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.     

The Lockhart Review: where now for Australia?

In 2005 a Legislation Review Committee, known as the Lockhart Review, undertook a review of the Commonwealth legislation regulating human embryo research. The report that emanated from the review was released in December 2005. If the report recommendations are implemented by the Federal Government, Australian scientists will be permitted to create human embryo entities currently known as "human embryo clones" by the process known as somatic cell nuclear transfer to develop stem cell lines for research purposes. Many argue that stem cells have the potential to be developed into valuable medical therapies that could assist with, or cure, serious diseases such as Type 1 diabetes and Parkinson's disease. This article analyses the evidence presented to the Lockhart Review and the report recommendations. It assesses where the Lockhart recommendations would place Australia in terms of worldwide embryo research. It is argued that the Federal Government should fully embrace the recommendations so that Australia can progress stem cell research to its fullest potential.     

Development of stem cells from umbilical cord blood and blood banking: "non-controversial" and "free of political and ethical debate"?

Opponents of human embryo research have understandably welcomed pluripotent stem cells being derived from body cells including cells from umbilical cords after childbirth. The cord would otherwise be discarded and embryos are not destroyed. However, there are other ethical, legal and political issues in cord blood collection, whether for the child's future use, or a public blood bank. Information and consent procedures may be misleading. Some parents have false hopes about potential outcomes. The right of access to stored blood and other benefits is sometimes uncertain for children and their families. Private stem cell repositories may compete with public ones. People may want to impose conditions on donation. Quality control may be an issue.     

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.     

Ambiguity of the embryo protection in the Human Rights and Biomedicine Convention: experiences from the Nordic countries

Until 1998 research on in vitro human embryos concentrated on the issues related to assisted reproduction. The situation changed dramatically when the first scientific report on the laboratory culture of human embryonic stem cells was published. This scientific breakthrough with new therapeutic promises put human embryo into a new, more vulnerable position. Combined with creation of embryos via somatic cell nuclear transfer, it inveigles into mass production of embryos, first for scientific purposes, but later perhaps for the healing of people. This article examines the efficacy of the Convention on Human Rights and Biomedicine in protecting embryos in this new era of embryo research. The interpretative latitude of Article 18 of the Convention is demonstrated, and legislation in three Nordic countries with highly variable approach to embryo research regulation is analysed. I examine how this divergence is possible in the light of the Convention text. In the end, potential reasons for variation in regulation in the otherwise similar Nordic countries are discussed, as well as under what conditions harmonisation of regulation on embryo research, a highly value-charged matter, could be possible at the European level.     

Stem cell frontiers: science, ethics and regulation

The isolation of human stem cells and the cloning of "Dolly" in the late 1990s, based on primate and other animal studies in the previous 20 years, created an explosion of interest that continues with daily reports in much of the world's press. The science has progressed steadily but not always smoothly, with promising discoveries in the potency and flexibility of cells derived from embryonic, umbilical cord and adult tissues. The promise of a revolutionary new era in health and medical sciences and systems requires careful scientific method, ethical debate and supportive legal and regulatory frameworks to achieve success. The frontiers of the science are focusing on the regulation of cell lineage choice and the development of designer stem cells for therapeutic cloning; the ethical debate focuses on the special status of the human embryo and the pathways to applications; while legal and regulatory frameworks differ around the world. There is some risk that the promises are overtaking the reality of progress, with the rush for results and premature offering of dubious remedies compromising scientific method and credibility. Stem cells should not be the snake oil of our times, nor should short cuts and short sell promises, fuelled by illusions of fame and fortune, risk the trust of the public in science and medicine.     

The legal concept of personhood in Colombia: are there biological reasons to change it?]

Nowadays, as a consequence of scientific advances in embryology, genetics and assisted reproduction techniques, the scientific community ask for new laws to establish new parameters to use with these recent discoveries. Discoveries that have changed the legal concept of "person". In many countries this concept is absolutely useless when facing new techniques such as cloning, stem cell research and embryo storage. That is why it is necessary to change its definition to guarantee the right to life and give a better protection to human embryos.     

Jewish Perspectives on the Use of Preimplantation Genetic Diagnosis

This article presents an analysis of the ethical considerations raised by preimplantation genetic diagnosis (PGD) from a Jewish perspective. It weighs the Jewish imperatives to pursue good health against a number of harms that may follow from the expanded use of PGD technology, including increased medical risk to the mother, the destruction of embryos and possible emotional harm to the child born from this procedure. It pays special attention to the potential harms that may befall those in society who do not have access to PGD or who choose not to employ it.     

The problems and possibilities in regulating technological frontiers: the politics of the new anxiety?

