The Human Fertilisation and Embryology Act 2008: a missed opportunity?Amel AlghraniCorrespondence to Dr Amel Alghrani, Institute for Science, Ethics and Innovation, Centre for Social Ethics and Policy, School of Law, University of Manchester, Oxford Road, Manchester, M13 9PL; [email protected] 16 September 2009 Accepted 24 September 2009 Regulating reproduction is no easy feat. In the past three decades we have witnessed a reproductive revolution and great strides have been made to alleviate the effects of infertility. Reproductive advances such as (...) in-vitro fertilisation , sex selection, reproductive cloning and embryo selection for the purpose of creating “saviour siblings” have all emerged as part of a rapid and ever-changing branch of medicine, each promising to upset the status quo and transform human reproduction.Following much activity in this area, the lengthy process of updating the legislation is now complete. The Human Fertilisation and Embryology Act 2008 received Royal Assent on 13 November 2008. The majority of the HFE Act 2008’s amendments will come into force in October of this year, with the exception of the provisions pertaining to parenthood, which commenced in April 2009. Welcoming Royal Assent, Professor Lisa Jardine, Chair of the Human Fertilisation and Embryology Authority, stated:“This is a momentous day for the HFEA and for those with fertility problems. The regulatory system that has served us so well has been renewed. Parliament has provided a clear framework for the future and a solid base on which to regulate 21st century practice within 21st century law.”1However, as scientific endeavours into developments such as artificial gametes, womb transplantation and ectogenesis continue apace, it could be argued that Jardine was perhaps overly optimistic about the achievements of the new legislation. The HFE Act 2008 is an amending statute, and as Jackson 2 notes “much of the regulatory architecture” in the 1990 legislation “remains intact”. In retaining the architecture of the 1990 legislation, and merely amending or adding certain provisions, has the government missed an ideal opportunity to consider how to equip the regulatory framework for the next phase/era of assisted reproduction?The next …. (shrink)

Based on the "Guide to the Human Fertilisation and Embryology Act 1990", this volume reviews the regulation of assisted conception including complex moral issues such as abortion, embryo research and cloning.

This article briefly reviews the various papers contained in this volume. They were originally presented at a research workshop held at Keele University in the UK in February 2003. It is suggested that the different papers raise a series of related legal, social and ethical issues and can be collectively seen to demonstrate the fact that policy formation in relation to reproductive matters is highly contested. It is concluded that ethical policy formation in this area needs to be based on (...) actual evidence of harm rather than assumed harm and that this therefore entails more empirical research into reproductive matters. (shrink)

This note suggests that, viewed from a feminist perspective, the reforms contained in the Human Fertilisation and Embryology Act 2008 represent a missed opportunity to re-think the appropriate model of regulation to govern fertility treatment and embryology research in the UK. It argues that reform of the legislation was driven largely by the government’s desire to avoid re-igniting controversies over the legal status of the embryo and abortion and to maintain Britain’s position at the forefront of embryo research (...) and related biotechnologies. It also highlights the importance of media debates, which were highly selective, to the reform process, and suggests that in order to inject feminist values into the process of legislative reform, feminists need to become more media savvy. In the short term, it suggests that there is little prospect of a radical re-thinking of the appropriate ethico-legal response to the wide variety of family forms that reproductive technologies potentially enable, much less of considering our ethical obligations to the new forms of embryos that are now permitted by the 2008 Act. In the meantime, however, it argues that these issues provide productive opportunities for feminist legal theorists to address questions that have been erased or obscured in the course of the 2008 reforms. (shrink)

