Despite the progress achieved over the last decade after the birth of the first cloned mammal, the efficiency of reproductive cloning remains invariably low. However, research aiming at the use of nuclear transfer for the production of patient‐tailored stem cells for cell/tissue therapy is progressing rapidly. Yet, reproductive cloning has many potential implications for animal breeding, transgenic research and the conservation of endangered species. In this article we suggest that the changes in the epi‐/genotype observed in cloned (...) embryos arise from unbalanced nuclear reprogramming between parental chromosomes. It is probable that the oocyte reprogramming machinery, devised for resident chromosomes, cannot target the paternal alleles of somatic cells. We, therefore, suggest that a reasonable approach to balance this asymmetry in nuclear reprogramming might involve the transient expression in donor cells of chromatin remodelling proteins, which are physiologically expressed during spermatogenesis, in order to induce a male‐specific chromatin organisation in the somatic cells before nuclear transfer. BioEssays 30:66–74, 2008. © 2007 Wiley Periodicals, Inc. (shrink)

Somatic cell nuclear transfer (SCNT) remains a controversial technique, one that has elicited a variety of regulatory responses throughout the world. On March 29, 2005, Canada's Assisted Human Reproduction Act came into force. This law prohibits a number of research activities, including SCNT. Given the pluralistic nature of Canadian society, the creation of this law stands as an interesting case study of the policy-making process and how and why a liberal democracy ends up making the relatively (...) rare decision to use a statutory prohibition, backed by severe penalties, to stop a particular scientific activity. In this article, we provide a comprehensive and systematic legal analysis of the legislative process and parliamentary debates associated with the passage of this law. (shrink)

We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang’s potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight framework of the Bioethics and Biosafety Act in South Korea and the US National Academies’ Guidelines for Human Embryonic Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act would institute centralized (...) oversight under governmental auspices while the Guidelines recommend politically-independent, decentralized oversight bodies including a special review body for human embryonic stem cell research at an institutional level and that the Guidelines would have provided more vigorous protection for the women who had undergone oocyte procurement for Hwang’s research than the Act. We also suggest additional regulations to protect those who provide oocytes for research in South Korea. (shrink)

Harvesting human embryonic stem (hES) cells is a highly controversial field of research because it rests on the destruction of human embryos. Altering the procedure of nuclear transfer (NT) is suggested to generate hES cell lines without ethical obstacles by claiming that no embryo would be involved. While discussing the nature of an embryo and related central questions concerning their moral status and the respect they deserve, this paper argues that the entity created by somatic (...) class='Hi'>cell nuclear transfer (SCNT) or altered nuclear transfer (ANT) is an embryo and has the same moral status as a natural embryo. Respect for the embryo is expressed by the ethical principles of proportionality, probability and subsidiarity. This paper argues that the human embryo should only be taken for research with high ranking goals, which are proven in animal experimentation and for which there are no alternatives. This makes ANT obsolete and shows that SCNT to produce hES cells is premature at the present time. (shrink)

ABSTRACT Recent developments allow for the creation of human stem cells without the creation of human embryos, a process called alternate nuclear transfer (‘ANT’). Pursuing this method of stem cell research makes sense for pro‐lifers if arguments for the sanctity of the human embryo do not apply to ANT. However, the technology that makes ANT possible undermines the erstwhile technical barrier between human embryos and somatic cell DNA. These advances bring home the force of hypothetical (...) arguments about the potential of the DNA in somatic cells, showing that there is not a morally relevant difference between the potential of an embryo and the potential of the DNA in a somatic cell. Therefore, the supposed distinction between entities that are potential human life and entities that are human life does not give any support to arguments for the sanctity of the human embryo because those arguments extend value to too many entities. (shrink)

Reprogramming of somatic cells to a pluripotent state holds huge potentials for regenerative medicine. However, a debate over which method is better, somatic cell nuclear transfer (SCNT) or induced pluripotent stem (iPS) cells, still persists. Both approaches have the potential to generate patient‐specific pluripotent stem cells for replacement therapy. Yet, although SCNT has been successfully applied in various vertebrates, no human pluripotent stem cells have been generated by SCNT due to technical, legal and ethical difficulties. (...) On the other hand, human iPS cell lines have been reported from both healthy and diseased individuals. A recent study reported the generation of triploid human pluripotent stem cells by transferring somatic nuclei into oocytes, a variant form of SCNT. In this essay, we discuss this progress and the potentials of these two reprogramming approaches for regenerative medicine. (shrink)

Recent arguments on the ethics of stem cell research have taken a novel approach to the question of the moral status of the embryo. One influential argument focuses on a property that the embryo is said to possess—namely, the property of being an entity with a rational nature or, less controversially, an entity that has the potential to acquire a rational nature—and claims that this property is also possessed by a somatic cell. Since nobody seriously thinks that (...) we have a duty to preserve the countless such cells we wash off our body every day in the shower, the argument is intended as a reductio ad absurdum of the claim that the embryo should be afforded the same moral status as a fully developed human being. This article argues that this argument is not successful and that it consequently plays into the hands of those who oppose embryonic stem cell research. It is therefore better to abandon this argument and focus instead on the different argument that potentiality, as such, is not a sufficient ground for the creation of moral obligations towards the embryo. (shrink)

