For the first time in history, genetics will enable science to completely identify each human as genetically unique. Will this knowledge reinforce the trend for more individual liberties or will it create a ‘brave new world’? A law policy approach to the problems raised by the human genome project shows how far our democratic institutions are from being the proper forum to discuss such issues. Because of the fears and anxiety raised in the population, and also because (...) of its wide implications on the everyday life, the human genome analysis more than any other project needs to succeed in setting up such a social assessment. Keywords: human genome project, judiciary law policy, legislative activity, new ethics institutions, methodology in law reform, public debate, social consensus CiteULike Connotea Del.icio.us What's this? (shrink)

The governance of human (germline) genome modification at the international and transnational level -- The regulation of human germline genome modification in Canada (E Kleiderman) -- The regulation of human germline genome modification in the United States (Kerry Macintosh) -- The regulation of human germline genome modification in Mexico (M Medina Arellano) -- The regulation of human germline genome modification in Europe (J Almqvist, C Romano) -- The regulation of (...) class='Hi'>human germline genome modification in the United Kingdom (J Lawford Davies) -- The regulation of human germline genome modification in Germany (T Faltus). (shrink)

The Human Genome Project is an expensive, ambitious, and controversial attempt to locate and map every one of the approximately 100,000 genes in the human body. If it works, and we are able, for instance, to identify markers for genetic diseases long before they develop, who will have the right to obtain such information? What will be the consequences for health care, health insurance, employability, and research priorities? And, more broadly, how will attitudes toward human differences (...) be affected, morally and socially, by the setting of a genetic “standard”? The compatibility of individual rights and genetic fairness is challenged by the technological possibilities of the future, making it difficult to create an agenda for a “just genetics.” Beginning with an account of the utopian dreams and authoritarian tendencies of historical eugenics movements, this book’s nine essays probe the potential social uses and abuses of detailed genetic information. Lucid and wide-ranging, these contributions will interest bioethicists, legal scholars, and policy makers. Essays: “The Genome Project and the Meaning of Difference,” Timothy F. Murphy “Eugenics and the Human Genome Project: Is the Past Prologue?,” Daniel J. Kevles “Handle with Care: Race, Class, and Genetics,” Arthur L. Caplan “Public Choices and Private Choices: Legal Regulation of Genetic Testing,” Lori B. Andrews “Rules for Gene Banks: Protecting Privacy in the Genetics Age,” George J. Annas “Use of Genetic Information by Private Insurers,” Robert J. Pokorski “The Genome Project, Individual Differences, and Just Health Care,” Norman Daniels “Just Genetics: A Problem Agenda,” Leonard M. Fleck “Justice and the Limitations of Genetic Knowledge,” Marc A. Lappé. (shrink)

"Databases containing the accumulated genomic data of the research community are growing exponentially. This book contains cutting-edge insights from scholars, bioethicists and legal practitioners who work at the ever-changing intersection of law and bioinformatics"--Page 4 of cover.

BackgroundHuman genome editing technologies offer much potential benefit. However, central to any conversation relating to the application of such technologies are certain ethical, legal, and social difficulties around their application. The recent misuse, or inappropriate use, by certain Chinese actors of the application of genome editing technologies has been, of late, well noted and described. Consequently, caution is expressed by various policy experts, scientists, bioethicists, and members of the public with regard to the appropriate use of human (...) germline genome editing and its possible future effect on future generations.Main textAs concerns about the applications of heritable genome editing have grown, so too have the questions around what is to be done to curtail ‘rogue actors’. This paper explores various ways in which to regulate genomic editing that are socially beneficial, while being cognisant of legal and ethical principles and rights values. This is done by evolving regulatory frameworks across jurisdictions in an attempt to raise issues, address common principles, and set responsible standards for stewardship of the novel technology.ConclusionsIt is suggested that robust and concrete regulatory measures be introduced that are culturally and contextually sensitive, inclusive, appropriate, and trustworthy – and are based on public empowerment and human rights objectives. Doing so will ensure that we are perfectly positioned to harness and promote the benefits that novel technologies have to offer, while safeguarding public health and curtailing the ambitions of rogue actors. This it is acknowledged is no easy task, so, as a point of departure, this paper sets out a path forward by means of certain, practical recommendations – by constructing genome editing regulation in a manner that both fulfils the desire to better progress human health and that can withstand legal and ethical scrutiny.The following observations and recommendations are made: Firstly, that a solution of effective, legitimate governance should consist of a combination of national and supranational legislative regulation or ‘hard’ law, in combination with ‘soft’ ethics, firmly anchored in and underpinned by human rights values. Second, that efforts to support legal and ethical solutions should be rigorous, practical, and robust, contribute to a reaffirmation of human rights in a contextually sensitive manner, and be transnational in reach. Lastly, that greater harmonisation across jurisdictions and increased public engagement be sought. This it is proposed will address the question of how to implement a normative framework which in turn can prevent future rogue actors. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- (...) cause the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

