National Academies Press: OpenBook

Heritable Human Genome Editing (2020)

Chapter: Appendix A: Information Sources and Methods

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Suggested Citation:"Appendix A: Information Sources and Methods." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
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Page 188
Suggested Citation:"Appendix A: Information Sources and Methods." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
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Page 189
Suggested Citation:"Appendix A: Information Sources and Methods." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
×
Page 190
Suggested Citation:"Appendix A: Information Sources and Methods." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
×
Page 191
Suggested Citation:"Appendix A: Information Sources and Methods." National Academy of Medicine, National Academy of Sciences, and the Royal Society. 2020. Heritable Human Genome Editing. Washington, DC: The National Academies Press. doi: 10.17226/25665.
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Page 192

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Appendix A Information Sources and Methods The International Commission on the Clinical Use of Human Germline Genome Editing was tasked with developing a framework for scientists, clinicians, and regulatory authorities to consider when assessing potential clinical uses of human germline genome editing, should society conclude that heritable human genome editing applications are acceptable. COMMISSION COMPOSITION The U.S National Academy of Medicine, the U.S. National Academy of Sciences, and the U.K.’s Royal Society appointed a Commission of 18 experts to undertake the statement of task. The Commission’s membership spans 10 nations and four continents and includes experts in science, medicine, genetics, ethics, psychology, regulation, and law. Appendix B provides biographical information for each Commissioner. In addition, an International Oversight Board of leaders from national academies of sciences and international institutions was charged with ensuring that the Commission followed due processes, including approving the statement of task and membership of the Commission and ensuring that the Commission’s report underwent rigorous external review prior to publication. MEETINGS AND INFORMATION-GATHERING ACTIVITIES The Commission deliberated from approximately June 2019 through March 2020 to conduct its assessment and prepare its final report. To address its task, the Commission analyzed information obtained from current literature and other publicly available resources and undertook information gathering activities such as inviting stakeholders to share perspectives at public meetings, holding webinars, and soliciting public input online and in person. Public Meetings and Webinars Sessions at meetings and webinars held over the course of the study enabled Commissioners to obtain input from a range of stakeholders and members of the public. The Commission’s first meeting was held in August 2019 in Washington, DC. Public sessions provided an opportunity for the Commission to discuss its statement of task with the co- chairs of IOB and sponsoring organizations and to hear presentations on the state of understanding of genetics and genetic manipulation, on somatic genome editing translational pathways from scientists, developers, and regulatory bodies, and on the views of genetic disease patient communities. In November 2019, the Commission held a second meeting and workshop in London, United Kingdom. The Commission heard from invited experts on topics such as the medical ethics of heritable human genome editing (HHGE), how clinical use of HHGE would intersect with the use of assisted reproductive technologies, and technologies that might enable HHGE, including making and validating edits in embryos and germ cells, and what we can learn from PREPUBLICATION COPY | UNCORRECTED PROOFS 188

animal models. In addition, the Commission hosted a session on governance developed in consultation with two members of the WHO Advisory Committee. At a third meeting in January 2020, Commission members developed the conclusions and recommendations presented in this report. In October 2019, the Commission also held a series of four public webinars on the state of research in relevant areas. These webinars covered a) informed consent in the context of HHGE; b) the impact of genome editing on embryo viability and the state of the science on editing spermatogonial stem cells; c) homology directed repair and single cell genomics; and d) validating on target and off target edits. The list of speakers who provided input to the Commission in these meeting and webinar sessions is below. Public Comments The Commission’s data-gathering meetings provided opportunities for the Commission to interact with a variety of stakeholders. Each public meeting included a public comment period, in which the Commission invited input from any interested party. The Commission also worked to make its activities as transparent and accessible as possible. The study websites hosted by the U.S. National Academies and the U.K.’s Royal Society were updated regularly to reflect recent and planned Commission activities. Study outreach included a study-specific email address for comments and questions. A subscription to email updates was available to share further information and solicit additional comments and input to the Commission. Live video streams with closed captioning were provided throughout the course of the study to allow the opportunity for input from those unable to attend public meetings in person. Information provided to the Commission from outside sources or through online comment is available by request through the National Academies’ Public Access Records Office. Call for Evidence To inform its deliberations, the Commission invited responses to a public call for evidence during fall 2019. Several of the questions invited broad input on considerations associated with HHGE, while others asked for technical input in areas such as preclinical safety and efficacy and the use of genome editing in human embryos. Still other questions asked about considerations for informed consent, long-term monitoring, and oversight of HHGE. There were 83 responses received. Respondents came from every continent and included academic leaders, lawyers, social scientists and philosophers, representatives from disability advocacy groups, journals, national ethics councils, industry, and scientific societies. Consulted Experts The following individuals were invited speakers at data-gathering sessions of the Commission or provided other expert input. PREPUBLICATION COPY | UNCORRECTED PROOFS 189

Sonia Abdelhak Institut Pasteur de Tunis, Tunisia Britt Adamson Princeton University Fabiana Arzuaga Ministry of Science, Technology and Productive Innovation, Argentina Richard Ashcroft City University of London, U.K. Christina Bergh University of Gothenburg, Sweden Peter Braude King’s College London, U.K. Annelien Bredenoord University Medical Centre Utrecht, Netherlands Aravinda Chakravarti New York University School of Medicine Sarah Chan University of Edinburgh, U.K. Ellen Clayton Vanderbilt University Chad Cowan Harvard Stem Cell Institute Tarek El-Toukhy Guy's and St Thomas' Hospital NHS Foundation Trust, U.K. Frances Flinter King’s College London, U.K. Denise Gavin U.S. Food and Drug Administration Melissa Goldstein George Washington University Margaret Hamburg U.S. National Academy of Medicine and Co-chair of WHO Expert Advisory Committee Muntaser Ibrahim University of Khartoum, Sudan PREPUBLICATION COPY | UNCORRECTED PROOFS 190

Pierre Jouannet Paris Descartes University, France Jin-Soo Kim Seoul National University Robert Klitzman Columbia University James Lawford Davies Hill Dickinson LLP, U.K. Jackie Leach Scully University of New South Wales, Australia and Newcastle University, U.K. Bruce Levine University of Pennsylvania Robin Lovell-Badge Francis Crick Institute, U.K. Sandy Macrae Sangamo Therapeutics Julie Makani Muhimbili University of Health and Allied Sciences, Tanzania Nick Meade Genetic Alliance U.K. Shoukhrat Mitalipov Oregon Health & Science University Vic Myer Editas Medicine Kathy Niakan Francis Crick Institute Sarah Norcross Progress Educational Trust Helen O’Neill University College London, U.K. Kyle Orwig Magee-Womens Research Institute PREPUBLICATION COPY | UNCORRECTED PROOFS 191

Matthew Porteus Stanford University Adam Pearson Actor, Presenter and Campaigner, U.K. Catherine Racowsky Brigham and Women’s Hospital, USA Azim Surani University of Cambridge, U.K. Sarah Teichmann Wellcome Sanger Institute Sharon Terry Genetic Alliance, USA Peter Thompson Human Fertilisation and Embryology Authority, U.K. Carrie Wolinetz National Institutes of Health, USA Xiaoliang Sunney Xie Peking University Hui Yang Institute of Neuroscience, Chinese Academy of Sciences, China Mohammed Zahir Muhimbili University of Health and Allied Sciences, Tanzania PREPUBLICATION COPY | UNCORRECTED PROOFS 192

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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.

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