National Academies Press: OpenBook

Human Genome Editing: Science, Ethics, and Governance (2017)

Chapter: Appendix C: Data Sources and Methods

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Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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C

Data Sources and Methods

The National Academy of Sciences and the National Academy of Medicine Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations was tasked with studying the scientific underpinnings of human gene-editing technologies—including human germline editing—and the clinical, ethical, legal, and social implications of their use. The committee also explored fundamental, underlying principles that could be adapted by any nation considering the development of guidelines for human gene editing. To respond comprehensively to its charge, the committee examined data from a variety of sources, including a review of the literature, open-session meetings and conference calls, public testimony and input, and other publicly available resources.

COMMITTEE COMPOSITION

The National Academies of Sciences, Engineering, and Medicine (the National Academies) appointed a committee of 22 experts to undertake the statement of task. The committee was composed of members with expertise in basic science, clinical research and medicine, law and regulation, ethics and religion, patient advocacy, science communication, public engagement, and the biomedical industry. Appendix D provides the biographical information for each committee member.

Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
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MEETINGS AND INFORMATION-GATHERING ACTIVITIES

The committee deliberated from December 2015 to January 2017 to conduct its assessment, and gathered information and data relevant to its statement of task by conducting a review of available literature, inviting stakeholders to share perspectives at public meetings, and soliciting public comments both online and in person.

Literature Review

Several strategies were used to identify literature relevant to the committee’s charge. A search of bibliographic databases, including PubMed, Scopus, Web of Science, ProQuest Research Library, Medline, Embase, and LexisNexis, was conducted to obtain articles from peer-reviewed journals that discussed basic research, clinical applications, patient safety, scientific standards, ethics, oversight, and social issues associated with human gene editing. Staff reviewed recent news and literature to identify articles relevant to the committee’s charge and created a database of references. In addition, committee members, speakers, sponsors, and other interested parties submitted articles, reports, and policy statements on these topics. The committee’s database included several hundred relevant articles and reports, and was updated continuously throughout the study process.

Public Meetings

Four of the five meetings held over the course of the study included sessions in which committee members obtained input from a range of stakeholders and members of the public. Three meetings were held in Washington, DC (December 2015, February 2016, and July 2016), and one meeting was held in Paris, France, hosted by the French National Academy of Medicine (April 2016).

The committee’s first meeting in December 2015 was held in association with the 3-day International Summit on Human Gene Editing: A Global Discussion, co-hosted by the U.S. National Academy of Sciences, U.S. National Academy of Medicine, Chinese Academy of Sciences, and The Royal Society of the United Kingdom. Although a separate ad hoc committee planned the summit, it provided a critical opportunity for the study committee to gather information. The summit convened experts from around the world to discuss scientific, ethical, and governance issues associated with human gene-editing research.1

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1 The list of speakers at the International Summit included Peter Braude, Annelien Bredenoord, Philip Campbell, Alta Charo, George Church, Ralph Cicerone, Chad Cowan, George Daley,

Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

The committee’s second meeting in February 2016 included perspectives from potentially affected stakeholder communities such as patient groups and representatives from companies developing gene editing–based therapeutics. It also featured presentations from experts on models for public engagement as well as federal and institutional oversight bodies.

The study’s third meeting in April 2016, hosted by the French National Academy of Medicine in Paris, France, explored the principles underlying governance of gene editing. Speakers during the meeting provided international perspectives spanning permissive, neutral, precautionary, and preventive governance approaches. Meeting discussions also addressed potential therapeutic clinical applications for human germline gene editing. This meeting was held the day following a gene-editing workshop convened by the Federation of European Academies of Medicine, the U.K. Academy of Medical Sciences, and the French Academy of Medicine (FEAM, UKAMS, and ANM, 2017). A number of committee members were able to participate in the preceding FEAM workshop, which provided an important opportunity to learn further about gene-editing regulatory and governance concerns and strategies across the European community.2

Finally, the study’s fourth meeting in July 2016 provided input on several of the social issues associated with human gene editing, including race and genetics in U.S. history and the intersection of moral views and public policy. The list of speakers who provided input to the committee in these meeting sessions is below.

