Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stemcells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a (...) safety trial, subacute incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial. (shrink)
In early 2009, President Obama overturned the ban on federal funding for research involving the derivation of human embryonic stemcells (hESC). The Food and Drug Administration (FDA) also approved Geron’s first-in-human hESC trial for spinal cord injury (SCI) patients. We anticipate an increase in both research in the United States to derive hESC and applications to the FDA for approval of clinical trials involving transplantation of hESCs. An increase of such clinical trials will require a concomitant increase (...) in the number of preceding preclinical assays. We examine important issues concerning the use of animals in SCI stem cell research that require a reevaluation of the moral permissibility of studies such as Geron’s. (shrink)
: Experiments involving the transplantation of human stemcells and their derivatives into early fetal or embryonic nonhuman animals raise novel ethical issues due to their possible implications for enhancing the moral status of the chimeric individual. Although status-enhancing research is not necessarily objectionable from the perspective of the chimeric individual, there are grounds for objecting to it in the conditions in which it is likely to occur. Translating this ethical conclusion into a policy recommendation, however, is complicated (...) by the fact that substantial empirical and ethical uncertainties remain about which transplants, if any, would significantly enhance the chimeric individual's moral status. Considerations of moral status justify either an early-termination policy on chimeric embryos, or, in the absence of such a policy, restrictions on the introduction of pluripotent human stemcells into early-stage developing animals, pending the resolution of those uncertainties. (shrink)
In 2001, the U.S. House of Representatives passed the "Human Cloning Prohibition Act" and President Bush announced his decision to allow only limited research on existing stem cell lines but not on "embryos." In contrast, the U.K. has explicitly authorized "therapeutic cloning." Much more will be said about bioethical, legal, and social implications, but subtleties of the science and careful definitions of terms have received much less consideration. Legislators and reporters struggle to discuss "cloning," "pluripotency," "stemcells," (...) and "embryos," and whether "adult" are preferable to "embryonic" stemcells as research subjects. They profess to abhor "copying humans" or "killing embryos." Do they know what they are talking about? Do we? This paper explores the historical, philosophical, and scientific contexts that inform this heated discussion. (shrink)
Over the past few years, several proposals aimed at procuring human pluripotent (embryonic-like) stemcells without involving the destruction of a human embryo have been proposed and widely discussed. This article focuses on a basic aspect of the debate, namely the plausibility of one or more of these new proposals being able to meet the ethical requirements that those who regard the human embryo as sacred have tried to impose on stemcells research in the last (...) ten years. The thesis of the article is that focusing the discussion only on the sources of stemcells has prevented a full understanding of the foundation, meaning and scope of these ethical requirements. To substantiate this thesis, the article takes into consideration two issues: the first has to do with the potential of the cells obtained through some of the new approaches (iPS included), the second (and decisive) with the argument of the ‘indirect complicity’, applied to the use of ‘contaminated’ knowledge. (shrink)
Embryonic stemcells are actively debated in political and public policy arenas. However, the connections between stem cell innovation and overall health care policy are seldom elucidated. As with many controversial aspects of medical care, the stem cell debate bridges to a variety of social conversations beyond abortion. Some issues, such as translational medicine, commercialization, patient and public safety, health care spending, physician practice, and access to insurance and health care services, are core health policy concerns. (...) Other issues, such as economic development, technologic progress, fiscal politics, and tort reform, are only indirectly related to the health care system but are frequently seen through a health care lens. These connections will help determine whether the stem cell debate reaches a resolution, and what that resolution might be. (shrink)
In a thought experiment we want to test how the emergence of adult neural stemcells could constitute an example for a scientific revolution in the sense of Thomas Kuhn. In his major work, The structure of scientific revolutions, 3rd edn, University of Chicago Press, Chicago (Kuhn 1996), the philosopher of science, Thomas Kuhn, states that scientific progress is not a cumulative process, but new theories appear by a rather revolutionary sequence of events. Kuhn built his theory on (...) landmark events taken from chemistry and physics, lacking examples from biology. Beginning with Ramon y Cajalâs famous quote, no new neurons after birth , from the early years of the twentieth century, and Reynolds and Weissâs conflicting finding in 1992 of adult neural stemcells giving rise to new neurons, we will test how the finding of neural stemcells in the adult brain matches with Kuhnâs theory. The pivotal problem of defining a paradigm will be our main focus, since the emergence of adult neural stemcells has been acclaimed by the scientific community as the rebuttal of Ramon y Cajalâs paradigm. (shrink)
Ford, Norman Once therapies using embryonic stemcells enter clinical practice, pressure will increase to find pluripotent stemcells for therapeutic purposes that are not derived from human embryos. This article explores several likely sources of such pluripotent cells.
