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.

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.

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.

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.

A survey of the regulation of human germline genome modification in eighteen countries and the emerging international standards.

With the advent of CRISPR gene-editing technology, designer babies have become a reality. Françoise Baylis insists that scientists alone cannot decide the terms of this new era in human evolution. Members of the public, with diverse interests and perspectives, must have a role in determining our future as a species.

The concepts of humanity, human dignity and mankind have emerged in different contexts across international law and biolaw. This raises many different questions. What are the aims for which 'humanity' is mobilised? How do these aims affect the ensuing interpretations of this concept? What are the negative counterparts of humanity, mankind and human dignity? And what happens if a concept developed in one particular context is taken up in another? By bringing together research from international law, biolaw and legal theory, this volume answers such questions by analysing how the concepts overlap and contradict each other across the disciplines. The result is not an examination of what humanity is but rather what it does and what it brings about in a variety of contexts.

Asks whether personalised medicine is superior to 'one-size-fits-all' treatment. Does it elevate individual choice above the common good?

Human genetic engineering may soon be possible. The gathering debate about this prospect already threatens to become mired in irresolvable disagreement. After surveying the scientific and technological developments that have brought us to this pass, The Ethics of Genetic Engineering focuses on the ethical and policy debate, noting the deep divide that separates proponents and opponents. The book locates the source of this divide in differing framing assumptions: reductionist pluralist on one side, holist communitarian on the other. The book argues that we must bridge this divide, drawing on the resources from both encampments, if we are to understand and cope with the distinctive problems posed by genetic engineering. These problems, termed "fractious problems," are novel, complex, ethically fraught, unavoidably of public concern, and unavoidably divisive. Berry examines three prominent ethical and political theories – utilitarianism, Kantianism, and virtue ethics – to consider their competency in bridging the divide and addressing these fractious problems. The book concludes that virtue ethics can best guide parental decision making and that a new policymaking approach sketched here, a "navigational approach," can best guide policymaking. These approaches enable us to gain a rich understanding of the problems posed and to craft resolutions adequate to their challenges.

The emergence of CRISPR/Cas9 technology has revolutionized gene editing. The Nobel prize for chemistry was awarded to Emmanuelle Charpentier and Jennifer Doudna, the scientists responsible for its discovery, in 2020 and it is considered the frontier of sophisticated medical science. This technology contains the promise that both gene therapy and eugenic control of human evolution is possible, even plausible, in our near future. This book looks at these developements in the context of the history of previous social and scientific attempts at genetic editing, and explores the policy and ethical challenges they raise. It presents the case for altering the human germ-line (which contains and controls hereditary genetic information) to eliminate a large number of genetic diseases controlled by a single or few genes, while pointing out that gene therapy is likely to be ineffective for diseases with more complex causes. In parallel it explores the possibility of genetic enhancement in a set of case studies. But it also argues that, in general, genetic enhancement is ethically problematic and should be approached with caution. Given the success of CRISPR/Cas9 gene editing, and the explosion of related techniques, in practice it would be virtually impossible to ban germ-line editing in our future. A more useful goal is to put regulation in place, with oversight that represents the interests of society. That, in turn, requires an informed public discussion of these issues, which is the intention of this book.