It is now 10 years ago that human embryonic stem cell research appeared as a major topic of societal concern following significant scientific breakthroughs.1 2 During these 10 years it has become obvious that stem cell research is embedded in a narrative characterised by hope and hype and that it has created heated moral and political debate. Although it would be tempting to try to deconstruct the importance attributed to hope in this story or (...) to unmask the different instigators active in promoting hype,3–5 the main aim of this editorial is to briefly review the controversies underlying the debate and propose some possible answers to a set of inter-related questions: What are the main disagreements in the stem cell debate? Is there any hope that we can resolve these main disagreements? Has the debate been a fruitful model for future debates about ethically contentious issues in biomedicine, or has it been characterised more by rhetoric than by argument? What kind of ethical debates are most efficient as models for future debates?The two authors agree with regard to the importance of asking these questions, but they disagree about at least some of the answers. Let us start with the questions about the debate and its use as a model for future debates.WHAT KIND OF ETHICAL DEBATE IS MOST EFFICIENT AS A MODEL FOR FUTURE DEBATES?Could it be the case that ethical debates that are characterised by overselling of the potential of the technology are more efficient as models for future debates about ethically contentious issues in biomedicine than more sober and “neutral” debates? The narratives of stem cell research are full of examples of overselling and underselling, and we will suggest that it is precisely for this reason that there is a lot to learn morally from reviewing the narratives. The two main forms of overselling are therapeutic …. (shrink)

It seems that if abortion is permissible, then stem cell research must be as well: it involves the death of a less significant thing (an embryo rather than a fetus) for a greater good (lives saved rather than nine months of physical imposition avoided). However, I argue in this essay that this natural thought is mistaken. In particular, on the assumption that embryos and fetuses have the full moral status of persons, abortion is permissible but one form (...) of stem cell research is notFthe practice of creating embryos and then destroying them to extract cell.. (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") stem cells. (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)

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

In order to study early human development while avoiding the burdens associated with human embryo research, scientists are redirecting their efforts towards so-called human embryo-like structures (hELS). hELS are created from clusters of human pluripotent stem cells and seem capable of mimicking early human development with increasing accuracy. Notwithstanding, hELS research finds itself at the intersection of historically controversial fields, and the expectation that it might be received as similarly sensitive is prompting proactive law reform in many (...) jurisdictions, including the Netherlands. However, studies on the public perception of hELS research remain scarce. To help guide policymakers and fill this gap in the literature, we conducted an explorative qualitative study aimed at mapping the range of perspectives in the Netherlands on the creation and research use of hELS. This article reports on a subset of our findings, namely those pertaining to (the degrees of and requirements for) confidence in research with hELS and its regulation. Despite commonly found disparities in confidence on emerging biotechnologies, we also found wide consensus regarding the requirements for having (more) confidence in hELS research. We conclude by reflecting on how these findings could be relevant to researchers and (Dutch) policymakers when interpreted within the context of their limitations. (shrink)

The recent successful conversion of adult cells into induced pluripotent stem (iPS) cells through direct reprogramming opens a new chapter in the study of disease and the development of regenerative medicine. It also provides a historic opportunity to turn away from the ethically problematic use of embryonic stem cells isolated through the destruction of human embryos. Moreover, because iPS cells are patient specific, they render therapeutic cloning unnecessary. To maximize therapeutic benefit, adult stem cell research (...) will need to be pursued in parallel with studies using iPS cells. Among the four alternative methods presented by the President’s Council on Bioethics, direct reprogram- ming is the most ethically acceptable. Nonetheless, iPS cells are tainted by their association with the human embryonic stem cell lines, derived in the past, which will be required for their validation. This concern is one that can be resolved. Human iPS cells will serve to stem the tide of human embryonic stem cell research, changing it and diverting stem cell research in a more ethical direction. (shrink)

Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson’s disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical (...) studies transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson’s disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinical research of Parkinson’s disease are derived. The potential benefits to research participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson’s disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potential risk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit to risk calculus and to provide participants with a reasonable choice before they enrol in clinical studies. (shrink)

: In February 2004, South Korean researchers became the first in the world to successfully harvest stem cells 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)