Multidisciplinary Perspectives on the Donation of StemCells and Reproductive Tissue Content Type Journal Article Category Symposium Pages 15-17 DOI 10.1007/s11673-011-9351-x Authors Catherine Waldby, School of Social and Political Sciences, University of Sydney, Sydney, Australia Ian Kerridge, Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building (K25), University of Sydney, Sydney, NSW 2006, Australia Loane Skene, Faculty of Law and Faculty of Medicine, Dentistry and Health Studies, University of Melbourne, Melbourne, VA, Australia Journal Journal of (...) Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529 Journal Volume Volume 9 Journal Issue Volume 9, Number 1. (shrink)
Ford, Norman Many people think that the Catholic Church is morally opposed to all research and therapeutic use of stemcells. This is far from the truth. The Church is rightly morally opposed to all destructive use of human embryos to obtain pluripotent embryonic stemcells, but it is not opposed to pluripotent stemcells ethically derived from adult cells.
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 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)
The first stage of the human embryonic stem(ES) cell research debate revolved aroundfundamental questions, such as whether theresearch should be done at all, what types ofresearch may be done, who should do theresearch, and how the research should befunded. Now that some of these questions arebeing answered, we are beginning to see thenext stage of the debate: the battle forproperty rights relating to human ES cells. The reason why property rights will be a keyissue in this debate is (...) simple and easy tounderstand: it costs a great deal of money todo this research, to develop new products, andto implement therapies; and private companies,researchers, and health professionals requirereturns on investments and reimbursements forgoods and services. This paper considersarguments for and against property rightsrelating to ES cells defends the followingpoints: (1) It should be legal to buy and sellES cells and products. (2) It should be legalto patent ES cells, products, and relatedtechnologies. (3) It should not be legal tobuy, sell, or patent human embryos. (4) Patentson ES cells, products, and related technologiesshould not be excessively broad. (5) Patents onES cells, products, and related technologiesshould be granted only when applicants statedefinite, plausible uses for their inventions. (6) There should be a research exemption in EScell patenting to allow academic scientists toconduct research in regenerative medicine. (7)It may be appropriate to take steps to preventcompanies from using patents in ES cells,products, and related technologies only toblock competitors. (8) As the field ofregenerative medicine continues to develop,societies should revisit issues relating toproperty rights on a continuing basis in orderto develop policies and develop regulations tomaximize the social, medical, economic, andscientific benefits of ES cell research andproduct development. (shrink)
Hematopoietic stem cell transplantation is a widely accepted practice in the United Kingdom (UK). The relatively liberal UK law permits donation both within families and from strangers, and even allows the creation of “saviour siblings” who are brought into being with the specific intent of having them donate stemcells to save other members of their family. This chapter describes the regulation of HSCT in the UK and highlights some ethical issues related to discrimination against some categories (...) of potential donors, the accuracy of the information provided to potential donors, and the controversy concerning saviour siblings. (shrink)
: Successful stem cell therapies might change the natural contours of human life. If that happened, it would unsettle our ethical commitments and encourage us to see the entire natural world merely as material to be manipulated.
This article contributes to the current debate on human embryonic stem cell researchers’ possible complicity in the destruction of human embryos and the relevance of such complicity for the issue of commodification of human embryos. I will discuss if, and to what extent, researchers who destroy human embryos, and researchers who merely use human embryos destroyed by others, have moral use rights, and/or moral property rights, in these embryos. I argue that the moral status of the human embryo, however (...) justified, places few restrictions on the latter researchers’ use of it, and property rights in it, once it is destroyed. I argue that the former researchers have no property rights in the destroyed embryo but use rights in it to the extent allowed by the legitimate owners of the destroyed embryo. I discuss the implications of this account for previous and current US federal law regulating human embryonic stem cell research. (shrink)
The world of science was stunned, and the hopes of many people dashed, when Professor Hwang Woo Suk of Seoul National University was recently found guilty of massive scientific fraud. Until January 2006 he was considered one of the world’s leading experts in cloning and stem cell research. Yet he was found by his own university to have fabricated all of the cell lines he claimed, in articles published in Science in 2004 and 2005, to have derived from cloned (...) human embryos. By the time he was exposed, Hwang had been given the title of leading scientist in Korea by his government. A postage stamp had been issued in his honour, showing a paralysed man leaping out of a wheelchair to embrace his lady love. Schoolchildren read specially produced stories of the indefatigable scientist who supposedly worked 365 days a year for the sake of saving humanity from disease and disability. When I spoke on the ethical wrongness of human embryonic stem cell research at a major conference in San Francisco in 2005, I overheard scientists — professors of high repute and excited graduate students alike — speaking in awed tones of the incredible technical skill that Hwang and his team were thought to have displayed. He told N din re Medicine that his dexterity was a cultural inheritance: "This work can be done much better in Oriental hands. We can pick up very slippery corn or rice with steel chopsticks.'. (shrink)