Of all the changes to the Human Fertilisation and Embryology Act 1990 that were introduced in 2008 by legislation of the same name, foremost to excite media attention and popular controversy was the amendment of the so-called welfare clause. This clause forms part of the licensing conditions which must be met by any clinic before offering those treatment services covered by the legislation. The 2008 Act deleted the statutory requirement that clinicians consider the need for a father of (...) any potential child before offering a woman treatment, substituting for it a requirement that clinicians must henceforth consider the child’s need for “supportive parenting”. In this paper, we first briefly recall the history of the introduction of s 13(5) in the 1990 Act, before going on to track discussion of its amendment through the lengthy reform process that preceded the introduction of the 2008 Act. We then discuss the meaning of the phrase “supportive parenting” with reference to guidance regarding its interpretation offered by the Human Fertilisation and Embryology Authority. While the changes to s 13(5) have been represented as suggesting a major change in the law, we suggest that the reworded section does not represent a significant break from the previous law as it had been interpreted in practice. This raises the question of why it was that an amendment that is likely to make very little difference to clinical practice tended to excite such attention (and with such polarising force). To this end, we locate debates regarding s 13(5) within a broader context of popular anxieties regarding the use of reproductive technologies and, specifically, what they mean for the position of men within the family. (shrink)

The Department of Health's Review of the Human Fertilisation and Embryology Act 1990 is a comprehensive public consultation on the regulation of the storage and use of gametes and embryos for fertility treatment and research in the UK. The consultation considers a range of issues, including the model and scope of regulation and proposals for a single body, the Regulatory Authority for Tissue and Embryos, to replace both the Human Fertilisation and Embryology Authority and the (...) class='Hi'>Human Tissue Authority by April 2008. The Department of Health published its report on the consultation in March 2006, and this is discussed here in relation to both the support and criticisms of the model and scope of the current and proposed regulatory frameworks, particularly with regard to policy decision-making by bodies such as HFEA and RATE. (shrink)

The debate about the moral status of the embryo has gained new impetus because of the advances in reproductive technology that have made early human embryo experimentation a possibility, and because of the public concern that this arouses. Several philosophical arguments claiming that fertilisation is the event that accords moral status to the embryo were initially formulated in the context of the abortion debate. Were they formulated with sufficient precision to account for the scientific facts as we now (...) understand them? Or do these arguments need modification? Aspects of three arguments for moral status being acquired at fertilisation are examined in relation to current scientific knowledge, highlighting the reasons why such arguments, at present, seem to provide an inadequate basis for the determination of moral status. (shrink)

ABSTRACT This article deals with a cluster of moral problems raised by the new techniques of human fertilisation. It is concerned primarily with the putative rights of embryos brought into being as a by‐product of the practice of in vitro fertilisation. In this connection it investigates the basis for the ascription of rights to entities and asserts the view that consciousness is a pre‐requisite for the possession of rights. It draws attention to the speciesism implicit in attitudes (...) of some of those who have contributed to the debate. It also examines other issues briefly, raising, for example, the question whether children by AID (or by in vitro fertilisation by donor) must be denied access to information about their genetic fathers; and looking at objections to the new techniques based on the so‐called unnaturalness of the procedures involved. (shrink)

Background: Today in vitro fertilisation is a widespread and important technique of reproductive medicine. When the technique was first used, it was considered ethically controversial. This is the first study conducted of adult IVF-offspring in order to learn about their ethical opinions and personal attitudes towards this medical technology.Methods: We recruited the participants from the first cases of in vitro fertilisation in Germany at the Gynaecological Clinic of the University Hospital Erlangen. Our qualitative interview study consisted of in-depth, (...) face-to-face interviews with 16 adults who had been conceived by IVF. Our data was analysed with methods of Grounded Theory.Results: For these adults, the most important factor influencing their personal attitudes towards IVF was the knowledge that they were deeply wanted children. The artificiality of their conception seemed irrelevant for their ethical opinion. All participants mentioned that it was important for them to be informed about the circumstances of their conception by their parents.Conclusions: IVF seems to be a medical technique which, although it affects intimate aspects of human existence, can be integrated into the lives of the affected persons without any great difficulties. The findings suggest that parents should inform their children about their fertilisation at an early age and as part of a process over time, not only on a single occasion. Physicians should advise IVF-parents accordingly. (shrink)