Embryonic Stem Cell Research raises ethical issues. In the process of research, embryos may be destroyed and, to some, such an act entails the ‘killing of human life’. Past studies have sought the views of scientists and the general public on the ethics of ESCR. This study, however, explores multi-faith ethical viewpoints, in particular, those of Buddhists, Hindus and Catholics in Malaysia, on ESCR. Responses were gathered via semi-structured, face-to-face interviews. Three main ethical quandaries emerged (...) from the data: sanctity of life, do no harm, and ‘intention’ of the research. Concerns regarding the sanctity of life are directed at particular research protocols which interfere with religious notions of human ensoulment and early consciousness. The principle of ‘do no harm’ which is closely related to ahimsa prohibits all acts of violence. Responses obtained indicate that respondents either discourage research that inflicts harm on living entities or allow ESCR with reservations. ‘Intention’ of the research seems to be an interesting and viable rationale that would permit ESCR for the Buddhists and Hindus. Research that is intended for the purpose of alleviating human suffering is seen as being ethical. This study also notes that Catholics oppose ESCR on the basis of the inviolability of human life. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United States: An UpdateMary A. Majumder (bio) and Cynthia B. Cohen (bio)On 9 March 2009, President Barack Obama (2009a) signed an executive order revoking the statement issued by President George W. Bush during a televised speech in August 2001, in which the latter had sharply restricted the scope of federally funded human embryonic stem (...) class='Hi'>cell (hESC) research to cell lines derived (without federal funding) prior to 9:00 P.M. EDT on 9 August 2001. Action by President Obama to remove the cut-off date had been expected. It came as a surprise, however, that he gave authority to determine the scope of eligible research to the Director of the National Institutes of Health (NIH), referencing only general concerns of responsibility, scientific worth, and legality.1 This contrasted not only with the approach of former President Bush, but also with that of former President Clinton, who had expressed personal opposition to the creation of embryos for research and had a distinction between hESCs derived from embryos created for research and those derived from spare embryos enshrined in NIH policy.President Obama’s remarks upon signing the executive order give some insight into the thinking behind his approach. Implicit in them are the views that earlystage human embryos outside the womb do not have full moral status and that the destruction of human embryos in the effort to care for and ease the suffering of human beings who do have full moral status does not devalue human life. The President also stressed that the decision to pursue hESC research reflected not only his opinion, but also a broad social consensus. He concluded with strong ethical commitments on two fronts:We will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society.(Obama 2009b)The specific guarantee that President Obama gave against government support for the development of cloning techniques for human reproductive purposes made his silence on the use of cloning for research seem significant. Comments he had made in the course of the campaign (Obama 2008) suggested that he would affirm [End Page 195] the Clinton-era policy of limiting federal funding to hESCs derived from spare embryos. Did this silence mean that President Obama was opening the door to federal funding of research cloning when and if scientists might manage that feat?2009 NIH GuidelinesThe answer to this question and several others came on 17 April, when Raynard Kington, the acting director of NIH, released Draft NIH Guidelines for Human Stem Cell Research (NIH 2009), developed by an NIH Stem Cell Task Force, along with a request for public comment within 30 days of their publication in the Federal Register.2 The 2009 Draft Guidelines exclude from federal funding the derivation of hESCs, a restriction mandated by the reenactment of the Dickey-Wicker Amendment as part of the 2009 Omnibus Appropriations Act (Public Law 111-8, Division F, Title V, § 509). The 2009 Draft Guidelines also exclude the use of hESCs derived from embryos created for research purposes, and so represent a refusal to open the funding door as broadly as the NIH interpretation of the Dickey-Wicker Amendment might allow, at least for the time being.It appears that the drafters used as their starting point the 2000 NIH Guidelines for Research Using Human Pluripotent Stem Cells (NIH 2000) dating from the Clinton Administration, rather than more recent guidelines from the National Academy of Sciences (National Research Council 2005; 2007; 2008) and other private bodies. Both the format and content of the 2000 and 2009 NIH efforts are similar, making the departures in the latter stand out in high relief. We highlight departures related to informed consent to embryo donation, creation of human-nonhuman chimeras, and the role of an NIH task force, updating our original comment (Cohen and Majumder 2009).Informed Consent to Embryo DonationThe 2009 NIH Draft Guidelines require that certain statements... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United StatesCynthia B. Cohen (bio) and Mary A. Majumder (bio)Human pluripotent stem cell research, meaning research into cells that can multiply indefinitely and differentiate into almost all the cells of the body, has become a minefield in which science, ethics, and politics have collided over the last decade in the United (...) States. President Barack Obama entered this highly charged territory when he indicated during his campaign that once in office he would issue an executive order expanding federally funded human embryonic stem cell (hESC) research and introduce rigorous oversight of it (Obama 2008a & b). Candidate Obama stated that he would require that the hESC lines involved were derived with donor consent from early embryos that otherwise would be discarded following in vitro fertilization (IVF) treatment. However, in contrast with the policy of President George W. Bush, he would do so without regard to the date of their derivation. He added that he would call upon the director of the National Institutes of Health (NIH) to develop guidelines for federally funded hESC and other pluripotent stem cell research that would draw from the guidelines developed in 2005 by the National Academies of Science (NAS) for privately funded research (National Research Council 2005).A similar policy was written into the 2008 version of the Stem Cell Research Enhancement Act, which reiterates the policy enunciated in earlier versions of this bill, passed twice by the Congress but vetoed by President Bush each time (House of Representatives, 110th Congress 2008).1 Depending on how one reads the 2008 version of the act, it could also apply in certain respects to hESC research that is not federally funded. We proceed on the assumption that the act applies at least to federally funded stem cell research. Therefore, it appears that the president or the Congress, or both, will approve of an expanded policy of federal funding of hESC research, as well as other forms of human pluripotent stem cell research. [End Page 79]This policy would make the guidelines developed by a committee appointed by NAS, a prestigious private body of American scientists and related experts, the primary basis for the development of new federal guidelines for oversight of hESC research in the United States. This would have certain advantages in that those familiar with the relevant scientific issues are likely to address them accurately and stem cell investigators are apt to accept restrictions on their research written by fellow scientists and ethics and policy experts whom they perceive as strong supporters of stem cell research. However, it also would have certain disadvantages. Chief among these is that the NAS committee appointed to write guidelines for this research, in its concern to see stem cell science move forward after a period in which many scientists and others maintained that it had been unduly restricted, might have overlooked or deferred consideration of some pressing ethical and policy issues. We maintain that this is the case—although we also maintain that the NAS guidelines provide a responsible foundation for developing NIH guidelines for stem cell research. Consequently, we propose that an NIH task force charged by the director of NIH with writing new guidelines for hESC and other stem cell research should revise and expand the NAS guidelines in ways that we propose below, as well as others that it considers necessary, and make it obligatory for those seeking federal funding of such research to follow these new guidelines.We highlight certain areas in which an ethical case can be made for strengthening the existing NAS guidelines and certain areas in which more fundamental ethical reflection—and building on that, additional guideline/policy development—seems warranted. Among the sections of the NAS guidelines that need clarification and reworking, we include those regarding consent to embryo donation, which provide one of their central focuses, and the development of human-nonhuman chimeras, which they address relatively briefly. In addition, we maintain that new guidelines need to be written to address the nascent ethical and policy issues raised by the possibility that human gametes will be induced from pluripotent stem cells in the next few years and that... (shrink)