The nineteenth century science of teratology concerned itself with the study of malformations or “monstrosities”, as they were then called. The first major contribution to the field was the work of Isidore Geoffroy Saint-Hilaire, Histoire Generale et Particulière des Anomalies de l’Organisation chez l’Homme et les Animaux, published in 1832, whose classifications formed the basis for the later experimental science of teratogeny, the art of reproducing monstrosities in animal embryos. In this article, I will argue that recent developments in the (...) field of regenerative medicine can be situated in the tradition of teratological and teratogenic studies dating back to the nineteenth century. In particular, I will be interested in the historical link between studies in teratogenesis (the artificial production of teratomas) and stem cell research. Recent advances in stem cell research, I will suggest, return us to the questions that animated nineteenth century investigations into the nature of the monstrous or the anomalous. In the process, our most intuitive conceptions of “life itself” are undergoing a profound transformation. (shrink)
Governance models for the oversight of human embryonic stem cell research have been proposed which mirror in large part familiar oversight mechanisms for research with human subjects and non-human animals. While such models are in principle readily endorsable, there are a set of concerns related to their implementation — such as ensuring that an elaborated informed consent process and conducting long-term monitoring of research subjects are tenable — which suggest areas where gathering data may facilitate more appropriate oversight. In (...) addition, it is unclear whether a new governance model based at individual institutions are sufficient to address the ethical issues inherent to this research. Regardless, some of the concerns that have arisen in considering the appropriate governance of stem cell research, particularly the important translational pathway of innovation in contrast to staged research, transparency and publication, and social justice, may be useful in science and translational research more broadly. (shrink)
Should innovative therapy occur only within a research paradigm and under institutional review board oversight? The health risks from current human embryonic stem cell clinical applications have raised again a fundamental question addressed first in papers submitted to inform the writing of the Belmont Report. Revisiting the thinking underlying the Belmont Report, together with examining changed circumstances since then, leads to a new model for overseeing innovative therapy based on its unique risks and context, important changes since the Belmont (...) Report, and new opportunities for addressing risks through safety and quality systems in health care. (shrink)
Pike, Gregory K The various levels at which misunderstanding exist with regards to stem cell research are discussed. The mismatch that exists between public perception and reality with regards to the same is highlighted.
Introduction The present volume contains the proceedings of the First International Conference on Medical Ethics which took place in Nicosia, from the 24th ...
Over the last decade, stem cell research has generated an enormous amount of public, political and bioethical debate. These debates have overwhelmingly tended to focus on two moral issues: the moral status of human embryos and the duty to care for the sick and vulnerable. This preoccupation, especially on the question of moral status, has not only dichotomized the debate around two fundamentally incommensurable positions, it has come at the cost of other important issues largely being ignored. In highlighting (...) some of the bioethical and regulatory deficiencies of this fixation, we draw on recent developments in the experimental use of autologous adult stemcells to argue for a more inclusive approach to the ethical issues surrounding stem cell research. (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)
As a moral philosopher, the perspective I will take in this chapter is one of argumentation and informed judgment about two main questions: whether individuals should ever choose to conduct human embryonic stem cell research, and whether the law should permit this type of research. I will also touch upon a secondary question, that of whether the government ought to pay for this type of research. I will discuss some of the main arguments at stake, and explain how the (...) ethical conflict over these questions differs from the political conflict over them. I will be guided throughout by the assumption that the unique scientific and clinical promise of human embryonic stem cell research is significant. Those who have doubts about this assumption should consult other chapters in this volume in which the issue is addressed directly. I begin with one of the basic facts relevant to the ethical issue of stem cell research: you and I, along with everybody else we know, developed out of clumps of primordial cells, which happen to be the very same clumps that serve as the source for human embryonic stemcells in the laboratory. Let us call these “source cells” for short, since they can be used in this way. Each individual has developed into whatever she is now out of a one-celled animal, which then became a blastocyst, a multi-celled human embryo. These blastocysts are partly made up of an inner mass of cells, and the body of every adult person has developed out of this inner mass. It is this very same clump from the inner part of the blastocyst that consists of source cells for human embryonic stem 1 cell research. These cells can be extracted and grown into a laboratory specimen of extraordinary interest to scientists. Before discussing the significance of the fact that all humans originate from these source cells, it is useful to begin by asking some perhaps rather simple-minded questions about how any one of us knows this fact to be true in the first place. How do I know that I developed from a single cell, and then a blastocyst? In my own case, the main way I know this is that other people have told me so.. (shrink)
