Embryonic stem cell research: one small step for science or one giant leap back for mankind?

At the forefront of modern debate over the ethical use of biotechnology is embryonic stem cell research. In this poignant analysis of its legitimacy, the author examines the history of this research in light of the United States' policy favoring the protection of human beings over scientific progress. Stem cells, which can divide in culture to create specialized cells in the human body, possess significant potential for curing disease, particularly when taken from human embryos. However, as evidenced by the research atrocities committed under the Nazi regime, the benefits of human research do not come without a cost to humanity. Recognizing this, the later trial of these scientists produced the Nuremberg Code, a set of natural law principles guiding future research on humans that continues to influence health policy decisions. Drawing on this background, the author first considers the appropriate legal status for a human embryo. Biologically, the characteristics of a human embryo place it between human tissue and a constitutional person. Judicially, the answer is even less clear. The author analyzes case law in the context of abortion and in vitro fertilization, as well as classifications by the common law, state legislation, and the National Bioethics Advisory Commission, to conclude that a human embryo should be subject to the same legal and ethical restrictions as any other "human subject." Accordingly, the author argues that embryonic stem cell research violates the ethical standards and purposes of the Nuremberg Code and should be banned by federal legislation. Such a prohibition will fulfill the societal policy choice of protecting potential life and vulnerable human subjects.     

Navigating tissue banking regulation: conceptual frameworks for researchers, administrators, regulators and policy-makers

In the "post-genomic" age of biomedical research, researchers often wish to utilise collections of human tissue. This type of research raises many ethical and legal issues and anyone wishing to use such collections is faced with an enormously complex set of regulatory requirements, many of which are still ambiguous, reflecting ongoing ethical and legal debate. Whilst there is no way of entirely avoiding such regulatory complexity and ambiguity, conceptual frameworks can assist those who wish to use, administer, authorise and generate policy on tissue banking research. Two conceptual frameworks are described here: a taxonomy of tissue banking practices, aimed at assisting those who need to ensure that tissue banks meet ethical and legal requirements; and a "syncretic" approach to policy-making, for those who wish to generate new policy, or streamline existing policy relating to tissue banking research.     

Resolving legal, ethical, and human rights challenges in HIV vaccine research

In the absence of a cure for AIDS, attention has turned to the possibility of developing a preventive vaccine for HIV infection. Yet many scientific, ethical, legal, and economic obstacles remain. At the current rate, the development and production of an effective vaccine could take 15 to 20 years or longer. If tens of millions more HIV infections and deaths are to be avoided in the coming decades, vaccine research needs to be greatly expedited. Furthermore, it must be undertaken ethically, and the products of this research must benefit people in developing countries. This article, an edited and updated version of a paper presented at "Putting Third First," addresses challenges arising in HIV preventive vaccine research in developing countries. It does not address clinical research in developing countries relating to treatments or therapeutic vaccines. Nor does it address legal and ethical issues relating to HIV vaccine research in industrialized countries, although similar issues arise in both contexts. The article concludes that while ethical codes are silent on the obligation to undertake research and development, international law provides strong legal obligations--particularly with regard to industrialized states--that should be invoked to accelerate HIV vaccine development, and distribution.     

Owning up to our Agendas: On the Role and Limits of Science in Debates about Embryos and Brain Death

The ethical issues integral to embryo research and brain death are intertwined with comprehensive views of life that are not explicitly discussed in most policy debate. I consider three representative views – a naturalist, romantic, and theist – and show how these might inform the way practical ethical issues are addressed. I then consider in detail one influential argument in embryo research that attempts to bypass deep values. I show that this twinning argument is deeply flawed. It presupposes naturalist commitments that are at issue in the embryo research debate, and exhibits a blindness to alternative philosophical viewpoints. By considering the work of Hans Driesch, the discoverer of the facts of embryology integral to the twinning argument, I show how the twinning facts are compatible with romantic and theistic accounts that affirm full moral status for the early embryo. While these alternative interpretations might have a tenuous status in current scientific debate, they should be respected in ethical and policy debate.     

