Regulating the collection and use of fetal stem cells

The British government is committed to supporting stem cell science and industry.¹ An important part of that commitment is a strong regulatory environment, seen as being embodied in the Human Fertilisation and Embryology Authority (HFEA), which oversees a strict but permissive regulatory framework and contains public concerns about the use in research and treatment of human embryos. However, the HFEA regulates only the use of embryos created in vitro. It has no jurisdiction over the use of aborted fetuses, which are still subject to guidelines drawn up 17 years ago and have been neglected in recent discussions around stem cell research.

Sustaining in vitro a human embryo beyond 14 days is legally and technically impossible, so investigators seeking embryonic material older than 14 days usually collect it after abortion (or, less often, after miscarriage or surgery for an ectopic pregnancy). The collection and use of aborted fetuses has been governed by the Polkinghorne guidelines,² which were drawn up in 1989 in response to controversy provoked by transplants of fetal neural tissue into the brains of people with Parkinson's disease. The Polkinghorne committee decided that professional self regulation overseen by research ethics committees offered the public sufficient reassurance about the proper collection and use of aborted fetuses. The following year, parliament gave human embryos in vitro the protection of the criminal law by passing the Human Fertilisation and Embryology Act 1990.

The Polkinghorne guidelines rest on the principle of separation and operationalise it in four ways. Firstly, decisions relating to abortion and to the subsequent use of fetal tissue must be made separately, and consent for the use of the fetus in research or therapy can be sought only after a woman has agreed to the termination. Secondly, a woman's consent to the use of the fetus in research is general: she is not allowed to specify how her fetal tissue may or may not be used. Thirdly, the practice of abortion must be physically separate from the use of fetal tissue in research or therapy. Fourthly, separation of source and user must be complete: the source records the identity of the woman but does not divulge it to the user, thereby ensuring that the user knows nothing of the provenance of the material. An intermediary is recommended as the best way of achieving separation.

Review of the Polkinghorne guidelines is long overdue. In excluding clinical investigators from the clinical care of women undergoing pregnancy termination the guidelines codifed distrust of clinicians who undertake research, and, according to the Royal College of Obstetricians and Gynaecologists, inhibit the progress of modern fetal medicine and the collection of stem cells at the time of termination.³ The Polkinghorne approach of non-specific consent is also “increasingly out of step with modern expectations.”⁴

The Medical Research Council (MRC) fetal tissue bank until recently acted as intermediary between the abortion clinic and the laboratory. A study of stem cell scientists' views on the ethics of stem cell science in the laboratory noted that they trusted the MRC tissue bank for ensuring that fetal material had been ethically sourced (S Wainwright et al, BSA Medical Sociology Conference, 2005). However, the bank was closed in 2005.

The Human Tissue Act 2004 established the Human Tissue Authority as the regulatory body responsible for overseeing of the collection, storage, and use of human tissues. Embryos are not covered by the act, but, although not explicitly specified, aborted fetuses seem to fall within it and qualify as “relevant material.” New standards and practices relating to consent, donation, and storage of human tissues are being implemented, but how these relate to aborted fetuses is unclear and clarification by the Human Tissue Authority would be welcome.

The MRC is seeking to standardise procedures for seeking informed consent for donation of human embryos in assisted conception clinics in order to meet the ethical requirements of the UK stem cell bank.⁵ However, termination of pregnancy takes place in different clinical environments from fertility clinics and so far no fetal stem cells have been deposited in the stem cell bank.

If fetal stem cells are to be used in stem cell therapy then procedures for dealing with traceability, quality control, and risk management at the point of tissue collection need to be considered in order to comply with European Union's regulatory requirements on clinical grade tissue banks⁶ and advanced cell therapies.⁷ As the UK's authority responsible for implementing these European regulations, the Human Tissue Authority's remit with regard to abortion practices and the collection of fetal material for stem cell derivation remains to be clarified and the implications for clinical practice widely discussed.