Stem cell research is a newly emerging technology that promises a wide variety of benefits for humanity. It has, however, also caused much ethical, legal, and theological debate. While some forms of its application were prohibited in the beginning, they have now started to be used in many countries. This fact obliges us to discuss the regulation of stem cell research at national and international level. It is obvious that in order to make regulations and to draw up (...) legislation at national or international levels it helps to know the perspectives of different cultures and faith traditions. In this article the issue is explored from an Islamic perspective. Firstly, some basic information is given about Islam to explain how laws are drawn up and regulations made in this tradition. Secondly, the principles on which the laws and regulations are based are applied to stem cell research, and finally the permitted and prohibited methods of stem cell research are described. The discussions throughout the paper demonstrate that while some ethicists argue that stem cell research is unethical in the Islamic tradition, tradition permits it as long as such research is aimed at improving human health. (shrink)

Stem cell policy in the United States is an amalgam of federal and state policies. The scientific development of human pluripotent embryonic stem cells triggered a contentious national stem cell policy debate during the administration of President George W. Bush. The Bush “compromise” that allowed federal funding to study only a very limited number of ESC derived cell lines did not satisfy either the researchers or the patient advocates who saw great medical potential being stifled. (...) Neither more restrictive legislation nor expansion of federal funding proved politically possible and the federal impasse opened the door for a variety of state-based experiments. In 2004, California became the largest and most influential state venture into stem cell research by passing “Prop 71,” a voter initiative that created a new stem cell agency and funded it with $3 billion. Several states followed suit with similar programs to protect the right of investigators to do stem cell research and in some cases to invest state funding in such projects. Other states devised legislation to restrict stem cell research and in five states, criminal penalties were included. Thus, the US stem cell policy is a patchwork of multiple, often conflicting, state and federal policies. (shrink)

The closely related debates concerning abortion, the protection of the embryo and stem cell science have captured the legislative agenda in Mexico in recent years. This paper examines some contemporary debates related to stem cell science and the legal and political action that has followed in the wake of the latest Supreme Court judgment on abortion, which debates are directly linked to the degrees of protection of the embryo stipulated in the Mexican Constitution. While some Mexican states have (...) opted to take no further action, others, where conservative political forces are in the majority, have been very active in seeking to ensure that their constitutions are amended to protect human life from conception onwards. This intense legislative activity has not, however, been repeated at the federal level, where there is currently no overarching national regulatory framework governing stem cell research. Although major efforts have been made by the conservative block within the Senate to bring forward legislative proposals for the prohibition of human embryonic stem cell research, and despite the public expression by the federal government of its commitment to encourage inward investment and innovation in the area of biotechnology, stem cell science has, so far, remained unregulated. The legislative challenge is to resist the pressure that has been injected by religious leaders and to act in accordance with the values and principles adopted by the community in the Mexican Constitution. In the final analysis, Mexico faces particular difficulties in accommodating conservative political forces on one hand, while recognising on the other its need, as an emerging economy, to promote a progressive approach to innovation in biotechnology. (shrink)

This book explores the ethical and governance concerns of stem cell technology, taking a comparative approach between countries of differing socio-economic status. The book provides a typology of different stem cell types and discusses key ethical issues surrounding the use of human stem cells in research. Topics covered include the moral status of human embryos, various religious perspectives, and the challenges posed by unproven stem cell interventions. The book also examines the existing governance frameworks in (...) the UK, Singapore, and Malaysia, identifying the laws, guidelines, and advisory bodies established to address the identified ethical issues. Applicable lessons on establishing robust regulatory frameworks, fostering public trust, and ensuring responsible research practices are outlined. By providing a comparative analysis of the interplay between ethics, governance, and the socio-economic contexts of these three commonwealth countries, this book will interest health law, research ethics and bioethics scholars. (shrink)

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

My aim in this paper is simply to show that, in bioethics no less than in other areas of health care, policy in democracies is shaped not only by principles and values, but also — and to some extent independently — by the shape and history of particular political institutions and past policies. “Path dependency,” or what one scholar has called the “accidental logics” of already-existing institutions, condition and guide national policy choices. These institutional and historical pressures can even create (...) substantial policy divergences between quite likeminded nations. I shall illustrate the point using some comparative data about national policies regarding research on human embryonic stem cells. The fact that gaps can develop between values and policies is readily visible to anyone who compares national stemcell research policies to the expressed attitudes of the citizens of various democratic countries regarding human embryonic stem-cell research. The role of path dependency and the accidental logics of institutional structure in creating those gaps can be illustrated by tracking down the details of the development of human embryonic stem cell policies in a few different countries. (shrink)