A remarkable event occurred at the December 3, 2004, meeting of the U. S. President’s Council on Bioethics. Council member William Hurlbut, a physician and Consulting Professor in the Program in Human Biology at Stanford University, formally unveiled a proposal that he claimed would solve the ethical problems surrounding the extraction of stem cells from human embryos. The proposal would involve the creation of genetically defective embryos that “never rise to the level of integrated organismal existence essential to be designated (...) human life with potential,” and therefore could be used as morally acceptable sources of stem cells for research and therapy. The aim of this essay is to show that Hurlbut’s proposal does not solve the ethical problems associated with human embryonic stem cell research. Two major reasons are presented. First, the proposal, which involves modification of a somatic cell nucleus, suffers from an ethical problem that is common to all types of human genetic engineering: since the procedure is not foolproof, there will be failures. In the case of the procedure Hurlbut proposes, some normal (albeit cloned) embryos will be produced. Second, the embryo engineered in the manner described is, at least in the early stages of its development, fully human despite its genetic defect. This essay also will show how a reasonable person might mistakenly view the proposal as legitimate if he or she makes the error of conflating genetic determinism with Aristotelian teleology. Finally, it will argue that ethical clarity can be achieved by seeing the embryo as a holistic entity possessing emergent properties that cannot simply be spelled out by genes. (shrink)

The mammalian egg employs a wide spectrum of epigenome modification machinery to reprogram the sperm nucleus shortly after fertilization. This event is required for transcriptional activation of the paternal/zygotic genome and progression through cleavage divisions. Reprogramming of paternal nuclei requires replacement of sperm protamines with canonical and non‐canonical histones, covalent modification of histone tails, and chemical modification of DNA (notably oxidative demethylation of methylated cytosines). In this essay we highlight the role maternal histone variants play during developmental reprogramming following fertilization. (...) We discuss how reduced maternal histone variant incorporation in somatic nuclear transfer experiments may explain the reduced viability of resulting embryos and how knowledge of repressive and activating maternal factors may be used to improve somatic cell reprogramming. (shrink)

First put forth in June 2005, the altered nuclear transfer-oocyte assisted reprogramming (ANT-OAR) proposal has been promoted as an ethically-acceptable alternative to the embryo-destructive methods now used to obtain embryonic stem cells. According to its proponents, the goal of ANT-OAR is to use the cloning process to create a pluripotent stem cell. This would be achieved through overexpression of the transcription factor Nanog (or a hypothetical substitute) both in the enucleated egg cell and in the (...) class='Hi'>somatic cell prior to transfer of its nucleus. Although the ethical acceptability of ANT-OAR has been publicly debated, its scientific feasibility has not. This paper aims to help rectify this situation. It argues that ANT-OAR, as currently conceived, cannot realistically work. It presents evidence from the scientific literature showing that Nanog cannot single-handedly establish pluripotency in cells, but rather works together with a network of other transcription factors to maintain pluripotency. It argues that ANT-OAR is based on a flawed understanding of stem cell biology, and emphasizes that, in this debate about embryonic stem cells, scientists must strive to accurately and realistically assess the feasibility of the embryo research strategies they propose. (shrink)

A common feature of scientific and ethical debates is that clones are generally described and understood as “copies” or, more specifically defined, as “genetic copies.” The attempt of this paper is to question this widespread definition. It first argues that the terminology of “clone as copy” can only be understood as a metaphor, and therefore, a clone is not a “genetic copy” in a strict literal sense, but in a figurative one. Second, the copy metaphor has a normative component that (...) is problematic in the context of descriptive science and may support or indicate the ethically relevant phenomenon of objectification of animals. In order to support the argument against the common conception of a clone as a copy, the biotechnological principles of somatic cell nuclear transfer cloning will be examined. On this basis, it will be shown that the metaphor is valid because of similarities between the phenotype, the genotype, or the nuclear DNA sequence of the clone and its progenitor by using three prominent levels of comparison. Focusing on the process of SCNT, it will be shown that cloning as copying or doubling has to be redefined for scientific purposes because it is neither necessary nor does it fit to the biotechnological principles of cloning. It is more accurate to understand SCNT cloning as a process of splitting rather than of doubling or copying. In the second part, a deconstructivist analysis based on Jacques Derrida’s description in Positions will reveal the normative potential of the original–copy dichotomy. I will be showing that it includes an asymmetrical power structure between the original and the copy and that this structure can be reversed or at least considered unstable. Therefore, arguments that build on that metaphor must be reconsidered. Moreover, the analysis reveals that applying a terminology to humans and animals that is commonly used for things becomes the language of objectification. Two selected examples, fungibility and violability, based on Martha Nussbaum’s notion of objectification will support the thesis of objectification, display its normative consequences, and put the clone as a copy metaphor in a broader range of ethically questionable research tendencies. (shrink)

Most opponents of somatic cell nuclear transfer and embryonic stem cell technologies base their arguments on the twin assertions that the embryo is either a human being or a potential human being, and that it is wrong to destroy a human being or potential human being in order to produce stem cell lines. Proponents’ justifications of stem cell research are more varied, but not enough to escape the charge of obsession with the status (...) of the embryo. What unites the two warring sides in ‘the stem cell wars’ is that women are equally invisible to both: ‘the lady vanishes.’ Yet the most legitimate property in the body is that which women possess in their reproductive tissue and the products of their reproductive labour. By drawing on the accepted characterisation in the common law of property as a bundle of rights, and on a Hegelian model of contract as mutual recognition, we can lessen the impact of the tendency to regard women and their ova as merely receptacles and women’s reproductive labour as unimportant. (shrink)

Most opponents of somatic cell nuclear transfer and embryonic stem cell technologies base their arguments on the twin assertions that the embryo is either a human being or a potential human being, and that it is wrong to destroy a human being or potential human being in order to produce stem cell lines. Proponents’ justifications of stem cell research are more varied, but not enough to escape the charge of obsession with the status (...) of the embryo. What unites the two warring sides in ‘the stem cell wars’ is that women are equally invisible to both: ‘the lady vanishes.’ Yet the most legitimate property in the body is that which women possess in their reproductive tissue and the products of their reproductive labour. By drawing on the accepted characterisation in the common law of property as a bundle of rights, and on a Hegelian model of contract as mutual recognition, we can lessen the impact of the tendency to regard women and their ova as merely receptacles and women’s reproductive labour as unimportant. (shrink)

