commonly proposed for uses such as insect vector control. The ability of heritable genetic changes to spread through an ecosystem raises its own complex set of scientific, ethical, and governance challenges (NASEM, 2016b). · Workshop on Gene Editing to Modify Animal Genomes for Research: Scientific and Ethical Considerations (Institute for Animal Laboratory Research [ILAR] Roundtable)—Genome-editing tools can be used to produce laboratory animal models enabling better study of diseases, as well as to produce livestock with desired traits. The workshop explored animal uses of genome editing, along with associated ethical and regulatory considerations.a · Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System—As the types of products that can be created through biotechnology expand, these products are evaluated in regulatory frameworks initially created decades ago. This ongoing study is examining capabilities and expertise that may be needed by U.S. regulatory systems to assess and regulate future products that could be created through a number of technologies, including genome editing. The study is not addressing the development and regulation of human drugs or medical devices.b Other Studies on Clinical Research and Applications Not specific to genome editing but pertinent to discussions about all of its clinical applications are several other recent National Academies reports. · Oversight and Review of Clinical Gene Transfer Protocols: Assessing the Role of the Recombinant DNA Advisory Committee was a report on the role of the U.S. Recombinant DNA Advisory Committee (RAC), recommending that it move toward more judicious use of its advisory power to review specific protocols, and that it focus primarily on novel applications of gene therapy or on providing a venue for broad public debate about the therapy (IOM2014). · Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations: presents an analysis of the special opportunities and concerns associated with making changes in mitochondrial DNA in gametes or embryos (NASEM, 2016e). · Guidelines for Embryonic Stem Cell Research (IOM, 2005; NRC and IOM, 2007, 2008, 2010): outline the regulatory landscape and provide a roadmap for professional self-regulation for emerging technologies that generate considerable public interest and controversy. Studies on Public Engagement and Science Communication · Communicating science effectively: A research agenda finds that people rarely make decisions based only on scientific information; they also consider their own goals and values, and a focus on knowledge alone is not enough to achieve communication goals (NASEM 2016a). · Public participation in environmental assessment and decision making (NRC 2008) describes how public participation can improve the quality and legitimacy of policy Copyright © National Academy of Sciences. All rights reserved. Human Genome Editing: Science, Ethics, and Governance INTRODUCTION 15 PREPUBLICATION COPY—SUBJECT TO FURTHER EDITORIAL REVISION decisions, and enhance trust and understanding among all parties. · Understanding risk: Informing decisions in a democratic society describes how risk characterization must be responsive to the problem to be solved and to the interests of the parties affected (NRC 1996). In concert with the National Academies’ Human Gene-Editing Initiative, these studies represent a series of efforts exploring scientific, ethical, and governance issues raised by potential uses of genome-editing. __ a ILAR roundtable—gene editing to modify animal genomes for research scientific and ethical considerations. http://nas-sites.org/ilar-roundtable/roundtable-activities/gene-editing-to-modify-animalgenomes-for-research (accessed October 21, 2016). b Future biotechnology products and opportunities to enhance capabilities of the biotechnology regulatory system. http://nas-sites.org/biotech (accessed October 21, 2016). This committee was convened to continue the dialogue initiated by the International Summit and to undertake a year-long, in-depth consensus study. As specified in its statement of task (see Box 1-1), the committee examined the state of the science in human genome editing, its potential applications, and the ethical issues that need to be considered in deciding how to govern the use of these powerful new tools. This report is the product of that study and, as with all other Academies consensus studies, underwent peer review by an independent panel of experts. Additional activities of the Chinese Academy of Sciences and The Royal Society of the United Kingdom are anticipated, including another international summit to take place in China in 2017. BACKGROUND U.S. and International Policy Discussions Among the earliest calls for a detailed examination of the implications of genome-editing technologies were those made by members of the scientific community engaged in developing these tools and advancing their clinical applications. In 2015 a group of investigators and ethicists, including CRISPR/Cas9 developers, met in Napa, California, and subsequently published a request for the community to explore the nature of human genome editing and provide guidance on its acceptable uses (Baltimore et al., 2015). That same