This article appears in the November 2004 edition of the Catholic Medical Quarterly
Recent Developments in Human Stem Cell Research in the UK:
Facts and Moral Assessment
The HFEA and licences
On August 11th, 2004 the HFEA granted a licence to Newcastle Fertility Centre for Life to clone embryos for stem-cell research purposes, using oocytes left over after fertility treatment. This is the first cloning licence granted since the HFE (Research Purposes) Regulations 2001(which extended the purposes for which the HFEA can licence embryo research) and the subsequent Human Reproductive Cloning Act 2001 allowed research for therapeutic purposes on stem cells derived from human embryos, but forbade cloning for reproductive purposes.
A second application for permission to clone human embryos was submitted on September 28th 2004 by Professor Ian Wilmut of the Roslin Institute and Professor Christopher Shaw, of the Institute of Psychiatry at King’s College London. This was granted a licence on February 9th 2005. There is also a research application by St Mary’s Manchester Fertility Services, which is seeking permission to derive human embryonic stem-cell (hES) lines from embryos created from unused parthenogenically activated oocytes or from abnormally fertilised embryos.
In the autumn of 2004, eleven licenses had been granted for research involving embryonic stem cell research, one of which involved cloning, so-called therapeutic cloning, two of which involve parthenogenesis (the development of and embryo from an oocyte), while the other protocols approved involve the creation of stem-cell lines from embryos or oocytes originally created for IVF but subsequently donated for research.1
Under the present regulations any embryo research must relate to one or more of the following purposes: advances in the treatment of infertility; increased knowledge about congenital diseases, causes of miscarriage or embryological development, development of more effective contraceptives; detection of genetic or chromosomal abnormalities before implantation; increased knowledge about serious disease or development of treatment for serious disease. Also, it is a condition of all licenses granted for hES research that a sample of all hES lines be placed in the Medical Research Council (MRC) Stem cell Bank.
The UK Stem Cell Bank
The MRC Stem Cell Bank, funded by the MRC and the Biotechnology and Biological Sciences Research Council, was officially opened on May 19th 2004. Based at the National Institute for Biological Control, in Hertfordshire, the bank is run by the National Institute for Biological Standards and Control, which is responsible for storing, and supplying ethically approved, quality controlled hES as well as foetal and adult stem cell lines for research. Applications to deposit hES lines in the bank or to access banked hES lines are authorised by a Steering Committee, chaired by Lord Patel and consisting of medical and scientific experts, ethicists and consumer representatives. In the words of the HFEA’s 12th Annual Report (covering the year from the end of August 2003 with a forward look to August 2004): ‘The Committee will regulate the use of embryonic stem cell lines and develop codes of practice for the stem-cell bank and for the use of stem cell-lines. The existence of the bank will also ensure that the use of embryos in research is minimised’.2
The purpose of the bank is to serve as a resource to support the advancement of hES research. And it will supply accredited scientists and as well as pharmaceutical companies with hES lines with a view to developing cell therapies. The first two hES lines stored at the bank were developed at King’s College London and the Newcastle Fertility Centre for Life. The King’s College team, one of the first to be granted a licence from the HFEA to carry out hES research, were the first in the UK to develop an hES line. The line was developed from an embryo left over after IVF.
The use of the bank, which is the world’s first of its kind, is open to researchers from other countries. They are welcome both to store hES lines and to access such lines for research.
MRC Cambridge Centre for Stem Cell Biology and Medicine
On Monday 21st June, 2004, the MRC announced funding of £1.5m towards the establishment of a new research centre at the University of Cambridge to develop treatments for ‘diabetes and diseases of the brain, including Parkinson’s disease and multiple sclerosis’3. The Centre is also receiving a £9.3m university grant and a £2.8 private endowment as well as smaller donations, all in all together with the MRC grant, reaching a total of 16.5m.
The objective of the new centre is the development of new clinical therapies. According to the MRC Press release on June 21st, ‘the MRC Centre will combine the strengths of six leading UK stem-cell research teams, into three autonomous Programmes: Stem Cell Medicine, Stem Cell Genetics and Stem Cell Biology, and will form the hub or an over-arching Cambridge Stem Cell Institute’4. Professor Roger Pedersen, Professor of Regenerative Medicine at the University of Cambridge, who left sunny California and the Bush administration’s opposition to hES research for the more congenial scientific and political climate in the UK, will direct the first-mentioned programme with focus on ‘understanding how stem cells regulate their population size, how they respond to stimulation from their environment to undertake specialisation, and how their specialised cell fate becomes determined’.5 The second programme will be directed by Professor Azim Surani. It will focus on ‘how stem cells maintain the ability to specialise into multiple body tissues, what controls the pattern of gene expression responsible for specialisation, and how cells are able to adjust their specialised state during developmental changes, such as regeneration’6. A Director for the third programme is yet to be appointed.