ABSTRACT William Hurlbut, a Stanford University bioethicist and member of the President's Council on Bioethics, recently proposed a solution to the current impasse over human embryonic stem cell research in the United States. He suggested that researchers could use genetic engineering and somatic cell nuclear transfer (i.e. cloning) to develop human ‘pseudo‐embryos’ that have no potential to develop fully into human persons. According to Hurlbut, even thinkers who typically ascribe high moral status to human embryos (...) could approve of destroying these ‘pseudo‐embryos’ for the sake of harvesting human embryonic stem cells. This essay argues, first, that an argument based on the ‘paradox of the heap’ (an argument that many ‘pro‐life’ thinkers employ in order to defend the notion that human embryos have high moral value from the moment of conception) challenges the ethical legitimacy of Hurlbut's proposal. Second, the paper argues that this conflict may illustrate a reductio ad absurdum for this ‘pro‐life’ argument itself rather than being a problem for Hurlbut's proposal. As a result, the paper challenges the ‘pro‐life’ strategy of arguing that one should respond to uncertainty about the moral status of developing embryos by being morally ‘cautious’ and granting all human embryos full moral status from the moment of conception. It appears that one is faced with a complex series of choices (about where to draw the moral line between entities that are human persons and entities that are not), and a strict moral ‘cautiousness’ about this series of choices may ultimately lead to absurdity. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Direct Nuclear Reprogramming: Response to Condic, Lee, and GeorgeGerard Magill, Ph.D. and William B. NeavesWe read with great interest the response of Maureen Condic, Patrick Lee, and Robert George (2009) to our essay, “Ontological and Ethical Implications of Direct Nuclear Reprogramming” in the March 2009 issue of the Kennedy Institute of Ethics Journal (Magill and Neaves 2009). Much of their response addressed issues that are not in (...) dispute: somatic cells are not zygotes, neurons and hepatocytes are different, growth-factor signals from the trophoblast influence development of the inner cell mass, membranes derived from the trophectoderm are critically required for embryonic survival, and stem cells cannot produce a fetus “on their own.”The crucial point of disagreement deals with the fact that iPS cells are not totipotent but zygotes are. Zygotes can generate their own placental structures while iPS cells must be given them through tetraploid complementation. Condic, Lee, and George consider totipotency to be crucial to natural potentiality. We present an alternative view in our essay (Magill and Neaves 2009, pp. 28–29). Placental structures make no lasting contribution to the postnatal organism, and the equivalency of iPS cells with the inner cell mass of the blastocyst is apparent from tetraploid complementation experiments.The respondents acknowledge the following:... somatic cells can be “converted” into zygotes by the process of somatic cell nuclear transfer (SCNT) or direct reprogramming in combination with tetraploid complementation—just as sperm and egg cells can be “converted” into a zygote by the process of natural fertilization—....(Condic, Lee, and George 2009, p. 35)As the respondents recognize, different ways of manipulating cells can lead to embryogenesis: sperm and egg cells in the process of natural fertilization, the enucleated egg and an ordinary body cell in the process of somatic cell nuclear transfer, and reprogrammed skin cells and a tetraploid blastocyst in the case of induced pluripotent stem (iPS) cells. In each case, different cells are manipulated—or “converted” in the respondents’ terminology—in a process that alters their biological fate within a supportive environment facilitating embryogenesis.The developmental potential that resides in the human genome does not unfold in isolation, not even in a zygote. In all cases, whether involving a zygote or an iPS cell, interaction with a supportive environment is required to express the developmental program residing in the genome. [End Page 201]This biological reality supports what we have described as “early cellular development along the continuum of natural potentiality that can result in the formation of a fetus” (Magill and Neaves 2009, p. 30), and it presents a significant challenge to the natural potentiality argument.Gerard MagillVernon F. Gallagher Chair for the Integration of Science, Theology, Philosophy, and Law, and Professor, Center for Healthcare Ethics Duquesne University Pittsburgh, PA.William B. NeavesPresident and CEO Stowers Institute for Medical Research and Professor of Basic Medical Science University of Missouri at Kansas City School of Medicine Kansas City, MOReferencesCondic, Maureen L.; Lee, Patrick; and George, Robert P. 2008. Ontological and Ethical Implications of Direct Nuclear Reprogramming: Response to Magill and Neaves. Kennedy Institute of Ethics Journal 19: 33–40. Google ScholarMagill, Gerard, and Neaves William B. 2009. Ontological and Ethical Implications of Direct Nuclear Reprogramming. Kennedy Institute of Ethics Journal 19: 23–32. Google ScholarCopyright © 2009 The Johns Hopkins University Press... (shrink)

ABSTRACT This paper examines three arguments that use the concept of potential to identify embryos that are morally suitable for embryonic stem cell research (ESCR). According to the first argument, due to Ronald Green, the fact that they are scheduled for disposal makes embryos left over from IVF treatments morally appropriate for research. Paul McHugh argues that embryos created by somatic cell nuclear transfer differ from those that result directly from the meeting of sperm and (...) egg in having potential especially conducive to the therapeutic use of their stem cells. I reject both of these arguments. According to the way of making distinctions in embryonic potential that I defend, it is the absence of a functional relationship with a womb that marks embryos morally suitable for ESCR. (shrink)

