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The advent of the CRISPR/Cas9 class of genome editing tools is transforming not just science and medicine, but also law. When the genome of germline cells is modified, the modifications could be inherited, with far-reaching effects in time and scale. Legal systems are struggling with keeping up with the CRISPR revolution and both lawyers and scientists are often confused about existing regulations. This book contains an analysis of the national regulatory framework in eighteen selected countries. Written by national legal experts, it includes all major players in bioengineering, plus an analysis of the emerging international standards and a discussion of how international human rights standards should inform national and international regulatory frameworks. The authors propose a set of principles for the regulation of germline engineering, based on international human rights law, that can be the foundation for regulating heritable gene editing both at the level of countries as well as globally.
Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes, and spinal cord injury. Clinical trials of stem cell treatments are under way in countries around the world, but the evidence base to support the medical use of stem cells remains limited. Despite this paucity of clinical evidence, consumer demand for treatments using stem cells has risen, driven in part by a lack of available treatment options for debilitating diseases as well as direct-to-consumer advertising and public portrayals of stem cell-based treatments. Clinics that offer stem cell therapies for a wide range of diseases and conditions have been established throughout the world, both in newly industrialized countries such as China, India, and Mexico and in developed countries such as the United States and various European nations. Though these therapies are often promoted as being established and effective, they generally have not received stringent regulatory oversight and have not been tested with rigorous trials designed to determine their safety and likely benefits. In the absence of substantiated claims, the potential for harm to patients - as well as to the field of stem cell research in general - may outweigh the potential benefits. To explore these issues, the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research held a workshop in November 2013. "Stem Cell Therapies" summarizes the workshop. Researchers, clinicians, patients, policy makers, and others from North America, Europe, and Asia met to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from treatments that are dangerous or ineffective or by steering them toward treatments that are effective. This report discusses the current environment in which patients are receiving unregulated stem cell offerings, focusing on the treatments being offered and their risks and benefits. The report considers the evidence base for clinical application of stem cell technologies and ways to assure the quality of stem cell offerings.
The general scope of the book is the patentability and morality of human embryonic stem cell research in US, EU and China. The book observes fraudsters operate unsafe human embryonic stem cell therapies and officialdom turns a blind eye to the immoral human embryonic stem cell research in China. The book highlights that both patent control and federal funding control are inefficient and ineffective way to monitoring human embryonic stem cell research. The book finally proposed an approach for china to regulating human embryonic stem cell research-regulating research itself at the reconciled international regime. The potential reader includes academics and practitioners dealing with intellectual property, patent law and stem cell inventions. The topic discussed will also be interesting to a broad readership, including experts, regulators, policy makers and medical researchers in both ethical and legal disciplines in the field of embryonic stem cell research.
A discussion of all the key issues in the use of human pluripotent stem cells for treating degenerative diseases or for replacing tissues lost from trauma. On the practical side, the topics range from the problems of deriving human embryonic stem cells and driving their differentiation along specific lineages, regulating their development into mature cells, and bringing stem cell therapy to clinical trials. Regulatory issues are addressed in discussions of the ethical debate surrounding the derivation of human embryonic stem cells and the current policies governing their use in the United States and abroad, including the rules and conditions regulating federal funding and questions of intellectual property.
Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.
Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.
This book represents the coming together of a number of internationally renowned scholars from science, philosophy, law and social science. Each author presents a distinctive and critical account of the current ethical, social and jurisprudential issues concerning stem cell science: together covering both its research beginnings, and the future translation into the clinical setting. Original to this volume is an emphasis on the inter-state implications of developments in stem cell science from the perspective of a truly global collaboration of leading authors. Academics and policy-makers will find it an invaluable contribution to the socio-political and ethical discourse of stem cell science. Contributions from a team of leading academic experts Covers a wide array of disciplines: with original contributions focusing on the technological, legal, social and ethical aspects of stem cell science A unique collection of international perspectives on developments in stem cell science Book jacket.
Recent scientific breakthroughs, celebrity patient advocates, and conflicting religious beliefs have come together to bring the state of stem cell researchâ€"specifically embryonic stem cell researchâ€"into the political crosshairs. President Bush's watershed policy statement allows federal funding for embryonic stem cell research but only on a limited number of stem cell lines. Millions of Americans could be affected by the continuing political debate among policymakers and the public. Stem Cells and the Future of Regenerative Medicine provides a deeper exploration of the biological, ethical, and funding questions prompted by the therapeutic potential of undifferentiated human cells. In terms accessible to lay readers, the book summarizes what we know about adult and embryonic stem cells and discusses how to go about the transition from mouse studies to research that has therapeutic implications for people. Perhaps most important, Stem Cells and the Future of Regenerative Medicine also provides an overview of the moral and ethical problems that arise from the use of embryonic stem cells. This timely book compares the impact of public and private research funding and discusses approaches to appropriate research oversight. Based on the insights of leading scientists, ethicists, and other authorities, the book offers authoritative recommendations regarding the use of existing stem cell lines versus new lines in research, the important role of the federal government in this field of research, and other fundamental issues.
Focussing on China's stem cell research, this book investigates how, over the last decade, Chinese scientists, ethicists and policy-makers have developed a cosmopolitan sensibility in comprehending and responding to ethical and regulatory concerns.
Stem cell therapy is ushering in a new era of medicine in which we will be able to repair human organs and tissue at their most fundamental level- that of the cell. The power of stem cells to regenerate cells of specific types, such as heart, liver, and muscle, is unique and extraordinary. In 1998 researchers learned how to isolate and culture embryonic stem cells, which are only obtainable through the destruction of human embryos. An ethical debate has raged since then about the ethics of this research, usually pitting pro-life advocates vs. those who see the great promise of curing some of humanity's most persistent diseases. In this book Cynthia Cohen agrees that we need to work toward a consensus on the issue of how we treat the embryo. But more broadly she claims that we need to transform and expand the ethical and policy debates on stem cells (adult and embryonic). This important and much-needed book is both a primer and a means by which to understand the implications of this research. Cohen starts by introducing readers to the basic science of stem cell research, and the core ethical questions surrounding the embryo. She then expands the scope of the debate, looking at the moral questions that will crop up down the line, such as e.g. the use of therapeutic cloning to overcome the body's immune resistance to stem cells; the ethics of using animals to test stem cells; how to disentangle federal and state legal and regulatory policies in pursuit of a coherent national policy; and how to develop an ethics of stem cell research that will accommodate new techniques and controversies that we cannot even foresee now. Her final chapter develops a concrete plan for an oversight system for this research. This is the first single-author book that addresses the many broad ethical and legal issues related to stem cells, and it should be of great interest to bioethicists, researchers, clinicians, philosophers, theologians, lawyers, policy makers, and general readers.