Accountability,Governance and Biobanks: The Ethics and Governance Committee as Guardian or as Toothless Tiger?

The huge potential of biobanks/genetic databases for the research community has been recognised across jurisdictions in both publicly funded and commercial sectors. But although there is tremendous potential there are likewise potential difficulties. The long-term storage of personal health information and samples poses major challenges. This is an area is fraught with ethical and legal uncertainties. Biobanks raise many questions of the control of rights, of consent, of privacy and confidentiality and of property in human material. It is thus unsurprising then that there has been a lively debate as to how biobanks should operate, the boundaries of participation and what governance structure, if any they should adopt, a debate which has been engaged in across the academic community and by funders and researchers alike. This paper asks despite the good intentions can ad hoc ethics and ethics and governance committees long term provide an effective solution to the legal and regulatory challenges arising from biobanks.     

Stem cell research in Germany: Ethics of healing vs. human dignity

On 25 April 2002, the German Parliament has passed a strict new law referring to stem cell research. This law took effect on July 1, 2002. The so-called embryonic Stem Cell Act (Stammzellgesetz — StZG) permits the import of embryonic stem (ES) cells isolated from surplus IvF-embryos for research reasons. The production itself of ES cells from human blastocysts has been prohibited by the German Embryo Protection Act of 1990, with the exception of the use of ES cells which exist already. The debate on the legitimate use of ES cells escalated, after the main German research funding agency, the Deutsche Forschungsgemeinschaft (DFG), unexpectedly published new guidelines recommending are stricted use of human ES cells for research. Meanwhile, the debate has ethically dividedsociety, political parties, government and church members into a group supporting and a group rejecting ES cell research. The arguments in favour of such a research can be summarized as arguments derived from a new ethics ofhealing calling for a therapeutic imperative, whereas the arguments against can be summarized as arguments violating the fundamental principle of human dignity as they imply the destruction of human embryos. This article willtry to present and evaluate various ethical arguments founded on the latest biological and medical data on the potential use of stem cell technologies. It will finally come to the conclusion that ES cell research is opposed to human dignity, since the procedures of isolating ES cells require the destruction and instrumentalization of human embryos. Human embryos are human beings at a very early stage of their development, fully possessing the ability of completing their development. At this very early stage, human embryos are extremely dependent and fragile, and thus vulnerable corporealities. Vulnerability and human dignity demand the protection of the embryo's corporeal integrity. Hence, this essay will try to propagate research with adult stem(AS) cells, a procedure which does not require the destruction of human embryos; with regard to the necessary plasticity, it should be emphasized that AS cells very much resemble ES cells.This revised version was published online in October 2005 with corrections to the Cover Date.     

Therapeutic cloning and the constitution--a Canadian perspective

Recent developments in the field of therapeutic cloning have been welcomed by many in the medical community as important breakthroughs that may help provide a better understanding of a variety of human diseases. Nevertheless, research in this field appears to have struck a sensitive nerve in society. A large amount of social debate has been generated regarding the validity of therapeutic cloning, and there are many seeking legislation to have the practice restricted. It is unclear, however, whether such restrictions can be legally justified. Analysing cloning in such a social and legal context raises a number of questions. What scientific procedures are behind therapeutic cloning? What is the legal status of the cultured or unimplanted embryo? Can cloning be considered an aspect of reproductive liberty as protected by the constitution? What medical advances might therapeutic cloning further? What social benefits and harms might arise from its promotion or restriction? Such questions, and the broader debate surrounding human therapeutic cloning, are addressed in this paper in three parts. Part 1 presents an overview of the basic biological principles behind cloning and the science behind the therapeutic cloning of specific cells and tissues. Part 2 analyses ss. 7, 2, 15(1) and 1 of the Canadian Charter of Rights and Freedoms and how they may be implicated by legal incursions into the field of human cloning. Several Charter-based arguments, both for and against the practice, are presented. Finally, Part 3 assesses some recent scientific developments in cloning technology, and how they affect the debate over the constitutionality of human therapeutic cloning.     