Abstract I argue that embryonic stem cell research is fair to the embryo, even on the assumption that the embryo has attained full personhood and an attendant right to life at conception. This is because the only feasible alternatives open to the embryo are to exist briefly in an unconscious state and be killed or to not exist at all. Hence, one is neither depriving the embryo of an enduring life it would otherwise have had nor is one causing (...) the embryo pain. I also argue that a rational agent in a situation relevantly similar to that of the embryo would consent to such research, and I use this insight to ground two justice-based arguments in favor of this research. Content Type Journal Article Category Original Research Pages 1-9 DOI 10.1007/s11673-012-9364-0 Authors Aaron Rizzieri, The Humanities Department (E-202), LaGuardia Community College, 31-10 Thompson Ave, Long Island City, NY 11101, USA Journal Journal of Bioethical Inquiry Online ISSN 1872-4353 Print ISSN 1176-7529. (shrink)
To determine the knowledge, attitude, and ethical concerns of medical students and graduates with regard to Embryonic Stem Cell (ESC) research. This questionnaire based descriptive study was conducted at the Civil Hospital Karachi (CHK), Pakistan from February to July 2008. A well structured questionnaire was administered to medical students and graduate doctors, which included their demographic profile as well as questions in line with the study objective. Informed consent was taken and full confidentiality was assured to the participants. Data (...) were entered in a Statistical Package for Social Sciences (SPSS version.12) and analyzed. A total of 204 male and 216 female medical students and doctors were administered questionnaires out of which 105 males (51.4%) and 108 females (50%) were aware of the embryonic stem cell research and its ethical implications. Forty percent males and 47% of females were of the opinion that life begins at conception. Forty-six percent males and 39% females were in favor of stem cell research while only 31% males and 28% females supported the ESC research. Less than 1/3 of students supported using frozen embryos for research purposes while more than 2/3 indicated that they were unlikely to support abortion for stem cell research purposes. The majority of the students were in favor of stem cell research with some reservations regarding ESC research. A sizeable number of students withheld their views, reflecting their poor understanding of medical ethics. The result of the study indicates a need for incorporating bioethics into the medical curriculum. (shrink)
The paper looks in detail at patients that were treated at one of the most discussed companies operating in the field of untried stem cell treatments, Beike Biotech of Shenzhen, China. Our data show that patients who had been treated at Beike Biotech view themselves as proactively pursuing treatment choices that are not available in their home countries. These patients typically come from a broad variety of countries: China, the United Kingdom, the United States, South Africa and Australia. Among (...) the patients we interviewed there seemed to be both an awareness of the general risks involved in such experimental treatments and a readiness to accept those risks weighed against the possible benefits. We interpret this evidence as possibly reflecting the emergence of risk-taking patients as ‘consumers’ of medical options as well as the drive of patients to seek treatment options in the global arena, rather than being hindered by the ethical and regulatory constraints of their home countries. Further, we found that these patients tend to operate in more or less stable networks and groups in which they interact and cooperate closely and develop opinions and assessments of available treatment options for their ailments. These patients also perform a multiple role as patients, research subjects, and research funders because they are required to pay their way into treatment and research activities. This new social dynamics of patienthood has important implications for the ethical governance of stem cell treatments. (shrink)
If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.
Is it permissible to use a human embryo in stem cell research, or in general as a means for benefit of others? Acknowledging each embryo as an object of moral concern, Louis M.Guenin argues that it is morally permissible to decline intrauterine transfer of an embryo formed outside the body, and that from this permission and the duty of beneficence, there follows a consensus justification for using donated embryos in service of humanitarian ends. He then proceeds to show how (...) this justification commands assent even within moral and religious views commonly thought to oppose embryo use. Beneath his moral reasoning lies a carefully constructed metaphysical foundation incorporating accounts of the ontology of development, embryos, and species. He also incisively discusses nonreprocloning, reprocloning, ectogenesis, and related scientific frontiers. This compelling philosophical study will interest all concerned to understand virtue and obligation in the relief of suffering. (shrink)
In this article I rebut conservative objections to five phases of embryonic stem cell research. I argue that researchers using existing embryonic stem cell lines are not complicit in the past destruction of embryos because beneficiaries of immoral acts are not necessary morally tainted. Second, such researchers do not encourage the destruction of additional embryos because fertility clinics presently destroy more spare embryos than researchers need. Third, actually harvesting stemcells from slated-to-be-discarded embryos is not wrong. (...) The embryos are not sacrificed for the good of others because they would have been destroyed anyway. Fourth, harvesting stemcells from embryos that are not doomed is morally acceptable, because preserving frozen embryos is futile therapy. Finally, creating embryos solely for the sake of harvesting stemcells from them is morally acceptable because the assumption that embryos have the right to life has very counterintuitive implications. (shrink)
Direct reprogramming of human skin cells makes available a source of pluripotent stemcells without the perceived evil of embryo destruction, but the advent of such a powerful biotechnology entangles stem cell research in other forms of moral complicity. Induced pluripotent stem cell (iPSC) research had its origins in human embryonic stem cell research and the projected biomedical applications of iPS cells almost certainly will require more embryonic stem cell research. Policies that (...) inhibit iPSC research in order to avoid moral complicity are themselves complicit in preventable harms to patients. Moral complicity may be unavoidable, but a Blue Ribbon Panel charged with assessing the need for additional embryonic stem cell lines may ease a transition from embryonic stem cell research to clinical applications of iPS cells. (shrink)