This article contributes to the current debate on human embryonic stem cell researchers’ possible complicity in the destruction of human embryos and the relevance of such complicity for the issue of commodification of human embryos. I will discuss if, and to what extent, researchers who destroy human embryos, and researchers who merely use human embryos destroyed by others, have moral use rights, and/or moral property rights, in these embryos. I argue that the moral status of the human embryo, (...) however justified, places few restrictions on the latter researchers’ use of it, and property rights in it, once it is destroyed. I argue that the former researchers have no property rights in the destroyed embryo but use rights in it to the extent allowed by the legitimate owners of the destroyed embryo. I discuss the implications of this account for previous and current US federal law regulating human embryonic stem cell research. (shrink)

This paper examines the logic and morality of the German Stem Cell Act of 2002. After a brief description of the law’s scope and intent, its ethical dimensions are analysed in terms of symbolic threats, indirect consequences, and the encouragement of immorality. The conclusions are twofold. For those who want to accept the law, the arguments for its rationality and morality can be sound. For others, the emphasis on the uniqueness of the German experience, the combination of absolute and (...) qualified value judgments, and the lingering questions of indirect encouragement of immoral activities will probably be too much. (shrink)

The extent to which society utilises the law to enforce its moral judgments remains a dominant issue in this era of embryonic stem cell research, preimplantation genetic diagnosis, and human reproductive cloning. Balancing the potential health benefits and diverse moral values of society can be a tremendous challenge. In this context, governments often adopt legislative bans and prohibitions and rely on the inflexible and often inappropriate tool of criminal law. Legal prohibitions in the field of reproductive genetics are (...) not likely to reflect adequately the depth and diversity of competing stakeholder positions. Rather, a comprehensive and readily responsive regulatory policy is required. Such a policy must attend to the evolving scientific developments and ethical considerations. We outline a proposal for effective, responsive, and coherent oversight of new reproductive genetic technologies. (shrink)

The prelims comprise: Why Embryonic Stem Cells? Stem Cells for Organ and Tissue Transplant Immortality A Guarded Welcome for Stem Cell Research The Precautionary Principle The Ethics of ES Cell Research Stem Cells from Early Embryos The Moral Status of the Embryo Lessons from Sexual Reproduction Establishing a Pregnancy by Sexual Reproduction The Incoherence of Current US Federal Law The Symbolic Value of Life ART and Spare Embryos Tissue from Fetuses Doing Something (...) Good is Better than Doing Nothing! Interim Conclusions Genetic Identity Moral Complicity Acknowledgments. (shrink)

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents (...) and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create. (shrink)

As a moral philosopher, the perspective I will take in this chapter is one of argumentation and informed judgment about two main questions: whether individuals should ever choose to conduct human embryonic stem cell research, and whether the law should permit this type of research. I will also touch upon a secondary question, that of whether the government ought to pay for this type of research. I will discuss some of the main arguments at stake, and explain how (...) the ethical conflict over these questions differs from the political conflict over them. I will be guided throughout by the assumption that the unique scientific and clinical promise of human embryonic stem cell research is significant. Those who have doubts about this assumption should consult other chapters in this volume in which the issue is addressed directly. I begin with one of the basic facts relevant to the ethical issue of stem cell research: you and I, along with everybody else we know, developed out of clumps of primordial cells, which happen to be the very same clumps that serve as the source for human embryonic stem cells in the laboratory. Let us call these “source cells” for short, since they can be used in this way. Each individual has developed into whatever she is now out of a one-celled animal, which then became a blastocyst, a multi-celled human embryo. These blastocysts are partly made up of an inner mass of cells, and the body of every adult person has developed out of this inner mass. It is this very same clump from the inner part of the blastocyst that consists of source cells for human embryonic stem 1 cell research. These cells can be extracted and grown into a laboratory specimen of extraordinary interest to scientists. Before discussing the significance of the fact that all humans originate from these source cells, it is useful to begin by asking some perhaps rather simple-minded questions about how any one of us knows this fact to be true in the first place. How do I know that I developed from a single cell, and then a blastocyst? In my own case, the main way I know this is that other people have told me so.. (shrink)