More than 20 affiliated research team leaders are said to provide further dimensions to the Institute’s three stem cell research programmes. The Institute has also initiated a process of active recruitments to attract scientists of excellence.
The Institute for Stem cell Research’s first stem cell project licensed by the HFEA involved the derivation of pluripotent hES lines from embryos leftover from IVF.
The Newcastle Fertility Centre for Life
The Newcastle Fertility Centre for Life clearly has set its mind on being in the forefront in the area of human somatic cell nuclear transfer (SCNT) research, that is to say, cloning research. It is here that the so-called therapeutic cloning research led by Professor Alison Murdoch and Dr Miodrag Stojkovic—and approved on August 11th 2004-- will take place. The protocol licensed involves research using ‘leftover eggs’ from IVF treatment. These, then, will be used to create embryos by cloning for research with a view to finding cures for various diseases such as diabetes, Alzheimer’s and Parkinson’s as well as for injuries resulting in paralysis.
The technique that will be used is the same as that used to create Dolly the sheep, the first mammal to be created by cloning. Speaking on the BBC Radio 4’s Today programme on June 16th, Professor Murdoch said that they will be ‘trying to create material that would be genetically identical to the person who needs treatment’. She explained that this was in order to avoid rejection. And she expressed the hope that in ten years time they would be able to take skin cells from a person with diabetes and (by means of SCNT and harvesting the stem cells of resulting cloned embryos) create cells for him that would make insulin, and so free him from the burden of taking insulin for the rest of his life.
The aim may be good, but the means by which the Newcastle cloning team are hoping to achieve it are controversial. However, there are many who can see no problem either with cloning or with parthenogensis, although they realise that both procedures involve the deliberate creation of human embryos for the purpose of destroying them for research purposes. They see no problem because they do not regard the human embryo as a member of the human family, but see it as no more than a blob of cells—albeit admittedly alive and of human origin. Many who have no problem with cloning or parthenogensis seem to think that the embryo so created by a-sexual reproduction, has a different moral status from the embryo originating from the fusion of male and female gametes, be it in vitro or in vivo. This view is disputed below.
The Roslin Institute
Among the centres licensed by the HFEA to undertake hES line research is the Roslin Institute, where Dolly, the cloned sheep, was created. Professor Ian Wilmut, of the Institute, and Professor Christopher Shaw, professor of neurology at King’s College London, who together have applied for a licence to clone human embryos, are intending to extend the Institute’s vast research programme to include research into causes of motor neurone disease.
Apart from cloning sheep, the Institute has been undertaking research involving both mouse and human embryonic stem cells. Regarding that research, the Institute’s website informs us that ‘much of the programme is in collaboration with the Geron Corporation of California and uses embryonic stem cell lines derived from Dr James Thomson and his colleagues at the University of Wisconsin’. These are human embryonic stem cells, derived from pre-implantation embryos, that is, embryos created by IVF, but donated for research. The objectives of this research are: the development of methods for differentiation of hES into specific lineages, including neural cells, bone cells and blood cells; understanding of the mechanisms involved in allowing hES cells to multiply indefinitely in the laboratory; isolation of new hES lines, development of improved culture environments for sustaining undifferentiated hES.
The aim of new the cloning-research programme is to gain a better understanding of the development of motor neurone disease. About 10% of cases are thought to be genetic. But only one gene has been linked to the condition, SOD-1, thought responsible for 2% of cases. It is hoped that the new research will clues to the causes of the other 8% of genetically linked cases of the disease. The researchers would use the nuclei of skin cells from taken from sufferers of motor neurone disease to create human embryos by cloning, using oocytes left over after IVF treatment. The embryonic stem cells would then be ‘harvested’ and coaxed to develop into neurons to be used as models to study the disease.
The moral status of the human embryo created by SCNR, that is, cloning or by parthenogenesis
In order morally to justify embryonic stem cell research involving cloning or parthenogenesis those who undertake it would have to show one of two things. Either they have to show that no human embryo has the moral status of a human being and therefore can be killed. Or, if they believe that the embryo conceived in the human embrace has the moral status of a human being and that it is wrong to kill it, they have to argue that there is a morally relevant difference between embryos so conceived and those created in the laboratory by IVF or by cloning or parthenogenesis.
Put it this way, is the human embryo to be counted as a human being? Do embryos created outside the maternal body have a different moral status than embryos conceived within the maternal body? Do embryos of a-sexual origin, not originating from the fusion of male and female gametes, but created by SCNF or parthenogenesis have a different moral status from those derived from a combination of male and female gametes?