: Embryonic stemcells, which have the potential to save many lives, must be recovered from aborted fetuses or live embryos. Although tissue from aborted fetuses can be used without moral complicity in the underlying abortion, obtaining stemcells from embryos necessarily kills them, thus raising difficult questions about the use of embryonic human material to save others. This article draws on previous controversies over embryo research and distinctions between intrinsic and symbolic moral status to analyze (...) these issues. It argues that stem cell research with spare embryos produced during infertility treatment, or even embryos created specifically for research or therapeutic purposes, is ethically acceptable and should receive federal funding. (shrink)
Research using human embryonic stemcells raises an array of complex ethical issues, including, but by no means limited to, the moral status of developing human life. Unfortunately much of the public discussion fails to take into account this complexity. Advocacy for liberal and conservative positions on human embryonic stem cell research can be simplistic and misleading. Ethical concepts such as truth-telling, scientific integrity, and social justice should be part of the debate over federal support for human (...) embryonic stem cell research. Moreover, the debate should be conducted in accord with principles of deliberative democracy, including respect for people holding competing views. (shrink)
An important contribution of Christian ethics in the pluralistic world of the twenty-first century is to emphasize inclusivity. Rather than promoting the interests of certain groups at the expense of the most vulnerable, society does well to prioritize ways forward that benefit all. For stem cell research, inclusivity entails benefiting or at least protecting the beneficiaries of treatment, the sources of materials, and the subjects of research. Adult stemcells are already benefiting many ill patients without causing (...) harm, and select adult cells may prove even more beneficial in the future. Other types of stemcells require other bodily materials such as eggs and somatic cells that should be obtained without unduly harming those who provide them. Research subjects, especially the most vulnerable, require protection as well. Should human embryos be included among them? Considerations of location, formation, individuation, and intention are here examined. Ultimately, for safety reasons as well as workability, pluripotency, and compatibility, relatively new types of pluripotent stemcells, especially induced pluripotent stemcells, warrant special priority according to an inclusive ethics. (shrink)
: In February 2004, South Korean researchers became the first in the world to successfully harvest stemcells and establish a stem cell line from a cloned human embryo. This is just one of eight possible policy options concerning human embryonic stem cell research. In practice, every kind of stem cell research can be done in one country or another. This paper evaluates the eight policy options concerning human embryonic stem cell research in light (...) of the arguments and decisions behind them. (shrink)
Until now, philosophical debate about human embryonic stem cell (hESC) research has largely been limited to its ethical dimensions and implications. Although the importance and urgency of these ethical debates should not be underestimated, the almost undivided attention that mainstream and feminist philosophers have paid to the ethical dimensions of hESC research suggests that the only philosophically interesting questions and concerns about it are by and large ethical in nature. My argument goes some distance to challenge the assumption that (...) ethical considerations alone must be foregrounded in philosophical discussions about hESC research by introducing a critical stance on the epistemological and ontological assumptions that underlie and condition it. A central aim of the paper is to show how Foucault's insights into knowledge-power, taken in combination with Hacking's claims about styles of reasoning, can make these assumptions evident, as well as cast light on their potentially deleterious implications for disabled people. Arguing in this way also enables me to draw out constitutive effects of research on stemcells, that is, to indicate how the discursive practices surrounding research on stemcells, as well as the technology itself, contribute to the constitution of impairment. (shrink)
: The medical and clinical promise of stem cell research is widely heralded, but moral judgments about it collide. This article takes general stock of such judgments and offers one specific resolution. It canvasses a spectrum of value judgments on sources, complicity, adult stemcells, and public and private contexts. It then examines how debates about abortion and stem cell research converge and diverge. Finally, it proposes to extend the principle of "nothing is lost" to current (...) debates. This extension links historic discussions of the ethics of direct killing with unprecedented possibilities that in vitro fertilization procedures yield. A definite normative region to inhabit is located, within a larger range of rival value judgments. The creation of embryos for research purposes only should be resisted, yet research on "excess" embryos is permissible by virtue of an appeal to the "nothing is lost" principle. (shrink)
Feminists have indicated the inadequacies of bioethical debates about human embryonic stem cell research, which have for the most part revolved around concerns about the moral status of the human embryo. Feminists have argued, for instance, that inquiry concerning the ethics and politics of human embryonic stem cell research should consider the relations of social power in which the research is embedded. My argument is that this feminist work on stemcells is itself inadequate, however, insofar (...) as it has not incorporated an analysis of disability into its considerations of the ethical and political issues that surround the phenomena. Thus, I consider claims that disability theorists and anti-disability activists have made about the research. I conclude by indicating that stem cell research must be situated within a cultural matrix that operates in the service of normalisation. (shrink)
