This paper considers the legislative debates in Australia that led to the passage of the Research Involving Human Embryos Act (Cth 2002) and the Prohibition of Human Cloning Act (Cth 2002). In the first part of the paper, we discuss the debate surrounding the legislation with particular emphasis on the ways in which demands for public consultation, public debate and the education of Australians about the potential ethical and scientific impact of human embryonic stem cells (hESC) research were deployed, (...) and the explicit and implicit framing of the scope of public consultation. We then ask whether, given the calls for public consultations, debate and understanding, current work in democratic theory could be helpful in analysing the process of policy-making in these areas. In particular, we canvass the literature relating to aggregative and deliberative models of democracy for processes that support the legitimacy of policy. We identify features of the debate that reflect the appeal of deliberative approaches as well as some of the possible hurdles or limitations to developing deliberative democratic approaches to policy in ethically contentious areas. (shrink)

Given the promise of stem cell therapies, scientists throughout the world are conducting stem cell research using various kinds of stem cells including human embryonic stem cells. However, HESC research is very controversial in some societies as the extraction of stem cells involves the destruction of the human embryo. The ethical concerns of this kind of research have led scientists to search for other methods to derive stem cells that do not involve the destruction of embryos. These different types (...) of stem cell research are said to sidestep the ethical dilemma associated with HESC research and so are considered as ethically acceptable ways to obtain stem cells; possibly, they may even mark the end of HESC research. However, each of these stem cell methods presents its own challenges, scientific and ethical, as this article explores. This paper examines the impact of the emergence of different types of stem cell research and discusses whether it is still necessary for scientists to conduct the contentious HESC research. (shrink)

In his discussion of in vitrogametogenesis, Rob Sparrow claims that an ethical barrier to development of this technology is that many jurisdictions currently prohibit the practice of creating embryos solely for the purpose of research. However, he suggests that this ethical barrier will soon be eroded, in view of the fact that in vitro gametogenesis could serve as a powerful new technology to overcome infertility. In this commentary, I argue that Sparrow is being overly optimistic in his analysis here. I (...) claim that the debate over so-called compromise positions in the human embryonic stem cell debate suggests that the purpose of the research for which a research embryo is created is unlikely to be considered as having any significant bearing on the moral permissibility of the practice for those who oppose it. Even though in vitro gametogenesis could serve as a powerful new technology to overcome infertility, I argue that opponents of the practice of creating embryos solely for research purposes would still view the creation of research embryos that the development of in vitro gametogenesis would require, as being incompatible with affording the embryo proper moral respect. I conclude by suggesting that Sparrow's analysis of the potential benefits of in vitro gametogenesis provides us with further reasons to scrutinise the unconvincing arguments that are often cited in favour of prohibiting the practice of creating embryos solely for research purposes. (shrink)

In November 2004, the Swiss population voted to accept a law on research using human embryonic stem cells. In this paper, we use Switzerland as a case study of the shaping of the ostensibly ethical debate on the use of embryos in embryonic stem cell research by legal, political and social constraints. We describe how the national and international context affected the content and wording of the law. We discuss the consequences of the revised law's separation of stem cell research (...) from other forms of embryo research, its definitions of embryo and of spare embryos, and the introduction of donorship into the Swiss ethical debate on IVF. We focus on the exclusion of the potential embryo donors' voices and perspectives from the debate, and consider the effects of this exclusion on ethical discourse and the political process. (shrink)

According to the judgement of the European Court of Justice in 2014, human parthenogenetic stem cells are excluded from the patenting prohibition of procedures based on hESC by the European Biopatent Directive, because human parthenotes are not human embryos. This article is based on the thesis that in light of the technological advances in the field of stem cell research, the attribution of the term ‘human embryo’ to certain entities on a descriptive level as well as the attribution of (...) a normative protection status to certain entities based on the criterion of totipotency, are becoming increasingly unclear. The example of human parthenotes in particular demonstrates that totipotency is not at all a necessary condition for the attribution of the term ‘human embryo’. Furthermore, the example of hiPSC and somatic cells particularly shows that totipotency is also not a sufficient condition for the attribution of a normative protection status to certain entities. Therefore, it is not a suitable criterion for distinguishing between human embryos worthy of protection and human non-embryos not worthy of protection. Consequently, this conclusion has repercussions for the patenting question. The strict delineation between an ethically problematic commercial use of human embryos and the concomitant patenting prohibition of hESC-based procedures and an ethically unproblematic commercial use of human non-embryos and the therefore either unrestrictedly permitted or even unregulated patenting of procedures based on these alleged alternatives becomes increasingly blurred. (shrink)

Opponents of human embryonic stem cell (hESC) research claim that such research is incompatible with the moral principle that it is always wrong intentionally to end a human life. In this essay, I discuss how that principle might be revised so that it is subject to as few difficulties as possible. I then argue that even the most defensible version of the principle is compatible with the moral permissibility of hESC research.

Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (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)

While society debates whether and how to use public funds to support work on human embryonic stem cells (hESCs), many scientific groups and businesses debate a different question — the extent to which patents that cover such stem cells 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)

Moral status is the moral value that something has in its own right, independently of the interests or concerns of others. Research using human embryonic stem cells implicates issues about moral status because the current method of extracting hESCs involves the destruction of a human embryo, the moral status of which is contested. Moral status issues can also arise, however, when hESCs are transplanted into embryonic or fetal animals, thereby creating human/ nonhuman stem cell chimeras. In particular, one concern about (...) chimera research is that it could confer upon an animal the moral status of a normal human adult, but then impermissibly fail to accord the animal the protections it merits in virtue of its enhanced status. Understanding the public policy implications of this ethical conclusion is complicated by the fact that certain views about the moral status of the embryo cannot legitimately be used to justify public policy decisions. Arguments like those employed in the abortion debate for the conclusion that abortion should be legally permissible even if abortion is not morally permissible also support, to a more limited degree, a liberal policy on hESC research involving the creation of chimeras. (shrink)

We argue in this essay that (1) the embryo is an irredeemably ambiguous entity and its ambiguity casts serious doubt on the arguments claiming its full protection or, at least, its protection against its use as a means fo research, (2) those who claim the embryo should be protected as "one of us" are committed to a position even they do not uphold in their practices, (3) views that defend the protection of the embryo in virtue of its potentiality to (...) become a person fail, and (4) the embryo does not have any rights or interests to be protected. Given that many are willing to treat the embryo as a means in other practices, and that human embryonic stem cell (hESC) research holds the potential to benefit many people, one cannot but conclude that hESC research is permissible and, because of its immense promise for alleviating human even obligatory. (shrink)

BackgroundHuman embryonic stem cells as a source for the development of advanced therapy medicinal products are considered for treatment of Parkinson’s disease. Research has shown promising results and opened an avenue of great importance for patients who currently lack a disease modifying therapy. The use of hESC has given rise to moral concerns and been the focus of often heated debates on the moral status of human embryos. Approval for marketing is still pending.ObjectiveTo Investigate the perspectives and concerns of (...) patients with PD, patients being the directly concerned stakeholders in the ethical discussion.MethodsQualitative semi-structured interviews related to this new therapy in seventeen patients from two Swedish cities.ResultsThe participants expressed various interests related to the use of human embryos for development of medicinal therapies; however, overall, they were positive towards the use of hESC for treatment of PD. It was deemed important that the donating woman or couple made the choice to donate embryos voluntarily. Furthermore, there were concerns that the industry does not always prioritise the patient over profit; thus, transparency was seen as important. (shrink)

The author supported Barack Obama for president, and he agrees with Obama on most issues. However, he opposes the federal funding of human embryonic stem cell (hESC) research. Besides involving the destruction of human life, hESC research can (1) result in the exploitation of women, and (2) cause human reproduction to become a means to an end, i.e., human embryos will become commodities to be bought and sold. Recent scientific developments show the growing potential of induced pluripotent stem (...) (iPS) cells and the diminishing promise of their embryonic counterparts. When President Obama lifted restrictions on hESC research on March 9, 2009, he missed an opportunity to show moral leadership on a politically controversial issue. (shrink)