Proponents of the view that the human embryo, or foetus, or infant, do not have the same moral status as a hale and healthy adult human being, argue on the basis of a qualitative understanding of what it means to be a human being, or a person. They argue that in order to be a human being, or a person, it is necessary to possess certain qualities. Peter Singer is a well-known proponent of this view. On his view it is necessary to possess self-consciousness and a certain degree of rationality to be a human being or a person7. Indeed, on his view, a chimpanzee might be described as a person, whereas the infant could not be so described, because it does not yet possess self-consciousness and rationality. This kind of argument is disingenuous. It has absurd consequences.
If possession or expression of rationality and self-consciousness are the criteria of personhood or the basis for counting somebody as fully human, then, arguably, a person under a general anaesthetic is in the same boat as the human foetus: he or she is not a person and not fully human until he or she wakes up. And should he or she never wake up, but fall into a coma, he or she would never again be a person or fully human. On this line of reasoning, the person under a general anaesthetic is disposable like the early foetus and the embryo, so too is the person with advanced Alzheimer’s, the infant and even the two-year and old child.
But it is absurd to say that a person under a general anaesthetic is not a person and not fully human. Likewise it is absurd and very counter-intuitive not to describe the old lady with Alzheimer’s or the two-year old child as persons. The person under a general anaesthetic, like the embryo and the foetus has the potential to gain consciousness and rationality. In other words, the anaesthetised adult has the potential to (re-)gain consciousness.
Others argue that the embryo and early foetus do not have the moral status of a proper human, or person, because they are not viable, that is, are not yet capable of living outside the maternal body. Thus they argue that abortion is justified until the foetus has reached viability. But the embryo and the early foetus have the potential to reach ‘viability’. This is, however, with an ‘if’. That is to say, if certain conditions are fulfilled, the embryo and the early foetus will reach viability and, indeed, with time gain consciousness and rationality. Provided, it is allowed to continue growing in a hospitable environment, does not succumb to accident or ill health and is not intentionally destroyed, it will grow to reach viability and later on to gain self-consciousness and rationality. It has an inherent potential to do so. This is part of its nature. Therefore, on an essentialist, as opposed to a qualitative, understanding of what it means to be a human being, or a person, it is already a human being or a person.
On an essentialist understanding, the human embryo is undeniably human, because it is of human origin, clearly alive and in possession of the potential to grow into a mature human being, a potential that will be realised provided certain conditions are fulfilled. As to the argument that some or many embryos never develop very far wherefore the early embryo should no be afforded the moral status of a human being, I am dealing with that at the end of this paper.
What those who deny that the human embryo is a member of the human family fail to see is that human life is an indivisible whole. Once my life started there was no point at which I was not. Once your life started there was no point at which you were not. Because each one of us stared out as an embryo, it is true to say that killing an embryo is killing a human person. Had they killed you as an embryo, they would actually have killed you; and you are a person. It is for this reason that John Paul II says, that there should be no discrimination on the basis of age or developmental stage. In the encyclical Evangelium Vitae he writes: ‘Where life is involved, the service of charity must be profoundly consistent. It cannot tolerate bias and discrimination, for human life is sacred and inviolable at every stage and in every situation; it is an indivisible good. We need then to "show care" for life and for all life and for the life of everyone’8.
Another way of making the point about the personhood of the early embryo is by reference to the Book of Genesis and the Gospels. In the Book of Genesis we are told not only that life is a gift from God but also that we human beings are created in the image of God. But if life is a gift, then it is clearly a gift from its very beginning, from its embryonic stage. Also, if you and I are created in the image of God, we must, from the very outset, have been created in order to be like God. Moreover, the Gospel promise, ‘I came that they may have life, and have it abundantly’ (Jn 10:10), reveals how valuable each human life is from its very first moment. For earthly life is the fundamental condition of our ultimate union with God.
As to the suggestion that embryos conceived outside the womb have a different moral status than those conceived within the maternal body, on what grounds could that possibly be argued? How could the environment in which the early embryo begins its life alter its nature? A chicken hatched in a man-made machine is just as much a chicken as one hatched under mother hen. Some say that implantation marks the beginning of human life, as truly human or personal. If that is so, this is true both of the naturally conceived embryo and of that conceived in vitro. But, as I have argued elsewhere9, how could a process such as implantation relating to the environment and the source of sustenance of the embryo constitute a criterion of humanhood or personhood?
It has been argued that the embryo lacks the potential to develop into a mature human being or person unless it is implanted in utero. That is just not true. The early embryo does not lack this potential. Its nature is no different from the embryo that comes into being in vivo. None of us can live without proper nourishment and without a proper environment. I you were placed without food and clothing on the top mountain unable to reach help in sub-zero temperatures, you would not live long. But this fact would hardly make you non-human or a non-person. That the embryo who is not implanted in the womb lacks those favourable circumstances under which it might realise its potential to develop into a mature human being, does not mean that it does not have the potential to do so. Nor does it mean that it is not as fully human as the embryo conceived within the maternal body. In sum, the argument that the embryo created in vitro is not to be counted as (fully) human, because it is unable to continue living unless it is implanted in a womb, is flawed.