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. (shrink)

Research using human embryonic stem cells 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)

In 1998, researchers established the first human embryonic stem cell line. Their scientific triumph triggered an ethics and policy argument that persists today. Bioethicists, religious leaders, government officials, patient advocates, and scientists continue to debate whether this research poses a promise, a threat, or a mixed ethical picture for society.Scientists are understandably excited about the knowledge that could come from studying human embryonic stem cells. Most of them believe these cells offer a precious opportunity to (...) learn more about why diseases develop and how they might be prevented or attacked. In their quest to gain support for stem cell research, scientists and others have claimed that the research could generate cures and treatment for everything from heart disease to cancer. (shrink)

Embryonic stem cell research has been a source of ethical, legal, and social controversy since the first successful culturing of human ESCs in the laboratory in 1998. The controversy has slowed the pace of stem cell science and shaped many aspects of its subsequent development. This paper assesses the main issues that have bedeviled stem cell progress and identifies the ethical fault lines that are likely to continue.The time is appropriate for such an (...) assessment because the field is poised for a period of rapid development. President Obama has removed the Bush administration’s restrictions on federal funding. A huge influx of federal research funds is in the offing and presumably a more rapid maturing of the science will take place. Stem cell science is also moving into the clinical realm. In March 2009, the Food and Drug Administration approved the first clinical trial with an ESC-derived therapy for spinal cord injuries, an important first step — though by no means a final or a sure one — in moving ESC research out of the laboratory into clinical medicine. Finally, recent work with induced pluripotent stem cells suggests that non-embryonic sources of pluripotent stem cells may one day be routinely available. Such a development will lessen the temperature of the ethical debate while raising other issues. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United StatesCynthia B. Cohen (bio) and Mary A. Majumder (bio)Human pluripotent stem cell research, meaning research into cells that can multiply indefinitely and differentiate into almost all the cells of the body, has become a minefield in which science, ethics, and politics have collided over the last decade in the United (...) States. President Barack Obama entered this highly charged territory when he indicated during his campaign that once in office he would issue an executive order expanding federally funded human embryonic stem cell (hESC) research and introduce rigorous oversight of it (Obama 2008a & b). Candidate Obama stated that he would require that the hESC lines involved were derived with donor consent from early embryos that otherwise would be discarded following in vitro fertilization (IVF) treatment. However, in contrast with the policy of President George W. Bush, he would do so without regard to the date of their derivation. He added that he would call upon the director of the National Institutes of Health (NIH) to develop guidelines for federally funded hESC and other pluripotent stem cell research that would draw from the guidelines developed in 2005 by the National Academies of Science (NAS) for privately funded research (National Research Council 2005).A similar policy was written into the 2008 version of the Stem Cell Research Enhancement Act, which reiterates the policy enunciated in earlier versions of this bill, passed twice by the Congress but vetoed by President Bush each time (House of Representatives, 110th Congress 2008).1 Depending on how one reads the 2008 version of the act, it could also apply in certain respects to hESC research that is not federally funded. We proceed on the assumption that the act applies at least to federally funded stem cell research. Therefore, it appears that the president or the Congress, or both, will approve of an expanded policy of federal funding of hESC research, as well as other forms of human pluripotent stem cell research. [End Page 79]This policy would make the guidelines developed by a committee appointed by NAS, a prestigious private body of American scientists and related experts, the primary basis for the development of new federal guidelines for oversight of hESC research in the United States. This would have certain advantages in that those familiar with the relevant scientific issues are likely to address them accurately and stem cell investigators are apt to accept restrictions on their research written by fellow scientists and ethics and policy experts whom they perceive as strong supporters of stem cell research. However, it also would have certain disadvantages. Chief among these is that the NAS committee appointed to write guidelines for this research, in its concern to see stem cell science move forward after a period in which many scientists and others maintained that it had been unduly restricted, might have overlooked or deferred consideration of some pressing ethical and policy issues. We maintain that this is the case—although we also maintain that the NAS guidelines provide a responsible foundation for developing NIH guidelines for stem cell research. Consequently, we propose that an NIH task force charged by the director of NIH with writing new guidelines for hESC and other stem cell research should revise and expand the NAS guidelines in ways that we propose below, as well as others that it considers necessary, and make it obligatory for those seeking federal funding of such research to follow these new guidelines.We highlight certain areas in which an ethical case can be made for strengthening the existing NAS guidelines and certain areas in which more fundamental ethical reflection—and building on that, additional guideline/policy development—seems warranted. Among the sections of the NAS guidelines that need clarification and reworking, we include those regarding consent to embryo donation, which provide one of their central focuses, and the development of human-nonhuman chimeras, which they address relatively briefly. In addition, we maintain that new guidelines need to be written to address the nascent ethical and policy issues raised by the possibility that human gametes will be induced from pluripotent stem cells in the next few years and that... (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 stem cells, 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)

Embryonic stem cell research holds great promise for biomedical research, but involves the destruction of human embryos. Katrien Devolder explores the tension between the view that embryos should never be deliberately harmed, and the view that such research must go forward. She provides an in-depth analysis of major attempts to resolve the problem.