Many states in the U.S. have adopted policies regarding human embryonic stem cell (hESC) research in the last few years. Some have arrived at these policies through legislative debate, some by referendum, and some by executive order. New York has chosen a unique structure for addressing policy decisions regarding this morally controversial issue by creating the Empire State Stem Cell Board with two Committees—an Ethics Committee and a Funding Committee. This essay explores the pros and cons of various policy (...) arrangements for making public policy decisions about morally controversial issues in bioethics (as well as other issues) through the lens of Deliberative Democracy, focusing on the principles of reciprocity, publicity, and accountability. Although New York's unique mechanism potentially offers an opportunity to make policy decisions regarding a morally controversial subject like hESC research in accord with the principles of Deliberative Democracy, this essay demonstrates its failure to do so in actual fact. A few relatively simple changes could make New York's program a real model for putting Deliberative Democracy into practice in making policy decisions regarding controversial bioethical issues. (shrink)

In order to reach its full potential, human embryonic stem cell (hESC) research requires the use of human oocytes. There is currently a shortage of human eggs for research, and this shortage is likely to continue, as many states and countries prohibit their sale for research purposes, while at the same time condoning unregulated markets for oocytes for use in assisted reproduction. In this essay I first explore possible alternative sources of oocytes for hESC research and conclude that, (...) at present, women are the best source. I then examine arguments about exploitation and commodification that are often raised to prohibit payment to women for oocytes in both the reproductive and research contexts and find these arguments wanting. I conclude by suggesting that ethical concerns raised about a market in oocytes do not warrant a prohibition on the sale of eggs, but that a regulated market can consistently minimize ethical concerns while respecting women and providing important resources for advances in hESC research. (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 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)

Many who believe that human embryos have moral status are convinced that their use in human embryonic stem cell (hESC) research can be morally justified as long as they are discarded embryos left over from fertility treatments. This is one reason why this view about discarded embryos has played such a prominent role in the debate over publicly funding hESC research in the United States and other countries. Many believe that this view offers the best chance of a (...) compromise between the different sides in this debate. This paper focuses on what seems to be the most plausible argument for this view about discarded embryos. It shows that this argument is unsound regardless of how one understands the claim that embryos have moral status. It also discusses the implications of this conclusion for attempts to use this argument as a basis for public policy. (shrink)

Aiwha Ong and Nancy Chen’s anthology Asian Biotech (Duke, 2010) wonderfully and incisively captures the initial results of a period of intense investment throughout much of Northeast, South and Southeast Asia in the most recent two to three decades in the emerging biosciences, grouping its collection of papers according to broad thematic clusters. Documenting a series of diverse, changing practices with respect to the use of bodies and human tissues in clinical trials, the related establishment of blood and tissue storage (...) facilities, and even cutting-edge efforts to work with HESC technologies, the volume offers a comprehensive view of a rapidly emerging field in a part of the world that has only recently begun to appear as a major contributor to global techno-scientific activity, with state actors frequently leading the mobilization efforts. Juxtaposed against this thematic content, this review seeks to place the volume in conversation with a longer history, especially existing work in the history of the life sciences, which has until now been dominated by accounts of laboratories primarily based in the West. Rich with implications for a changing ethical practice driven by material changes in medical and scientific practice, Asian Biotech initiates any number of debates to open up a new field of inquiry. (shrink)

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening (...) the position of certain patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore. (shrink)

Embryonic stem cells (ESCs) are now classified into two types of pluripotency: “naïve” and “primed” based upon their differing characteristics. Conventional human ESCs have much more in common with mouse epiblast stem cells and are now deemed to be primed. Naïve human ESCs that resemble mouse ESCs have recently been generated from their primed counterpart by cellular reprogramming. Isolation of naïve hESCs from human embryos has proven to be difficult. Is the inability to capture naïve hESCs the result of suboptimal (...) derivation conditions or because they are so transient they cannot be “captured” in vitro? Prevailing evidence surrounding this issue are inconclusive and require additional human embryo research. However, negative public opinion regarding human embryo research, may make this an uphill battle. The solution may come from cellular reprogramming. (shrink)

This article is a response to McLeod and Baylis (2007) who speculate on the dangers of requesting fresh ‘spare’ embryos from IVF patients for human embryonic stem cell (hESC) research, particularly when those embryos are good enough to be transferred back to the woman. They argue that these embryos should be frozen instead. We explore what is meant by ‘spare’ embryos. We then provide empirical evidence, from a study of embryo donation and of embryo donors' views, to substantiate some (...) of their speculations about the problems associated with requesting fresh embryos. However, we also question whether such problems are resolved by embryo freezing, since further empirical evidence suggests that this raises other social and ethical problems for patients. There is little evidence that the request for embryos for research, in itself, causes patients distress. We suggest, however, that no requests for fresh embryos should be made in the first cycle of IVF treatment. Deferring the request to a later cycle ensures that potential donors are better informed (by experience and reflection) about the possible destinations of their embryos and about the definition of ‘spare embryos’. Both this article, and that by McLeod and Baylis, emphasize the need to consider the views and experiences of embryo donors when evaluating the ethics of embryo donation for hESC research. (shrink)