The derivation and potential use of human embryonic stem cells

Human embryonic stem cells lines can be derived from human blastocysts at high efficiency (>50%) by immunosurgical isolation of the inner cell mass and culture on embryonic fibroblast cell lines. These cells will spontaneously differentiate into all the primary embryonic lineages in vitro and in vivo, but they are unable to form an integrated embryo or body plan by themselves or when combined with trophectoderm cells. They may be directed into a number of specific cell types and this enrichment process requires specific growth factors, cell-surface molecules, matrix molecules and secreted products of other cell types. Embryonic stem (ES) cells are immortal and represent a major potential for cell therapies for regenerative medicine. Their use in transplantation may depend on the formation of a large bank of suitable human leucocyte antigen (HLA) types or the genetic erasure of their HLA expression. Successful transplantation may also require induction of tolerance in recipients and ongoing immune suppression. Although it is possible to customize ES cells by therapeutic cloning or cytoplasmic transfer, it would appear unlikely that these strategies will be used extensively for producing ES cells compatible for transplantation. Embryonic stem cell research may deliver a new pathway for regenerative medicine.     

Human gene patents: core issues in a multi-layered debate

After ten years of debate Directive 98/44/EG on the legal protection of biotechnological inventions was adopted in 1998. This directive takes decisions on some controversial bioethical and legal issues and offers the European biotech industries more space to develop their inventions, but leaves a number of philosophical and moral issues unresolved. This paper distinguishes between different layers in the debate and maps its modes of argumentation. Major philosophical, ethical and conceptual issues are located. It is argued that further analysis of these issues can help resolve further ethical and legal difficulties as regards patenting of human DNA. As the allegedly special status of genetic material remains unclear, the status of (human) DNA and its relation to the human body and personal identity should be further explored. This revised version was published online in July 2006 with corrections to the Cover Date.     

Human embryonic stem cells: challenges and opportunities

Human and non-human primate embryonic stem (ES) cells are invaluable resources for developmental studies, pharmaceutical research and a better understanding of human disease and replacement therapies. In 1998, subsequent to the establishment of the first monkey ES cell line in 1995, the first human ES cell line was developed. Later, three of the National Institute of Health (NIH) lines (BG01, BG02 and BG03) were derived from embryos that would have been discarded because of their poor quality. A major challenge to research in this area is maintaining the unique characteristics and a normal karyotype in the NIH-registered human ES cell lines. A normal karyotype can be maintained under certain culture conditions. In addition, a major goal in stem cell research is to direct ES cells towards a limited cell fate, with research progressing towards the derivation of a variety of cell types. We and others have built on findings in vertebrate (frog, chicken and mouse) neural development and from mouse ES cell research to derive neural stem cells from human ES cells. We have directed these derived human neural stem cells to differentiate into motoneurons using a combination of developmental cues (growth factors) that are spatially and temporally defined. These and other human ES cell derivatives will be used to screen new compounds and develop innovative cell therapies for degenerative diseases.     

Columbia University's Axel Patents: Technology Transfer and Implications for the Bayh-Dole Act

Context: The Bayh-Dole Act of 1980, which gave federal grantees and contractors the right to patent and license inventions stemming from federally funded research, was intended to encourage commercial dissemination of research that would otherwise languish for want of a patent incentive. The case of Columbia University''s Axel patents, which claimed a scientific method to introduce foreign proteins into nucleated cells, illustrates a secondary outcome of the Bayh-Dole Act: the incentive for federal grantees and contractors to pursue royalty revenues from patented research, even for inventions for which commercial use did not require patents.Methods: This article describes oral interviews with two of the three inventors and a former high-ranking administrator at Columbia; correspondence with several faculty members at Columbia to obtain key royalty figures and information about Columbia''s licensing strategy; patent searches; examinations of legal records of court proceedings; and analysis of citation trends for the seminal papers disclosing the invention of cotransformation.Findings: Columbia University and the inventors profited handsomely from the Axel patents, earning $790 million in revenues through licensing arrangements that tapped profits from end products made by biotechnology and pharmaceutical companies. Columbia''s aggressive effort to extend the patent duration also led to considerable legal expenditures and fierce controversy. In particular, obtaining and enforcing a 2002 patent proved costly, politically difficult, and financially fruitless and attracted intense criticism for behavior unbecoming a nonprofit academic institution.Conclusions: This case study raises several important questions about the logic and future revisions of the Bayh-Dole Act: Are revenue generation and financial rewards for inventing valuable technologies legitimate goals for this act? If so, does the federal government need credible mechanisms for oversight of, or checks and balances on, the rights conferred?     