For the first time in the history of civilization, humans have procured the power to rewrite nature's book of life. Following the discovery of CRISPR and other key scientific developments at the dawn of the twenty-first century, humankind has-for better or worse-reached the Rubicon of precise genetic manipulation, which existed only in science fiction until now. Those familiar with genome editing understand its colossal power and potential to become a global transformative agent that surpasses the impact of electricity, the (...) atomic bomb, or the Internet. REWRITING NATURE is an interdisciplinary odyssey through the law, science, and policy of genome editing-the most significant breakthrough of our generation. The volume addresses a critical need to bridge gaps between law, science, and policy, and challenges the conventional, false dichotomy frequently associated with mutually exclusive normative roles for science and law. Through exploration of heuristic inquiries into an array of interdisciplinary fields, the book seeks to ignite thoughtful dialogues about authentic-rather than manufactured or sensationalized-issues raised by the technology. This timely resource is intended for keen audiences focused on venturing beyond the headlines and talking points to develop a deeper understanding of the prospects and challenges of genome editing. (shrink)

Dieser Beitrag geht von dem Standpunkt aus, daß das menschliche Genom nicht als Privateigentum der jeweils betroffenen Person, sondern als Gemeingut der Menschheit anzusehen ist. Es wird weiter dargestellt, daß die Genomforschung selbst sowie die Anwendung der durch sie entwickelten Handlungsmöglichkeiten sowohl positive als auch negative Aspekte hat. Angesichts ihres Potentials zum Guten wäre es jedoch verfehlt, aufgrund von meist religiös basierten oder kurzsichtigen tutioristischen Bedenken, die nur auf die Möglichkeit eines Mißbrauchs des so erworbenen Wissens ausgerichtet sind, die Forschung (...) selbst oder die Weiterentwicklung und Anwendung des errungenen Wissens vollständig zu unterbinden. Andererseits wäre es jedoch auch verfehlt, auf die Einsicht und den guten Willen der Forscher allein zu bauen, oder gar die Forschung und die Entwicklung des damit verbundenen Wissenstransfers sich selbst steuern zu lassen, da ein solcher Standpunkt das Erbgut der Menschheit der Willkür eines unkontrollierbaren Prozesses aussetzen würde, der allzu leicht den skrupellosen Interessen einer voreingenommenen und nur am eigenen Vorteil interessierten Minderheit anheim fallen könnte. Es wäre daher angemessen, der Forschung klare Grenzen zu setzen und den Wissenstransfer durch entsprechende Regeln strengen Kontrollen zu unterwerfen. Es gäbe hierbei verschiedene Möglichkeiten, angemessene Regeln zu entwickeln und Kontrollen einzuschalten: z.B. durch die koordinierte Entwicklung diesbezüglicher nationaler Gesetze, deren Einhaltung dann den jeweiligen Ländern als nationale Pflicht zukommen würde; durch das Abschließen von internationalen Abkommen, deren Einhaltung von internationalen Gremien überprüft werden könnte; durch die Entwicklung angemessener Regeln seitens der internationalen wissenschaftlichen und medizinischen Gemeinschaft, welche dann die Einhaltung dieser Regeln als Bedingung zur Teilnahme am internationalen wissenschaftlichen Austausch machen könnte; usw. Der vorliegende Beitrag unterwirft diese und ähnliche Vorschläge einer kurzen kritischen Analyse und gelangt zu dem Schluß, daß Regulierung und Kontrolle nur insoweit vertretbar sind, als sie auf ethische Grundprinzipien zurückgeführt werden können und damit auf ethischer Basis beruhen. Die diesbezüglichen ethischen Grundprinzipien werden identifiziert und auf die vorliegende Problematik angewandt. Ferner wird der Schluß nahegelegt, daß eine ethisch basierte Regulierung allein nicht zur angemessenen Kontrolle genügt, sondern daß es auch einer international akkreditierten Instanz bedarf, welche über genügend Mittel verfügt, um die Befolgung dieser ethisch basierten Regeln zu überprüfen und, falls erforderlich, durch angemessene Maßnahmen zu erzwingen. (shrink)

This book explores international governance of the human genome from a human rights perspective and challenges paradigms of property that are entrenched in relevant international instruments.