In an article in an earlier edition of the Journal of Medical Ethics (1) Dr Iglesias bases her analysis upon the mediaeval interpretation of Platonic metaphysics and Aristotelian logic as given by Aquinas. Propositional forms are applied to the analysis of experience. This results in a very abstract analysis. The essential connection of events and their changing temporal relationships are ignored. The dichotomy between body and soul is a central concept. The unchanging elements in experience are assumed to be more (...) real than the actual world of experienced process. Such a view makes the analysis of the temporal factors in experience impossible. Its abstractness is quite unsuitable for the analysis of the ontological structure and development of the neonate from fertilisation to birth. A N Whitehead made the notion of organism central to his philosophy. He refused to place human experience outside nature, or admit dualism. His philosophy of organism is an attempt to uncover the essential elements connecting human experience with the physical and biological sciences. Time, change and process are, in his view, more real than the static abstractions obtainable by the use of the fallacy of misplaced concreteness. Use of the latter negates the essential connectedness of events and the importance of temporarily and change (2). In this paper I argue that the embryo, being an organism, is not analysable in terms of thinghood. It is a process. To apply Aristotelian logical concepts to it is to distort the real nature of the datum. (shrink)

The purpose of this essay is to stimulate academic discussion about the ethical justification of using human primordial stem cells for tissue transplantation, cell replacement, and gene therapy. There are intriguing alternatives to using embryos obtained from elective abortions and in vitro fertilisation to reconstitute damaged or dysfunctional human organs. These include the expansion and transplantation of latent adult progenitor cells.

This article notes differences in legislation in Germany and Great Britain regarding human embryo research and looks for an explanation in their divergent intellectual traditions. Whereas the German Stem Cell Act invokes an anthropological concept of human dignity to ground its ban on using embryos for research, there is no definition of what it means to be human in either the British Human Fertilisation and Embryology Act or in the advisory Warnock-Report. After studying the differences (...) and providing some philosophical background, the essay distinguishes two notions that are significant for understanding human dignity. It then proposes from a theological point of view a basic understanding within a relational anthropology, and comes to the conclusion that because of continuity in development and their relational constitution, humans embryos should be accepted as human from the moment of conception. (shrink)

The Chief Medical Officer of Health of the United Kingdom has recommended that the 1990 Human Fertilisation and Embryology Act should be amended to allow cloning in humans for research purposes only. He also recommended that: “The transfer of an embryo created by cell nuclear replacement into the uterus of a woman (so called ‘reproductive cloning’) should remain a criminal offence” (recommendation 7, Ref. 1). This recommendation implies that nuclear replacement and cloning are the same. They are not. (...) Nuclear transfer constitutes reproductive cloning only when the individual created is genetically identical to the nuclear donor. In this paper, we describe a possible future use of nuclear transfer for the treatment of infertile individuals. The treatment yields an individual that receives approximately equal genetic contributions from each parent. We use this example to illustrate how semantic confusion might lead to plausibly moral and justifiable treatments being legally banned. In doing so, we hope to encourage a more accurate and informed use of language in science, law and politics, so that legislation is properly informed by science and achieves what it intends. BioEssays 23:359–364, 2001. © 2001 John Wiley & Sons, Inc. (shrink)

Non‐invasive microanalytical methods have been devised to study the energy metabolism of single human preimplantation embryos. Psyruvate, which is added routinely to all media used to culture human embryos, is consumed throughout the preimplantation period, with glucose assuming an increasing role at embryo compaction and blastocyst formation. All of the glucose consumed may be accounted for by the appearance of lactate in the incubation medium. The enzyme hexokinase my be involved in regulating this aerobic glycolysis. There is cosiderable (...) indirect evidence for the utilisation of endogenous as opposed to exogenous energy substrates, the most likely candidate being protein. Information on early human embryo metabolismis likely to find application in a number of areas: these include the improvement of techniques for assisted human conception, notably in the selection of embryos for transfer following In Vitro Fertilisation; the diagnosis of gentic defects at the preimplantation stage; increased undersding of the causes of implantation failure and miscarriage, and the development of novel post‐coital contraceptives. (shrink)