The revolution in science, biotechnology and medicine of the past 30 years demands a revisitation of old institutional forms and responses, including those of law itself. Scientific citizenship requires that law develop a moral vision and vocabulary so that we shape the moral dimensions of the emergent bioeconomy. Chief among those in the field of biotechnology are technologies of human reproductive cloning, therapeutic cloning and stem cell research using human embryos. Where there are deep pluralist divisions is in relation to therapeutic cloning and embryonic stem cell research. Regulatory flexibility may be opportune in delimiting the extent to which government need stray into this realm of "moral politics". As Brownsword has written, an important developmental vector is what has become known in administrative and public law literature as the concept of "smart regulation". This concept is examined and an attempt to apply it to these fields is made. The enlarged nature of human action -- enlarged in magnitude, reach and novelty -- raises moral issues beyond interpersonal ethics and requires reflection; responsibility is centre stage and calls for lengthened foresight -- what has been called a "scientific futurology". This is also examined.     

Theorizing waste in abortion and fetal ovarian tissue use.

This article explores the theoretical implications of the concept of waste as it specifically relates to arguments in favour of fetal ovarian tissue use as a source of donor eggs. The author begins by discussing medico-scientific constructions of women's reproductive bodies as wasteful. The article explores the works of Drucilla Cornell on bodily borders, Julia Kristeva on abjection, and Mary Douglas on pollution to develop a nuanced understanding of the relations between waste, women's reproductivity, and abortion in North American mainstream and medico-scientific cultures. This layered reading of waste and abortion deconstructs a significant assumption of arguments in favour of fetal ovarian tissue use as ethical--that such tissue is just "waste." The author suggests that theorizing waste this way may contribute to ethical analyses of uses of other reproductive materials (that is, embryos) that are supported, in part, by an assumption that those materials would otherwise be "wasted."     

Research with human embryo stem cells. Foundations and judicial limits]

Research with human embryos, and particularly, the use for scientific purposes of human embryonic stem cells has given raise to different sort of problems at the international level. One of the most strict regulation in this field, is this lecture Professors Albin Eser and Hans-Georg Koch analyse the german legal framework in relation with the use of embryos and human embryonic stem cells for scientific purposes.     

The attack of the clones: patent law and stem cell research

This article considers the integral role played by patent law in respect of stem cell research. It highlights concerns about commercialization, access to essential medicines and bioethics. The article maintains that there is a fundamental ambiguity in the Patents Act 1990 (Cth) as to whether stem cell research is patentable subject matter. There is a need to revise the legislation in light of the establishment of the National Stem Cell Centre and the passing of the Research Involving Embryos Act 2002 (Cth). The article raises concerns about the strong patent protection secured by the Wisconsin Alumni Research Foundation and Geron Corporation in respect of stem cell research in the United States. It contends that a number of legal reforms could safeguard access to stem cell lines, and resulting drugs and therapies. Finally, this article explores how ethical concerns are addressed within the framework of the European Biotechnology Directive. It examines the decision of the European Patent Office in relation to the so-called "Edinburgh patent", and the inquiry of the European Group on Ethics in Science and New Technologies into "The Ethical Aspects of Patenting Involving Human Stem Cells".     

Legal protection of the genetic heritage in Brazil (comments on the new "Biosafety Law" of March 24, 2005)]

The purpose of the current article is to outline and comment the most important aspects of the regulation of Brazil's criminal legislation about the protection of the human genome, which establishes crimes related to genetic manipulation and to the dissemination of transgenics in the environment. It also refers to the problems related to the application of the old legal text (Law 8.974/1995), which punished conducts that stayed without the enough development. These gaps complicated so much the application of those rules that the Brazilian Parliament has recently proposed the complete modification of the present legislation by a new Biosecurity Law (Law 11.105/2005). This law for the first time authorizes research with human embrionyc stem cells in Brazil, trying thus to solve in this way the problem of cryoconserved human embryos produced by in vitro fertilization programmes. The new law is analyzed here from a legal and ethical view point.     

Directed embryo donation: free choice or discrimination?

The issue of whether to allow or prohibit the directed anonymous donation of human embryos for reproductive use has been publicly contentious. The claims that directed donation are a donor's autonomous right contrast with claims that the practice is discriminatory. Recent legislation and legal recommendation on the issue has been inconsistent or contradictory. This article specifically addresses the question as to whether the directed donation of embryos is the exercise of free choice or an act of discrimination. This question is considered from both ethical and legal viewpoints.     

The regulation of science and the Charter of Rights: would a ban on non-reproductive human cloning unjustifiably violate freedom of expression?