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)

This timely work brings together a group of the nation's leading experts in genetics, medicine, history of science, health, law, philosophy of science, and medical ethics to assess the current state of modern human genetics, and to begin to chart the legal and ethical guidelines needed to prevent the misuse of human genetics from leading to the abuse of human beings. The six sections of the book, read together, map the social policy con tours of modern (...) class='Hi'>human genetics. The first part describes the science of the Human Genome Project. The second addresses specific social policy implications, including the relevance of recombinant DNA history, the eugenics legacy, military applications, and issues of race and class in the context of genetic discrimination. Broader philosophical issues, including reductionism and determinism, the concept of disease, and using germline gene therapy to "improve" human beings are discussed in the third part. (shrink)

One of the most important and contentious policy issues surrounding genetics is whether genetic information should be treated separately from other medical information. The view that genetics raises distinct issues is what Thomas Murray labeled “genetic exceptionalism,” borrowing from the earlier term “HIV exceptional-ism.” The issue of whether the use of genetic information should be addressed separately from other health information is not merely an academic concern, however. Since the Human Genome Project began in 1990, nearly every state (...) has enacted legislation prohibiting genetic discrimination in health insurance; two-thirds of the states have enacted laws prohibiting genetic discrimination in employment, and other state laws have been enacted dealing with genetic discrimination in life insurance, genetic privacy, and genetic testing. Bills in Congress also would prohibit genetic discrimination in health insurance and employment. (shrink)

This article considers the practical question of how research institutions should best structure their legal relationship with the human genomic data that they generate. The analysis, based on South African law, is framed by the legal position that although a research institution that generates human genomic data is not automatically the owner thereof, it is well positioned to claim ownership of newly generated data instances. Given that the research institution exerts effort to generate the data, it can be (...) argued that it has a moral right to claim ownership of such data. Combined with the fact that it has an interest in having comprehensive rights in such data, it appears that the prudent policy for research institutions is to claim ownership of the human genomic data instances that they generate. This policy is tested against two opposing policy positions. The first opposing policy position is that research participants should own the data that relate to them. However, in light of data protection legislation that already provides extensive protections to research participants, bestowing data ownership on research participants would offer little benefit to such individuals, while leading to significant practical problems for research institutions. The second opposing policy position is that the concept of ownership should be abandoned in favour of data custodianship. This opposing position is problematic, as avoiding reference to ownership is a denial of legal reality and hence not a useful policy. Also, avoiding reference to ownership will leave research institutions with limited legal remedies in the event of appropriation of data by third parties. Accordingly, it is concluded that the wisest policy for research institutions is indeed to explicitly claim ownership of the human genomic data instances that they generate. (shrink)

This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have contributed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter (...) offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and offers dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: Bioethics, health and human rights Medical liability Law and emerging health technologies Public health law Personalized medicine The law and ethics of access to medicines in developing countries Medical research in the genome era Emerging legal and ethical issues in reproductive technologies This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics. (shrink)

This paper surveys the conceptions of law and of legislation to be found in the philosophy of Julian the Emperor. A hierarchy of levels of law is described, going from transcendent divine orders and paradigmatic laws down to the laws of nature, laws innate in human souls and regional laws. Julian’s ideal legislator is discussed, as inspired by transcendent, paradigmatic laws and as subordinate to law and its protector. An example of Julian’s legislation is discussed. Attention is (...) paid to Julian’s use of Plato’s Republic, Statesman, and Laws. (shrink)