Änderungen im Bereich der medizinischen Technologie können Änderungen der Begriffswelt, Änderungen der ethischen Perspektiven und Änderungen im Recht hervorrufen. Neue Entwicklungen der Reproduktionstechnik, z.B. in vitro Fertilisation, Leihmutterschaft etc., bilden eine Herausforderung für die traditionellen Konzepte von "Elternschaft", die von uns verlangen, die sonst vorausgesetzte Identität von genetischer Mutter, Geburtsmutter und Sozialmutter etc. zu überdenken. Ich untersuche in diesem Beitrag die möglichen Auswirkungen des Genomprojekts auf einige der geläufigen Annahmen über menschliche Beziehungen, Willensentschlüsse und Tugenden. Ein Beispiel: Würden Sie (...) jemanden heiraten, von dem bekannt ist, daß er/sie in einigen Jahren die Alzheimersche Krankheit ausbilden wird? Würde die Idee einer "lebenslangen Verbindung" hier eine andere moralische Bedeutung erlangen, vielleicht schlicht veralten oder sogar als supererogatorisch einzuschätzen sein? (shrink)

Human reproductive cloning has not yet resulted in any live births. There has been widespread condemnation of the practice in both the scientific world and the public sphere, and many countries explicitly outlaw the practice. Concerns about the procedure range from uncertainties about its physical safety to questions about the psychological well-being of clones. Yet, key aspects such as the philosophical implications of harm to future entities and a comparison with established reproductive technologies such as in vitro fertilisation (...) are often overlooked in discussions about HRC. Furthermore, there are people who are willing to use the technology. Several scientists have been outspoken in their intent to pursue HRC. The importance of concerns about the physical safety of children created by HRC and comparisons with concerns about the safety of IVF are discussed. A model to be used to determine when it is acceptable to use HRC and other new assisted reproductive technologies, balancing reproductive freedom and safety concerns, is proposed. Justifications underpinning potential applications of HRC are discussed, and it is determined that these are highly analogous to rationalisations used to justify IVF treatment. It is concluded that people wishing to conceive using HRC should have a prima facie negative right to do so. (shrink)

The United Kingdom's Human Fertilisation and Embryology Bill, introduced into Parliament on the 8th of November 2007 contains a number of controversial proposals inter alia expressly permitting the creation of inter-species embryos for research and destruction and increasing the scope for human cloning also for destructive research. It is supposed that there ought not to be a blanket ban on the creation of human clones, hybrids, cybrids and chimeras because these embryos are valuable for research purposes. (...) The prohibition on the gestation of non-permitted embryos and interspecies embryos is used to generate confidence that embryos with compromised origins would not be gestated and reared. The argument outlined here demonstrates how uncertain are any legal prohibitions on gestation. Accordingly, the practical import of the distinction between compromised embryos for research and the same for live birth is equally dubious. The legislation would not, on this analysis, supply effective controls over this reproductive technology. (shrink)

Reproductive cloning has thrown up new scientific possibilities, ethical conundrums, and legal challenges. An initial question, considered by the English courts in 2003, was whether the technique presently available, that of cell nucleus replacement, falls outside the provisions of the Human Fertilisation and Embryology Act 1990. If it does, the creation and use, including use in research protocols, of human embryos would be unregulated, disclosing a need to consider remedial legislation. The resolution by the courts of this (...) legal question dramatically engages them in a resolution of fundamental ethical dilemmas, and discloses the possibilities and limitation of negotiating science policy through the processes of litigation. (shrink)

This chapter contains sections titled: References Further reading.