现代生命医学与美国相关法律的发展

近30年来现代医学技术的高速发展及惊人进步挑战着世界各国的法律及道德观念.本世纪更因生命科学的巨大发展而被命名为生命科学世纪.现代生命科学在变革世界的同时也带来了史无前例的道德伦理问题,引发了激烈的争论.为了适应这些新的发展,美国的法律做出了相应的变革.这些新的法律法规影响着美国人民的工作生活及几乎所有的法律领域,例如医疗法、家庭法、遗产法、商业法、专利法、刑法等都极大程度地受到现代医学及相关法律的制约与影响.当代各个领域中的美国律师及政治领导人必须熟悉生命医学的有关法律,以为社会提供高质量和全方位的服务.生命医学法律更是当代世界及美国政坛的激战舞台,美国总统布什于2006年7月19日第一次使用了总统否决权,驳回了美国国会新通过的干细胞研究的法律,此举引发了激烈的政治波澜.着重介绍当代美国生命医学法律中的最热点论题,包括医疗决定权、安乐死、人类克隆及人胚胎干细胞研究等有关法律的发展过程及存在的问题与面临的挑战.     

DNA databases for criminal investigation purposes: technical aspects and ethical-legal problems]

Advances in DNA technology and the discovery of DNA polymorphisms have opened up the possibility of creating data bases of individuals' DNA for criminal investigation purposes. In many European countries laws are being drawn up or have been passed to regulate such data bases. In Spain theres is a need for an urgent ethical and legal debate on ther appropriateness. The article is divided into two parts. In the first, the authors discuss the technical principles underlying these data bases. In the second, they set out their legal and ethical views on regulation in Spain.     

Displaced agendas: current regulatory strategies for germline gene therapy

Recent developments in biotechnology are radically affecting the nature of reproduction and the manner in which we approach disease. In particular, germline gene therapy, or the insertion of genetic material into cells while they are developing and dividing, offers the promise of eradicating genetic defects in humans during embryonic development. In this article, the authors argue that the social and ethical implications of the developments in the field of germline gene therapy have not yet received adequate consideration. Unlike previous technologies which targeted already-developed cells, germline gene therapy can potentially correct and eliminate genetic deficiencies at the developmental stages of a cell. This raises issues of genetic enhancement beyond the therapeutic applications of this technology. However, the authors submit that an established pattern of subordinating social and ethical issues to technical and scientific debate in the regulatory arena is repeating itself in the case of discussions over germline gene therapy. The authors suggest that the American scientific regulatory process fails to fully meet the challenges of this technology, particularly because social and ethical issues are not formally considered in the existing process. They therefore suggest that American regulatory agencies should look to the approach taken by Europe with regard to germline gene therapy as an emerging technology, and that it may be necessary to incorporate effective public debate over social and ethical concerns into a regulatory process which is primarily concerned only with the efficacy of new technologies.     

Lengthening the stem: allowing federally funded researchers to derive human pluripotent stem cells from embryos

Recent developments in fetal tissue research and stem cell research have led to dramatic breakthroughs in the search for cures for Parkinson's disease, Alzheimer's disease, diabetes, and a host of neurological disorders. Because this research involves fetal tissue and stem cells from human embryos, many complicated ethical and legal implications surround it. This Note explores the history of fetal tissue research and stem cell research, examines the surrounding ethical and legal issues, looks at the current state of federal law, and concludes that Congress should allow federally funded researchers to derive stem cells from discarded human embryos obtained from in vitro fertilization clinics.     

Ethical issues in international biomedical research: an overview

Human subjects research has been the focus of numerous controversies over the years. The dilemma lies between the potential harm to individuals who participate in research and the knowledge to be gained from the research study that might benefit society. When research is conducted in developing countries by researchers and sponsors from the United States and other industrialized countries, differences in history, culture, politics, wealth, and power between the countries give rise to unique challenges. In this Article, the author identifies several ethical issues to be considered when research is conducted in developing countries and provides the legal and ethical framework for their resolution.     

