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.     

Cloning for therapeutic purposes: ethical and policy considerations

This essay reviews how cloning techniques may be used for therapeutic purposes, analyzes ethical implications, and makes recommendations for public policy discourse. Although cloning may bring many potential benefits, they remain uncertain. Furthermore, human embryo research is morally problematic. Therefore, alternatives to human cloning for therapeutic aims should be sought at present. In addition to central ethical issues, public discourse should maintain an emphasis on the value of the human embryo over scientific expediency, the relativity of health, and the principle of justice. Society should support the laudable mission of medical research, while also attending to the moral concerns often threatened by the promises of scientific progress.     

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 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.     

The governance of human genetic research databases in mental health research

The field of mental health offers a valuable context in which to examine new challenges presented by human genetic research databases to the legal, ethical and regulatory frameworks for human genetic research. Longitudinal prospective genetic research of psychiatric disorders often involves access to human genetic research databases and to stored tissue for future uses that cannot be specified at the time the patient consents to their collection. The potential of such research to contribute to an improved understanding and treatment of complex genetic diseases such as schizophrenia presupposes sound ethical, legal and regulatory frameworks to ensure public trust and preparedness to participate in such research. This article provides a brief overview of some of the ethical and legal challenges posed by human genetic research databases and their implications for how genetic research should be conducted in the field of mental health.     

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.     

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.     

Underwhelmed: hyperbole,regulatory policy,and the genetic revolution

Rapid advances in the field of genetics in recent years have caused some commentators to suggest the emergence of a "genetic revolution." Such advances have been both praised as the "future of medicine" and condemned for encouraging the acceptance in society of laissez-faire eugenics. Yet the effect of technological advances flowing from the science of genetics appear somewhat overstated as few products of the genetic revolution, particularly in the areas of gene therapy and genetic testing, have managed to satisfy scientists' expectations to date. Furthermore, misdirected regulation of such advances can exacerbate the social, legal, and ethical problems associated with genetics, particularly in the context of health care, where issues of human cloning and the use of premature genetic testing technologies dominate current public debate. In this article, the author criticizes the hyperbolic rhetoric surrounding the genetic revolution and calls for a more balanced and informed approach to the development of genetic policies and regulations. Such an approach should include substantial interdisciplinary debate and an active role on the part of government in the identification and communication of accurate information relating to the effects of recent technological advances in the field of genetics.     

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.     

MEDICALLY ASSISTED HUMAN REPRODUCTIVE TECHNOLOGIES (ART) AND HUMAN RIGHTS — THE EUROPEAN PERSPECTIVE

The present article examines how the progress of science, and in particular, medically assisted human reproductive technologies (ART) have provoked a revolution in the sphere of family relations, generating a series of ethical and legal conflicts. The article focuses on the European perspective, without ignoring the international sphere, given the globalization of the phenomenon. The emerging legal issues are analyzed through the filter of international human rights, not only an important aspect to take into consideration in the context of bioethics in general, but a “passage obligé” given that certain concepts find their explanation and coordinates in international human rights law. It is from this perspective that the relationship between ART and human rights is presented. The applicable international and European legal instruments and principles shall be mentioned, as well as a brief comparison of national legal frameworks in Europe. The emerging bioethical and legal issues are examined in correlation with the response of the European Court of Human Rights through its case law aimed at balancing conflicting rights when faced with issues pertaining to ART. Lastly, the article presents in more detail the particular legal issues under debate in France and Italy, two European countries with specific legislation in the field.     

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.     

Rewriting the future? Biomedical advances and legal dilemmas

Developments in medical science have sparked public debate about the legal and ethical implications of new technologies. Within these debates a number of distinct discourses are evident, including discourses about the positive and negative implications of technological advances, the influence of globalisation on regulatory choice, and the challenges of articulating common values in a pluralistic society. This article argues that an understanding of these discourses is an essential part of understanding the nature of contemporary regulatory dilemmas.     

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.     

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.     

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.     

Engineering human tissue and regulation: confronting biology and law to bridge the gaps

There are a number of difficulties confronting the regulation of human tissue engineered products, from the scientific, ethical and legal perspectives. Many of these issues are international in scope and any responses must consider the global implications of marketing and monitoring these products. The article argues that as tissue engineered products become more available regulatory authorities should not be pressured into adopting possibly inappropriate measures, but must consider all the factors relevant to human health, including the need for innovative regulatory mechanisms as well as innovative tissue products themselves.     

Harmonizing the international regulation of embryonic stem cell research: possibilities, promises and potential pitfalls

Despite near unanimous global opposition to human reproductive cloning, the United Nations has been unable to reach a consensus as to how cloning practices should be regulated at the international level. As a result, the U.N. objective of establishing binding international regulations governing cloning and stem cell research has yet to be achieved. Given the lack of consensus that exists within the global community on this topic, it seems that any attempt to harmonize the international regulation of cloning and stem cell science will face important obstacles. This paper seeks to illuminate the particular challenges to harmonizing international laws and policies related to stem cell research and human cloning, and to investigate potential methods for overcoming these challenges. By drawing on two other areas in which regulatory harmonization has been attempted, namely: environmental and human safety aspects of international trade, and pharmaceutical research and development, we study approaches to global regulatory harmonization. We conclude that while the challenges to harmonization are diverse and important, so too are the benefits of establishing uniformity in approaches to stem cell research worldwide. This paper proposes a model for harmonizing the regulation of stem cell research that focuses on broader norms and principles rather than specific rules. It further recommends that such harmonization should occur through a process initiated and developed by an independent international agency marked by diversity, both in terms of the cultural identities and perspectives represented, and the interdisciplinary expertise of its members.     

克隆人立法的宪法规制

克隆羊"多莉"诞生以来,克隆技术迅猛发展,克隆人问题的现实性日益彰显。我国秉持"禁止生殖性克隆、支持治疗性克隆"的指导思想,出台了相关规章禁止克隆人。然而,目前我国克隆人的相关立法有违背宪法上的法律保留原则和比例原则之嫌,存在着合宪性问题。建议全国人大根据法律保留和比例原则制定专门的《克隆技术管理法》,明确界定克隆人的相关概念,禁止任何人从事生殖性克隆,并明确规定监管机关的监管职责以及违法应当承担的法律责任,同时将生殖性克隆入罪、明确立法的"落日条款",以消解当前克隆人立法的合宪性问题,实现克隆人立法的宪法规制。     

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.     

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.