Should clinicians ask women to donate or even sell their eggs for stem cell research? Enucleated ova are crucial in somatic cell nuclear transfer technologies, but risky for women’s health. Until comparatively recently, very few commentators debated the ethical issues in egg donation and sale, concentrating on the embryo’s status. The unmasking of Hwang Woo Suk, who used over 2,200 ova in his fraudulent research, has finally brought the question of ova donation and sale into (...) prominence. In this article we offer an international comparison of recent responses to this crucial question and suggest that the levels of risk are too imprecise to enable women to give meaningful informed consent for egg extraction. What we do know of the risks also indicates that they are too high and that potential donors or sellers are not being fully informed of their extent, raising disturbing ethical issues concerning commodification, deception, coercion, and exploitation. (shrink)

Neither of the two central moral and political obstacles to human embryonic stem cell research survives critical scrutinyThis paper argues that neither of the two central moral and political obstacles to human embryonic stem cell research survives critical scrutiny: first, that derivation of HESCs requires the destruction of human embryos which are full human persons or are at least deserving of respect incompatible with their destruction; second, that creation of HESCs using somatic cell nuclear (...) class='Hi'>transfer or cloning is immoral. First, different sources of HESCs are distinguished and the distinct moral objections that might apply to each. Second, it is argued that none of the properties plausibly conferring personhood on an entity is possessed by human embryos, and then shown how destruction of an embryo for research with the prospect of important medical benefits can be compatible with respecting it. Third, it is shown that the main objection to human cloning is only to reproductive cloning and that the objection to creating human beings with the intention of destroying them does not apply to SCNT. Finally, the concern that acquiring human eggs for SCNT would involve exploiting women donors is addressed, and it is shown how that can be avoided.Human embryonic stem cell research has become one of the more politically and morally controversial issues of our time. There is wide variability in what HESC research, if any, is permitted in countries around the world. Within the United States HESC research was a major issue in the last presidential election and some states, such as California, are devoting substantial public monies to fund this research while others prohibit it. In this paper I will explore some of the main obstacles to reaching consensus on this issue in the hope of at least narrowing the disagreement …. (shrink)

The natural replacement of damaged cells by stem cells occurs actively and often in adult tissues, especially rapidly dividing cells such as blood cells. An exciting case in Boston, however, posits a kind of natural stem cell therapy provided to a mother by her fetus—long after the fetus is born. Because there is a profound lack of medical intervention, this therapy seems natural enough and is unlikely to be morally suspect. Nevertheless, we feel morally uncertain when we consider giving (...) this type of therapy to patients who would not naturally receive it. Much has been written about the ethics of stem cell research and therapy; this paper will focus on how recent advances in biotechnology and biological understandings of development narrow the debate. Here, the author briefly reviews current stem cell research practices, revisits the natural stem cell therapy case for moral evaluation, and ultimately demonstrates the importance of permissible stem cell research and therapy, even absent an agreement about the definition of when embryonic life begins.Although one promising technology, blighted ovum utilisation, uses fertilised but developmentally bankrupt eggs, it is argued that utilisation of unfertilised eggs to derive totipotent stem cells obviates the moral debate over when life begins. There are two existing technologies that fulfil this criterion: somatic cell nuclear transfer and parthenogenic stem cell derivation. Although these technologies are far from therapeutic, concerns over the morality of embryonic stem cell derivation should not hinder their advancement. (shrink)

Many Christian scholars, if not all of them, consider Genesis to be foundational texts of the Bible and the spring for all the other doctrines of the Scripture. Therefore, I'm considering the attempt to search and find arguments for cell therapy ethical issues in the fundamental text of Genesis as a challenging and educative task. Moreover, this could be the first step in analyzing the relationships between Christian religions and bioethics, in terms of finding reasonable decisions for ethical challenges, (...) raised by the current biomedical research. As for many other dilemmas of humanity, we have to recall the text of Genesis for analyzing the goodness or evilness of our actions in translational medicine, even though that is not the only way to get a reasonable ethical decision. My contribution is an essay that is trying to correlate the Genesis lessons with the needed arguments in deciding what could be good and what could be evil in the stem cell research, according to the religious convictions. The biggest challenges of biomedical research for Christian religions were due to the human cloning issue, made possible by the somatic cell nuclear transfer, but those challenges update the older debates on birth control pill, technologically assisted reproduction, or gene therapy. Issues related to in vitro fertilization, gene enhancement and gene therapy, human cell cloning, embryonic stem cell using, and chimera cell obtaining for research are being considered and related to the putative arguments extracted from the book of Genesis, describing the origins. As a matter of fact, I may conclude that the single way to reach a reasonable ethical decision in our society is to intersect ethics, science and theology and to engage large debates involving scientists, theologians, civil society representatives, ethicists (experts in applied ethics) and moral philosophers, having the two latest professionals as referees. (shrink)

Stem cell research has important implications for medicine. The source of stem cells influences their therapeutic potential, with stem cells derived from early-stage embryos remaining the most versatile. Somatic cell nuclear transfer (SCNT), a source of embryonic stem cells, allows for understandings about disease development and, more importantly, the ability to yield embryonic stem cell lines that are genetically matched to the somatic cell donor. However, SCNT requires women to donate eggs, which (...) involves injection of ovulation-inducing hormones and egg retrieval through laparoscopy or transvaginal needle aspiration. Risks from this procedure are fiercely debated, most notably risk of ovarian hyperstimulation syndrome (OHSS). This review examines risk of OHSS resulting from oocyte donation. We conclude that risk posed by OHSS in egg donation is not significant enough to warrant undue concern, and much of this can be eliminated when proper precautions are taken. This bears relevance to the future of stem cell research policymaking. (shrink)

In recent decades, debates about exploitation have tended to be subsumed by debates about choice and autonomy. This phenomenon has affected international feminism adversely, creating polarized debates over such issues as prostitution. Equally grave is the more recent tendency, even among some feminists, to assume that a woman’s free choice to accept payment for egg “donation” in somatic cell nuclear transfer stem cell research absolves researchers of any charge of exploitation or abuse of research subjects. (...) This paper suggests that much of this dissension among feminists is due to conflicting understandings of the crucial but neglected concept of exploitation. Analyzing two possible senses of exploitation—a disparity between value “in” and value “out” versus an affront to dignity—this paper argues that both are underpinned by what Carole Pateman identifies as gender subordination. In conclusion it is suggested that transnational feminism return to a more traditionally feminist stance, which explicitly focuses on opposing the subordination and exploitation of women. (shrink)

It is argued that the use of induced pluripotent stem cells for regenerative therapy may soon be ethically practicable and could sidestep the various objections pertaining to other types of stem cell (human embryonic stem cells, and stem cells obtained by altered nuclear transfer or somatic cell nuclear transfer).