: In 1998, researchers discovered that embryonic stemcells could be derived from early human embryos. This discovery has raised a series of ethical and public-policy questions that are now being confronted by multiple international organizations, nations, cultures, and religious traditions. This essay surveys policies for human embryonic stem cell research in four regions of the world, reports on the recent debate at the United Nations about one type of such research, and reviews the positions that various (...) religious traditions have adopted regarding this novel type of research. In several instances the religious traditions seem to have influenced the public-policy debates. (shrink)
In 2004 and 2005, Woo-Suk Hwang achieved international stardom with publications in Science reporting on successful research involving the creation of stemcells from cloned human embryos. The wonder and success all began to unravel, however, when serious ethical concerns were raised about the source of the eggs for this research. When the egg scandal had completely unfolded, it turned out that many of the women who provided eggs for stem cell research had not provided valid consents (...) and that nearly 75% of the women egg providers had received cash or in-kind payments. Among those who did not receive direct benefits, some cited patriotism as their reason for participating in embryonic stem cell research, hence the question “for love or money?”—namely, patriotism versus payment. This paper summarizes the Hwang debacle with particular attention to the egg scandal and ends with some preliminary thoughts on patriotism as a motive for research participation. (shrink)
This overview of 10 years of stem cell controversy reviews the moral conflict that has made ESCs so controversial and how this conflict plays itself out in the legal realm, focusing on the constitutional status of efforts to ban ESC research or ESC-derived therapies. It provides a history of the federal funding debate from the Carter to the Obama administrations, and the importance of the Raab memo in authorizing federal funding for research with privately derived ESCs despite the Dickey-Wicker (...) ban on federal funding of embryo research. It also reviews the role that scientists themselves have played in developing regulations for ESC research, the emergence of ESCROs as special review bodies for ESC research, and the thorough consent requirements for donation of IVF embryos to ESC research. With research now transitioning from the lab to the clinic, the article reviews the challenges of ensuring safety and consent in translational research. It concludes with a call for respecting those persons who have to using or working with ESC products and an account of how obtaining stemcells from a person's own cells will alleviate some but not all of the controversy surrounding ESC research. (shrink)
: The transplantation of adult human neural stemcells into prenatal non-humans offers an avenue for studying human neural cell development without direct use of human embryos. However, such experiments raise significant ethical concerns about mixing human and nonhuman materials in ways that could result in the development of human-nonhuman chimeras. This paper examines four arguments against such research, the moral taboo, species integrity, "unnaturalness," and human dignity arguments, and finds the last plausible. It argues that the transfer (...) of human brain or retinal stemcells to nonhuman embryos would not result in the development of human-nonhuman chimeras that denigrate human dignity, provided such stemcells are dissociated. The article provides guidelines that set ethical boundaries for conducting such research that are consonant with the requirements of human dignity. (shrink)
This paper will address the translation of basic stem cell research into clinical research. While “stem cell” trials are sometimes used to describe established practices of bone marrow transplantation or transplantation of primary cells derived from bone marrow, for the purposes of this paper, I am primarily focusing on stem cell trials which are far less established, including use of hESC derived stemcells. The central ethical challenges in stem cell clinical trials arise (...) in frontier research, not in standard, well-established areas of research. (shrink)
This paper aims to bring the epistemic dimensions of stem cell experiments out of the background, and show that they can be critically evaluated. After introducing some basic concepts of stem cell biology, I set out the current “gold standard” for experimental success in that field (§2). I then trace the origin of this standard to a 1988 controversy over blood stemcells (§3). Understanding the outcome of this controversy requires attention to the details of experimental (...) techniques, the organization of epistemic communities, and relations between the two (§4). With its resolution, a standard for experimental success was established for HSC research, which in turn serves as an exemplar for studies of other stemcells. This historical case study reveals a robust standard for experimental success in stem cell biology: to trace processes of development at the single-cell level, in the form of cell lineage hierarchies. Experiments conforming to this standard can be further critically assessed as means to the therapeutic end of stem cell research: use of stemcells to repair human organs and tissues. (shrink)
: This response to Nikolaus Knoepffler's paper in the same issue of the Journal agrees that if the arguments supporting the first two of the eight human embryonic stem cell research policy options discussed are unsound, as Knoepffler argues, then it seems natural to move to the increasingly permissive options. If the arguments are sound, however, then the more permissive options should be rejected. It is argued that three of the rejected arguments, taken together, constitute very good reasons to (...) hold that a human embryo is endowed with dignity from fertilization onward. Thus, countries that want their public policies to match the moral imperative of respect for human beings should refrain from allowing destructive human embryo research and should devote considerable energy and public funds to research and clinical trials using non-embryonic ("adult") stemcells. (shrink)