In a well known story Derek Parfit describes a disconnection between two entities that normally (in real life) travel together through space and time, namely your personal identity consisting of both mind and body. Realising the possibility of separation, even if it might never happen in real life, new questions arise that cast doubt on old solutions. In human reproduction, in real life, at present the fetus spends approximately nine months inside the pregnant woman. But, we might envisage other (...) possibilities. Historically, the first era is the normal conception inside the woman, the growth of the fetus in the womb and then, after nine months, birth and the appearance of a new individual. The second era is In Vitro Fertilisation (IVF). The fetus starts outside the woman as a fertilised egg, moves to the body of the woman and spends nine month there, where the body of the woman and the fetus travel together in space-time to separate at birth. In the third era of reproductive ectogenesis, the two never travel together. The fetus spends its gestational time entirely outside the woman’s body. We have two entities separated in space-time the whole time. The intimate connection consisting in the fetus being a part of the woman’s body is gone. (shrink)

BackgroundThis article explores the reasons in favour of revising and extending the current 14-day statutory limit to maintaining human embryos in culture. This limit is enshrined in law in over a dozen countries, including the United Kingdom. In two recently published studies, scientists have shown that embryos can be sustained in vitro for about 13 days after fertilisation. Positive reactions to these results have gone hand in hand with calls for revising the 14-day rule, which only allows embryo (...) research until the 14th day after fertilisation.Main textThe article explores the most prominent arguments in favour of and against the extension of the 14-day limit for conducting research on human embryos. It situates these arguments within the history of the 14-day limit. I start by discussing the history of the 14-day limit in the United Kingdom and the reasons behind the decision to opt for a compromise between competing moral views. I then analyse the arguments that those who are generally in favour of embryo research put forward in support of extending the 14-day rule, namely the argument of the beneficence of research and the argument of technical feasibility. I then show how these two arguments played a role in the recent approval of two novel techniques for the replacement of faulty mitochondrial DNA in the United Kingdom. Despite the popularity and widespread use of these arguments, I argue that they are ultimately problematic and should not be straightforwardly accepted. I end by making a case for respecting value pluralism in the context of embryo research, and I present two reasons in favour of respecting value pluralism: the argument of public trust and the argument of democracy.ConclusionI argue that 14-day limit for embryo research is not a valuable tool despite being a solution of compromise, but rather because of it. The importance of respecting value pluralism needs to be considered in any evaluation concerning a potential change to the 14-day rule. (shrink)

For most of the 20th century, it was possible to regard fertilisation as the identifiable point when life begins, because this moment could be defined unequivocally and was thought to be the single most essential biological step in the establishment of a new human entity. Since the successful reproductive cloning of Dolly and other mammals, it is clear that any human cell has the potential to supply the full genome of an embryo, and hence a person, without (...) going through fertilisation. At what point in time do such embryos acquire the respect accorded to human beings? The authors argue that the time of implantation is the most useful point at which the potential and the intention to create a new person are translated into reality, because from that point a new life develops. Implantation differentiates a somatic cell in culture from a human entity that has acquired its own identity and developmental potential. The authors examine the value of quickening or viability as alternative developmental stages in the process of acquiring respect for the Dolly embryo. (shrink)

The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell replacement therapy. First-in-human (...) trials, in particular, raise a number of ethical concerns including informed consent, subject recruitment and harm minimisation as well as the inherent uncertainty and risks which are involved in testing medical procedures on humans for the first time. These issues, while a feature of any human research, become more complex in the case of iPS cell therapy, given the seriousness of the potential risks, the unreliability of available animal models, the vulnerability of the target patient group, and the high stakes of such an intensely public area of science. Our paper will present a detailed case study of iPS cell replacement therapy for Parkinson's disease to highlight these broader ethical and epistemological concerns. If we accept that iPS cell technology is fraught with challenges which go far beyond merely refuting the potentiality of the stem cell line, we conclude that iPS cell research should not replace, but proceed alongside embryonic and adult somatic stem cell research to promote cross-fertilisation of knowledge and better clinical outcomes. (shrink)

Human tissue and body parts have been used in one way or another for millennia. They have been preserved and displayed, both in museums and public shows. Real human hair is used for wigs, while some artists even use human tissue in their works. Blood, bone marrow, whole organs and a host of other structures and human substances are all transplanted into living persons to treat illness. New life can be created from gametes through in vitro (...) fertilisation , while the creation of cell lines keeps tissue alive indefinitely. These uses create significant challenges for the legal system in the UK. The major challenge for the law is to balance the competing demands of those groups who have vested interests in human tissue—researchers, medical practitioners, patients, families, the community and the police, among many others. It must provide sufficient control to users of tissue, but also take account of the fact that our bodies hold psychological importance for us while we live and, after we die, for those we leave behind. To some degree the law has been successful, but we still lack a comprehensive, coherent approach to the regulation of human tissue. Partially as a reaction to this lack of a comprehensive approach, some commentators have turned to applying the concept of property to human tissue means to achieve regulatory outcomes they support. (shrink)