Research on the socio-ethical impact of biomarker use and the communication processes in ECNIS NoE and NewGeneris IP

Current research projects using human biomarkers in their search for better knowledge on the interaction between environment and human health are facing sensitive ethical issues. Researchers may be put in situations in which it is unclear how to act in accordance with all necessary legal requirements on ethical aspects of research. As a consequence, scientific opportunities and important developments of which many individuals will benefit, may be missed. Sound scientific research in the field of environment and health may benefit from a "rethinking" of current theoretical frameworks and procedures issuing from clinical medicine, putting emphasis on decisional autonomy and the protection of the individual and to a much lesser degree taking into account the concept of "public interest". The protection of individuals participating in studies in the field of environmental health calls, e.g., new communication strategies from recruitment to debriefing, at individual as well as at societal levels. Research on the socio ethical aspects on HBM within ECNIS and Newgeneris is situated at the interface of science, ethics and law and should be considered in the context of one final goal: contributing to guidelines for a harmonized socio-ethical and legal approach of human biomonitoring activities in the EU, including procedures for effective and appropriate communication both a the individual and at the collective level, resulting in a European research atmosphere in which scientific research related to development and use of human biomarkers is promoted, and in which a simultaneous protection of the rights and dignity of the study subjects is guaranteed. A harmonized socio-ethical and legal approach not only increases the possibilities for comparison between data generated but may also allow for more equality in the protection of the rights of each citizen of the European Union.     

Ethical implications of clinical trials in Tunisia

Clinical trials are necessary for medical advancement. They must respect legal obligations. Ethical questions related to protection of the human being's rights are yielded by these trials. Joining research to medical core is problematical in consideration of patient's consent to clinical trial. Exclusion by the Tunisian law of persons under age, pregnant or breast-feeding women from medical experimentation in the aim of protecting them against clinical research adverse events or abuses is ethically questionable since it deprives them from a possible medical progress. So why not to involve them in clinical research when there is an expected benefit, after bringing them protection as vulnerable persons like we should do for instance for the elderly, handicapped persons or prisoners. Legal creation of research ethics committees is important for the respect of experimentation rules on human beings.     

<Emphasis Type="Italic">Yearworth v. North Bristol NHS trust</Emphasis>: a property case of uncertain significance?

It has long been the position in law that, subject to some minor but important exceptions, property cannot be held in the human body, whether living or dead. In the recent case of Yearworth and Others v North Bristol NHS Trust, however, the Court of Appeal for England and Wales revisited the property debate and threw into doubt a number of doctrines with respect to property and the body. This brief article analyses Yearworth, (1) reviewing the facts and the Court’s decision with respect to the originators’ proprietary and contractual interests in their body and bodily products, (2) considering the significance of relying on property and its use a legal metaphor, (3) questioning the scope of the property right created, and (4) querying whether an alternate conceptual approach to extending rights and a remedy was warranted. It concludes that, while Yearworth engages with, and impacts on, important theoretical and practical issues—from legal, healthcare and research perspectives—it does not offer a great deal of guidance and, for that reason, its precedential significance is in doubt.     

卫生法学名实考

卫生法学是一门新兴交叉学科，是研究与人体生命健康相关的法律规范的科学。从语意上理解，卫生法应该包括以防病治病为核心的医疗在内的涉及与健康有关的全部法律规范。从内容上看：主要包括疾病预防、公共卫生、医疗机构、医疗技术人员、医用产品（包括药品和器械）、医患关系、医学科学发展中的新问题等。医事法、医疗法都应该属于卫生法的一个部门。     

International perspectives on the ethics and regulation of human cell and tissue transplantation

The transplantation of human cells and tissues has become a global enterprise for both life-saving and life-enhancing purposes. Yet current practices raise numerous ethical and policy issues relating to informed consent for donation, profit-making, and quality and safety in the procurement, processing, distribution, and international circulation of human cells and tissues. This paper reports on recent developments in the international debate surrounding these issues, and in particular on the attention cell and tissue transplantation has received in WHO's ongoing process of updating its 1991 Guiding principles on human organ transplantation. Several of the organizers of an international working group of stakeholders from a wide range of backgrounds that convened in Zurich in July 2006 summarize the areas of normative agreement and disagreement, and identify open questions regarding facts and fundamental concepts of potential normative significance. These issues must be addressed through development of common medical, scientific, legal and ethical requirements for human cell and tissue transplantation on a global basis. While guidance must accommodate the distinct ethical issues raised by activities involving human cells and tissues, consistency with normative frameworks for organ transplantation remains a prime objective.     