Embryo litigation -- Access to ART treatment : insurance and discrimination -- General professional liability litigation -- Paternity and donor insemination -- Maternity and egg donation -- Traditional and gestational surrogacy arrangements -- Posthumous reproduction : access and parentage -- Same-sex parentage and ART -- Genetics (PGD) and ART -- ART-related embryonic stem cell legal developments -- ART-related adoption litigation -- ART-related fetal litigation and abortion-related litigation.

: This essay considers the implications of President George W. Bush's proposal for human embryonic stem cell research. Through the perspective of patent law, privacy, and informed consent, we elucidate the ongoing controversy about the moral standing of human embryonic stem cells and their derivatives and consider how the inconsistencies in the president's proposal will affect clinical practice and research.

Skene and Parker1 raise a number of concerns about religious doctrine unduly influencing law and public policy through amicus curiae contributions to civil litigations or direct lobbying of politicians. Oakley2 picks this up in the same issue with an emphasis on the Roman Catholic Church’s interest in preventing the destruction of embryos for embryonic stem cell research. Skene, Parker, and Oakley seem to be concerned mostly with religious views having undue influence on public policy. My concern is the (...) negative effect that such Church influenced public policy may have on the progress of the biomedical research that is itself foundational to the debate. Oakley seems to be particularly incensed that, as he puts it: “Those who support a total ban on embryonic stem cell research sometimes talk as if theirs are the only views based on moral principle”.2 What seems to be at issue here though are not the moral principles of the sanctity and dignity of human life, but the application of those moral principles to biomedical research.The Roman Catholic Church has historically defended the sanctity and dignity of human life to varying degrees at different times. Human life for much of the past 2000 years was defined by the Church as the presence of the soul, which was thought at different times to appear at various different stages during development. Only recently, with the advent of modern biology, has the Roman Catholic Church shifted its position to claim that the fertilised egg also qualifies as the right sort of human life.3 It should be noted that this doctrinal change was fundamentally driven by developments in our understanding of embryology and not the process of ensoulment.The Church’s current position on the embryo is thus based not solely on Church doctrine but also on …. (shrink)

Essays on stem cell policy seem to fall into three categories. Some essays in this collection are about logic and principles. Others are about practices and beliefs. The former group draws lines and defends them, a normative project. The latter group attempts to explain the lines that already exist, a descriptive project that may have important normative goals. Still other essays, by scientists, are about growing stem cell lines instead of drawing them.The purpose of this essay is to (...) situate the lines being drawn around stem cell science in the larger landscape of health policy. I am interested in the things that cause health policy to take particular directions and the consequences of those directions for cost, access, and quality — all of which are determined in part by biomedical innovations such as those potentially derived from stem cells. (shrink)

This paper analyzes and evaluates the 2007 majority opinion of the German National Ethics Council which seeks to establish new information (as to the inferior quality of legally procurable human embryonic stem cells) as a sufficient reason for a relaxation of the 2002 Stem Cell Law. A micro-level analysis of the opinion’s central section is conducted and evaluated vis à vis the strongest known opponent position in the national debate at that time. The argumentation is claimed (...) to rely on an unsupported semantic assumption regarding the parthood relation of the 2002 compromise and to misconstrue the strongest known opponent position. (shrink)

In Islam, the acquisition of knowledge is a form of worship. But human achievement must be exercised in conformity with God's will. Warnings against feelings of superiority often are coupled with the command to remain within the confines of God's laws and limits. Because of the fear of arrogance and disregard of the balance created by God, any new knowledge or discovery must be applied with careful consideration to maintaining balance in the creation. Knowledge must be applied to ascertain equity (...) and justice for all of humanity. Research in Islam must be linked to the broad ethical base set forth in the Qur'an and the Sunnah. Whether embryonic stem cell research or cloning is ethically acceptable in Islam depends on the benefits derived from such applications. What is most important for the scholars is to adhere to the concepts of compassion, mercy, and benefit to everyone. (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)