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research as the field debated the issues of consent, (...) moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)

Sarah Franklin’s Biological relatives: IVF, stem cells, and the future of kinship and Charis Thompson’s Good science: the ethical choreography of stem cell research, examine recently normalized biotechnologies. Franklin’s monograph extends her previous work on in vitro fertilization , deconstructing the success of a technology that, she argues, has grown “curiouser and curiouser” while taking hold in scientific and social life. IVF in its diverse aspects becomes a lens for scrutinizing our ambivalence about new technology, which (...) Franklin articulates by putting disparate literatures into conversation: feminist science studies, political economy, fine art, and more. Thompson’s Good science focuses more concretely on the first decade of human pluripotent stem cell research, tracing the field from the innovation of cultured human embryonic stem cells through Bush-era policy debates, to current acceptance of stem cell research as a part of the scientific and policy landscape. Th .. (shrink)

A basic component of moral objections to embryonic stem cell research is the claim that human embryos have the same moral status as typical adult human beings. There is no reason to accept this claim, however, unless adult humans once existed as embryos—that is, unless the developmental history of adult humans contains embryos to which the adults are numerically identical. The purpose of this paper is to argue that there are no such identities, and hence that no (...) adult human being ever existed as an embryo. (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 stem cells from a person's own cells will alleviate some but not all of the controversy surrounding ESC research. (shrink)

Stem cell research and associated or derivative biotechnologies are proceeding at a pace that has left bioethics behind as a discipline that is more or less reactionary to their developments. Further, much of the available ethical deliberation remains determined by the conceptual framework of late modern metaphysics and the correlative ethical theories of utilitarianism and deontology. Lacking, to any meaningful extent, is a sustained engagement with ontological and epistemological critiques, such as with “postmodern” thinking like that of (...) Heidegger’s existential phenomenology. Some basic “Heideggerian” conceptual strategies are reviewed here as a way of remedying this deficiency and adding to ethical deliberation about current stem cell research practices. (shrink)

In this timely collection, some of the world's leading ethicists grapple with the variety of issues posed by human embryonic stem cell research. Investigates the moral status of the embryo including the creation of chimeras and paying for gametes (eggs and sperm) and embryos for research purposes Provides a thorough evaluation of the ethics and politics of regulating hESC research, and the privacy, confidentiality, and informed consent in the conduct of research and clinical (...) investigations Essential reading for scientists, philosophers, policy makers, and all who are interested in the ethical conduct of science Contributors include David DeGrazia, Lori Gruen, Elizabeth Harman, John Harris, Jeff McMahan, Don Marquis and Peter Singer. (shrink)

