Regulation of embryo research: the IVF experience'

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Regulation of embryo research the IVF experience.
Newcastle Fertility Centre at Life
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Embryo research in Newcastle

• First licence 1992
• Current licences
• RO145
• RO152
• RO153
• Whats new?
• stem cells, but no new ethical issues in relation
  to embryo donation to research.
• UK 32 HFEA Research Licences, 16 stem cells
  derivation, 5 PGD related

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House of Lords Select Committee 2001 Nuclear
reprogramming/CNR/Therapeutic cloning

• In the committees view CNR is a sufficiently
  serious and important objective.. to justify the
  use of CNR, if licensed by the HFEA..

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Egg sharing

• Women agree to donate half their eggs, treatment
  costs paid by recipient.
• SEED Report (www.hfea.gov.uk) 2007
• Ethical issues is this payment for eggs and is
  it appropriate
• What will be the consequences for the child

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Is it ethical to donate eggs to research?Is
egg sharing for research OK?
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egg sharing for research in Newcastle

• Ethics committee submitted Nov 2005, approved
  Dec 2005
• Application to vary licence submitted HFEA Dec
  2005
• Approved by HFEA Ethics Committee Feb2006
• HFE Authority meeting review Feb and May 2006
• Consultation of egg donation announced May 2006
• HFEA Licence Committee Approval June 2006
• MRC Funding application submitted Sept 2006
• Public consultation completed Dec 2007
• Licence approval confirmed Jan 2007
• MRC Ethics review Feb 2007
• MRC Funding approved Sept 2007
• Permissive legislation but prohibitive regulation?

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The way forward?

• Trust
• Is the regulation appropriate?

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Trust

• Compare and contrast the Abortion Act 1967 and
  the Human Fertilisation and Embryology Act 1990.

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Who is trusted to decide?

• Abortion that there is a substantial risk that
  if the child were born it would suffer from such
  physical or mental abnormalities as to be
  seriously handicapped.
• PGD that no embryo may be transferred to a
  woman where that embryo has been subject to a
  test, which supplies genetic information about
  the embryo, that is not expressly authorised by
  the licence issued to the centre.
• Embryo research increase knowledge of serious
  disease

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The way forward?

• Trust
• Is the regulation appropriate?

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Is the regulation appropriate?

• Embryo research
• Who is harmed?
• Assessment of the risk
• What is the cost of regulation?

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Comparative Cost of Regulation
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