Human rights law has been called upon to help with the problem of persistently high greenhouse gas emissions. An obligation on states and other legal entities to lower their emissions (mitigation) is said to be deducible from that body of law. I refute this thesis. First, I consider two practical difficulties—causality and non-triviality—that face a plaintiff who, with emission mitigation as the objective, attempts to prove a human rights violation using the regular pattern of proof for a violation. (...) Proponents of the “human rights approach” to mitigation have held that proof of an emission “contribution” by the defendant together with proof of an “impact” by climate change on the plaintiff’s human rights are sufficient to discharge the evidentiary burden for the proof of causation. The rest of the causation chain is simply presumed. Thus, the original proof pattern for a human rights violation is abandoned. The proponents’ answer to the triviality difficulty has been to aggregate emitters into very large entities and sue _them_. However, aggregation can be shown to lead to a _reductio ad absurdum_. In my argument’s second part, I identify a more fundamental difficulty with the human rights approach to mitigation: The defendant’s emissions do not amount to a norm violation. Everyone contributes emissions without legislative or other prohibition. Treaty law on climate change itself recognizes emitting behaviour as lawful and permits the continuation of state emissions through to at least 2050. A rise in global warming from preindustrial levels to 1.5° Celsius with room for an even greater rise to close to 2° Celsius has been _budgeted for_ by the Paris Agreement on Climate Change. The setting up of a budget affirms the normalized status of within-budget emissions. This universal license to emit denies the human rights approach to mitigation the very conditions of application of human rights law. (shrink)

The human genome has always been the source of a great variety in behaviour and reactions ranging from the most cruel nationalistic, racist and other social conflicts to the most innocuous family quarrels. The concept of heredity has justified racial discrimination in its harshest form; the concept of sex division has caused social and legal discrimination between men and women, while some countries even permit sex selection. Sex related family disputes are neither harmless nor without serious consequences.Since the (...) days of Mendel the human genome and its behaviour have been the subject of scientific research.1 Today, by means of gene therapy, it has become the subject of interventions to improve human health and to control the genetic quality and behaviour of the embryo. (shrink)

Law, often neglected in treatments of the Republic, is essential to the philosopher-kings’ rule. Only law accomplishes the partial divinization of citizens at which philosophical politics aims. Socrates’ interrogation of Thrasymachus and Glaucon reveals law to be a command whereby citizens participate in philosophical knowledge and limit the pleonexia congenital to humanity. Law does so primarily by instilling in souls a true opinion resistant to pleonectic passion, producing a state of political virtue. This primary work is supported by the musical (...) and poetical education, itself shaped by law for the sake of law. Law persuades and compels the soul by appealing to both reason and spiritedness, enabling them to overcome the appetites. The soul’s consequent acceptance of truth and resistance to the passions indeed makes it resemble divinity. In so transforming the citizens through the law, the philosopher-king also unifies the city and makes it happy under his rule. (shrink)

This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the (...) various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society. (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)

The Human Rights Studies Programme, School of International Studies (JNU), in collaboration with the Centre for Inner Asian Studies, School of International Studies (JNU), and the Indian Law Institute (Delhi), organized a Human Rights Day Webinar on the Intersections of Human Rights and Criminal Law on December 9-10, 2021. Experts and young scholars from the field shared their insights and research on the webinar theme. The presentations were organized under four sessions, including Session I on Rights Jurisprudence (...) and Criminal Law, Session II on Proposals for Criminalisation and Decriminalisation, Session III on Crimes, Victims, and Punishments, and Session IV on Reforms in the Future. The Webinar was conceptualized keeping in view the responsibility of states under international human rights law to prohibit and punish for the protection of human rights and the redressal of violations. The obligations of States to prohibit and punish inform the development of criminal rules and procedures under different legal systems, leading to the near universalization of legislative frameworks, legal justifications, and punishments. In the working of international human rights institutions, the criminal laws adopted by States are an indicator or marker of the level of compliance of States with the international mandates. In recent years, the interface between the two fields, i.e., international human rights and domestic criminal laws, has sparked great jurisprudential, political, and constitutional debates in different parts of the world. Against this backdrop, the Webinar was organized on Human Rights Day to discuss the relevant issues. (shrink)