Stem cell research is very promising. The use of human embryos has been confronted with objections based on ethical and religious positions. The recent production of reprogrammed adult (induced pluripotent) cells does not – in the opinion of scientists – reduce the need to continue human embryonic stem cell research. So the debate continues.Islam always encouraged scientific research, particularly research directed toward finding cures for human disease. Based on the expectation of potential (...) benefits, Islamic teachings permit and support human embryonic stem cell research. The majority of Muslim scholars also support therapeutic cloning. This permissibility is conditional on the use of supernumerary early pre-embryos which are obtained during infertility treatment in vitro fertilization (IVF) clinics. The early pre-embryos are considered in Islamic jurisprudence as worthy of respect but do not have the full sanctity offered to the embryo after implantation in the uterus and especially after ensoulment.In this paper the Islamic positions regarding human embryonic stem cell research and therapeutic cloning are reviewed in some detail, whereas positions in other religious traditions are mentioned only briefly.The status of human embryonic stem cell research and therapeutic cloning in different countries, including the USA and especially in Muslim countries, is discussed. (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 stem cells 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 stem cells 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 stem cells from them is morally acceptable because the assumption that embryos have the right to life has very counterintuitive implications. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 97-114 [Access article in PDF] Stem Cell Research in the U.S. after the President's Speech of August 2001 Cynthia B. Cohen On 9 August 2001, in a nationally televised speech, President Bush addressed the contentious question of whether to provide federal funds for human embryonic stem cell research (White House 2001).1 This research involves (...) taking the primordial cells found in embryos and transforming them into certain specialized cells, such as those of the heart, nerves, and muscles, with the ultimate goal of transferring these cells into patients to repair damaged cells and tissues. In his remarks, the President authorized funding for research only on stem cells already harvested from remaining embryos at in vitro fertilization (IVF) centers as of 9 August 2001, the date of the speech. In a "Fact Sheet" about embryonic stem cell research, he added the ethical requirements that (1) the donors of embryos gave informed consent to the derivation of stem cells from their embryos, (2) the embryos were created solely for reproductive purposes, and (3) no financial inducements were given to the embryo donors. The President also prohibited federally funded research on embryonic stem cells derived from embryos after 9 August 2001, as well as the creation of embryos for research purposes and the cloning of human embryos for both reproductive and research purposes. He did not seek to ban the pursuit of embryonic stem cell research with private funds. "This allows us to explore the promise and potential of stem-cell research without crossing a fundamental moral line by providing taxpayer funding that would sanction or encourage further destruction of embryos," the President stated (White House 2001).The President's speech stirred intense controversy. Many applauded the new policy because it allowed some embryonic stem cell research to proceed, thereby raising hope that treatments might be developed for those suffering from such conditions as Parkinson's disease, Alzheimer's disease, and diabetes. Others supported it on grounds that it would discourage the future destruction of embryos in stem cell research. They maintained that although it was wrong to have derived stem cells from embryos, this wrong was no longer remediable and it therefore was justifiable to allow research using such embryos to proceed. Some, however, objected to the new policy because they held that it unduly limited the [End Page 97] number of embryonic stem cells available for federally funded research. Still others opposed it on grounds that it made the federal government complicit in what they took to be the wrongful destruction of human embryos that had taken place prior to 9 August 2001. The President established the President's Council on Bioethics by executive order in November 2001 and charged it, among other tasks, with monitoring stem cell research and recommending guidelines and regulations for biomedical innovations.Questions about the moral status of human embryos have so captured public attention since the President issued his remarks that other significant ethical and policy issues raised about stem cell research inside the Beltway have remained in the shadows. A number of individuals and organizations—legislators, scientists, patient groups, the President's Council on Bioethics, ethicists, religious task forces, and social commentators—have attempted to bring these other issues to legislative and public attention. They also have revisited the more publicly prominent question of what sorts of protections we owe to human embryos. In response, Congress has attempted to address several of these newly emerging issues at hearings and in legislation. I review these efforts, consider developing issues and arguments, and conclude by exploring possible future directions for federal and private sector stem cell policy. The Availability of Embryonic Stem Cell Lines to Federally Funded Researchers President Bush, in developing his stem cell research policy, accepted a distinction between the "derivation" and the "use" of embryos enunciated by the General Counsel of the Department of Health and Human Services toward the end of the Clinton administration. This distinction was adopted to avoid contravening the Dickey-Wicker Amendment (added... (shrink)

This essay will address the ethical issues that have emerged in the first considerations of the newly emerging stem cell technology. Many of us in the field of bioethics were deliberating related issues as we first learned of the new science and confronted the ethical issues it raised. In this essay, I will draw on the work of colleagues who were asked to reflect on early stages of the research (members of the IRBs, the Geron Ethicist Advisory (...) Board, and the National Bioethics Advisory Commission) as the field debated the issues of consent, moral status, use of animal tissues, abortion, use of fetal tissue, and the nature and goals of entrepreneurial research. In this new capacity, ethicists weighed the problem of privacy, the role of justice considerations, and the issues of the marketplace in science. At this point, it is clear that far more issues remain unresolved than are settled, that there is largely unexplored territory ahead, and that the single most important task that faces us as a field is a steady call for ongoing conversation and public debate. (shrink)

Recent advances in stem cell research suggest that in the future it may be possible to create eggs and sperm from human stem cells through a process that we term in vitro gametogenesis (IVG). IVG would allow treatment of some currently untreatable forms of infertility. It may also allow same-sex couples to have genetically-related children. For example, cells taken from one man could potentially be used to create an egg, which could then be fertilised using naturally (...) produced sperm from another man to create a genetically-related child with half of its DNA from each of the men. In this chapter, we consider whether this technology could justifiably be denied to same-sex couples if it were made available as a fertility treatment to different-sex couples. We argue that it could not. (shrink)

