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)

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)

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

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)

In lieu of an abstract, here is a brief excerpt of the content:Contradiction and Legislation Regarding the Right to LifeKevin L. Flannery, S.J.Unborn Human Life and Fundamental Rights: Leading Constitutional Cases under Scrutiny. Edited by Pilar Zambrano and William Saunders, with concluding reflections by John Finnis. Berlin: Peter Lang, 2019.The most fundamental principle of law is the principle of non-contradiction. This is Thomas Aquinas's position in the seminal article on the natural law, Summa theologiae I-II, question 94, article 2, (...) where, citing Aristotle, he formulates the principle as, "One should not simultaneously affirm and negate." Lafter in the same article, Thomas offers a practical formulation of the same principle, "Good is to be done and pursued and evil avoided"; but in law, since it is contained in propositions (airmations and negations) as distinct from ideas regarding the pursuit of goods, the prior formulation is the more immediately relevant of the two.The book under review is important in that, by going through the legal history regarding abortion and related issues in a number of different countries—the United States, Canada, Italy, Spain, Poland, Ireland (Eire), Costa Rica, Argentina, Chile, Mexico, and Peru—it causes to emerge any number of times the realization that legislation and judicial decisions in favor of abortion "rights" invariably infect a legal system with contradictions and inconsistencies of various sorts. The present essay is, therefore, not your typical book review. Its objective is simply to list some of the legal contradictions and inconsistencies identified by the book's various authors as they describe the legal status of the unborn in their respective nations. [End Page 1323]William Saunders's very clear and comprehensive first chapter is entitled, "Judicial Interference in the Protection of Human Life in the United States: Actions and Consequences." In it, he describes, among other things, the Human Cloning Prohibition Act passed by the U.S. House of Representatives in 2003, which prohibited "any person or entity, public or private" from performing human cloning (23). He speaks also of a bill proposed in the U.S. Senate once the Human Cloning Prohibition Act had passed in the House of Representatives. This Senate bill (which was entitle, "The Human Cloning Ban and Stem Cell Research Protection Act") would have prohibited "any person or other legal entity" from conducting human cloning, even while allowing nuclear transplantation, which it defines as "transferring the nucleus of a human somatic cell into an oocyte from which the nucleus... ha[s] been... removed or rendered inert." The problem here, as Saunders explains, is that this latter definition "is the very definition of cloning" (25). In other words, in the same year, two pieces of legislation were considered in the Congress of the United States, both purporting to ban human cloning, one of which would have permitted what the other described (correctly) as human cloning and so prohibited.In the second chapter, "Whither United States Abortion Law?" by Gerard V. Bradley, discussed, among other things, is the inconsistency between the United States Supreme Court's pro-abortion decision Roe v. Wade and various laws, both state and federal, prohibiting feticide. Bradley says of the 2004 federal Unborn Victims of Violence Act that, "in pertinent part it says that 'whoever' 'causes the death of or bodily injury to,' a 'child who is in utero' is guilty of an offense apart from any accompanying offense against the woman carrying the child." The penalty for such an act is the same as would be imposed if the act were inflicted upon the unborn child's mother: if, for instance, the mother was killed. "A child in utero," reports Bradley, "is defined as a member of the species homo sapiens, at any stage of development, who is carried in the womb'" (37).The problem here is that prosecutable under this law are acts identical with those performed legally by abortionists. Bradley mentions two cases in which a woman's male partner—in one case the woman's husband—effected by stealth the abortion of her child. In one case, the male purchased abortion pills and affixed to their container a pharmacy label indicating that it contained a common antibiotic; in the other, the husband obtained the same type of... (shrink)

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

In 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)

This book examines the field of bioethics from an international and regional legal perspective. It focuses on major international law documents such as the United Nations Universal Declaration on Bioethics and Human Rights and UNESCO declarations on human cloning and the human genome. Coverage of regional legal instruments includes the Council of Europe Convention on Human Rights and Biomedicine (the Oviedo Convention) and its Protocols on cloning, transplantation, and research with human beings. Work on surrogacy issues by the Hague Conference (...) on Private International Law is also discussed, as are some African regional legal instruments on biosafety, and stem cell research. (shrink)

Stem cell science is advancing at an unprecedented rate, with thousands of research papers being published every year and many clinical trials for a wide range of conditions underway as registered on ClinicalTrials.gov. This rapidly expanding and alluring field has brought with it ever more complex and multifaceted ethical issues, many of which require new guidelines, consent protocols and even change in legislation, since they do not fit comfortably in the existing bioethical regulations and protocols. Keeping up with (...) the ethical implications of stem cell research is daunting to the expert and non-expert. We review the various types of stem cells and then focus on multipotent and pluripotent cell types, since it is these cell types that bring with them the greatest research and therapeutic potential, while concurrently delivering novel ethical conundrums. Certain key considerations are currently lacking and what is needed is how to obtain permission from individuals who donate their biological material for both scientific inquiry and eventually, for their potential therapeutic utility. (shrink)

