Genome Editing Under Gene Technology Law: Legal Aspects and Latest Developments
Author: Tade Matthias Spranger
Publisher:
Published: 2021
Total Pages:
ISBN-13: 9783869653730
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Human Genome Editing
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2017-08-13
Total Pages: 329
ISBN-13: 0309452880
DOWNLOAD EBOOK →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.
Rewriting Nature
Author: Paul Enríquez
Publisher: Cambridge University Press
Published: 2021-06-24
Total Pages: 441
ISBN-13: 1108613624
DOWNLOAD EBOOK →History will mark the twenty-first century as the dawn of the age of precise genetic manipulation. Breakthroughs in genome editing are poised to enable humankind to fundamentally transform life on Earth. Those familiar with genome editing understand its potential to revolutionize civilization in ways that surpass the impact of the discovery of electricity and the development of gunpowder, the atomic bomb, or the Internet. Significant questions regarding how society should promote or hinder genome editing loom large in the horizon. And it is up to humans to decide the fate of this powerful technology. Rewriting Nature is a compelling, thought-provoking interdisciplinary exploration of the law, science, and policy of genome editing. The book guides readers through complex legal, scientific, ethical, political, economic, and social issues concerning this emerging technology, and challenges the conventional false dichotomy often associated with science and law, which contributes to a growing divide between both fields.
Heritable Human Genome Editing
Author: The Royal Society
Publisher: National Academies Press
Published: 2021-01-16
Total Pages: 239
ISBN-13: 0309671132
DOWNLOAD EBOOK →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.
Gene Editing Legal and Regulatory Implications
Human Germline Modification and the Right to Science
Author: Andrea Boggio
Publisher: Cambridge University Press
Published: 2020-01-09
Total Pages: 681
ISBN-13: 1108499872
DOWNLOAD EBOOK →A survey of the regulation of human germline genome modification in eighteen countries and the emerging international standards.
Biotechnology Law and Policy
Author: Alessandro Stasi
Publisher:
Published: 2023
Total Pages: 0
ISBN-13: 9789819921362
DOWNLOAD EBOOK →This book covers an extensive range of issues raised by biotechnological advancements from a regulatory perspective. Written in a clear and readable style, its main objective is to give readers an idea of the relationship between biotechnology and law. Biotechnology advancements and their ethical, moral, economic, and social implications in different fields and the consequential normative demands on the law are crucial to this book. The chapters cover a multitude of themes and some of the most important legal issues arising in relation to biotechnology, including the historical development of a legal framework sufficient to protect public safety, the current biotechnology regulatory system, and the rules directing the primary agencies that regulate the products of biotechnology, namely the US Food and Drug Administration, the US Department of Agriculture, and the US Environmental Protection Agency, patents and IP rights in biotechnology, the regulation of human genome editing and its impact on health research, law and emerging genome editing technologies from recombinant DNA to CRISPR/Cas9, the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and legal issues arising from the use of genetic engineered plants and animals. Presenting arguments that have been drawn from careful examination of various international documents and decisions made by legal institutions and judicial bodies, this book would be a valuable read for practitioners as well as academics of biotechnology law.
Guidelines for Human Embryonic Stem Cell Research
Author: National Research Council
Publisher: National Academies Press
Published: 2005-09-15
Total Pages: 224
ISBN-13: 0309096537
DOWNLOAD EBOOK →Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. This report provides guidelines for the conduct of hES cell research to address both ethical and scientific concerns. The guidelines are intended to enhance the integrity of privately funded hES cell research by encouraging responsible practices in the conduct of that research.
Genetically Engineered Crops
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2017-01-28
Total Pages: 607
ISBN-13: 0309437385
DOWNLOAD EBOOK →Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human health, the environment, and ethical considerations. At the same time, others are concerned that the technology is not reaching its potential to improve human health and the environment because of stringent regulations and reduced public funding to develop products offering more benefits to society. While the debate about these and other questions related to the genetic engineering techniques of the first 20 years goes on, emerging genetic-engineering technologies are adding new complexities to the conversation. Genetically Engineered Crops builds on previous related Academies reports published between 1987 and 2010 by undertaking a retrospective examination of the purported positive and adverse effects of GE crops and to anticipate what emerging genetic-engineering technologies hold for the future. This report indicates where there are uncertainties about the economic, agronomic, health, safety, or other impacts of GE crops and food, and makes recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GE technology.
CRISPR People
Author: Henry T. Greely
Publisher: MIT Press
Published: 2022-03-01
Total Pages: 395
ISBN-13: 0262543885
DOWNLOAD EBOOK →What does the birth of babies whose embryos had gone through genome editing mean--for science and for all of us? In November 2018, the world was shocked to learn that two babies had been born in China with DNA edited while they were embryos—as dramatic a development in genetics as the 1996 cloning of Dolly the sheep. In this book, Hank Greely, a leading authority on law and genetics, tells the fascinating story of this human experiment and its consequences. Greely explains what Chinese scientist He Jiankui did, how he did it, and how the public and other scientists learned about and reacted to this unprecedented genetic intervention. The two babies, nonidentical twin girls, were the first “CRISPR'd” people ever born (CRISPR, Clustered Regularly Interspaced Short Palindromic Repeats, is a powerful gene-editing method). Greely not only describes He's experiment and its public rollout (aided by a public relations adviser) but also considers, in a balanced and thoughtful way, the lessons to be drawn both from these CRISPR'd babies and, more broadly, from this kind of human DNA editing—“germline editing” that can be passed on from one generation to the next. Greely doesn't mince words, describing He's experiment as grossly reckless, irresponsible, immoral, and illegal. Although he sees no inherent or unmanageable barriers to human germline editing, he also sees very few good uses for it—other, less risky, technologies can achieve the same benefits. We should consider the implications carefully before we proceed.
