What has happened to the review of the Polkinghorne Guidelines on research using fetal tissue?

In England and Wales in 2007, almost 200,000 women elected to terminate a pregnancy. Yet my research into fetal stem cells carried out under the ESRC Stem Cell Initiative, found obtaining fetal tissue for research, including stem cell research, surprisingly difficult (1). To some extent the quasi-official regulations that govern the use of aborted fetuses in research are to blame. Called the Polkinghorne Guidelines, after John Polkinghorne, eminent physicist and theologian, who chaired the committee that drew them up, they were published by the Department of Health in 1989 and were organised around experimental transplants of fetal brain cells into the brains of sufferers of Parkinson's Disease.

Investigators have complained that the Guidelines insist on a choreography that is so complicated (and costly) that it is impeding research. The Royal College of Obstetricians (RCOG) objected to the rule that investigators must have no direct contact with women who undergo an elected pregnancy termination (2). Women's agreement must be sought by an intermediary who is neither a member of the clinical staff or the research team and their salary represents an additional expense. The separation principle, as it is known, does not apply to other types of tissue collections. It was justified by the Polkinghorne Committee on the grounds that investigators might encourage a woman, uncertain whether to proceed with a pregnancy termination, to go ahead with it, a view which suggests that women are gullible and investigators are ethically suspect - the latter view was hotly disputed by the RCOG. The choreography is unnecessary: termination of pregnancy in order to provide a fetus for research is not allowed under the Abortion Act 1967.

Paradoxically, despite the negative views of women and investigators that informed the Guidelines, no organisation was made responsible for overseeing their implementation. (Yet a year later Parliament introduced, in the Human Fertilisation and Embryology Act, a system of regulatory oversight, armed with criminal sanctions, which govern the use of pre-implantation embryos in research.) Instead the Guidelines stipulate that research proposals involving fetal tissue must be reviewed by a research ethics committee. However the National Research Ethics Service (NRES) makes no mention of them in its current Standard Operating Procedures (SOP) on the grounds that procedures for ethical review of applications involving fetal tissue are no different to other applications. Yet the Department of Health (DH), in the consultation process that led up to the Human Tissue Act 2004, singled them out for special treatment. In response to my enquiry about what had happened to the Polkinghorne Guidelines, the NRES said it is waiting for the outcome of their review by the DH and the Human Tissue Authority. The DoH's review of the Polkinghorne Guidelines began in 2003 and there is still no sight of its conclusions.

Can quasi-official guidelines simply disappear? Or is it the case that no-one is prepared to accept responsibility for them? These are not idle speculations. My research found that current arrangements for collecting aborted fetuses for research are difficult to establish and easily break down. The chief problem with the Guidelines is they were developed in response to claims by anti-abortion activists that women who elect to terminate a pregnancy are morally reprehensible, a claim which covers a large section of the population: one in three British women, by the time they reach the age of 45, will have experienced an abortion. However, instead of rejecting this claim which stigmatises women, the Guidelines incorporated it.

Anti-abortion activists have a vested interest in disrupting research using fetal tissue because if anything of value emerges from it they will be placed in a quandary as to whether to use it. This fear is evident in Dignitas Personae (The Dignity of the Person) (3), published in December 2008 by the Vatican Congregation for the Doctrine of the Faith. It states that only tissue of miscarried fetuses is eligible for use in research. No-one is benefiting from the delay: stem cell investigators must put up with unreliable sources of aborted fetal tissue, and women who elect to undergo an abortion continue to be treated as second-class citizens.