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.

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.

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.

In 2018 the first genetically modified babies were reportedly born in China, made possible by the invention of CRISPR technology in 2012. This controversial advancement overturned the pre-existing moral consensus, which had held for over fifty years before: while gene editing an adult person was morally acceptable, modifying babies, and thus subsequent generations, crossed a significant moral line. If this line is passed over, scientists will be left without an agreed-upon ethical limit. What do we do now? John H. Evans here provides a meta-level guide to how these debates move forward and their significance to society. He explains how the bioethical debate has long been characterized as a slippery slope, with consensually ethical use at the top, nightmarish dystopia at the bottom, and specific agreed-upon limits in between, which draw the lines between the ethical and the unethical. Evans frames his analysis around these limits, or barriers. Historically they have existed to guide scientists and to prevent the debate from slipping down the metaphorical slope into unacceptable eugenicist possibilities, such as in Aldous Huxley's novel Brave New World or the movie Gattaca. Evans examines the history of how barriers were placed, then fell, then replaced by new ones, and discusses how these insights inform where the debate may head. He evaluates other proposed barriers relevant to where we are now, projects that most of the barriers suggested by scientists and bioethicists will not hold, and cautiously identifies a few that could serve as the moral boundary for the next generation. At a critical time in this new era of intervention in the human genome, The Human Gene Editing Debate provides a necessary, comprehensive analysis of the conversation's direction, past, present, and future.

Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as malaria and dengue, which disproportionately impact low and middle income countries. However, due to their intrinsic qualities of rapid spread and irreversibility, gene drive systems raise many questions with respect to their safety relative to public and environmental health. Because gene drive systems are designed to alter the environments we share in ways that will be hard to anticipate and impossible to completely roll back, questions about the ethics surrounding use of this research are complex and will require very careful exploration. Gene Drives on the Horizon outlines the state of knowledge relative to the science, ethics, public engagement, and risk assessment as they pertain to research directions of gene drive systems and governance of the research process. This report offers principles for responsible practices of gene drive research and related applications for use by investigators, their institutions, the research funders, and regulators.

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.

The potential uses of CRISPR-Cas9 and other gene editing technologies are unprecedented in human history. Altering human DNA, however, raises enormously difficult questions. Some of these questions are about safety: Can these technologies be deployed without posing an unreasonable risk of physical harm to current and future generations? But gene editing technologies also raise other moral questions, which touch on deeply held, personal, cultural, and societal values. In the new essays collected here, an interdisciplinary group of scholars asks age-old questions about the nature and well-being of humans in the context of a revolutionary new biotechnology--one that has the potential to change the genetic make-up of both existing people and future generations.