Australian medical researchers are attempting to formulate a response to some of the ethical issues in medical research. The debate over the in vitro fertilisation programme has highlighted some community concern about research ethics and the role of the ethics committee. While very little is known about Australian ethics committees, it appears that a two-tiered approach comprising both ethical review and scientific review is acceptable to the research community. However, this approach plus some problems with the nature of informed (...) consent, begs the question of the role of these committees in the broader context of medical research in the community. Important aspects of a seminar for members of hospital ethics committees are reported. (shrink)

This paper suggests that medically the term a 'human being' should be defined by the presence of an active human brain. The brain is the only unique and irreplaceable organ in the human body, as the orchestrator of all organ systems and the seat of personality. Thus, the presence or absence of brain life truly defines the presence or absence of human life in the medical sense. When viewed in this way, human life may be (...) seen as a continuous spectrum between the onset of brain life in utero (eight weeks gestation), until the occurrence of brain death. At any point human tissue or organ systems may be present, but without the presence of a functional human brain, these do not constitute a 'human being', at least in a medical sense. The implications of this theory for various ethical concerns such as in vitro fertilisation and abortion are discussed. This theory is the most consistent possible for the definition of a human being with no contradictions inherent. However, having a good theory of definition of a 'human being' does not necessarily solve the ethical problems discussed herein. (shrink)

In vitro fertilization (IVF) involves making embryos outside of the human body, which has spurred debate about the status of the embryo, embryo research and donation. We explore couples’ perceptions about embryos and their thoughts and acceptability about various disposition decisions in Norway. Based on an ethnographic study including interviews and observations in an IVF clinic, we show that couples do not perceive their pre-implantation IVF embryos to be human lives; rather, they consider successful implantation the start of (...) life. We suggest that this response indicates a change in the perception of the human embryo or the fertilised egg from incipient life—a viewpoint that was dominant in the discussions of embryo research in the 1980s and 1990s. We also show how this view of the pre-implantation embryo elucidates why donating embryos to research appears acceptable but donating to other infertile couples seems rather difficult. Before transfer to a woman’s uterus, the embryo exists in a liminality; it is not yet human life but a living cell with potential for both research and pregnancy. When an embryo is implanted and pregnancy is confirmed, human life activates; the embryo becomes potential kin, influencing couples’ struggles with donating embryos to other couples. (shrink)

Some commentators argue that conception signals the onset of human personhood and that moral responsibilities toward zygotic or embryonic persons begin at this point, not the least of which is to protect them from exposure to death. Critics of the conception threshold of personhood ask how it can be morally consistent to object to the embryo loss that occurs in fertility medicine and research but not object to the significant embryo loss that occurs through conception in vivo. Using that (...) apparent inconsistency as a starting point, they argue that if that embryo loss is tolerable as a way of conceiving children, it should be tolerable in fertility medicine and human embryonic research. Double-effect reasoning shows, by contrast, that conception in vivo is justified even if it involves the death of persons because the motives for wanting children are not inherently objectionable, because the embryo loss that occurs in unassisted conception is not the means by which successful conception occurs, and because the effect of having children is proportionate to the loss involved. A similar outcome holds true for in vitro fertilisation in fertility medicine but not for in vitro fertilisation for research involving human embryos. (shrink)

In the recent UK debate on the Human Fertilisation and Embryology Bill, there have been conflicting claims about the extent of public support for, or opposition to, human–animal hybrids. Self-selecting polls tend to show opposition to hybrids. Representative-sample polling shows spontaneous opposition but can elicit conditional approval of research, combined with underlying unease. Public opinion is very finely divided, with people generally opposed to this research unless it is likely to lead to medical advances.