The notion of the human embryo is not immutable. Various scientific and technological breakthroughs in reproductive biology have compelled us to revisit the definition of the human embryo during the past 2 decades. Somatic cell nuclear transfer, oocyte haploidisation and, more recently, human stem cell-derived embryo models have challenged this scientific term, which has both ethical and legal repercussions. Here, we offer a legal perspective to identify a universally accepted definition of ‘embryo’ which could help (...) to ease and unify the regulation of such entities in different countries. (shrink)

In a recent publication Tom Douglas and Katrien Devolder have proposed a new account of genetic parenthood, building on the work of Heidi Mertes. Douglas and Devolder’s account aims to solve, among other things, the question of who are the genetic parents of an individual created through somatic cell nuclear transfer (i.e. cloning): (a) the nuclear DNA provider or (b) the progenitors of the nuclear DNA provider. Such a question cannot be answered by simply (...) appealing to the folk account of genetic parenthood, according to which the genetic parents of an individual are those individuals who produced the egg and sperm, respectively, which fused to create the embryo. It cannot be so as in cloning there is no fertilization as such. In this article I critically examine Douglas and Devolder’s new account of genetic parenthood and demonstrate that it is vulnerable to counterexamples that exploit the lack of a condition specifying that genetic parents should cause a child’s coming into existence. (shrink)

This paper uses the advent of human-animal hybrids, created though somatic cell nuclear transfer experiments in America and Australia, as a tool to deconstruct and challenge the dualistic belief that humans are morally distinct and superior to animals. The view that moral value corresponds to species membership creates a scientific and cultural environment that prohibits or restricts human embryo experimentation whilst permitting the extensive use of animals for research. The dualistic premise therefore motivates the creation of (...) human-animal hybrids for research as a way for scientists to side-step restrictive legislation. Furthermore, ethical frameworks that incorporate the dualistic assumption have been incapable of objectively assessing the moral value of hybrid embryos. This failure indicates the arbitrariness of the moral dichotomy between animals and humans. Moral dualism, based on species membership, should be replaced with a liberal ethical framework based on a consistent standard such as interests. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.1 (2002) 95-102 [Access article in PDF] Bioethics Inside the Beltway Some Initial Reflections on NBAC Eric M. Meslin and Harold T. Shapiro On 3 October 2001, Executive Order 12975 expired, and with it so too did the National Bioethics Advisory Commission (NBAC). Established by President Bill Clinton in 1995, NBAC was the fifth national committee since 1974 created to advise the U.S. government (...) on bioethics policy. In the long political tradition in this country that national bioethics policy advice should use temporary rather than permanent bodies, NBAC followed in the footsteps of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78); the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1980-83); the Ethics Advisory Board (1978-80); and the Biomedical Ethics Advisory Committee (1988-89). Arguably, other distinguished panels could lay claim to recognition as a "national bioethics committee" including the Advisory Committee on Human Radiation Experiments (ACHRE) (1994-95); the Fetal Tissue Transplantation Research Panel (1988); the Human Embryo Research Panel (1994); and the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), which continues to function.These committees and commissions form a kind of a continuum, albeit occasionally interrupted by periods during which no such bodies existed. Each arose from a particular confluence of events and circumstances. NBAC was no different; its history can be traced both to a series of discussions within the White House Office of Science and Technology Policy beginning in 1993 (NBAC 1998a, p. 3), and to a specific recommendation from ACHRE that called for a national committee to address ethical issues in human subjects research (ACHRE 1995, p. 817). Nbac's Impact In his useful comparison of the accomplishments of the National Commission and the President's Commission, Brad Gray concluded that seven lessons were learned, the sixth of which was that "nothing substitutes for having a perceptible impact on either policy or practice" (Gray 1995, p. 304). Assessing NBAC's [End Page 95] impact on "policy or practice" is difficult, particularly given the fact that it so recently completed its work. More time may be needed before a full assessment can be undertaken of the impact of its six reports (and their total of 120 recommendations). Instead, in this essay we offer some reflections on NBAC's initial impact, using some specific examples of how bioethics gets done Inside the Beltway. Eliciting Reaction If immediate reaction by the White House is any measure of impact, then Cloning Human Beings (NBAC 1997) had a significant one. The day after he received this report in a Rose Garden ceremony, President Clinton submitted a bill to Congress that would have extended the moratorium on federal funding to create a child using somatic cell nuclear transfer. This bill never passed, nor has any other bill emerged that has enjoyed the support of the House and the Senate. Five states have enacted legislation to date, but these vary in their permissibility from bans on all forms of cloning to bans similar to the one proposed by NBAC, which recommended a time-limited prohibition only on somatic cell transfer to create a child (reproductive cloning).If the Cloning report elicited speedy action from the White House, this paled in comparison to the reaction that led to and, in turn, was created by Ethical Issues in Human Stem Cell Research (NBAC 1999a). Those who believe that government moves slowly need only be reminded of the events of 8-14 November 1998 (and, as we shall mention below, the further events of 14 July 1999). Some will recall that early in the second week of November 1998, James Thomson and his colleagues published in Nature and John Gearhart and his colleagues published in the Proceedings of the National Academy of Sciences that they had isolated and cultured human primordial stem cells and germ cells respectively. Within days of these remarkable reports, Advanced Cell Technology (ACT) announced via an article written by Nicholas Wade in the... (shrink)