Background. South Africa (SA) currently has a golden opportunity to legislate on human heritable genome editing (HHGE), as the country is revising its assisted reproductive technology regulations. A set of sub-regulations that deals with HHGE, which could seamlessly slot into the current regulations, has already been developed. The principles underlying the proposed set of sub-regulations are as follows: HHGE should be regulated to improve the lives of the people and should not be banned; the well-established standard of safety (...) and efficacy should be used in the regulation of HHGE; quality of life is what matters, and not preserving a ‘normal’ genome; parents’ reproductive autonomy must be respected; and equality of access to approved HHGE technology should be promoted. Objectives. To ascertain whether the proposed set of sub-regulations that deals with HHGE is aligned with public opinion in SA, and SA’s Bill of Rights. Methods. Public opinion in SA is determined with reference to a deliberative public engagement study on HHGE conducted among South Africans, and the relevant rights in the Bill of Rights are interpreted with reference to recent case law. Results. This proposed set of sub-regulations that deals with HHGE is aligned with public opinion in SA, and SA’s Bill of Rights. Conclusion. Despite the legal and ethical complexities of HHGE, the proposed set of sub-regulations provides a targeted and effective legislative approach. They fit seamlessly into the country’s existing health law framework, creating specific legal standards for HHGE that align with both public opinion and the country’s Bill of Rights. (shrink)

This special issue of the Modern Law Review addresses a range of key issues - conceptual, ethical, political and practical - arising from the regulatory ...

Technologies like CRISPR and gene drives are ushering in a new era of genetic engineering, wherein the technical means to modify DNA are cheaper, faster, more accurate, more widely accessible, and with more far-reaching effects than ever before. These cutting-edge technologies raise legal, ethical, cultural, and ecological questions that are so broad and consequential for both human and other-than-human life that they can be difficult to grasp. What is clear, however, is that the power to directly alter not (...) just a singular form of life but also the genetics of entire species and thus the composition of ecosystems is currently both inadequately regulated and undertheorized. In Gene Editing, Law, and the Environment, distinguished scholars from law, the life sciences, philosophy, environmental studies, science and technology studies, animal health, and religious studies examine what is at stake with these new biotechnologies for life and law, both human and beyond. (shrink)

Aus dem Inhalt: Views from the North: Hans Petter Graver: Law, Justice and the State: Nordic Perspectives u Jacob Dahl Rendtorff: The Danish Welfare State: Philosophical Ideals and Systemic Reality u Sigri!Dur *orgeirsdottir: Feminist Ethics and Feminist Politics u Kuellike Lengi: The Situation of Human Rights in Estonia u Einar Palsson: Pythagoras and Early Icelandic Law u Law, Discourse and Rationality: Mats Flodin: Internal and External Rationality of Legal Systems u Logi Gunnarsson: A Discourse About Discourse u Hjordi!s Hakonardottir: (...) Legal Language: A Tool of Justice u Ghita Holmstrom-Hintikka: On the Use of Expert Witness in Legal Reasoning and Inquiry u Law, State and Nation: Agust H. Ing*orsson: Democracy, Bureaucracy and Marginalization of the State u Aleksander Peczenik: Law-State, Legal Certainty and Legitimacy of Law u Ove K. Pedersen/Sverre Raffnsoe: Reorganizing Society u Juha Raikka: Mill on National Sentiment u Pall Skulason: Concepts of the State and Classes of Value u Problems of Law and Rights: Britt-Mari Blegvad: How to Cope With Uncertainty: Trust and Law u Jon Wetlesen: Animal Rights or Human Duties?. (shrink)

This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and ...

The first IVF baby was born in the 1970s. Less than 20 years later, we had cloning and GM food, and information and communication technologies had transformed everyday life. In 2000, the human genome was sequenced. More recently, there has been much discussion of the economic and social benefits of nanotechnology, and synthetic biology has also been generating controversy. This important volume is a timely contribution to increasing calls for regulation - or better regulation - of these and (...) other new technologies. Drawing on an international team of legal scholars, it reviews and develops the role of human rights in the regulation of new technologies. Three controversies at the intersection between human rights and new technology are given particular attention. First, how the expansive application of human rights could contribute to the creation of a brave new world of choice, where human dignity is fundamentally compromised; second, how new technologies, and our regulatory responses to them, could be a threat to human rights; and, third, how human rights could be used to create better regulation of these technologies. (shrink)

A collection of essays on the human genome, European patent law, cloning, and genetic malpractice suits.

Thus, Meyers provides a valuable account, not only of current medical attitudes, but also of relevant case and statute law as it stands at present.