Public Comments

The committee’s data-gathering meetings also provided opportunities for the committee to engage and interact with a variety of stakeholders. Each public meeting included a public comment period, in which the committee invited input from any interested party. The committee also worked to make its activities as transparent and accessible as possible and to ac-

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Marcy Darnovsky, Victor Dzau, Fola Esan, Barbara Evans, William Foster, Bärbel Friedrich, Hille Haker, John Harris, John Holdren, Rudolf Jaenisch, Weizhi Ji, Pierre Jouannet, J. Keith Joung, Daniel Kevles, Jonathan Kimmelman, Eric Lander, Ephrat Levy-Lahad, Jinsong Li, Robin Lovell-Badge, Gary Marchant, Jennifer Merchant, Keymanthri Moodley, Indira Nath, Staffan Normark, Kyle Orwig, Pilar Ossorio, Duanquing Pei, Matthew Porteus, K. Vijay Raghavan, Klaus Rajewsky, Thomas Reiss, Janet Rossant, Ismail Serageldin, Bill Skarnes, John Skehel, Azim Surani, Sharon Terry, Adrian Thrasher, Fyodor Urnov, Marco Weinberg, Ernst-Ludwig Winnacker, Zhihong Xu, and Feng Zhang. Presentations and other materials from the Summit are available at http://nationalacademies.org/gene-editing/Gene-Edit-Summit/index.htm (accessed January 7, 2017).

2 The formal report of the FEAM workshop is available at http://www.feam-site.eu/cms/docs/activities/humangenomeeditingworkshop2016report.pdf.

Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

commodate those with special needs or those who may not have been able to attend in person.

The study website was updated regularly to reflect the recent and planned activities of the committee. Study outreach also included a study-specific email address for comments and questions and social media feeds and tags. A subscription to regular email updates was available to share further information and solicit additional comments and input to the committee.

Live video streams with closed captioning and links to an online public comment tool were provided throughout the course of the study to allow the opportunity for input from those unable to attend meetings in person. All online comments and submissions were catalogued in the study’s public access file. Any information provided to the committee from outside sources or through the online comment tool is available by request through the National Academies’ Public Access Records Office.

Speakers

The following individuals were invited speakers at data-gathering sessions of the committee:

Roberto Andorno, University of Zurich

Mónica López Barahona, Centro de Estudios Biosanitarios

Pierre Bégué, Académie Nationale de Médecine, France

Nick Bostrom, University of Oxford

Abby Bronson, Parent Project Muscular Dystrophy

Dominique Brossard, University of Wisconsin–Madison

Jacqueline Chin, National University of Singapore

Hans Clevers, Hubrecht Institute

Ronald Cole-Turner, Pittsburgh Theological Seminary

Francis Collins, National Institutes of Health

George William Foster, Congressman, IL-11

Søren Holm, University of Manchester

Rahman Jamal, National University of Malaysia

Bartha Knoppers, McGill University

Fredrik Lanner, Karolinska Institute

James Lawford-Davies, Hempsons Law Firm, United Kingdom

John Leonard, Intellia Therapeutics

Bruce Lewenstein, Cornell University

Andrew May, Caribou Biosciences

Vic Myer, Editas Medicine

Alondra Nelson, Columbia University

Erik Parens, Hastings Center

Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Guido Pennings, Ghent University, Belgium

Pearl O’Rourke, Partners HealthCare

Jackie Leach Scully, Newcastle University

Oliver Semler, University of Cologne

Trevor Thompson, Sickle Cell Foundation of Tennessee

Anna Veiga, Center of Regenerative Medicine, Barcelona, Spain

Thomas Voit, University College London

Elizabeth Vroom, United Parent Projects Muscular Dystrophy

Keith Wailoo, Princeton University

Michael Werner, Alliance for Regenerative Medicine

Nancy Wexler, Hereditary Disease Foundation

Bethan Wolfenden, Bento Bioworks

Carrie Wolinetz, National Institutes of Health

Philip Yeske, United Mitochondrial Disease Foundation

Xiaomei Zhai, Peking Union Medical College, China

Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

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Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 273
Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 274
Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 275
Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 276
Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 277
Suggested Citation:"Appendix C: Data Sources and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 278
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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.

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