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1 Introduction
Pages 15-28

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From page 15...
... As with other medical advances, each application comes with its own set of benefits, risks, regulatory questions, ethical issues, and societal implications. Important questions raised with respect to genome editing include how to balance potential benefits against the risk of unintended harms; how to govern the use of these technologies; how to incorporate societal values into salient clinical and policy considerations; and how to respect the in 1  The term "genome editing" is used throughout this report to refer to the processes by which the genome sequence is changed by adding, replacing, or removing DNA base pairs.
From page 16...
... While genome editing has potential applications for use in agriculture and nonhuman animals,3 this committee's task (see Box 1-1) was focused on human applications.4 The charge to the committee included elements pertaining to the state of the science in genome editing, possible clinical applications of these technologies, potential risks and benefits, whether standards can be established for quantifying unintended effects, whether current regulatory frameworks provide adequate oversight, and what overarching principles should guide the regulation of genome editing in humans.
From page 17...
... 5.  current ethical and legal standards for human subjects research ad Do equately address human gene editing, including germline editing?
From page 18...
... 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.
From page 19...
... . Professional bodies, international organizations, and national academies of sciences and medicine further raised the profile of genome editing by issuing statements on its appropriate uses, particularly in reference to the potential for creating heritable genetic modifications.
From page 20...
... . •  orkshop on Gene Editing to Modify Animal Genomes for Research: Sci W entific and Ethical Considerations (Institute for Animal Laboratory Research [ILAR]
From page 21...
... . 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.
From page 22...
... . The Netherlands "Public debate would give patients, care providers and society an opportunity to discuss controversial issues, to assess the risks, advantages and conditions of potential germline applications based on growing scientific insight, and to develop good practices and further regulation" (KNAW, 2016, p.
From page 23...
... These methods have rapidly been adopted by scientists worldwide and have greatly accelerated fundamental research that has included altering cells in the laboratory to study the functions of particular genes, developing models for studies of human diseases using stem cells or laboratory animals, creating modified plants and animals to improve food production, and developing therapeutic uses in humans. Genome editing has rapidly become an invaluable core technology in research laboratories and biotechnology companies, and is already moving into clinical trials (e.g., Cyranoski, 2016; Reardon, 2016; Urnov et al., 2010)
From page 24...
... . Moreover, as with other genetic technologies, such genome-editing applications may raise concerns about coercive and abusive eugenics programs of the past, which were based on faulty science and served discriminatory political goals (Wailoo et al., 2012)
From page 25...
... It included biologists, bioethicists, and social scientists, and incorporated perspectives from potentially affected patient and stakeholder communities. Because the ethical and social issues posed by human genome editing transcend national boundaries, the committee included not only
From page 26...
... These developments interface with those of genome editing because editing of stem cells has potential clinical applications for treating or preventing disease, and reproductive technologies would have to be used in combination with genome editing for any heritable application of the latter technologies. As these other technologies have advanced, legal and regulatory frameworks and ethical norms of conduct have been developed to provide guidance on their appropriate h ­ uman uses and oversight (Health Canada, 2016; HFEA, 2014; IOM, 2005; NASEM, 2016e; NRC and IOM, 2007, 2008; Nuffield Council, 2016a; Präg and Mills, 2015; Qiao and Feng, 2014)
From page 27...
... The chapter considers public engagement for different categories of genome-editing applications and explores strengths and limitations of potential models for undertaking such public engagement. Finally, Chapter 8 returns to the set of overarching principles and the responsibilities that flow from them in the context of human genome editing.


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