The focus of this book is on the epistemological and hermeneutic implications of data science and artificial intelligence for democracy and the Rule of Law. How do the normative effects of automated decision systems or the interventions of robotic fellow 'beings' compare to the legal effect of written and unwritten law? To investigate these questions the book brings together two disciplinary perspectives rarely combined within the framework of one volume. One starts from the perspective of 'code and law' and the (...) other develops from the domain of 'law and literature'. Integrating original analyses of relevant novels or films, the authors discuss how computational technologies challenge traditional forms of legal thought and affect the regulation of human behavior. Thus, pertinent questions are raised about the theoretical assumptions underlying both scientific and legal practice. (shrink)

The Human Genome Project has raised many issues regarding the contributions of genetics to a variety of diseases and societal conditions. With genetic testing now easily conducted with lowered costs in nonmedical domains, a variety of privacy issues must be considered. Such testing will result in the loss of significant privacy rights for the individual. Society must now consider such issues as the ownership of genetic data, confidentiality rights to such information, limits placed on genetic screening, and (...) class='Hi'>legislation to control genetic testing and its applications. There is often a conflict between individual rights to privacy and the need for societal protection. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Genome Research in an Interdependent WorldAlexander Morgan Capron (bio)This has been the year of agenda-setting conferences for the ambitious ELSI (ethical, legal and social issues) program of the Human Genome Project (HGP). But of the dozen or more major meetings of this sort held across the country, the one held at the National Institutes of Heakh (NIH) in Bethesda, MD, June 2-4, 1991, was (...) distinctive in several respects.1As its name implies, "Human Genome Research in an Interdependent World" was a global look at the issues raised by gene mapping and sequencing. Unlike previous conferences, however, this meeting looked beyond a comparative analysis of clinical and domestic legal issues, and concentrated on topics that may require responses on a truly international level if they are to be successfully resolved.The meeting's organizers gathered an impressive group of more than seventy participants from fifteen countries, including the first significant contingent of Soviet and Japanese scientists, physicians, and philosophers at an ELSI meeting. In addition to talks by the heads of the genome projects in the Soviet Union, Japan, and the United States, the meeting was keynoted by Dr. James Wyngaarden, director general of the Human Genome Organization (HUGO), and I had the honor of serving as its general chairman.The goal of the meeting was to consider an array of issues that scientists, philosophers, and lawyers from around the world suggested might have international significance, with an eye to deciding three things: (1) Does the issue deserve further attention? (2) Is the issue best addressed in an international or domestic context? and (3) Do structures exist to which the issue can be referred for resolution? In the final sessions, the entire group debated proposed resolutions on the various topics and narrowed the list needing further, intensive exploration.To provide an international framework for this process, the conference [End Page 247] established a Global Steering Committee on Ethical and Social Issues in Genome Research, which will coordinate the efforts of several task forces charged with refining the tentative resolutions adopted by the conference participants on June 4. The task forces are expected to be able to complete work on some topics by the time of the steering committee's first meeting, which was described by one participant as a "check point," probably within the coming year; on other topics, the task forces will provide interim reports and arrange to continue their analysis. Several topics—less complex or more embryonic—were referred directly to the steering committee. On all issues, a major objective will be to ascertain what existing or newly created structure or structures are capable of implementing the group's recommendations and then to monitor the issue to ensure that appropriate implementation is occurring.Issues to be Explored by Task ForcesInsurance and EmploymentWhile individuals may derive medically useful information from the expanded range of genetic tests that will flow from the HGP, they could also be harmed if test results become a basis for discrimination. An area of particular concern at the conference in Bethesda was whether genetic information should be used to decide eligibility for employment or the scope and cost of health and life insurance. The complexity of this issue is increased as barriers to worker migration fall (especially in Europe) and as more firms carry on business internationally. Furthermore, questions arise about the limits of required testing and whether individuals may decline to be informed of the results of tests.The task force will not only gather information on practices and legal standards throughout the world—especially in light of the differences among nations with regard to the linkage of employment and various forms of insurance—but will also examine international anti-discrimination laws as a possible means of supplementing domestic statutes and regulations. As a starting point, the Bethesda meeting agreed on a set of principles for the task force to refine.2ForensicsAlthough their legal status is not fully resolved, DNA tests are being used increasingly in judicial proceedings and civil and criminal investigations as a highly probative means to identify people. Most forensic uses of "DNA fingerprints" are domestic, but international cooperation among investigative bodies... (shrink)

