Download or read book Human Genome Editing written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-08-13 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies written by Nhmrc Staff and published by . This book was released on 1999 with total page 29 pages. Available in PDF, EPUB and Kindle. Book excerpt: Section 1 comprises the Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies, and replaces Supplementary Note 7 of the NHMRC Statement on Human Experimentation and Supplementary Notes (1992). Section 2 provides background information about human gene therapy and replaces the NHMRC information paper Human Gene Therapy and Related Procedures (1994). Guidelines on human genetic research, and research in general, are provided by the NHMRC's National Statement on Ethical Conduct in Research Involving Humans (1999), known as the National Statement. Guidelines for Ethical Review of Research Proposals for Human Somatic Cell Gene Therapy and Related Therapies should be read in conjunction with the National Statement.
Download or read book Oversight and Review of Clinical Gene Transfer Protocols written by Institute of Medicine and published by National Academies Press. This book was released on 2014-03-27 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.
Download or read book Xenotransplantation and Risk written by Sara Fovargue and published by Cambridge University Press. This book was released on 2011-11-17 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: Some developing biotechnologies challenge accepted legal and ethical norms because of the risks they pose. Xenotransplantation (cross-species transplantation) may prolong life but may also harm the xeno-recipient and the public due to its potential to transmit infectious diseases. These trans-boundary diseases emphasise the global nature of advances in health care and highlight the difficulties of identifying, monitoring and regulating such risks and thereby protecting individual and public health. Xenotransplantation raises questions about how uncertainty and risk are understood and accepted, and exposes tensions between private benefit and public health. Where public health is at risk, a precautionary approach informed by the harm principle supports prioritising the latter, but the issues raised by genetically engineered solid organ xenotransplants have not, as yet, been sufficiently discussed. This must occur prior to their clinical introduction because of the necessary changes to accepted norms which are needed to appropriately safeguard individual and public health.
Download or read book Heritable Human Genome Editing written by The Royal Society and published by National Academies Press. This book was released on 2021-01-16 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Stem Cells and the Future of Regenerative Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 2002-01-25 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Assessing Genetic Risks written by Institute of Medicine and published by National Academies Press. This book was released on 1994-01-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.
Download or read book Embryo Research in Pluralistic Europe written by D. Solter and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent advances in techniques and understanding in the fields of genetics, embryology and reproductive biology have opened up new ways to treat a wide range of medical problems. They range from new options for infertility treatment and pre-implantation genetic diagnosis to stem-cell-based therapies for debilitating diseases. Since all these approaches involve the manipulation of human gametes, embryos or embryonic cells, and could also permit more contentious uses, they have stimulated a controversial debate as to what aims are desirable and to what extent experiments on human embryos are morally permissible, if permissible at all. The situation is further complicated by the fact that scientific projects are increasingly realized through international co-operation and that patients are increasingly ready to seek morally contentious medical treatment wherever it is available and thus to bypass national legislation. In view of this situation the Europäische Akademie assembled a temporary interdisciplinary project group in which scientists from universities and non-university research organizations in Europe working on the relevant subjects were brought together and charged with establishing a knowledge base and providing suggestions for long-term solutions that would be acceptable for society. Presented here are the results of this project, ranging from a discussion of the theoretical and practical possibilities in human-embryo experimentation and its alternatives in research on adult stem cells, a comparison of the situations and prospects of regulation of embryo research in Europe, a survey of European public attitudes, and a philosophical analysis of the arguments and argumentative strategies used in the debate.
Download or read book Bioethics in Singapore written by John Elliott and published by World Scientific. This book was released on 2010 with total page 343 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an analysis of the ways in which the BAC has established an ethical framework for biomedical research in Singapore, following the launch of the Biomedical Sciences Initiative by the Singapore Government. The editors and authors have an intimate knowledge of the working of the BAC, and the focus of the book includes the ways in which international forces have influenced the form and substance of bioethics in Singapore. Together, the authors offer a comparative account of the institutionalisation of biomedical research ethics in Singapore, considered in the wider context of international regulatory efforts. The book reviews the work of the BAC by placing it within the broader cultural, social and political discourses that have emerged in relation to the life sciences since the turn of the 21st century. This book is not primarily intended to be a retrospect or an appraisal of the contribution of the BAC, though this is one aspect of it. Rather, the main intention is to make a substantive contribution to the rapidly emerging field of bioethics. Ethical discussions in the book include consideration of stem cell research and cloning, genetics and research with human participants, and focus on likely future developments as well as the past.Many of the contributors of the book have been personally involved in this work, and hence they write with an authoritative first-hand knowledge that scholars in bioethics and public policy may appreciate. As indicated above, the book also explains the way in which ethics and science ? international and local ? have interacted in a policy setting. Scholars and policy makers may find the Singaporean experience to be a valuable resource, as the approach has been to make the ethical governance of research in Singapore consistent with international best practice while observing the requirements of a properly localised application of universally accepted principles. In addition, at least three chapters (the first three chapters in particular) are accessible to the lay reader interested in the development of bioethics and biomedical sciences, both inside and outside Singapore, from 2000 (the year in which the BAC was established). Both scholars and interested lay readers are therefore likely to find this publication a valuable reference.