When fertility centers dispose of embryos, how should this be done? Current regulatory guidelines by the Human Fertilisation and Embryology Authority state that, when terminating the development of human embryos, a clinic should act with sensitivity, taking account of the embryo’s “special status” and respecting the interests of the gamete providers and recipients. As yet, it is unclear as to how and to what extent this achieved within fertility clinics in the UK. Resultantly, this paper examines the (...) largely undocumented domain of embryo disposal practice. By undertaking an empirical study into policy and procedure and noting divergence in clinic practice, it then comments on the ethical implications of these protocols for patients and practitioners. Specifically, this paper argues for a more holistic approach to embryo disposal. An approach that effectively meets the requirements of the lab, is respectful of the “special status” of the human embryo, and, perhaps most importantly, reflects the multifaceted needs of the patient. (shrink)

The recent desperation to clone human embryos may be seriously undermining accepted ethical principles of medical research, with potentially profound wider consequencesIn her editorial in the February 2005 issue of this journal, Nikola Biller-Andorno questioned whether the effort and resources that have been invested in debates about cloning at the United Nations might have been somewhat disproportionate, if a binding universal agreement on reproductive cloning cannot be reached.1 Although most of the overt disagreement has centred around “therapeutic” cloning, rather (...) than the potential use of nuclear transfer for reproduction, it is none the less clear that the delay and ultimate failure to date in achieving consensus on the former has also increased the likelihood of the latter becoming a foreseeable reality in the absence of a legally binding global convention. Whilst the much heralded promise of therapies has now been severely undermined by scandals of fraud,2 the available evidence from various primate studies3–5 and the history of similar work with other mammalian species6,7 have provided little reason to doubt that human reproductive cloning might be possible in principle . I completely agree with Dr Biller-Andorno’s appeal that we need to “foster a genuine, worldwide discourse on bioethical issues” and not let our debate get completely derailed by vested interests, whether politically or economically motivated. If we don’t, we can probably expect dire consequences for the future of biomedical research and its impact on society at large.Prior to the United Nations’ discussions regarding a ban on human cloning in October 2004, the Human Fertilisation and Embryology Authority in Great Britain announced that they had granted their first licence to clone human embryos by nuclear transfer,8 though no other applications had apparently been made following the legalisation …. (shrink)

There is a stark difference between American and British policy on embryo science and research cloning. The following survey of the discourse offered both in support of and in opposition to research cloning and embryo science in the United States and Great Britain will show that the same arguments were made in both countries. The fact that similar ethical argumentation occurred in environments where different policy was set is an indicator that current frames for ethical discourse on embryonic stem cell (...) research and human cloning do not effectively capture the debate in the form that politicians and possible consumers of services to be derived from embryo science face.The ethics surrounding embryo research and human cloning have been presented from virtually every possible viewpoint in all forms of medium. It is impossible to reprise every argument made on embryo science and research cloning; therefore, this survey will focus on some of the arguments made during the time leading up to the enactment of Great Britain's Human Fertilisation and Embryology Act of 1990 and the Human Fertilisation and Embryology regulations added to it in 2001. (shrink)

There is a stark difference between American and British policy on embryo science and research cloning. The following survey of the discourse offered both in support of and in opposition to research cloning and embryo science in the United States and Great Britain will show that the same arguments were made in both countries. The fact that similar ethical argumentation occurred in environments where different policy was set is an indicator that current frames for ethical discourse on embryonic stem cell (...) research and human cloning do not effectively capture the debate in the form that politicians and possible consumers of services to be derived from embryo science face.The ethics surrounding embryo research and human cloning have been presented from virtually every possible viewpoint in all forms of medium. It is impossible to reprise every argument made on embryo science and research cloning; therefore, this survey will focus on some of the arguments made during the time leading up to the enactment of Great Britain's Human Fertilisation and Embryology Act of 1990 and the Human Fertilisation and Embryology regulations added to it in 2001. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause (...) the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)