Fresh or frozen? Classifying ‘spare’ embryos for donation to human embryonic stem cell research

United Kingdom (UK) funding to build human embryonic stem cell (hESC) derivation labs within assisted conception units (ACU) was intended to facilitate the 'In-vitro fertilisation (IVF)-stem cell interface', including the flow of fresh 'spare' embryos to stem cell labs. However, in the three sites reported on here, which received this funding, most of the embryos used for hESC research came from long term cryopreservation storage and/or outside clinics. In this paper we explore some of the clinical, technical, social and ethical factors that might help to explain this situation. We report from our qualitative study of the ethical frameworks for approaching women/couples for donation of embryos to stem cell research. Members of staff took part in 44 interviews and six ethics discussion groups held at our study sites between February 2008 and October 2009. We focus here on their articulations of social and ethical, as well as scientific, dimensions in the contingent classification of 'spare' embryos, entailing uncertainty, fluidity and naturalisation in classifying work. Social and ethical factors include acknowledging and responding to uncertainty in classifying embryos; retaining 'fluidity' in the grading system to give embryos 'every chance'; tensions between standardisation and variation in enacting a 'fair' grading system; enhancement of patient choice and control, and prevention of regret; and incorporation of patients' values in construction of ethically acceptable embryo 'spareness' ('frozen' embryos, and embryos determined through preimplantation genetic diagnosis (PGD) to be genetically 'affected'). We argue that the success of the 'built moral environment' of ACU with adjoining stem cell laboratories building projects intended to facilitate the 'IVF-stem cell interface' may depend not only on architecture, but also on the part such social and ethical factors play in configuration of embryos as particular kinds of moral work objects.     

Fresh or frozen? Classifying ‘spare’ embryos for donation to human embryonic stem cell research

United Kingdom (UK) funding to build human embryonic stem cell (hESC) derivation labs within assisted conception units (ACU) was intended to facilitate the ‘In-vitro fertilisation (IVF)-stem cell interface’, including the flow of fresh ‘spare’ embryos to stem cell labs. However, in the three sites reported on here, which received this funding, most of the embryos used for hESC research came from long term cryopreservation storage and/or outside clinics. In this paper we explore some of the clinical, technical, social and ethical factors that might help to explain this situation. We report from our qualitative study of the ethical frameworks for approaching women/couples for donation of embryos to stem cell research. Members of staff took part in 44 interviews and six ethics discussion groups held at our study sites between February 2008 and October 2009. We focus here on their articulations of social and ethical, as well as scientific, dimensions in the contingent classification of ‘spare’ embryos, entailing uncertainty, fluidity and naturalisation in classifying work. Social and ethical factors include acknowledging and responding to uncertainty in classifying embryos; retaining ‘fluidity’ in the grading system to give embryos ‘every chance’; tensions between standardisation and variation in enacting a ‘fair’ grading system; enhancement of patient choice and control, and prevention of regret; and incorporation of patients’ values in construction of ethically acceptable embryo ‘spareness’ (‘frozen’ embryos, and embryos determined through preimplantation genetic diagnosis (PGD) to be genetically ‘affected’). We argue that the success of the ‘built moral environment’ of ACU with adjoining stem cell laboratories building projects intended to facilitate the ‘IVF-stem cell interface’ may depend not only on architecture, but also on the part such social and ethical factors play in configuration of embryos as particular kinds of moral work objects.     

The ethical challenge of stem cell research.

This article analyzes the ethical issues raised by embryonic stem cell research and recent recommendations by the National Bioethics Advisory Commission (NBAC) regarding federal support for this research. The authors identify the key ethical issue as the moral significance that should be granted to early embryos and discuss arguments supporting the diverse answers to that question and the implications each view has on the formulation of rules and policies for stem cell research. The authors conclude that several of NBAC's recommendations regarding the derivation of stem cells from embryos for research are ethically justifiable and sound public policy.     