In July 2018, the Nuffield Council on Bioethics released the report Genome editing and human reproduction: Social and ethical issues, concluding that human germline modification of human embryos for implantation is not ‘morally unacceptable in itself’ and could be ethically permissible in certain circumstances once the risks of adverse outcomes have been assessed and the procedure appears ‘reasonably safe’. The Nuffield Council set forth two main principles governing anticipated uses and envisions applications that may include health (...) enhancements as a public health measure. This essay provides a critique of three aspects in the Nuffield Council’s Report: its presumption of therapeutic efficacy, its inflation of parental rights to create a certain type of child, and its reliance on a specially commissioned report that appears to distort key definitions in international law. (shrink)

Over the past few years, developments in the science of precise editing of human genomes using CRISPR-Cas9 have led many countries that lack specific laws in this area, such as South Africa, to contemplate legal reform. Thaldar et al. recently published five principles to guide legal reform in SA on heritable genome editing. In a similar vein, concerns about the global impact of human germline genome editing have led to calls for a global regulatory mechanism. This (...) is what the World Health Organization has tried to achieve with the recently published ‘Draft governance framework for human genome editing’. In this article, we compare the policies proposed by the draft framework to the current SA legal position, as well as the five guiding principles. The article concludes that SA law is in need of reform in order to meet the global standards that the draft framework seems to be moving towards. (shrink)

Human population genetic research (HPGR) seeks to identify the diversity and variation of the human genome and how human group and individual genetic diversity has developed. This book asks whether developing countries are well prepared for the ethical and legal conduct of human population genetic research, with specific regard to vulnerable target group protection. The book highlights particular issues raised by genetic research on populations as a whole, such as the capacity for current frameworks of (...) Western developed countries to provide adequate protections for target groups in human population genetic research, and explores potential groups of people that may suffer harm in this kind of research. Using The People's Republic of China as a key example, Yue Wang argues that since the target groups of HPGR are almost always vulnerable groups from isolated and rural areas of developing countries, the ethical and legal frameworks for human subject protection need to be reconsidered in order to eliminate, or at least reduce, the vulnerability of those groups. While most research in this field focuses on the impact on individuals, this book breaks new ground in exploring how the interests of target groups are also seriously implicated in genetic work. The book argues that current regulations are far from sufficient to prevent harm to vulnerable groups and puts forward an alternative model for group protection in the context of human population genetic research in developing countries. The book will be of great interest to students and academics of medical law, ethics, and the implications of genetic research. (shrink)

The economic costs to the insurers of complementary routine genetic testing would outweigh the benefits. However, should testing technology in future be refined so as to produce a cheap and reliable test, there is no reason why insurers might not take up predictive testing as part of the normal underwriting process. It is this possibility which justifies formulating a pre-emptive policy. At the very least, there are reasons for promoting and protecting the welfare of the proposer so as to redress (...) the bargaining positions between him or her as a consumer of a service and the insurer as a commercial concern. Further considerations relate to the social purpose of insurance as a social mechanism, and the need to find ways of avoiding undermining this in light of Human Genome Project. (shrink)

In the opening years of the 21st century, it became fashionable to describe the human genome as belonging to the common heritage of humanity. The United Nations, in its Universal Declaration on the Human Genome and Human Rights, now identifies the human genome as part of the common heritage, as does the international Human Genome Organization and the Council of Europe. The common heritage concept has played a prominent role in arguments (...) against patenting the human genome or portions thereof. This essay considers whether the common heritage designation will advance the political and legal goals of its proponents. (shrink)

This essay identifies two legal lineages underlying the common heritage concept, and applies each to the human genome. The essay notes some advantages and disadvantages of each approach, and argues that patenting of human genes would be allowable under either approach.

Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues. In terms of privacy protection, anonymization (...) is generally not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research. (shrink)

The Human Genome Project showed that there is signifcant genetic variation within the population. Current research is accumulating large databases that may reveal genetic variations associated with disease or health risks, even if not intended as part of the study design. These incidental fnd-ings create legal, ethical, and fnancial challenges for researchers. Current federal and international guidelines are not adequate. Plans for dealing with incidental fndings need to be established in the study design and reviewed and approved by (...) the Institutional Review Board. (shrink)