint Committee on the Draft Human Tissue and Embryos Bill 2007  Who decides what the Government should enact in the new Bill? Will there be a consistent world opinion? – and does it matter? How do religious and non-religious views differ and how can this be taken into account in a multicultural society?   ‘Frankenstein’ researchers plan embryo with three parents ‘MOUSE MAN’ ARRIVING SOON Public Poll says ‘No’ to more embryo research Single embryo replacement policy Increased risk of death and complications in multiple pregnancies and births to mother and child  ‘A single child at a time is best’  Many European countries now have protocols for single embryo replacements and pregnancy rates have not dropped  Due to costs of IVF in UK, many families prefer twins  Single embryo replacement policy As seen as a part of - Good Medical practice – policy and protocols likely to be derived with Professional groups and Clinics.  Clinics will be given advice on evidence for use of single and two embryo replacements  Target level of multiples to be achieved over a few years  Regulation Better regulation – minimise impact on Clinics  Code of Practice developed to inform good practice  Inspecting and licensing for specific activities  Lead clinicians to pass test on the Act and Code of practice  Thank you for your attention