Abstract.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)

This paper discusses the hazards of regulating controversial biomedical research in light of the emergence of powerful, multi-national biotechnology corporations. Prohibitions on the use of government funds can simply force controversial research into the private sphere, and unilateral or multilateral research bans can simply encourage multi-national companies to conduct research in countries that lack restrictive laws. Thus, a net effect of government regulation is that research migrates from the public to the private sphere. Because private research receives less oversight and (...) external scrutiny than public research, it can threaten the welfare and rights of human subjects, scientific progress and openness, and the quality of the approval process for new biomedical technologies. In order to avoid the harmful effects of government regulation of biotechnology, society should promote meaningful discussion and dialogue among scientists, industry leaders, and the public before resorting to regulatory solutions. Legislative or executive initiatives should be applied with great discretion and care, and should be crafted in such a way that they protect public health and safety, promote scientific progress, and avoid the hazards of privatized research and polarized debates. (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)

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.

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)

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)

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)

This paper examines a case of failed interdisciplinary collaboration, between experimental stem cell research and theoretical systems biology. Recently, two groups of theoretical biologists have proposed dynamical systems models as a basis for understanding stem cells and their distinctive capacities. Experimental stem cell biologists, whose work focuses on manipulation of concrete cells, tissues and organisms, have largely ignored these proposals. I argue that ‘failure to communicate’ in this case is rooted in divergent views of explanation: (...) the theoretically-inclined modelers are committed to a version of the covering-law view, while experimental stem cell biologists aim at mechanistic explanations. I propose a way to reconcile these two explanatory approaches to cell development, and discuss the significance of this result for interdisciplinary collaboration in systems biology and beyond. (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)

Research using human embryonic stem cells raises an array of complex ethical issues, including, but by no means limited to, the moral status of developing human life. Unfortunately much of the public discussion fails to take into account this complexity. Advocacy for liberal and conservative positions on human embryonic stem cell research can be simplistic and misleading. Ethical concepts such as truth-telling, scientific integrity, and social justice should be part of the debate over federal support for human (...) embryonic stem cell research. Moreover, the debate should be conducted in accord with principles of deliberative democracy, including respect for people holding competing views. (shrink)

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)

Hematopoietic stem cell transplantation is a widely accepted practice in the United Kingdom (UK). The relatively liberal UK law permits donation both within families and from strangers, and even allows the creation of “saviour siblings” who are brought into being with the specific intent of having them donate stem cells to save other members of their family. This chapter describes the regulation of HSCT in the UK and highlights some ethical issues related to discrimination against some categories (...) of potential donors, the accuracy of the information provided to potential donors, and the controversy concerning saviour siblings. (shrink)

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)

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)

ABSTRACT 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)

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)

This paper identifies the legal and policy framework relating to the use of aborted fetuses in stem cell research and therapies and contrasts this with the collection of embryos for research. It suggests that more attention should be given to questions about the kind of consent sought by researchers from women and that there should be more transparency about how aborted fetuses are used. It reports on variability in current practices of research ethics committees and researchers and uncertainty about (...) the guidance available to them. It argues that there is a need for wide public discussion about the policy issues relating to fetal tissue use in stem cell research and the need for clarification of the law in this area. (shrink)

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (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)

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)

In bioethics as in other areas of health policy, historical institutional factors can shape policy independently of interests or public opinion. This article finds policy divergence among countries with similar national moral views of stem cell research, and explains that divergence as the product of path-dependency.

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)

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)

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)

This article highlights the current controversies around stem cell research and its application in clinical medicine. It aims to discuss the ethical concerns around how corporate involvement is corrupting the ethical progression in this field of research. The author appeals to medical and scientific communities to take cognisance of current practices and to facilitate the regulation of new stem cell therapies being advertised to the public.

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and (...) effectiveness of the current Guideline for Stem Cell Research and Therapy are examined. The study’s findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation of the International Society for Stem Cell Research containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders. (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)

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)

Controversy often follows when patents are obtained in a pioneering area of technology. Patent filing activity in the field of regenerative medicine and in relation to stem cells in particular has not escaped opprobrium, although it is instructive to compare the nature of the debates that are taking place over the patenting of stem cells in the US and Europe. In the US, debate over the early patent applications made by the Wisconsin Alumni Research Foundation has (...) been intense2, but at least it appears to have been grounded firmly in patent law principles. In Europe, the debate has skewed away from the basic patent law tenets of novelty, inventiveness and industrial utility and has entered something of a twilight zone, with the European Patent Office serving as a diffident forum for difficult moral and ethical arguments about the destruction of human embryos and the commercial exploitation of human life. (shrink)