Germany since 1990 has one of the strictest human embryo protection laws, yet according to the Stem Cell Act of 2002 allows, under strict conditions, the import and use of human embryonic stemcells (hESC) for high priority research goals. The author tries to show how this is taken to be coherent by the parliamentary majority (though not necessarily by the general public) in Germany. In doing so, he firstly looks into the chronicle of the debate in (...) Germany showing its different stages since 1999, then dwells upon the relation between the law and the role of ethics in this issue, and thirdly presents the two fundamentally different positions of the German debate, that is, that the human embryo created for IVF purposes is a human being and stands from its very beginnings under the constitutional principles of respect for, and protection of, human life versus the position that before being implanted the human embryo may become a human being and therefore belongs to the human species only potentially, so that its right to life protection may be assessable over against other high priority goals, such as research aiming at possible help for patients with life-endangering diseases. In spite of the Stem Cell Act of 2002, the debate of the German general public goes on, especially due to the recent EU 6th Research Framework Program which plans to also fund hESC research. (shrink)
Clinics and hospitals around the globe are offering stem cell treatments to persons with serious conditions for whom no effective therapies are available in their home countries. Many of these treatments, which are touted as cures for such conditions as Parkinson's and Alzheimer's Diseases, multiple sclerosis, and spinal cord injuries, have not gone through clinical trials that establish their safety and efficacy. Indeed, it is unclear whether some of them even utilize stemcells. State regulation of these (...) therapies tends to be weak or nonexistent in some of the countries in which they are offered. This puts those who believe they must travel abroad for stem cell treatments at risk of injury from procedures that .. (shrink)
Some stem cell researchers believe that it is easier to derive human embryonic stemcells from fresh rather than frozen embryos and they have had in vitro fertilization (IVF) clinicians invite their infertility patients to donate their fresh embryos for research use. These embryos include those that are deemed 'suitable for transfer' (i.e. to the woman's uterus) and those deemed unsuitable in this regard. This paper focuses on fresh embryos deemed suitable for transfer - hereafter 'fresh embryos'- (...) which IVF patients have good reason not to donate. We explain why donating them to research is not in the self-interests specifically of female IVF patients. Next, we consider the other-regarding interests of these patients and conclude that while fresh embryo donation may serve those interests, it does so at unnecessary cost to patients' self-interests. Lastly, we review some of the potential barriers to the autonomous donation of fresh embryos to research and highlight the risk that female IVF patients invited to donate these embryos will misunderstand key aspects of the donation decision, be coerced to donate, or be exploited in the consent process. On the basis of our analysis, we conclude that patients should not be asked to donate their fresh embryos to stem cell research. (shrink)
Stem cell biology is driven by experiment. Its major achievements are striking experimental productions: "immortal" human cell lines from spare embryos (Thomson et al. 1998); embryo-like cells from "reprogrammed" adult skin cells (Takahashi and Yamanaka 2006); muscle, blood and nerve tissue generated from stemcells in culture (Lanza et al. 2009, and references therein). Well-confirmed theories are not so prominent, though stem cell biologists do propose and test hypotheses at a profligate rate. 1 This (...) paper aims to characterize the role of experiment in stem cell biology, so as to answer the following question: how do experiments contribute to our knowledge of stemcells and related phenomena? The .. (shrink)
: Catholic teaching has no moral difficulties with research on stemcells derived from adult stemcells or fetal cord blood. The ethical problem comes with embryonic stemcells since their genesis involves the destruction of a human embryo. However, there seems to be significant promise of health benefits from such research. Although Catholic teaching does not permit any destruction of human embryos, the question remains whether researchers in a Catholic institution, or any researchers (...) opposed to destruction of human embryos, could participate in research on cultured embryonic stemcells, or whether a Catholic institution could use any therapy that ultimately results from such research. This position paper examines how such research could be conducted legitimately in a Catholic institution by using an ethical analysis involving a narrative context, the nature of the moral act, and the principle of material cooperation, along with references to significant ethical assessments. It also offers tentative guidelines that could be used by a Catholic institution in implementing such research. (shrink)
In the US, stem cell research is at a moral impasse—many see this research as ethically mandated due to its potential for ameliorating major diseases, while others see this research as ethically impermissible because it typically involves the destruction of embryos and use of ova from women. Because their creation does not require embryos or ova, induced pluripotent stemcells offer the most promising path for addressing the main ethical objections to stem cell research; however, this (...) technology is still in development. In order for scientists to advance induced pluripotent stem cell research to a point of translational readiness, they must continue to use ova and embryos in the interim. How then are we to ethically move forward with stem cell research? We argue that there is personal integrity and value in adopting a ‘moral compromise’ as a means for moving past the moral impasse in stem cell research. In a moral compromise, each party concedes part of their desired outcome in order to engage in a process that respects the values and desires of all parties equitably. Whereas some contend that moral compromise in stem cell research necessarily involves self-contradiction or loss of personal integrity, we argue that in the US context, stem cell research satisfies many of the key pre-conditions of an effective moral compromise. To illustrate our point, we offer a model solution wherein eggs and embryos are temporarily used until non-egg and non-embryonic sources of pluripotent stemcells are developed to a state of translational readiness. (shrink)