I argue that embryonic stem cell research is fair to the embryo, even on the assumption that the embryo has attained full personhood and an attendant right to life at conception. This is because the only feasible alternatives open to the embryo are to exist briefly in an unconscious state and be killed or to not exist at all. Hence, one is neither depriving the embryo of an enduring life it would otherwise have had nor is one causing (...) the embryo pain. I also argue that a rational agent in a situation relevantly similar to that of the embryo would consent to such research, and I use this insight to ground two justice-based arguments in favor of this research. (shrink)

On March 8, 2005, the General Assembly adopted the United Nations Declaration on Human Cloning in which Member States are called upon toa) protect adequately human life in the application of life sciencesb) prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human lifec) prohibit the application of genetic engineering techniques that may be contrary to human dignityd) prevent the exploitation of women in the application of life sciencese) adopt and implement (...) national legislation to bring into effect paragraphs a to df) take into account the pressing global issues such as HIV/AIDS, tuberculosis, and malaria, which affect in particular the developing countries. a. (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)

While society debates whether and how to use public funds to support work on human embryonic stem cells, 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, 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. (shrink)

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)

The repeal of the Eighth Amendment was a turning point in Irish social history, especially in relation to the Catholic Church. But abortion is not a settled matter and it will continue to generate controversy. Likewise, issues such as surrogacy and assisted dying will give rise to sharp differences of opinion. Legislation that seeks to address bioethical issues such as these will inevitably provoke demands for amendments or repeal. By examining developments in biomedical science, Irish law and some central aspects (...) of Catholic moral teaching, Don O'Leary builds a thorough analysis of the controversies relating to: contraception, abortion, IVF, surrogacy, human embryonic stem cell research, assisted suicide, church control of healthcare services. Biomedical Controversies in Catholic Ireland is essential reading for anyone who wishes to understand the historical background, ethical arguments and scientific advances that will inform debates about morality and social policy in the coming years. -- (from amazon.com). (shrink)

This article deals with the discussion on the status of the human embryo in Italy on a philosophical, socio-ethical and juridical level before, during and after the law. Different lines of thought are outlined and critically discussed. The focus is the debate over the so-called embryonic stem cells, pointing out the ethical premises and the juridical implications. The regulations in Italy are analysed in detail, referring to legislation and jurisprudence. In particular the author includes evidence for the (...) debate after the law came in, with specific attention on the question of the use of imported embryonic stem cells and public financing for research and the problem of the use of frozen and non-implantable embryos. (shrink)

The aim of establishing a consistent and unified approach in law concerning the ethics of commercializing human embryos and their derivative parts, products, or related technologies remains incomplete within the European Union. In an attempt to elucidate these problems and implications, I examine three separate moral considerations (i.e., exploitation, commodification, and objectification) that could be used to ground the putative wrongness associated with commercializing stem cells—in particular patenting these materials. It is argued that the moral justification for legal (...) prohibitions on such biological materials for commercial purposes is faced by a number of problematic issues. (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)

Nurses and midwives are part of health care in all the stages of our lives from preconception to death. Recent scientific advances have introduced new techniques of screening and diagnosis linked to stem cell isolation and therapies. These could affect us at any age and therefore nurses will be involved as carers and patients advocates for these techniques. In this article stem cell techniques and therapies are outlined, as well as some of the ethical challenges faced by various (...) nursing groups, whether in adult, learning difficulties, mental health, paediatric, primary care, public health or health visiting areas. Nurses have to understand the ethical issues and the rights of all parties (donor, recipient and families), which may conflict with each other, to be able to weigh up the benefits and costs to each group involved. Answers have to be found on a case-by-case basis within local moral frameworks and law. Nurses represent all parties in these therapies and act as advocates for every patient group. They need to act in an interprofessional environment to promote the best interests of all their clients, both clinically and ethically. (shrink)

In 2001, the U.S. House of Representatives passed the "Human Cloning Prohibition Act" and President Bush announced his decision to allow only limited research on existing stem cell lines but not on "embryos." In contrast, the U.K. has explicitly authorized "therapeutic cloning." Much more will be said about bioethical, legal, and social implications, but subtleties of the science and careful definitions of terms have received much less consideration. Legislators and reporters struggle to discuss "cloning," "pluripotency," "stem cells," (...) and "embryos," and whether "adult" are preferable to "embryonic" stem cells as research subjects. They profess to abhor "copying humans" or "killing embryos." Do they know what they are talking about? Do we? This paper explores the historical, philosophical, and scientific contexts that inform this heated discussion. (shrink)