Background With the huge number of patients who suffer from chronic and incurable diseases, medical scientists continue to search for new curative methods for patients in dire need of treatment. Interest in stem cells is growing, generating high expectations in terms of the possible benefits that could be derived from stem cell research and therapy. However, regardless of the hope of stem cells changing and improving lives, there are many ethical, religious, and political challenges and (...) controversies that affect the research, and mandated to establish ethical guidelines and regulations. In Saudi Arabia, key stakeholders play an active role in discussing the ethics of stem cell research and therapy. The focus of the study was to explore professionals’ perceptions related to the ethical challenges of using stem cells in research and treatment in Saudi Arabia. Results A qualitative research study was conducted to explore and describe the perceptions of 25 professionals employed at different tertiary hospitals in the various regions of Saudi. A thematic analysis was performed to search for and identify the most significant perceptions shared by the participants. Four themes were generated based on the ethical challenges of four areas related to stem cell use, including forbidden and permitted sources of stem cells, informed consent, beneficence, and ethical regulations and guidelines. Conclusion The study identified that there is a growing need to advance the knowledge, education, and awareness related to stem cell research and treatment in Saudi Arabia. (shrink)

Policy arguments in support of stem cell research often use economic benefit as a key rationale for permissive policies and increased government funding. Economic growth, job creation, improved productivity, and a reduction in the burden of disease are all worthy goals and, as such, can be used as powerful rhetorical tools in efforts to sway voters, politicians, and funding agencies. However, declarations of economic and commercial benefit — which can be found in policy reports, the scientific literature, (...) public funding policies, and the popular press — have arguably created a great deal of expectation. Can stem cell research deliver on the economic promise? And what are the implications of this economic ethos for the researchers who must work under its shadow? (shrink)

This paper is based on linked qualitative studies of the donation of human embryos to stem cell research carried out in the United Kingdom, Switzerland, and China. All three studies used semi-structured interview protocols to allow an in-depth examination of donors’ and non-donors’ rationales for their donation decisions, with the aim of gaining information on contextual and other factors that play a role in donor decisions and identifying how these relate to factors that are more usually included (...) in evaluations made by theoretical ethics. Our findings have implications for one factor that has previously been suggested as being of ethical concern: the role of gratitude. Our empirical work shows no evidence that interpersonal gratitude is an important factor, but it does support the existence of a solidarity-based desire to “give something back” to medical research. Thus, we use empirical data to expand and refine the conceptual basis of bioethically theorizing the IVF–stem cell interface. (shrink)

In the context of stem cell research, the promise of economic growth has become a common policy argument for adoption of permissive policies and increased government funding. However, declarations of economic and commercial benefit, which can be found in policy reports, the scientific literature, public funding policies, and the popular press, have arguably created a great deal of expectation. Can stem cell research deliver on the economic promise? And what are the implications of this (...) economic ethos for the researchers who must work under its shadow? (shrink)

In this paper the permissibility of stem cell research on early human embryos is defended. It is argued that, in order to have moral status, an individual must have an interest in its own wellbeing. Sentience is a prerequisite for having an interest in avoiding pain, and personhood is a prerequisite for having an interest in the continuation of one's own existence. Early human embryos are not sentient and therefore they are not recipients of direct moral consideration. (...) Early human embryos do not satisfy the requirements for personhood, but there are arguments to the effect that they should be treated as persons nonetheless. These are the arguments from potentiality, symbolic value and the principle of human dignity. These arguments are challenged in this paper and it is claimed that they offer us no good reason to believe that early human embryos should be treated as persons. (shrink)

: Pluripotent human stem cell research may offer new treatments for hundreds of diseases, but opponents of this research argue that such therapy comes attached to a Faustian bargain: cures at the cost of the destruction of many frozen embryos. The National Bioethics Advisory Commission (NBAC), government officials, and many scholars of bioethics, including, in these pages, John Robertson, have not offered an adequate response to ethical objections to stem cell research. Instead of (...) examining the ethical issues involved in sacrificing human embryos for the goal of curing fatal and disabling diseases, they seek to either dismiss the moral concerns of those with objections or to find an "accommodation" with those opposed to stem cell research. An ethical argument can be made that it is justifiable to modify or destroy certain human embryos in the pursuit of cures for dread and lethal diseases. Until this argument is made, the case for stem cell research will rest on political foundations rather than on the ethical foundations that the funding of stem cell research requires. (shrink)