In the wake of two recent developments in stem cell research, it is a fitting time to reassess the claim that stemcells will radically transform the concept and function of medicine. The first is the U.S. Food and Drug Administration’s decision in January 2009 to approve Geron Corporation’s Phase I clinical trial using human embryonic stemcells for patients with spinal cord injuries. The second is the National Institutes of Health’s decision to permit federal (...) funding of research using donated IVF human embryos in their July 2009 Guidelines on Human Stem Cell Research. We are now poised to see whether stem cell research can deliver on what it promises. However, what exactly does it promise and how? Moreover, who is doing the promising? Turning to the use of metaphor can help us to answer these questions and enable us to develop a better appreciation of the unique features of promised stem cell therapies. Indeed, metaphors have exerted profound influence in medicine, and it is fitting that we seek new metaphors for new therapies where appropriate. In this case, other metaphors such as magic bullets or the Holy Grail cannot capture what is unique about stemcells. Accordingly, I propose a new metaphor: the stem cell superhero. Stem cell superheroes are characterized by the following traits: they are seemingly capable of fighting the evil of virtually all disease (unlike “magic bullets”) and they seem to be our only hope of doing so, although to summon them we must make difficult moral choices. In the course of assessing the merits of three recent yet covert references to the superhero metaphor, I conclude that this powerful new paradigm employs a problematic logic (i.e., we cannot know that something is “our only hope”), but that the aspiration as such is a good one. (shrink)
: This essay considers the implications of President George W. Bush's proposal for human embryonic stem cell research. Through the perspective of patent law, privacy, and informed consent, we elucidate the ongoing controversy about the moral standing of human embryonic stemcells and their derivatives and consider how the inconsistencies in the president's proposal will affect clinical practice and research.
The complexities of modern science are not adequately reflected in many bioethical discussions. This is especially problematic in highly contested cases where there is significant pressure to generate clinical applications fast, as in stem cell research. In those cases a more integrated approach to bioethics, which we call systems bioethics, can provide a useful framework to address ethical and policy issues. Much as systems biology brings together different experimental and methodological approaches in an integrative way, systems bioethics integrates aspects (...) of the history and philosophy of science, social and political theory, and normative analysis with the science in question. In this paper we outline how a careful analysis of the science of stem cell research can help to refocus the discussions related to the clinical applications of stemcells. We show how inaccurate or inadequate scientific assumptions help to create a set of unrealistic expectations and badly inform ethical deliberations and policy development. Systems bioethics offers resources for moving beyond the current impasse. (shrink)
: The controversy about research on human embryonic stemcells both divides and defines us, raising fundamental ethical and religious questions about the nature of the self and the limits of science. This article uses Jewish sources to articulate fundamental concerns about the forbiddenness of knowledge in general and of knowledge thought of as magical creation. Alchemy, and the turning of elements into gold and into substances for longevity, and magic used for the creation of living beings was (...) at stake in various Talmudic texts. Since contemporary discourse calls regenerative science magical, and makes claims about its restorative power, careful reflection on when magic is forbidden and when it is responsible allows a novel understanding of ethical questions in stem cell research. (shrink)
Stem cell research has important implications for medicine. The source of stemcells influences their therapeutic potential, with stemcells derived from early-stage embryos remaining the most versatile. Somatic cell nuclear transfer (SCNT), a source of embryonic stemcells, 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)
While society debates whether and how to use public funds to support work on human embryonic stemcells (hESCs), many scientific groups and businesses debate a different question — the extent to which patents that cover such stemcells should be permitted to limit or to tax their research. The Wisconsin Alumni Research Foundation (WARF), a non-profit foundation that manages intellectual property generated by researchers at the University of Wisconsin at Madison, owns three patents that have (...) been at the heart of the latter controversy The story of WARF's patents and the controversy they have fostered highlights not only continuing tensions between proprietary and nonproprietary approaches to developing science and technology, but also an at least partly reassuring capacity of public and private sectors to deal with those tensions in a way that can render them substantially manageable, and frequently more manageable as a technology matures. More particularly, the cumulative story of WARF's patents features three leitmotifs that suggest how an attentive and engaged public sector might commonly succeed in working with public and private sector actors to achieve workable balances between proprietary rights and more general social interests: (1) right holders' decisions to pursue less than full rights assertion or enforcement; (2) the ability of government and other public sector actors to help bring about such decisions through co-option or pressure; and (3) the frequent availability or development of technological alternatives that limit research bottlenecks. (shrink)