Non-Reproductive Human Cloning (NRHC) allows researchers to develop and clone cells, including non-reproductive cells, and to research the etiology and transmission of disease. The ability to clone specific stem cells may also allow researchers to clone cells with genetic defects and analyze those cells with more precisions. Despite those potential benefits, Parliament has banned such cloning due to a myriad of social and ethical concerns. In May 2002, the Canadian Government introduced Bill C-13 on assisted human reproductive technologies. Bill C-13 deals with both the scientific and the clinical use of human reproductive materials, and it prohibits a number of other activities, including NRHC. Although the Supreme Court of Canada has never ruled on whether scientific experiments area form of expression, academic support exists for this notion. The authors go through the legal analysis that would be required to find that scientific experiments are expression, focusing in part on whether NRHC could be considered violent and thus fall outside the protection of section 2(b). The latter question is complicated by the ongoing policy debate over whether an "embryonic cell" is property of human life. The authors then consider whether a ban on NRHC could be justified under section 1 of the Charter. They conclude that both the breadth of the legislative purpose and the proportionality of the measure are problematic. Proportionality is a specific concern because the ban could be viewed as an outright denial of scientific freedom of expression. Although consistent with current jurisprudence on freedom of expression, this paper runs against the flow of government policy in the areas of regulation and prohibition of non-reproductive human cloning. As there has been no Charter litigation to date on whether scientific research is a form of expression, the authors introduce a new way of looking at the legality of the regulation of new reproductive technologies.     

Treating or Tracking? Regulatory Challenges of Nano‐Enabled ICT Implants

The increasing commercialisation of human ICT implants has generated debate over the ethical, legal, and social implications of their use. The convergence of nanotechnologies with ICT is likely to further challenge the current legal frameworks that regulate them. The aim of this article is to examine the effectiveness of the European data protection legal framework for regulating this “next generation” of nano‐enabled ICT human implantable devices. The article highlights the potential regulatory challenges posed by the applications and makes a series of recommendations as to how the current European legal framework on data protection will respond to them.     

The search for truth and freedom: ethical issues surrounding human cloning and stem cell research

The reality of cloning and stem cell research has provoked wonder, fear and anger. These developments have the potential fundamentally to alter humanity. But how well informed is the range of views being expressed? Is progress being threatened by understandable but uninformed fears? Or are scientists rushing toward an ethical abyss, so concerned with what they can do that they never stop to ask what they should do? This article identifies some of the fears and hopes surrounding cloning and stem cell research. It aims to provoke ethical debate in evaluating such research.     

Which bank? A guardian model for regulation of embryonic stem cell research in Australia

In late 2005 the Legislation Review: Prohibition of Human Cloning Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth) recommended the establishment of an Australian stem cell bank. This article aims to address a lack of discussion of issues surrounding stem cell banking by suggesting possible answers to the questions of whether Australia should establish a stem cell bank and what its underlying philosophy and functions should be. Answers are developed through an analysis of regulatory, scientific and intellectual property issues relating to embryonic stem cell research in the United Kingdom, United States and Australia. This includes a detailed analysis of the United Kingdom Stem Cell Bank. It is argued that a "guardian" model stem cell bank should be established in Australia. This bank would aim to promote the maximum public benefit from human embryonic stem cell research by providing careful regulatory oversight and addressing ethical issues, while also facilitating research by addressing practical scientific concerns and intellectual property issues.     

Regulating developments in embryonic stem cell research in Africa: a third person's perspective

Among the many advances in modern biotechnology, embryonic stem (ES) cell research has raised perhaps the most intense debate over the ethical, legal and policy issues involved. This debate has centred inter alia on the lives and well-being of the donors or participants in clinical trials, the presumed lives of embryos, the possibility of reproductive cloning, and government funding, among others. These ethical, legal and policy issues tend to overlap and cut across all strata of society, with opponents of the research calling for prohibition and proponents calling for promotion. One important question is whether African countries should regulate to limit or promote developments in ES cell research. This article argues that, in view of the dynamism of modern biotechnology, African countries should regulate in such a way as to maximise the benefits while minimising the disadvantages associated with the research.     

Cloning and stem cell research: a critical overview of the present legislative regime in Australia and the way forward

The application of stem cell research in biomedical science has recently sparked debates similar to the calls nearly 25 years ago for a ban involving recombinant DNA. This article critically examines the present legislative framework in Australia governing stem cell research and cloning, after briefly seeking a clear understanding of what these procedures involve, as well as suggesting an ethical paradigm within which these issues can be approached. The deficiencies in the proposed legislative framework are also highlighted. Australia has a duty to future generations to pursue the benefits unlocked by this type of research and it is hoped that the next two years will lead to more insights regarding the potential of such research and hence a revision of the present legal impediments.