Von der Grundlagenforschung in die Klinik

Translation from the laboratory to the clinic is one of the key problems of stem cell research. One reason for this is that stem cell science is ethically charged and therefore its successful therapeutic application would support its social legitimacy and further funding. We discuss translation both theoretically and with reference to an example, namely efforts regarding the creation of cardiomyocytes from embryonic stem cell lines with the aim to regenerate a patient's myocardium post trauma. Using this case we explain the facts that need to be established scientifically and the subsequent steps that need to be taken in order to develop and implement clinical application. We also discuss aspects of current scientific development related to the moral charge of the research, in particular emerging methods aimed at the derivation of pluripotent cells, such as the hybridization of human DNA and animal egg cells, or the genetic modification of adult somatic cell nuclei in culture to induce pluripotency.     

Integrity and moral residue: nurses as participants in a moral community

Abstract This paper will examine the concepts of integrity and moral residue as they relate to nursing practice in the current health care environment. I will begin with my definition and conception of ethical practice, and, based on that, will go on to argue for the importance of recognizing that nurses often find themselves in the position of compromising their moral integrity in order to maintain their self‐survival in the hospital or health care environment. I will argue that moral integrity is necessary to a moral life, and is relational in nature. When integrity is threatened, the result is moral distress, moral residue, and in some cases, abandonment of the profession. The solution will require more than teaching bioethics to nursing students and nurses. It will require changes in the health care environment, organizational culture and the education of nurses, with an emphasis on building a moral community as an environment in which to practise ethically.     

In Defence of Moral Pluralism and Compromise in Health Care Networks

The organisation of health care is rapidly changing. There is a trend to move away from individual health care institutions towards transmural integrated care and interorganizational collaboration in networks. However, within such collaboration and network there is often likely to be a pluralism of values as different health care institutions often have very different values. For this paper, we examine three different models of how we believe institutions can come to collaborate in networks, and thus reap the potential benefits of such collaboration, despite having different moral beliefs or values. A first way is the pragmatic way in which the different health care institutions avoid ethical reflection and focus on solutions. A second possible route is that of consensus where health care institutions base their collaboration on values that they all share. The third, and final, approach is that of compromise. Although moral compromise is often seen in a negative light, we argue that in many cases compromise might be necessary and ethically justified. In a final section, we will shift our focus from discussing various theoretical methods to allow collaboration to the potential content of consensus or compromise.     

Humane embryonale Stammzellen im Kontext internationaler Forschungsaktivitäten

Research involving pluripotent human embryonic stem cells (hESCs) is a rapidly growing field of science. Since hESCs originate from early human embryos, alternative methods for producing pluripotent cells have been developed. This article introduces some of those strategies and, in addition, covers international efforts to establish consistent international standards for cultivation, characterization and preservation of hESCs. Furthermore, global trends to form networks in the field of stem cell research as well as endeavors to harmonize ethical standards for hESC research are presented. Finally, potential applications of hESCs in the field of pharmacology/toxicology are discussed as well as recent results of animal studies using hESCs.     

Ethical boundary-work in the embryonic stem cell laboratory

Most accounts of the ethics of stem cell research are de- contextualised reviews of the ethical and legal literature. In this chapter we present a socially embedded account of some of the ethical implications of stem cell research, from the perspectives of scientists directly involved in this area. Based on an ethnography of two leading embryonic stem cell laboratories in the UK, our data form part of the findings from a larger project mapping the scientific, medical, social and ethical dimensions of innovative stem cell treatment, focusing on the areas of liver cell and pancreatic islet cell transplantation. We explore three key issues: what individual scientists themselves view as ethical sources of human embryos and stem cells; their perceptions of human embryos and stem cells; and how scientists perceive regulatory frameworks in stem cell research. We argue that these dimensions of laboratory practice are all examples of 'ethical boundary-work', which is becoming an integral part of the routine practice and performance of biomedical science. Our work adds to the relatively few sociological studies that explore ethics in clinical settings and to an even smaller body of work that explores scientists' views on the ethical issues relating to their research.     