One of the goals of medicine is to improve well-being, in line with the principle of beneficence. Likewise, scientists claim that the goal of human embryonic stem cell research is to find treatments for diseases. In hESC research, stem cells are harvested from a 5-day-old embryo. Surplus embryos from infertility treatments or embryos created for the sole purpose of harvesting stem cells are used in the research, and in the process the embryos get destroyed. The use of human embryos (...) for research purpose raises ethical concern. In this context, the religious leaders play the role to be the moral compass and “reality check” to engage with the public. In Malaysia, the Ministry of Health has outlined the Guidelines for Stem Cell Research and Therapy, reflecting on Islamic principles. Since there has not been much focus on the viewpoints of other faiths in Malaysia, this study attempts to explore the ethical guiding principles deliberated by religious leaders from the Buddhist, Hindu and Catholic traditions and identify if there is a common ground between the mainstream religious views and principles of medical ethics, in relation to hESC research. Eleven religious leaders representing the Buddhist, Hindu and Catholic traditions were interviewed. Interestingly, though reasoning of religious leaders came from different angles, their underlying concerns revolve around the values of “do no harm” and “intention to save lives”. These values are also the key principles in medical ethics. The findings are applied to answer the question as to whether religious and medical guiding principles can co-exist and complement in ethical decision-making, without compromising the values. (shrink)

There is a widely acknowledged shortage of and an increasing demand for transplantable human organs and tissues (e.g., kidney, heart, lung, liver, cornea) in developed and developing countries around the world. In response to this need, Lott and Savulescu (2007) propose the creation of a human embryonic stem (hESC) bank to facilitate the equitable and efficient dissemination of human leukocyte anti- gen (HLA) matched tissues and organs to patients in need of replacement. Although not an unreasonable proposal, the authors (...) go on to make a much stronger claim. They argue that hESCs are such important tools for addressing the massive unmet global need for organs that it is ethically justified to require mandatory banking of spare embryos, and they argue for the use of financial (or other) inducements to procure embryos for the derivation of hESCs. (shrink)

BackgroundNew disease-modifying ways to treat Parkinson’s disease (PD) may soon become a reality with intracerebral transplantation of cell products produced from human embryonic stem cells (hESCs). The aim of this study was to assess what factors influence preferences of patients with PD regarding stem-cell based therapies to treat PD in the future.MethodsPatients with PD were invited to complete a web-based discrete choice experiment to assess the importance of the following attributes: (i) type of treatment, (ii) aim of treatment, (iii) available (...) knowledge of the different types of treatments, (iv) effect on symptoms, and (v) risk for severe side effects. Latent class conditional logistic regression models were used to determine preference estimates and heterogeneity in respondents’ preferences.ResultsA substantial difference in respondents’ preferences was observed in three latent preference patterns (classes). “Effect on symptoms” was the most important attribute in class 1, closely followed by “type of treatment,” with medications as preferred to other treatment alternatives. Effect on symptoms was also the most important attribute in class 2, with treatment with hESCs preferred over other treatment alternatives. Likewise for class 3, that mainly focused on “type of treatment” in the decision-making. Respondents’ class membership was influenced by their experience in treatment, side effects, and advanced treatment therapy as well as religious beliefs.ConclusionsMost of the respondents would accept a treatment with products emanating from hESCs, regardless of views on the moral status of embryos. Preferences of patients with PD may provide guidance in clinical decision-making regarding treatments deriving from stem cells. (shrink)

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

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)

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)

Many assumed that the Obama administration would usher in a sea change from the previous administration by expanding NIH support for human embryonic stem cell (hESC) research and reducing the patchwork of state and federal regulations that currently governs it. This article examines the extent to which NIH’s new Guidelines are likely to accomplish these goals.

