Regulation of stem cell research in the United Kingdom
The UK has a comprehensive and well-established regulatory framework for stem cell research. Embryonic stem cell research is allowed subject to a licence from the Human Fertilisation and Embryology Authority (HFEA).
Current legal position
Research on human embryos is allowed for certain purposes, outlined in the Human Fertilisation and Embryology Act (1990) and the subsequent Human Fertilisation and Embryology (Research Purposes) Regulations 2001:
- to promote advances in the treatment of infertility
- to increase knowledge about the causes of congenital disease
- to increase knowledge about the causes of miscarriages
- to develop more effective techniques of contraception
- to develop methods for detecting the presence of gene or chromosome abnormalities
- to increase knowledge about the development of embryos
- to increase knowledge about serious disease
- to enable any such knowledge to be applied in developing treatments for serious disease
The use of embryos in stem cell research can be carried out only with authority from the HFEA. Licences are granted only if the HFEA is satisfied that any proposed use of embryos is absolutely necessary for the purposes of the research.
Licensed research can only take place on embryos created in vitro: embryos that have developed from eggs fertilized outside the body. Most embryos used in UK stem cell research are embryos initially created for use in fertility treatment, but not used. These 'surplus' IVF embryos, if donated with the full consent of the parents, can be used for research.
Licensed research can only take place on embryos up to 14 days. Stem cells are isolated from the blastocyst much sooner than this – at 5 to 6 days.
A 2008 amendment allowed the HFEA the power to grant licences to add limited amounts of animal cells to human ones to make hybrids such as true chimeras, true hybrids and transgenic human embryos. Any such licences must be for specific research purposes. Human reproductive cloning is illegal in the UK. As a result of the Human Reproductive Cloning Act (2001) nobody in the UK is allowed to use cell nuclear replacement, or any other technique, to create a child.
The Human Tissue Act 2004 regulates the use of human biological materials including the storage, use and removal of human tissue and cells, and is overseen by the Human Tissue Authority.
Ethical and regulatory oversight
The regulatory pathway for stem cell research in the UK is well established, and is documented for different research scenarios (human stem cells only) in the UK Stem Cell Toolkit.
Regulators include the Human Tissue Authority (HTA), the HFEA and the Medicines and Healthcare products Regulatory Agency (MHRA), all of which work closely in areas of mutual interest. Regulators also hold joint advisory meetings to provide guidance to operators. In 2010, there were proposals to abolish the HFEA and transfer regulation of stem cell research to the UK Department of Health. The outcome of these proposals is uncertain at the time of writing.
The Gene Therapy Advisory Committee (GTAC) is a research ethics committee that considers all proposals for research on human subjects using cells from human stem cell lines. Independent bodies such as the Nuffield Council of Bioethics and the Royal Society have also examined and issued reports on ethical issues relating to stem cell research.
Relevant laws, policies and links
- Human Fertilisation and Embryology Act, 2008 at http://www.legislation.gov.uk/ukpga/2008/22/contents
- Human Fertilisation and Embryology (Research Purposes) Regulations 2001, at http://www.legislation.gov.uk/uksi/2001/188/pdfs/uksi_20010188_en.pdf
- Human Fertilisation and Embryology Act 1990, at http://www.legislation.gov.uk/ukpga/1990/37/contents, accessed 4 April 2011
- Human Tissue Act 2004, at http://www.legislation.gov.uk/ukpga/2004/30/contents
- Human Tissue Authority
- Human Fertilisation and Embryology Authority
- UK Stem Cell Initiative (UKSCI)
- "Stem Cell Therapy: the ethical issues - a discussion paper" (2000), Nuffield Council of Bioethics, at http://www.nuffieldbioethics.org/sites/default/files/Stem%20cell%20therapy%20discussion%20paper.pdf
- "Human Tissue: an ethical and legal analysis (1995)", Nuffield Council of Bioethics, at http://www.nuffieldbioethics.org/sites/default/files/Human%20tissue.pdf
- House of Lords Select Committee on Stem Cell Research (2002), http://www.parliament.the-stationery-office.co.uk/pa/ld200102/ldselect/ldstem/83/8301.htm
- Dickenson, Professor Donna: "Should the UK have a national bioethics committee?" Bionews, 13 October 2008, at http://www.bionews.org.uk/page_38020.asp
- Raper, Dr Vivienne: "New breed of fertility watchdog on way", Bionews 26 July 2010, at http://www.bionews.org.uk/page_67397.asp