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)

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

Can one consistently deny the permissibility of abortion while endorsing the killing of human embryos for the sake of stem cell research? The question is not trivial; for even if one accepts that abortion is prima facie wrong in all cases, there are significant differences with many of the embryos used for stem cell research from those involved in abortion—most prominently, many have been abandoned in vitro, and appear to have no reasonably likely meaningful future. On these grounds (...) one might think to maintain a strong position against abortion but endorse killing human embryos for the sake of stem cell research and its promising benefits. I will argue, however, that these differences are not decisive. Thus, one who accepts a strong view against abortion is committed to the moral impermissibility of killing human embryos for the sake of stem cell research. I do not argue for the moral standing of either abortion or the killing of embryos for stem cell research; I only argue for the relation between the two. Thus the conclusion is relevant to those with a strong view in favor of the permissibility of killing embryos for the sake of research as much as for those who may strongly oppose abortion; neither can consider their position in isolation from the other. (shrink)

Armed with expanded federal funding for human embryonic stem cell research and new methods for deriving pluripotent stem cells, stem cell researchers in the U.S. are poised to proceed with unprecedented speed toward the development of new clinical therapies. Staring into the new dawn of regenerative medicine, many observers may assume that the only responsible route to the clinic, both scientifically and ethically, is through FDA-approved clinical trials processes. Conventional wisdom dictates that, like pharmaceutical drugs (...) and the use of biological therapeutics, stem cell-based therapies will have to pass through a series of controlled studies — initially to assess safety and toxicity, then efficacy and comparative efficacy — before they can be justifiably administered to patients outside a clinical trials context. (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)

As elsewhere, the ethical debate on embryonic stem cell research in Central Europe, especially Germany and Switzerland, involves controversy over the status of the human embryo. There is a distinctive Kantian flavor to the standard arguments however, and we show how they often embody a set of misunderstandings and argumentative shortcuts we term "embryological Kantianism." We also undertake a broader analysis of three arguments typically presented in this debate, especially in official position papers, namely the identity, continuity, and (...) potentiality arguments. It turns out that these arguments do not support the strong, quasi-personal status accorded to the embryos in these official opinions. (shrink)

The possibility of obtaining stem cells from human embryos has given rise to an intensive legal and ethical debate. In this paper, attention is paid to the normative disparity and ambiguity in Europe. An argument for the need for a minimal legal harmonization is made; and a prudent and flexible way to reach this successfully is suggested. Establishing a common legal framework seems to be the only way to guarantee true competitiveness for the European scientific community.

The possibility of obtaining stem cells from human embryos has given rise to an intensive legal and ethical debate. In this paper, attention is paid to the normative disparity and ambiguity in Europe. An argument for the need for a minimal legal harmonization is made; and a prudent and flexible way to reach this successfully is suggested. Establishing a common legal framework seems to be the only way to guarantee true competitiveness for the European scientific community.

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)

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)

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

Since their derivation, human embryonic stem (hES) cells have been used for a variety of applications including developmental biology, pathology, chemical biology, genomics, and proteomics. However, their most important potential application is the generation of cells and tissues, which can be used for cell‐based therapies. One of the main drawbacks of hES cell culture is that they are particularly sensitive to dissociation, which is required for passaging, expansion, cryopreservation, and other applications. Recently, it has been discovered (...) that an inhibitor of Rho kinase (ROCKi; Y‐27632) increases the survival rate of dissociated, single hES cells. This breakthrough has allowed new methods in hES cell culture to be developed, with the promise of increasing hES cell numbers into the realm of clinical relevance. In our studies demonstrating that ROCKi dramatically increases hES cell cryopreservation efficiency, we have observed that ROCKi treatment does not decrease hES cell's susceptibility to apoptosis. Rather, we hypothesize that ROCKi treatment desensitizes single hES cells to their environment reducing the odds that individual cells will undergo anoikis. (shrink)