This paper proposes a classification of hESC research regulation by shifting from the statutory content of relevant national Laws to the method of decision-making process, in order to verify whether it is possible to identify a connection between the concrete characters of that process and its outcome. A set of procedural indexes are identified and applied to the analysed legal systems. According to an increasing fulfilment of indexes, we may individuate two main regulatory families: the ‘value oriented’ and the (...) ‘procedure oriented’ ones. The latter is developing an increasing impact within European context: it is characterised by a mix of regulatory sources, each developing a specific function. Within this model, statutory law cannot infringe a regulatory space reserved to expertise and selfregulation, developing a subsidiary function; furthermore, it has to recognise the integrative role of expertise within statutory-making process. (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 stem cells (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)

The debate concerning the moral permissibility of using human embryos in human embryonic stem cell (hESC) research has long centred on the question of the embryo's supposed right to life. However, in focussing only on this question, many opponents to hESC research have escaped rigorous scrutiny by making vague and unfounded appeals to the concept of moral respect in order to justify their opposition to certain hESC practices. In this paper, I offer a critical analysis of the (...) concept of moral respect, and its use to support the intuitively appealing principle of proportionality in hESC research. I argue that if proponents of this principle are to justify its adoption by appealing to the concept of moral respect, they must explain two things concerning the nature of the moral respect owed to embryos. First, they must explain which particular aspect of the embryo is morally relevant, and why. Second, they must explain why some uses of embryos in research fail to acknowledge what is morally relevant about the embryo, and thereby involve a violation of the moral respect that they are due. I shall show that providing such explanations may be more difficult than it first appears. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Response to Byrnes and FurtonMark T. Brown, Ph.D.In “Moral Complicity in Induced Pluripotent Stem Cell Research” (MCIPS) (Brown 2009), I sketched the moral complicity implications of alternative national stem cell policies with respect to direct reprogramming techniques that appear to result in pluripotent stem cells derived from skin cells, hair cells, and possibly other somatic cells. This aspect of the stem cell debate was considered from the perspective of (...) those who are pro embryo life and who attribute to human embryos a complete set of basic human rights, including a stringent right to life; and from the perspective of advocates of embryonic stem cell research who do not recognize full moral equivalence between human embryos and human children and who do not ascribe to human embryos an inviolable right to life. The moral complicity concerns of embryonic stem cell research advocates focus upon the scope of medical beneficence with respect to patients whose quality of life and personal autonomy are negatively impacted by the interval between the time when they might have gotten effective medical treatment through unimpeded stem cell science and the time at which stem cell science constrained by pro embryo life moral complicity concerns arrives at a similar destination. The moral complicity concerns of embryo life proponents focus upon noncooperation in past and future destruction of human embryos in order to derive in vitro embryonic stem cell lines.Among the policy alternatives considered were proposals that would be responsive to the possibility that induced pluripotent stem cells (iPSC) at some point may provide a source of stem cell lines that would substitute for human embryonic stem [End Page 206] cell (hESC) lines in cell replacement therapy. If functional equivalence between iPSC lines and hESC lines for cell replacement purposes were confirmed, a national stem cell research policy might be crafted that could accommodate the central moral complicity concerns both of persons who are embryo life advocates and of advocates of embryonic stem cell research. Policy alternatives considered in MCIPS included those based upon the assumption that currently existing embryonic stem cell lines are sufficient to conduct iPSC/hESC functional equivalence studies and policy options based upon the assumption that currently existing hESC lines fall short of what would be required for methodologically sound validation studies. The moral complicity implications for those who are embryo life advocates of both sets of policies were outlined, as were the moral complicity implications of alternative policies for embryonic stem cell research advocates. Since moral complicity concerns are one factor that those who formulate national stem cell policy should consider, MCIPS was an attempt to provide some guidance to policymakers with respect to how alternative policies accommodate or fail to accommodate the moral complicity concerns of various constituencies.In a 2008 article, Malcolm Byrnes (2008, p. 286) appears to consider both empirical assumptions regarding the sufficiency of existing stem cell lines for meaningful functional equivalence studies, and for that reason I drew upon his paper to frame the moral complicity implications for advocates of embryo life of national stem cell policy based upon either assumption. In his paper, Byrnes refers both to stem cell scientists who “suggest” that the hESC lines approved by President Bush in 2001 are sufficient and to stem cell scientists who believe that more hESC lines are needed. Based on my reading of his paper, I erroneously included Byrnes in the group who were willing to consider new hESC derivations in order to complete functional equivalence studies. However, my description of the moral complicity implications for advocates of embryo life of policies that enable new hESC derivations was an exercise in contingency planning, and certainly not intended as “a condemnation” of Byrnes (2009, p. 203). Similarly, what Byrnes (2009, p. 204) sees as “ironic” is simply a description later in my paper of policy options based upon an alternative factual assumption.Byrnes’s position seems to be that existing hESC lines are sufficient to conduct iPSC/hESC functional equivalence studies and that no additional hESC lines should be derived. Although it appears that I did mischaracterize Byrnes’s view of the permissibility of deriving additional hESC lines for equivalence studies, I think my interpretation was... (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 stem cells, that is, to indicate how the discursive practices surrounding research on stem cells, as well as the technology itself, contribute to the constitution of impairment. (shrink)