On 19 December 2005 the recommendations of the Lockhart Review were released. One of the key recommendations was that current laws be amended to permit the creation of embryonic stem cells by somatic cell nuclear transfer. The Lockhart Report analysed the ethical arguments for and against the creation of embryos by nuclear transfer. It rationalised that, although there were various objections to such technology from some sections of Australian society, the good that this science (...) has the potential to produce in the form of stem cell therapies to assist with or cure disease should prevail This article will critically analyse the ethical arguments presented to the Lockhart Review and assess how the Review Committee resolved the debate as to the ethical status of a preimplantation embryo. It will be contended that the recommendations for reform should be fully implemented by the Federal Government, to enable scientists to have full access to both embryonic and adult stem cells, including custom-made stem cell lines created through the SCNT process, to allow medical research to progress to its fullest potential. (shrink)

To clone humans is deliberately to generate two or more individuals who share the same nuclear deoxyribonucleic acid. Using animals, researchers have performed two basic types of cloning that will eventually yield commercial benefits. Embryo twinning involves separating the individual cells of an embryo and allowing each to cleave for later transfer to a uterus. Cloning by nuclear transfer involves removing the nuclei from embryonic cells or fetal or adult somatic cells and fusing those nuclei (...) with enucleated donor egg cells. Although for the purposes of commercial biotechnology these techniques do not raise undue concern when attempted with animals, embryo twinning, embryo nuclear transfer, fetal somatic cell nuclear transfer, and adult somatic cell nuclear transfer all provoke intense ethical discussions when considered for human use. (shrink)

Much of the literature on therapeutic somatic cell nuclear transfer covers the moral arguments for and against proceeding and the policy stall occasioned by conflicts over the moral status of embryos. Yet it is also worthwhile to view policy from the standpoint of the resources available as well as of deficiencies in those resources. This article uses the idea of a policy community to examine policy making from a starting point that focuses not on what divides, (...) but rather on the groups and individuals committed to enabling ES cell research and therapeutic SCNT. Although written with international dimensions in mind, the article focuses on the United States, where the politics are particularly volatile and the likelihood of policy leadership at the national level is remote. (shrink)

Ford, Norman Victoria's Minister for Health, the Hon. Bronwyn Pike MLA introduced a Bill to allow therapeutic cloning in Victoria on March 13, 2007. If this Bill is passed, Victoria would be the first State to permit somatic cell nuclear transfer (therapeutic cloning) and thereby open the way for the destruction of cloned human embryos for therapeutic purposes and medical research.

In the 1980s, new reproductive technologies such as in vitro fertilisation and embryo transfer became commercially available in the United States, and somatic cell nuclear transfer—the cloning process by which Dolly the Sheep would be conceived in 1996—was in its experimental phase. While anxieties concerning these new technologies escalated in the popular sensorium, Laurie Anderson explored the phenomenon of cloning in a short musical film called What You Mean We? (1986) in which Anderson consults a (...) design team to clone herself in order to manage her demanding workload. The videographic image of the clone is Anderson herself, performing in drag, and her clone’s body is partially created through the use of a pitch shifter which changes Anderson’s voice to that of the cloned—but ostensibly male—version of herself. In this article, I investigate Anderson’s technological consideration of the body, which extends beyond her own corporeality, to interrogate the biological and affective capacities of clones. I consider how Anderson addresses the convergence of reproductive technologies, the market and the creation of subjects within this market as participating in a shift in how voices are heard, governed and reproduced in the latter half of the twentieth century. (shrink)

Since the first successful attempt to clone a dog in 2005, dogs have been cloned by Somatic Cell Nuclear Transfer for a variety of purposes. One of these is to clone dogs as companion animals. In this paper we discuss some of the ethical implications that cloning companion dogs through SCNT encompasses, specifically in relation to human–dog relationships, but also regarding animal welfare and animal integrity. We argue that insofar as we understand the relationship with our (...) companion dogs as one of friendship, the meaningfulness of cloning a companion dog is seriously questionable. Cloning may both disrupt the uniqueness of the relationship, as the shared history underlying the relationship can neither be repeated nor copied, and it may violate the meaning we attribute to friendship, as the notion of singularity inherent in our understanding of friendship is incompatible with the replaceability embedded in the practice of cloning. We further argue that the application of cloning technology to companion dogs can be interpreted as a violation of the integrity of dogs on at least two accounts: negative welfare implications associated with the cloning process, and the instrumentalisation of the dog inherent in cloning. (shrink)

Since early 1997, when the creation of Dolly the sheep by somatic cell nuclear transfer was announced in Nature, numerous government reports, essays, articles and books have considered the ethical problems and policy issues surrounding human reproductive cloning. In this article, I consider what response a modern liberal society should give to the prospect of human cloning, if it became safe and practical. Some opponents of human cloning have argued that permitting it would place us on (...) a slippery slope to a repugnant future society, comparable to that portrayed in Aldous Huxley’s novel, Brave New World.I conclude that, leaving aside concerns about safety, none of the psychological or social considerations discussed in this article provides an adequate policy justification for invoking the state’s coercive powers to prevent human cloning. (shrink)