The suggestion that embryos created by a-sexual processes such as cloning and parthenogenesis, have a different moral status than embryos created sexually through the union of male and female gametes, this suggestion is no more plausible that the last one. We have seen that mammals can be created by cloning. Even if most cloned mammals are affected by abnormalities of different kinds, there is no disputing that cloned calves are bovine or that Dolly, the cloned sheep, was a real sheep. This shows that as an embryo Dolly had the potential to develop into a mature sheep. Similarly, if a cloned baby were born, it would show that as an embryo it had the potential to develop and grow into a baby just like an embryo conceived through the fusion of a male and female gamete. This cloned embryo would therefore have the same moral status as an embryo sexually conceived. There is no evidence yet to the effect that a child has been born as a result of cloning. But it is possible that a baby will one day in the future be born as a result of cloning. At present cloned human embryos may not be created under optimal conditions. They may lack those favourable circumstances required to ensure their well-being and development. That does not mean that they do not have the potential to develop into mature human beings. They may have the potential to develop into mature human beings, and if they do, then they have the same moral status as embryos that are sexually conceived. These considerations call for caution and bid us not to treat the cloned human embryo as disposable material.
Of course, many or most cloned mammal embryos may be affected by grave abnormalities, leading to premature death, soon after implantation or possibly even before implantation. That does not mean that their moral status is inferior to embryos sexually conceived. Indeed, the majority of embryos sexually conceived within the maternal body are believed to be abnormal and lost. Embryos conceived in vivo with severe chromosomal abnormalities tend to abort spontaneously and early. Should we say of all human embryos with grave chromosomal, or other, abnormalities preventing sustained development that they are not human beings or that they are not fully human? Should we say that the wastefulness of nature shows that no early embryos are fully human? Or should we count abnormalities cutting embryonic or foetal life short as a kind of health problem? There are good grounds for counting them as a kind of health problem, and as such as a problem that might conceivably be overcome. For the day may come when we can cure gravely abnormal embryos and enable them to mature normally. The very fact that this possibility is conceivable makes for an argument to the effect that even embryos with grave abnormalities may have a potential to grow into mature human beings, which gives pause for thought.
At present many IVF embryos are discarded because they are abnormal. And it is often argued that this is alright because even in natural conception there is much wastage. But this is a spurious argument. We are not responsible for what happens in nature, whereas we are responsible for what happens as a result of our actions. By creating and wasting embryos, even gravely abnormal ones, we are killing. Do we know what potential they have? Can we be sure that those embryos are so gravely abnormal as not to be counted as human?
The same kinds of argument may be mounted in support of the embryo created by parthenogenesis. Today it is not possible to achieve a live human birth as a result of parthenogenesis. Tomorrow it might, however, be possible. Moreover, even if that is not likely, there are still reasons for not discriminating between embryos sexually conceived within the human body and those conceived outside it. Nor should we discriminate between the embryo sexually conceived and that created a-sexually. The human embryo whatever its provenance and irrespective of whether or not it is sexually conceived or a-sexually created, is clearly of human origin and alive. And to the extent that the nascent embryo created by cloning or parthenogenesis is indistinguishable from an embryo sexually conceived in the maternal body, there is good reason to afford it the same moral status as the embryo sexually conceived in the maternal body.
In short, as John Paul II points out, ‘what is at stake is so important that, from the standpoint of moral obligation, the mere probability that a human person is involved would suffice to justify an absolutely clear prohibition of any intervention aimed at killing a human embryo’10.
This statement is made on the basis of information provided by the HFEA’s own website.
HFEA 12th Annual Report, London 2004, p. 21.
MRC Press Release, 21 June 2004.
Web Home page, Cambridge Stem Cell Institute.
Peter Singer, Rethinking Life and Death, Oxford 1995; Peter Singer and helga Kuhse, Should the baby Live, Oxford, 1985.
John PaulI, Encyclical Letter Evangelium Vitae, 1995, para. 87.
Agneta Sutton, ‘Revisiting Reproductive Technology’s Slippery Slope in the Light of the Concepts of Imago Dei, Co-creation and Stewardship, Ethics and Medicine, 2002, Vol. 18:3, pp. 145-154; ‘Is the Human Embryo our Neighbour?’, Ethics and Medicine, 2000, Vol. 16:2, pp.57-60.
John Paul II, Encyclical Letter, Evangelium Vitae, 1995, para. 60.
Agneta Sutton is Senior Lecturer in the Department of Theology, University College, Chichester