We discuss in this essay the alternative techniques proposed for the isolation of human embryonic stem cells (hESCs) that attempt to satisfy moral issues surrounding killing embryos but show that these techniques are either redundant or do not achieve their intended aim. We discuss the difficulties associated with defining a human embryo and how the lack of clarity on this issue antagonises the ethical debate and impedes hESC research. We present scientific evidence showing that isolation of hESCs does not (...) necessarily "kill" human embryos. In addition, we argue that even those who accord inviolable moral status to the embryo should agree that hESC research is morally obligatory, as it is beneficial to the developmental potential of the embryo and society as a whole. (shrink)

The compromise position concerning the moral permissibility of different forms of human embryonic stem cell research has two commitments. The first commitment of this position is that it is morally permissible to derive hESCs from unwanted IVF embryos, despite the fact that this process involves the destruction of these embryos. The second commitment of this position is that it is morally impermissible to create human embryos for the sole purpose of destroying them in order to harvest their hESCs. I argue (...) that this compromise position concerning the moral permissibility of different forms of hESC research is theoretically tenable, but unappealing. In order to do so, I first claim that although it may be morally permissible to destroy embryos insofar as they do not have a right to life, it can still be coherent to view them as deserving moral respect. I then argue that one may plausibly view the practice of deriving hESCs from unwanted IVF embryos as being compatible with affording the embryo proper moral respect, whilst also maintaining that creating embryos for the sole purpose of destroying them in order to harvest their hESCs is incompatible with affording this respect. However, although I argue that one may plausibly adopt the compromise position in view of this moral difference between the two forms of hESC research, I also suggest that the compromise position is unappealing. My justification for this conclusion is that there are good reasons to support the claim that therapeutic cloning is morally permissible, even if we concede that it violates the moral respect due to the embryo. (shrink)

This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and (...) dilemmas of our staff participants. We explore the views of our study participants in relation to two themes: (1) rights to information and anticipating how donors might be informed about future research findings and (2) occupational work goals and trust. (shrink)

In early 2009, President Obama overturned the ban on federal funding for research involving the derivation of human embryonic stem cells (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)

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

The discovery of an alternative method of producing induced human stem cells will affect the ethical evaluation of human embryonic stem cell researchOn 20 November 2007 two groups of researchers announced that they had independently managed to produce induced Pluripotent Cells from human adult somatic cells.1 2 The two groups used slightly different procedures, but both approaches involved overexpression of a group of four genes known to be actively expressed in human embryonic stem cells . The cells produced are very (...) similar to human embryonic stem cells, they are pluripotent and they differentiate to specific cell types when treated according to protocols leading to that specific differentiation in hESC.WHAT ARE THE IMPLICATIONS OF THESE RESULTS FOR STEM CELL ETHICS?There seems to be at least two areas of debate and research where there are important implications and one area where there are none.Let us deal with the area where these results have absolutely no implications first: the contentious debate about the moral status of the embryo. Nothing in these research results will or can affect the position of those who believe that they have good arguments showing either that the embryo has no moral status at all, or that the embryo has such significant moral status that …. (shrink)