Stem cell research in Germany: Ethics of healing vs. human dignity

On 25 April 2002, the German Parliament has passed a strict new law referring to stem cell research. This law took effect on July 1, 2002. The so-called embryonic Stem Cell Act (Stammzellgesetz — StZG) permits the import of embryonic stem (ES) cells isolated from surplus IvF-embryos for research reasons. The production itself of ES cells from human blastocysts has been prohibited by the German Embryo Protection Act of 1990, with the exception of the use of ES cells which exist already. The debate on the legitimate use of ES cells escalated, after the main German research funding agency, the Deutsche Forschungsgemeinschaft (DFG), unexpectedly published new guidelines recommending are stricted use of human ES cells for research. Meanwhile, the debate has ethically dividedsociety, political parties, government and church members into a group supporting and a group rejecting ES cell research. The arguments in favour of such a research can be summarized as arguments derived from a new ethics ofhealing calling for a therapeutic imperative, whereas the arguments against can be summarized as arguments violating the fundamental principle of human dignity as they imply the destruction of human embryos. This article willtry to present and evaluate various ethical arguments founded on the latest biological and medical data on the potential use of stem cell technologies. It will finally come to the conclusion that ES cell research is opposed to human dignity, since the procedures of isolating ES cells require the destruction and instrumentalization of human embryos. Human embryos are human beings at a very early stage of their development, fully possessing the ability of completing their development. At this very early stage, human embryos are extremely dependent and fragile, and thus vulnerable corporealities. Vulnerability and human dignity demand the protection of the embryo's corporeal integrity. Hence, this essay will try to propagate research with adult stem(AS) cells, a procedure which does not require the destruction of human embryos; with regard to the necessary plasticity, it should be emphasized that AS cells very much resemble ES cells.This revised version was published online in October 2005 with corrections to the Cover Date.     

Profitable Exchanges for Scientists: The Case of Swedish Human Embryonic Stem Cell Research

In this article two inter-related issues concerning the ongoing commercialisation of biomedical research are analyzed. One aim is to explain how scientists and clinicians at Swedish public institutions can make profits, both commercially and scientifically, by controlling rare human biological material, like embryos and embryonic stem cell lines. This control in no way presupposes legal ownership or other property rights as an initial condition. We show how ethically sensitive material (embryos and stem cell lines) have been used in Sweden as a foundation for a commercial stem cell enterprise--despite all official Swedish strictures against commercialisation in this area. We also show how political decisions may amplify the value of controlling this kind of biological material. Another aim of the article is to analyze and discuss the meaning of this kind of academic commercial enterprise in a wider context of research funding strategies. A conclusion that is drawn is that the academic turn to commercial funding sources is dependent on the decline of public funding.     

Shifting paradigms? Reflections on regenerative medicine,embryonic stem cells and pharmaceuticals

Will human embryonic stem (hES) cells lead to a revolutionary new regenerative medicine? We begin to answer this question by drawing on interviews with scientists and clinicians from leading labs and clinics in the UK and the USA, exploring their views on the bench‐bedside interface in the fields of hES cells, neuroscience and diabetes. We employ Bourdieu's concepts of field, habitus and capital in order to understand stem cell science and cell transplantation. We also build on research on the sociology of expectations, and explore expectations of pharmaceutical approaches in hES research through our concept of ‘expectational capital’. In the process we discuss emerging expectations within stem cell research, most especially the ‘disease in a dish’ approach, where hES cells will be used as tools for unravelling the mechanisms of disease to enable the development of new drugs. We argue that experts’ persuasive promises advance their interests in the uncertain stem cell field, and explore how this performative strategy might stabilise the emerging ‘disease in a dish’ model of translational research.     

Stem cells and lineage development in the mammalian blastocyst

The mammalian blastocyst is the source of the most pluripotent stem cells known: embryonic stem (ES) cells. However, ES cells are not totipotent; in mouse chimeras, they do not contribute to extra-embryonic cell types of the trophectoderm (TE) and primitive endoderm (PrE) lineages. Understanding the genetic pathways that control pluripotency v. extra-embryonic lineage restriction is key to understanding not only normal embryonic development, but also how to reprogramme adult cells to pluripotency. The trophectoderm and primitive endoderm lineages also provide the first signals that drive patterned differentiation of the pluripotent epiblast cells of the embryo. My laboratory has produced permanent mouse cell lines from both the TE and the PrE, termed trophoblast stem (TS) and eXtra-embryonic ENdoderm (XEN) cells. We have used these cells to explore the genetic and molecular hierarchy of lineage restriction and identify the key factors that distinguish the ES cell v. the TS or XEN cell fate. The major molecular pathways of lineage commitment defined in mouse embryos and stem cells are probably conserved across mammalian species, but more comparative studies of lineage development in embryos of non-rodent mammals will likely yield interesting differences in terms of timing and details.     