Wrongful life actions: the legal and ethical hurdles

This article discusses the various legal and ethical issues arising out of the cause of action for wrongful life. This action involves a claim by a child that but for the negligence of the doctor, hospital or other medical institution, his or her mother would have terminated the pregnancy and he or she would not have been born. The courts have generally rejected this cause of action on the basis of legal, ethical and policy considerations. The author proposes that the legal hurdles can be overcome and that the ethical and policy considerations do not outweigh the desirability of upholding wrongful life claims.     

Umbilical cord blood banking and the next generation of human tissue regulation: an agenda for research

The transformation of umbilical cord blood from being a waste product to being a valuable source of stem cells has led to the emergence of significant legal, ethical and social issues. This editorial proposes an agenda for research into the regulation of umbilical cord blood banking which focuses on issues of characterisation, consent, the interplay of public and private services, and the importance of applying property concepts. It concludes by stressing the need for reform to be based on well-informed public debate.     

A nation's genes for a cure to cancer: evolving ethical, social and legal issues regarding population genetic databases

The advent of the human genome sequence has focused research on understanding underlying genetic links to complex diseases such as cancer, asthma and heart disease. In the past few years, individual countries, such as Iceland, Estonia, Singapore and the United Kingdom, have created national databases of their citizens' DNA for comparative research. Most recently, an international consortium including Nigeria, Japan, China and the United States launched a $100 million project called the International HapMap to map the human genome according to haplotypes, blocks of DNA that contain genetic variation. Such population genetic databases present challenging ethical, social and legal issues, yet regulation of genetic information has developed sporadically, from region to region, without a consistent international standard. Without a clear understanding of the consequences of genetic research in terms of individual and community-wide discrimination and stigmatization, genetic databases raise concerns about the protection of genetic information. This Note provides a survey of the evolving landscape of population genetic databases as a legislative and public policy tool for national and international regulators. It compares different approaches to regulating the collection and use of population genetic databases in order to understand what areas of consensus are formulating a foundation for an international standard. As the first population genetics project that will span multiple countries for the collection of DNA, the International HapMap has the potential to become an influential standard for the protection of population genetic information. This Note highlights issues among the national databases and the HapMap project that raise ethical, social and legal concerns for the future and recommends further protections for both individual donors and community interests.     

The Legal Regulation of Medical Science

Recent developments in reproductive technology have stimulated widespread public debate and controversy, especially regarding the social, ethical, moral, and legal implications of in vitro fertilization and human embryo experimentation. These issues have received a great deal of public attention in Australia over the past two decades. Some jurisdictions have implemented legislation to regulate and prohibit aspects of medical science. This discussion examines the emergence and career of the Infertility (Medical Procedures) Act 1984 in Australia and its regulation of embryo experimentation. The central argument is that law neither simply reacts to scientific developments nor merely reflects alleged community values, but actively constitutes and defines the boundaries of medical science. This fluidity or flexibility provides medical scientists with opportunities to make claims for the legitimate right to undertake certain experiments free from the interference of nonscientists. The controversy surrounding embryo experimentation highlights the ambiguities in distinguishing the proper sphere of science from ethical and legal jurisdictions.     

Human-nonhuman chimeras: a regulatory proposal on the blurring of species lines

The chimera of modern biotechnology is defined broadly as a single organism composed of a mixture of materials from two or more organisms possessing distinct genetic backgrounds. Unlike the United States, which does not regulate chimeras directly, Canada has responded to the unregulated pursuit of chimera technology by banning certain chimeras as part of comprehensive legislation designed to regulate human reproductive technologies. In 2004, the Canadian Parliament passed the Assisted Human Reproduction Act despite criticism urging greater legislative justification for the Act's provisions and modification to it statutory definitions. Because current regulatory mechanisms in the United States, including patent law and administrative oversight, fail to regulate chimera technology, the United States should enact new legislation, using Canada's legislation as a model, to prohibit embryonic chimeras and to regulate other human-nonhuman combinations. Unregulated biotechnology threatens to disrupt legal and social institutions; therefore, the United States must make a balanced effort now to protect the public interest.     