To clone humans is deliberately to generate two or more individuals who share the same nuclear deoxyribonucleic acid. Using animals, researchers have performed two basic types of cloning that will eventually yield commercial benefits. Embryo twinning involves separating the individual cells of an embryo and allowing each to cleave for later transfer to a uterus. Cloning by nuclear transfer involves removing the nuclei from embryonic cells or fetal or adult somatic cells and fusing those nuclei (...) with enucleated donor egg cells. Although for the purposes of commercial biotechnology these techniques do not raise undue concern when attempted with animals, embryo twinning, embryo nuclear transfer, fetal somatic cell nuclear transfer, and adult somatic cell nuclear transfer all provoke intense ethical discussions when considered for human use. (shrink)

Carson Strong has argued that if human cloning were safe it should be available to some infertile couples as a matter of ethics and law. He holds that cloning by somatic cell nuclear transfer should be available as a reproductive option for infertile couples who could not otherwise have a child genetically related to one member of the couple. In this analysis, Strong overlooks an important category of people to whom his argument might apply, couples he (...) has not failed to consider elsewhere. In this discussion, however, Strong refers exclusively to opposite sex couples facing obstacles such as surgically removed ovaries and the inability to produce sperm. In fact, however, there are many adult couples who, while fertile in and of themselves, are not fertile as couples. This group includes not only opposite sex couples but coupled same sex partners as well. I believe the defenses Strong offers regarding the use of SCNT by opposite sex infertile couples would extend to same sex couples for two reasons. First, some same sex couples might face the inability to have a genetically related child, and second, Strong's arguments ultimately ground a general defense of SCNT independent of the question of a couple's fertility. (shrink)

Hello readers! Hope everyone is fine especially in this season where we often are prone to attacks of cold or flu. The holiday season is at our threshold, and we wish everyone to be in the best of health and happiness.This issue of the BJB is very interesting with topics stretching from Non Communicable Diseases to the ethical issues related to the habitation of the planet Mars, and proves how forward looking are our readers and authors.Mohammad Rashedul Islam et al (...) discuss the application of the SARA method in a district in Bangladesh. The method is based on the principle of Service Availability and Readiness Assessment of WHO. The study in a district in Bangladesh found that about 62% of all the facilities were ready to provide general services like basic amenities with basic equipment, standard precautions for infection prevention, diagnostic capacity and essential medicines. However in case of Non-Communicable Diseases (NCD), only 40% of the health facilities had chronic respiratory disease and cardiovascular diseases diagnosis/management and only 32% had availability of diabetes diagnosis/management. Therefore, service availability and readiness of the health facilities to provide NCD related health services were not satisfactory. The authors emphasize that SARA which is a tool to monitor facilities to be ready for provision of services including NCD, should be used by all clinic managers.The very scientific and forward looking article titled “SCNT Method and the Application for Patent Eligibility on Cloned Animals” by Norman K. Swazo reviews US federal court decisions regarding applications for patent in the case of live-born animal clones. A decision issued from the United States Court of Appeals for the Federal Circuit established an earlier decision of the Patent Trial and Appeal Board that live-born animals cloned by the somatic cell nuclear transfer method (SCNT) like cattle, sheep, pigs, and goats are not patentable, so a scientist using the method is not eligible for a patent claim on the animals. The author feels that this decision has ethical implications related to the moral status of cloned animals. The author argues whether the end product of a SCNT (somatic cell nuclear transfer) application is same as an invention or only a revelation of nature at the cellular level. The author quotes Article 11 of Universal Declaration on the Human Genome and Human Rights UNDHGR “Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted.” He concludes that the judicial assessments in the USA deciding on the question of patenting of animal clones provide important barriers to human reproductive cloning research, safeguarding moral and legal commitment to human dignity. The article on Ethics in Public Health Research and Clinical Research by Muhammad Waseem Khanet al discusses on the need to continue to focus on ethical values in conducting any research. Tha authors stress the importance, either in public health research or clinical research, of the need to recognize an ethical standard that respects individual’s autonomy and community’s wellbeing. This can be achieved through collective collaboration for the protection of individual’s autonomy, dignity and wellbeing. Research ethics is a fundamental criterion to be complied with throughout a research study. The very interesting article on Planetary Protection for Mars: Time for Reconsideration by Svetoslav Alexandrov looks into the ethical questions beyond mother earth but which could be affected by people from our planet. In this manuscript the author discusses the ethics of the protection of hypothetical organisms on Mars in terms of planned manned space missions and subsequent colonization. The author discusses the possible problems related to a process called terraformation where the planet is converted to make it suitable for Earth life. He argues that terraformation will change the whole condition of the planet. The author quotes Carl Sagan, of The Planetary Society: “If there is life, then I believe we should do nothing to disturb that life. Mars then, belongs to the Martians, even if they are microbes”. I think we all agree with this brilliant recommendation.The article ‘We Still Need to Improve Our Research Writing Ethics’ by Sheikh Arslan Sehgal looks into the value of maintaining professional integrity of research work. Particularly with issues like plagiarism, ethics, authorship and data fabrication. He argues that the scientific community must obey the scientific ethical norms and rules. He feels that ethical problems must be resolved for the advancement of research in countries including Pakistan. The author recommends teaching students the international, institutional and professional standards regarding research and authorship issue. Thus from the beginning researchers will know the key components of ethics in conducting research and the end product will be research work of quality and acceptability.Dear Readers, we look forward to your articles, commentaries, observations on different issues which touch our lives and will help in broadening our knowledge and understanding of Bioethics. (shrink)