There is a lack of consensus on whether the derivation and use of human embryonic stem cells (hESCs) from embryos remaining after infertility treatment morally require the informed consent of third-party gamete donors who contributed to the creation of the embryos. The principal guidelines for oversight and funding of hESC research in the United States make minimal or no demands for consent from gamete donors. In this article, I consider the arguments supporting and opposing gamete donor consent for (...) class='Hi'>hESC research and embryo research more broadly. I argue that it is not morally permissible to use leftover embryos in research without the informed consent of gamete donors, and that we should place restrictions on the use of existing hESC lines that may have been derived without informed consent. While the standard argument for this position relies on an appeal to gamete donors’ interest in controlling what happens with their genetic material, I identify shortcomings with the standard approach and seek instead to locate the deeper moral foundations for gamete donor consent in rights to bodily integrity. (shrink)

In der Debatte um die embryonale Stammzellenforschung führen die Verfechter der Würde des Embryos gerne eine Gemeinsamkeit von Embryonen und reversibel Komatösen an: Beide sind bloß potentiell Personen. Wenn aber Komatösen fraglos personale Würde zukommt, weshalb sollte man sie Embryonen absprechen? In ihrem AufsatzIn dubio pro embryone kombinieren G. Damschen und D. Schönecker diese Analogie mit einem Vorsichtsargument: Weil die Analogie zumindest gute Gründe für die Annahme biete, Embryonen komme eine menschliche Würde zu, sei angesichts der Schwere des möglichen Unrechts (...) die embryonale Stammzellenforschung nicht zu verantworten. Im Folgenden möchte ich darlegen, weshalb die Analogie nicht ausreicht, um ein solches Vorsichtsargument zu etablieren. In einem ersten Schritt soll gezeigt werden, wie man der Analogie begegnen kann, weshalb das entsprechende Argument also nicht zwingend ist. Um ein Vorsichtsargument zu begründen, würde es allerdings genügen, wenn die Analogie „hinlänglich plausible“ Gründe zugunsten der Würde von Embryonen liefert. In einem zweiten Schritt soll daher – aufbauend auf allgemeinen Überlegungen zum Vorsichtsargument – dargelegt werden, dass die Analogie selbst unter dieser Annahme nicht überzeugen kann. (shrink)

In contrast to embryo donation, the permissibility of 2PN cell donation is highly controversial in Germany. This article is based on there being a legal loophole with respect to 2PN cell donation, which results from an inconsistency within the Embryo Protection Act on the normative status of 2PN cells. Following that thesis, the article argues that, on the basis of the normative criterion totipotency (i.e. the capacity to develop into a born human being), 2PN cells should also be considered human (...) embryos within the meaning of the Act and thereby be protected by that Act in the same way as embryos. However, the normative assumption that 2PN cells should already be endowed with human dignity and the right to life has absurd consequences. Moreover, the consistent continuation of the Embryo Protection Act, as well as of the underlying ethical position or argumentation (i.e. the potentiality argument), leads to the even more absurd consequence of having to place every human somatic cell under the protection of human dignity and the right to life. As totipotency or the developmental potential therefore cannot delimit entities considered worthy of protection (i.e. human embryos) from entities considered not worthy of protection (i.e. 2PN cells, gametes, hESC, hiPSC and human somatic cells), it is not a suitable normative criterion. As a paradigmatic case, 2PN cell donation demonstrates that by retaining this normative criterion the now obsolete German Embryo Protection (Act) ultimately undermines itself. (shrink)

Stem cell research is undeniably valuable and has generated excitement in the scientific community because of its potential use in developing new therapeutic treatments for chronic and debilitating diseases. Many researchers believe that the development of new human embryonic stem cell (hESC) lines is necessary for success in this research forum. A review of hESC research based on the four principles of biomedical ethics—autonomy, beneficence, nonmaleficence, and justice—reveals areas of ethical conflict. Specifically, the ethical principles of beneficence and (...) nonmaleficence conflict with the destruction of human embryos in hESC research. Two other ethical approaches that may also be used to evaluate hESC research are the utilitarian and Kantian perspectives. Human embryonic stem cell research demonstrates a divergence from morality because persons (embryos) are treated as means rather than as ends in themselves. Using adult stem cells for research is a viable option that does not pose ethical concerns and yet answers the duty of beneficence that a moral obligation to humanity demands. National Catholic Bioethics Quarterly 7.1 (Spring 2007): 257–262. (shrink)

This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future attention to advance directives; the (...) recent emergence of medical–legal partnerships and their benefits for patients; the obesity epidemic and its implications for the child’s right to health under international conventions. (shrink)