: Stem cell research that requires the destruction of human embryos is incompatible with Catholic moral principles, and with any ethic that gives serious weight to the moral status of the human embryo. Moreover, because there are promising and morally acceptable alternative approaches to the repair and regeneration of human tissues, and because treatments that rely on destruction of human embryos would be morally offensive to many patients, embryonic stem cell research may play a (...) far less significant role in medical progress than proponents believe. (shrink)

Paper providing an ethical framework for stem cell research in Europe.

Regulation of stem cell research in Europe should not take place without public and scholarly inputThe European Union has, at present, no jurisdiction over research carried out in the member states, or concerning the “ethics” of member states. This does not, however, mean that decisions made by the European institutions cannot influence such matters greatly.There has recently been a lot of focus on the decision not to fund embryonic stem cell research during (...) the first year of the 6th framework programme , but behind the scenes a much more important and wide ranging set of regulations are being prepared.The European Commission has prepared a draft directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells.1 The purpose of this directive was originally to “ensure the quality and safety of human tissues and cells for clinical use” in the EU. This is clearly a laudable objective, fully in line with the EU’s jurisdiction in consumer protection and public health.During the intricate processes of political …. (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)

After a long and successful career in tracheal surgery and lung cancer, Paolo Macchiarini became very famous in 2008 with the transplantation of a trachea from a cadaver that then apparently used the patient’s own stem cells to supposedly regenerate new trachea, i.e., tissue-engineered tracheae. Among the nine patients that received this revolutionary treatment, using biological or artificial tracheae, under Macchiarini’s supervision, six have reportedly died. Although several critics had expressed concerns with the procedures, allegations of misconduct against Macchiarini (...) first arose in August of 2014 by four Karolinska Institutet (KI) colleagues, and an independent investigation was called for by KI based on claims made in seven published papers. Among the claims were the fact that the procedure constituted a high risk, information on the patients was incomplete and that there was no or incomplete ethical approval, thus constituting misconduct. His CV was also shown to contain inaccuracies. By September 10, 2016, most of these claims have now proved to be true, and Macchiarini was found guilty of misconduct by KI. This paper looks primarily at earlier published papers by Macchiarini and his collaborators in a search for clues to better understand the evolution of altruism, or narcissism. An assessment of the controversial papers, and of letters written by critics and skeptics like Pierre R. Delaere, indicate that insufficient experimental evidence was presented for several case studies, and that claims made about the success of the procedures exceeded what was shown by the evidence. A domino effect of personal and professional tragedies ensued, in rapid succession, between 2014 and 2016. The effect on the field of stem cell research has been chilling, and the side-effects have taken their toll, with several high-profile resignations, primarily at KI, within the Swedish education system and in the Nobel Committee. This case has mesmerized the bioethics and biomedical communities for years. (shrink)

Stem cell research regulations are highly variable across nations, notwithstanding shared and common ethical concerns. Dominant in political debates has been the so-called embryo question. However, the permissibility of human embryonic stem cell research varies among national regulatory frameworks. Scholars have explained differences by resorting to notions of political culture, traditions of ethical reasoning, discursive strategies and political manoeuvring of involved actors. Explanations based on the role of religion or other cultural structural variables are (...) also employed. This paper analyses the emerging of the Italian regulatory framework on stem cell research using an analytical framework that considers the interplay between cultural structural features, political culture, traditions of ethical reasoning, institutional settings and the discursive and political agency of the actors involved. It aims also to explain the role of Roman Catholic Church in shaping the Italian stem cell research regulation not by treating religion as an autonomous causal factor, but through the analysis of the agency of Catholic and allied actors in the Italian political culture and institutional setting. (shrink)

The possibility of creating human embryonic stem cell lines from the inner cell mass of blastocysts has led to considerable debate about how these scientific developments should be regulated. Part of this debate has focused on the ethical analysis and part on how this analysis should influence policymaking.