Two groups of scientists have just announced what is being described as a leap forward in human stem cell research.1–3 Both have found ways of producing what are being called “induced pluripotent cells” , stem cells that they hope will demonstrate the same key properties of regeneration and unrestricted differentiation that human embryonic stem cells possess, but which are derived from skin cells not from embryos. In simple terms, these scientists have succeeded in reprogramming skin cells to behave like (...) hESCs.Stem cell research has been hailed as one of the most important and exciting areas of science, because it is believed that these types of cells will not only play an important part in regenerative medicine, but also yield valuable scientific information. These latest developments in cell reprogramming represent a milestone for stem cell science. No longer does the paradigm of irreversible cell specialisation hold true; instead, almost any type of cell might have the potential to become any other.The advent of techniques for producing these iPCs has also been hailed as an ethical breakthrough. Up until now, the production of hESCs has required a process which involves the destruction of embryos. Many of these embryos are available as by-products of IVF; but in addition, the process of somatic cell nuclear transfer to produce cloned embryonic stem cells requires a supply of human oocytes, which must currently be harvested from female donors at no insignificant cost. In a nutshell, iPCs seem to enable us to produce “embryo-free” human pluripotent stem cells, and in a “gender-neutral” way—that is, without the need for human oocytes.The response from the scientific community, ethical commentators and the public has, however, reflected an inherent confusion over the ethical significance of this research. The anti-embryo …. (shrink)

Carson Strong has argued that if human cloning were safe it should be available to some infertile couples as a matter of ethics and law. He holds that cloning by somatic cell nuclear transfer should be available as a reproductive option for infertile couples who could not otherwise have a child genetically related to one member of the couple. In this analysis, Strong overlooks an important category of people to whom his argument might apply, couples he (...) has not failed to consider elsewhere. In this discussion, however, Strong refers exclusively to opposite sex couples facing obstacles such as surgically removed ovaries and the inability to produce sperm. In fact, however, there are many adult couples who, while fertile in and of themselves, are not fertile as couples. This group includes not only opposite sex couples but coupled same sex partners as well. I believe the defenses Strong offers regarding the use of SCNT by opposite sex infertile couples would extend to same sex couples for two reasons. First, some same sex couples might face the inability to have a genetically related child, and second, Strong's arguments ultimately ground a general defense of SCNT independent of the question of a couple's fertility. (shrink)

Cloning scares the hell out of people, because the idea of cloning people scares the hell out of people. Some of this fear is well-founded. Like any new reproductive technology, the cloning of entire human organisms can be put to good or bad effect, for good or bad reasons. But much of the fear is not well-founded. Before you could say “Hello, Dolly,” the U.S. administration moved to ban federal funding of human cloning research; and there is considerable support in (...) Congress for an outright ban on the use of somatic cell nuclear transfer technology for the purpose of human cloning. Why? Here is part of Clinton’s statement announcing the funding ban. (shrink)

Patents recognize economic right and are important for both individual and social economic benefit. Nonetheless, mere economic right does not eliminate the requirement for moral assessment when adjudicating intellectual property claims, especially in the case of claims associated with applications of biomedical technology [e.g., somatic cell nuclear transfer methods]. This is so for applications for patent in the case of live-born animal clones, as governed in the setting of the judicial system of the USA. Here recent (...) federal court decisions in the USA are reviewed, and the ethical ambiguities of this judicial review are engaged in light of the current prohibitions on human reproductive cloning. It is concluded that the legal proscription of patents on animal clones bodes well for human accountability to present and future generations in the event of human reproductive cloning. (shrink)

Carson Strong's article “Cloning and Infertility” has initiated a conversation in this journal about the ethical and policy issues surrounding the question of who, if anyone, should be allowed access to human reproductive cloning technology, should somatic cell nuclear transfer ever become technically feasible and safe. Strong's position in that article is that infertile opposite sex couples for whom cloning is the last resort for having a genetically related child are the only people who should be (...) granted access to such technology, primarily because this need to have a genetically related child would give such couples respectable reasons for cloning themselves. Also, every child has a basic right to a “decent minimum opportunity for development.” Thus it would be morally wrong, other things being equal, to clone a person with cystic fibrosis or spina bifida but morally permissible to clone a nearsighted person, because nearsightedness is not sufficiently disabling to violate the child's birthright. With this caveat, he concludes that protecting reproductive freedom requires that physicians be allowed to provide cloning services only to that small subset of infertile opposite sex couples who would need it as a last resort, should human reproductive cloning ever become safe and feasible. (shrink)

Novel therapies resulting from regenerative medicine and tissue engineering technology may offer new hope for patients with injuries, end-stage organ failure, degenerative disorders and many other clinical issues. Currently, patients suffering from diseased and injured organs are treated with transplanted organs. However, there is a shortage of donor organs that is worsening yearly as the population ages and new cases of organ failure increase. Scientists in the field of regenerative medicine and tissue engineering are now applying the principles of (...) class='Hi'>cell transplantation, material science, and bioengineering to construct biological substitutes that can restore and maintain normal function in diseased and injured tissues. In addition, the stem cell field is a rapidly advancing part of regenerative medicine, and new discoveries in this field create new options for this type of therapy. For example, new types of stem cells, such as amniotic fluid and placental stem cells, that can circumvent the ethical issues associated with embryonic stem cells have been discovered. The process of somatic cell nuclear transfer and the creation of induced pluripotent cells provide still other potential sources of stem cells for cell-based tissue engineering applications. While stem cells are still in the research phase, some therapies arising from tissue engineering endeavors that make use of autologous, adult cells have already entered the clinical setting, indicating that regenerative medicine holds much promise for the future. (shrink)

There is ongoing debate about whether it is ethically acceptable to allow the creation of cloned embryos in order to produce human stem cells. A cloned embryo is created through a process called somatic-cell nuclear transfer, often known as ‘therapeutic’ cloning. The value of stem cells lies in their capacity to become any sort of cell in the human body. This capacity is particularly useful for treating medical conditions where stem cells can be used to (...) repair or replace damaged tissue. The value of a cloned embryo is that the DNA from a person who needs stem cell treatment can be used to create the clone and thereby minimise the likelihood that any inserted stem cells will be rejected. Research on the use of cloned stem cells is in its earliest stage. (shrink)