Download or read book Ethics Law and Society written by Søren Holm and published by Routledge. This book was released on 2019-09-11 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: This key collection brings together a selection of papers commissioned and published by the Cardiff Centre for Ethics, Law & Society. It incorporates contributions from a group of international experts along with a selection of short opinion pieces written in response to specific ethical issues. The collection addresses issues arising in biomedical and medical ethics ranging from assisted reproductive technologies to the role of clinical ethics committees. It examines broader societal issues with particular emphasis on sustainability and the environment and also focuses on issues of human rights in current global contexts. The contributors collect responses to issues arising from high profile cases such as the legitimacy of war in Iraq to physician-related suicide. The volume will provide a valuable resource for practitioners and academics with an interest in ethics across a range of disciplines.
Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer. This book was released on 2015-09-15 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Download or read book Ethics Law and Society written by Jennifer Gunning and published by Taylor & Francis. This book was released on 2022-07-30 with total page 1808 pages. Available in PDF, EPUB and Kindle. Book excerpt: This key collection brings together a selection of papers commissioned and published by the Cardiff Centre for Ethics, Law & Society. It incorporates contributions from a group of international experts along with a selection of short opinion pieces written in response to specific ethical issues. The collection addresses issues arising in biomedical and medical ethics ranging from assisted reproductive technologies to the role of clinical ethics committees. It examines broader societal issues with particular emphasis on sustainability and the environment and also focuses on issues of human rights in current global contexts. The contributors collect responses to issues arising from high profile cases such as the legitimacy of war in Iraq to physician-related suicide. The volume will provide a valuable resource for practitioners and academics with an interest in ethics across a range of disciplines.
Download or read book Pilgrims in Medicine Conscience Legalism and Human Rights written by Thomas Alured Faunce and published by Martinus Nijhoff Publishers. This book was released on 2005-01-01 with total page 676 pages. Available in PDF, EPUB and Kindle. Book excerpt: This arrestingly novel work develops a normative synthesis of medical humanities, virtue ethics, medical ethics, health law and human rights. It presents an ambitious, complex and coherent argument for the reconceptualisation of the doctor-patient relationship and its regulation utilising approaches often thought of as being separate, if not opposed (virtue-based ethics and universal human rights). The case is argued gracefully, with moderation, but also with respect for opposing positions. The book's analysis of the foundational professional virtue of therapeutic loyalty is an original departure from the traditional discourse of "patient autonomy," and the ethical and legal "duties" of the medical practitioner. The central argument is not merely presented, as bookends, in the introduction and conclusion. It is cogently represented in each chapter and section and measured against the material considered. A remarkable feature is the use of aptly selected "canonical" literature to inform the argument. These references run from Hesse's "The Glass Bead Game" in the abstract, to Joyce's "Ulysses" in the conclusion. They include excerpts from and discussion about Bergman, Borges, Boswell, Tolstoy, de Beauvoir, Chekhov, Dostoevsky, Samuel Johnson, Aristotle, Orwell, Osler, Chaucer, Schweitzer, Shakespeare, Thorwalds, Kafka and William Carlos Williams. Such references are used not merely as an artistic and decorative leitmotif, but become a critical, narrative element and another complex and rich layer to this work. The breadth and quality of the references are testimony to the author's clear understanding of the modern law and literature movement. This work provides the basis of a medicalschool course. As many medical educators as possible should also be encouraged to read this work for the insights it will give them into using their own personal life narratives and those of their patients to inform their decision-making process. This thesis will also be of value to the judiciary, whose members are often called upon to make normatively difficult judgments about medical care and medical rules. The human rights material leads to a hopeful view of an international movement toward a universal synthesis between medical ethics and human rights in all doctor-patient relationships.
Download or read book Society and Genetic Information written by Judit S ndor and published by Central European University Press. This book was released on 2003-01-01 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: The genetic era has given rise to significant legal dilemmas: who may own genetic data, when can a genetic test be performed on children, how can genetic-based discrimination be avoided, or to what extent and in what ways can genetic data be protected? The book addresses the social, ethical, and legal implications of collecting, storing, analyzing, and commercializing genetic information. Prominent biologists, medical doctors, lawyers, anthropologists, philosophers, sociologists, and theologians from different countries provide their views on the complex biological and social impacts of the imminent proliferation of genetic information. The authors explore the various uses and applications of genetic information, and discuss the current dilemmas of making laws in the field of genetics. Different models of national genome projects and biobanks, as well as the related international legal documents and national laws are also discussed. Various genome projects and biobanks are analyzed in detail.
Download or read book Federal Register written by and published by . This book was released on 1985-08-19 with total page 1200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Recombinant DNA Research written by and published by . This book was released on 1995 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Documents relating to "NIH guidelines for research involving recombinant DNA molecules".
Download or read book Medical Ethics written by Alastair V. Campbell and published by . This book was released on 2005-06-30 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition is a practical introduction to the ethical questions that doctors and other health professionals are likely to encounter during their working lives.
