Question
asked Her Majesty's Government:To what extent the Polkinghorne Guidelines established in 1989 should still apply to research using foetal tissue; how implementation of these guidelines compares in practice to the regulation of research involving human embryos; how calls for greater transparency and consistency have been addressed since the publication of a report in the Royal Society of Medicine's Clinical Ethics journal in 2006 (Volume 1, pages 216–8); and what are the justifications for any known differences regarding separation of treatment and research roles in obtaining material from foetuses or patients undergoing fertility treatment.
Answer
Since the publication of the Polkinghorne Guidelines in 1989 (amended 1995), new statutory frameworks have been put in place to regulate fertility treatment and embryo research and to regulate the use of tissue for research. The Human Fertilisation and Embryology Act 1990 regulates fertility treatments, involving the creation of embryos outside the body, for example in vitro fertilisation (IVF), and the use of donated gametes (sperm and eggs) and embryos, and the use of human embryos in research. The Human Tissue Act 2004 regulates the removal, storage, use and disposal of relevant material for scheduled purposes including research. Relevant material is defined as any material consisting of or including human cells with the exception of gametes, embryos outside the human body and hair and nail from a living person. The Human Tissue Authority has published a code of practice on consent for the use of human tissue for certain purposes including research. The code recognises the sensitivity surrounding the use of foetal tissue for research and says that best practice is to obtain fully informed consent for the use of foetal tissue in research or for other purposes specified in the Human Tissue Act 2004. Both fertility treatment and embryo research require a licence from the Human Fertilisation and Embryology Authority (HFEA). While the majority of research involves the use of embryos donated by patients who no longer wish to use them in their own treatment, the processes of treatment and research are kept separate. The HFEA's code of practice provides guidance to clinics and research centres about the proper conduct of licensed activities. Research Ethics Committee approval is always required for the use of foetal tissue, products of conception and live human embryos in research.