医学临床科研的伦理和法律问题

医学科学的发展和进步离不开医学临床科研 ,医学临床科研涉及的伦理、法律和社会问题越来越受到人们的关注。由于医学科研对象的特殊性 ,医学科研必须严格遵守国家有关法律、法规 ,自觉维护社会公益、秩序和伦理道德 ,严格履行知情同意原则 ,充分保障受试者的身心健康和合法权益 ,避免产生法律纠纷 ,促进医学科学的不断进步和可持续发展。     

Some Legal Aspects of Modern Reproductive Technology

Many of the legal consequences of the modern reproductive technologies(in vitro fertilization and related, adjunct technologies) havenot been addressed by governments or society. This paper proposesmethods of thinking about the complex legal issues arising asa result of the application of technology to human reproduction.The questions considered include: reproductive rights; accessto services; societal obligations to the infertile; and therole of the law in controlling and monitoring the applicationof technology.     

Educating about biomedical research ethics

This article examines the global and worsening problem of research misconduct as it relates to bio-medico-legal education. While research misconduct has serious legal implications, few adequate legal remedies exist to deal with it. With respect to teaching, research ethics education should be mandatory for biomedical students and physicians. Although teaching alone will not prevent misconduct, it promotes integrity, accountability, and responsibility in research. Policies and law enforcement should send a clear message that researchers should adhere to the highest standards of ethics in research. It is vital that researchers and physicians understand basic aspects of law and the legal system in order to develop understanding of the medico-legal issues not just in the legal context, but with a sound grounding in ethics, social and theoretical contexts so that they can practice good medicine. Routine and holistic research ethics education across the curriculum for medical students and resident physicians, and continuing medical education for practicing doctors, are probably the best ways to accomplish this goal.     

Realizing Universal Health Coverage in East Africa: the relevance of human rights

Applying a robust human rights framework would change thinking and decision-making in efforts to achieve Universal Health Coverage (UHC), and advance efforts to promote women’s, children’s, and adolescents’ health in East Africa, which is a priority under the Sustainable Development Agenda. Nevertheless, there is a gap between global rhetoric of human rights and ongoing health reform efforts. This debate article seeks to fill part of that gap by setting out principles of human rights-based approaches (HRBAs), and then applying those principles to questions that countries undertaking efforts toward UHC and promoting women’s, children’s and adolescents’ health, will need to face, focusing in particular on ensuring enabling legal and policy frameworks, establishing fair financing; priority-setting processes, and meaningful oversight and accountability mechanisms. In a region where democratic institutions are notoriously weak, we argue that the explicit application of a meaningful human rights framework could enhance equity, participation and accountability, and in turn the democratic legitimacy of health reform initiatives being undertaken in the region.     

Pre-Persons, Commodities or Cyborgs: The Legal Construction and Representation of the Embryo

This paper explores how embryos have been representedin law. It argues that two main models haveunderpinned legal discourse concerning the embryo. Onediscourse, which has become increasingly prevalent,views embryos as legal subjects or persons. Suchrepresentations are facilitated by technologicaldevelopments such as ultrasound imaging. In additionto influencing Parliamentary debate prior to thepassage of the Human Fertilisation and Embryology Act1990, images of embryos as persons featureprominently in popular culture, including advertisingand films, and this discourse came to the fore in the`orphaned embryo' debate in 1996. The main opposingdiscourse dismisses embryos as commodifiable objects,which fits with a trend towards legal recognition thatreproductive materials such as sperm may be classifiedas property which may be donated or sold. In thecase of cryo-preserved embryos these competingperspectives have resulted in litigation over thestatus of frozen embryos. In this paper I argue thatit might be productive to shift the debate from thispolarised dispute over whether embryos matter or not,whether they are pre-persons or commodities. Instead,I suggest that we should attempt to locate them in abiotechnological milieu, where cyborg metaphors may beutilised, and questions of how we should treat embryoswould be contextualised alongside our response toother cyborgs.