Posthumous reproduction and the meanings of autonomy

In recent years there has been considerable debate over the legal and ethical issues associated with posthumous reproduction. This article analyses recent cases and legal regulation of reproductive technologies in Australia. The issues associated with posthumous reproduction are explored through a consideration of the nature of an individual's interest in their reproductive material. The suitability of a property-based model as a means of conceptualising interests in reproductive material is explored. The article concludes that the issues in this area need to be analysed in terms of autonomy interests that are understood relationally.     

Capital punishment in Poland: The debate continues

Throughout its modern history, Poland has not escaped controversies surrounding the use of the death penalty. Tracing the historical development of laws dealing with the issue demonstrates an evolution influenced by various legal, political, social, philosophical, and international factors, leading up to the current absence of the penalty from the Polish legal system. The debate in society revolves around some stereotypical views held by different social groups. One of the biggest challenges is how to reconcile those views with empirical evidence, especially on issues like the deterrent effect of capital punishment. The authors describe the death penalty debate in Poland from these perspectives and take a retentionist position with regard to some selected crimes. As long as there are individuals willing to take other people's lives in a premeditated and deliberate manner demonstrating callous contempt for another person's existence, death remains the only punishment satisfying a sense of social justice and upholding the value of human life.     

Genetic enhancement in the twenty-first century: three problems in legal imagining

By what method should we resolve the ethical and public policy issues surrounding genetic enhancement: a utilitarian calculus, appeal to Scripture, application of neo-Kantian principles? In this Article, the author claims that, despite the diversity of our basic methodological commitments, we can advance our shared understanding of the issues surrounding genetic enhancement and come to agree upon certain central features as essential to any adequate method for resolving those issues. The author attempts to make modest headway on both fronts by engaging in "legal imagining." Legal imagining consists of examining hypothetical problems from the lawyer's perspective, the perspective of a caring, professional friend. This Article examines and discusses three problems in legal imagining.     

Can the United Nations support "objective" and unhampered illicit drug policy research?

Policies towards mind-altering drugs are controversial and vary among countries and cultures. Many nations feel that the United Nations should be a forum where anti-drug issues can be discussed openly and `objectively'. During the 1990s I participated frequently in U.N. sponsored research projects. This essay summarize what has been a challenging and exciting experience and raises many questions about the U.N.'s capacity to do and or fund `objective' drug research. This is so because of pressures on the U.N. from drug-policy setting countries, lack of independent funds for the U.N. drug policy agencies, the structure and internal dynamics of the U.N. bureaucracies, and the background of the involved U.N. staff. As a result of these factors, the U.N. has promoted a repressive anti-drug agenda and does not allow open debate of many of key anti-drug issues currently discussed in many coutries. This is unfortunate because the UN. has the largest amount of information about illicit drugs anywhere in the world and can play a key role improving anti-drug policies that currently are unsatisfactory to both, drug hawks and doves.     

The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research

This article examines the legal status of "soft law" in the fields of medicine and medical research. Many areas of clinical practice and research involve complex and rapidly changing issues for which the law provides no guidance. Instead, guidance for physicians and researchers comes from what has often been called "soft law"--non-legislative, non-regulatory sources, such as ethics policy statements, codes, and guidelines from professional or quasi-governmental bodies. This article traces the evolution of these "soft law" instruments: how they are created, how they are adopted within the professional community, and how they become accepted by the courts. It studies the relationship between soft law instruments and the courts. It includes an examination of the approaches to judicial analysis used by the courts in theory and in practice. The authors then examine the jurisprudence to see how courts will adopt professional norms as the legal standard of care in some circumstances and not others. They consider the legal concerns and ethical issues surrounding the weight attached to professional practices and norms in law. The authors demonstrate how practices and policies that guide professional conduct may ultimately bear weight as norms recognizable and enforceable within the legal sphere.