Embryonic Stem Cell Patents and Human Dignity

This article examines the assertion that human embryonic stem cells patents are immoral because they violate human dignity. After analyzing the concept of human dignity and its role in bioethics debates, this article argues that patents on human embryos or totipotent embryonic stem cells violate human dignity, but that patents on pluripotent or multipotent stem cells do not. Since patents on pluripotent or multipotent stem cells may still threaten human dignity by encouraging people to treat embryos as property, patent agencies should carefully monitor and control these patents to ensure that patents are not inadvertently awarded on embryos or totipotent stem cells.     

National risk signatures and human embryonic stem cell research in mainland China

The international development of human embryonic stem cell research has become closely tied to global bioethics, which places moral responsibility on stem cell researchers. This article argues that the development of bioethical regulation of human embryonic stem cell research is better understood by approaching the institutionalisation of bioethics in terms of risk perceptions of stem cell scientists. Eschewing approaches that understand bioethical risk as a mere matter of morality or as a social construct, this article emphasises the materiality and strategic reasoning of bioethical views on risks associated with human embryonic stem cell research. Such an approach allows the identification of forms of risk rooted in the everyday practice of Chinese human embryonic stem cell research, including moral risk (as a violation of cultural values), material risk (in relation to the distribution of material resources and wealth), political risk (in terms of the political economy of bioethics and public debate) and reputational risk (in terms of personal and national honour). Although this analysis builds on Tom Horlick-Jones's concept of risk signatures of new technologies, which emphasise the capacities of different technologies to engender and delimit the particular social and cultural interpretations of the risks they generate, the article reveals the existence of a certain global awareness among stem cell scientists of risk signatures. They display a creative and strategic awareness regarding the possible opportunities and constraints the risk signature of human embryonic stem cell research affords in their particular institutional context compared to those of others abroad and at home in different environments. The existence of this form of reflexivity requires recognition and methodological accommodation.     

胚胎干细胞及诱导多能干细胞在胚胎毒性研究中的应用

药物对于生殖细胞或者早期胚胎的影响将会引起不孕或者种植前胚胎的发育异常,进而引起胚胎毒性或者是后代的畸形,因此药物的临床应用需要有可靠的实验数据证明其对胚胎的影响,而胚胎干细胞(embryonic stem cell,ESC)由于其无限增殖及多向分化的潜能而作为研究药物胚胎毒性的细胞模型得到广泛应用,以ESC为基础的胚胎干细胞实验(embryonic stem cell test,EST)是获得国际认可的胚胎毒性评价的体外替代方法,但是该实验方法的快速性和准确性存在一定的局限性,目前该细胞模型的研究主要集中于快速性和准确性的优化。新兴的诱导多能干细胞(induced pluripotent stem cells,i PSC),由于具有与ESC相似的增殖和分化特性,目前也被逐步应用于药物胚胎毒性的研究。     

Embryo futures and stem cell research: the management of informed uncertainty

In the social worlds of assisted conception and stem cell science, uncertainties proliferate and particular framings of the future may be highly strategic. In this article we explore meanings and articulations of the future using data from our study of ethical and social issues implicated by the donation of embryos to human embryonic stem cell research in three linked assisted conception units and stem cell laboratories in the UK. Framings of the future in this field inform the professional management of uncertainty and we explore some of the tensions this involves in practice. The bifurcation of choices for donating embryos into accepting informed uncertainty or not donating at all was identified through the research process of interviews and ethics discussion groups. Professional staff accounts in this study contained moral orientations that valued ideas such as engendering patient trust by offering full information, the sense of collective ownership of the National Heath Service and publicly funded science and ideas for how donors might be able to give restricted consent as a third option.     

What does "respect for embryos" mean in the context of stem cell research?

This article addresses two questions: 1) how to understand "respect for embryos," and 2) whether the distinction between surplus embryos from in vitro fertilization and embryos created for research purposes has validity. I caution against confusing respect for embryos as a form of human life with the respect that persons, as autonomous agents, deserve. I also argue that there is no moral difference between research that uses spare embryos and research that uses embryos created for that purpose. The value of the research is what determines whether it accords with the principle of respect for embryos, not the source of the embryos.