Getting serious about the challenge of regulating germline gene therapy
The announcement of He Jiankui's germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and ethical grounds. That criticism is warranted. There is little room for anything other than vociferous condemnation of He's announce...
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Published in | PLoS biology Vol. 17; no. 4; p. e3000223 |
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Main Author | |
Format | Journal Article |
Language | English |
Published |
United States
Public Library of Science
30.04.2019
Public Library of Science (PLoS) |
Subjects | |
Online Access | Get full text |
ISSN | 1545-7885 1544-9173 1545-7885 |
DOI | 10.1371/journal.pbio.3000223 |
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Abstract | The announcement of He Jiankui's germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and ethical grounds. That criticism is warranted. There is little room for anything other than vociferous condemnation of He's announcement. Presenting the results of groundbreaking work by press conference and YouTube is not science. The issue now is not whether the work supporting the claims reported from China was done in an ethical manner. It was not. What is required to move forward is a justification for doing germline editing in humans. Many think there is none, and prohibitions abound. If such work is justifiable, a serious, rigorous framework must be imposed that insures that such research is done following the highest ethical standards that both protect human subjects and insure public trust and support. |
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AbstractList | The announcement of He Jiankui's germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and ethical grounds. That criticism is warranted. There is little room for anything other than vociferous condemnation of He's announcement. Presenting the results of groundbreaking work by press conference and YouTube is not science. The issue now is not whether the work supporting the claims reported from China was done in an ethical manner. It was not. What is required to move forward is a justification for doing germline editing in humans. Many think there is none, and prohibitions abound. If such work is justifiable, a serious, rigorous framework must be imposed that insures that such research is done following the highest ethical standards that both protect human subjects and insure public trust and support. The announcement of He Jiankui's germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and ethical grounds. That criticism is warranted. There is little room for anything other than vociferous condemnation of He's announcement. Presenting the results of groundbreaking work by press conference and YouTube is not science. The issue now is not whether the work supporting the claims reported from China was done in an ethical manner. It was not. What is required to move forward is a justification for doing germline editing in humans. Many think there is none, and prohibitions abound. If such work is justifiable, a serious, rigorous framework must be imposed that insures that such research is done following the highest ethical standards that both protect human subjects and insure public trust and support.The announcement of He Jiankui's germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and ethical grounds. That criticism is warranted. There is little room for anything other than vociferous condemnation of He's announcement. Presenting the results of groundbreaking work by press conference and YouTube is not science. The issue now is not whether the work supporting the claims reported from China was done in an ethical manner. It was not. What is required to move forward is a justification for doing germline editing in humans. Many think there is none, and prohibitions abound. If such work is justifiable, a serious, rigorous framework must be imposed that insures that such research is done following the highest ethical standards that both protect human subjects and insure public trust and support. The announcement of He Jiankui’s germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and ethical grounds. That criticism is warranted. There is little room for anything other than vociferous condemnation of He's announcement. Presenting the results of groundbreaking work by press conference and YouTube is not science. The issue now is not whether the work supporting the claims reported from China was done in an ethical manner. It was not. What is required to move forward is a justification for doing germline editing in humans. Many think there is none, and prohibitions abound. If such work is justifiable, a serious, rigorous framework must be imposed that insures that such research is done following the highest ethical standards that both protect human subjects and insure public trust and support. The announcement of an experiment on human embryos using germline genetic engineering has been met with near universal condemnation on ethical and scientific grounds. But should germline genetic research still be pursued, and if so, why? This Perspective article argues that it should, but only if it is conducted under a transparent and enforceable ethical/regulatory framework |
Audience | Academic |
Author | Caplan, Arthur |
AuthorAffiliation | Division of Medical Ethics, New York University School of Medicine, New York, New York, United States of America |
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Cites_doi | 10.1038/nbt.4337 10.1038/519410a 10.15252/embr.201745246 10.15252/embr.201541337 10.1089/hum.2013.2524 10.1371/journal.pbio.2001934 10.1016/j.ymgme.2008.12.016 10.1038/d41586-018-07777-0 10.1016/S0140-6736(18)33080-0 10.1007/s13238-015-0153-5 |
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Copyright | COPYRIGHT 2019 Public Library of Science 2019 Arthur Caplan. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2019 Arthur Caplan 2019 Arthur Caplan |
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References | ref20 C Wang (ref3) 2019; 393 CP Neuhaus (ref13) 2017; 15 JM Wilson (ref15) 2009; 96 E Lanphier (ref12) 2015; 519 AL Caplan (ref11) 2015; 16 ref16 ref19 NA Wivel (ref17) 2014; 25 ref18 ref8 ref7 P Liang (ref6) 2015; 6 ref9 H Wang (ref4) 2018; 564 P Sykora (ref10) 2017; 18 S Krimsky (ref2) 2019; 37 ref5 B. Sacks (ref1) 2018 CD Swarnalatha (ref14) 2007 |
References_xml | – year: 2018 ident: ref1 article-title: A Pair Of Genetically Edited Babies Might Have Been Successfully Born In China – volume: 37 start-page: 19 issue: 1 year: 2019 ident: ref2 article-title: Ten ways in which He Jiankui violated ethics publication-title: Nature Biotechnology doi: 10.1038/nbt.4337 – volume: 519 start-page: 410 issue: 7544 year: 2015 ident: ref12 article-title: Don’t edit the human germ line publication-title: Nature News doi: 10.1038/519410a – year: 2007 ident: ref14 article-title: Principles of biotechnology – ident: ref5 – ident: ref7 – volume: 18 start-page: 1871 issue: 11 year: 2017 ident: ref10 article-title: The Council of Europe should not reaffirm the ban on germline genome editing in humans publication-title: EMBO reports doi: 10.15252/embr.201745246 – ident: ref20 – volume: 16 start-page: 1421 issue: 11 year: 2015 ident: ref11 article-title: No time to waste—the ethical challenges created by CRISPR: CRISPR/Cas, being an efficient, simple, and cheap technology to edit the genome of any organism, raises many ethical and regulatory issues beyond the use to manipulate human germ line cells publication-title: EMBO reports doi: 10.15252/embr.201541337 – volume: 25 start-page: 19 issue: 1 year: 2014 ident: ref17 article-title: Historical perspectives pertaining to the NIH recombinant DNA advisory committee publication-title: Human gene therapy doi: 10.1089/hum.2013.2524 – volume: 15 start-page: e2001934 issue: 3 year: 2017 ident: ref13 article-title: Genome editing: Bioethics shows the way publication-title: PLoS Biol doi: 10.1371/journal.pbio.2001934 – volume: 96 start-page: 151 issue: 4 year: 2009 ident: ref15 article-title: Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency publication-title: Molecular genetics and metabolism doi: 10.1016/j.ymgme.2008.12.016 – volume: 564 start-page: 345 issue: 7736 year: 2018 ident: ref4 article-title: CRISPR twins: a condemnation from Chinese academic societies publication-title: Nature doi: 10.1038/d41586-018-07777-0 – ident: ref9 – ident: ref8 – ident: ref19 – ident: ref18 – volume: 393 start-page: 25 issue: 10166 year: 2019 ident: ref3 article-title: Gene-edited babies: Chinese Academy of Medical Sciences’ response and action publication-title: The Lancet doi: 10.1016/S0140-6736(18)33080-0 – ident: ref16 – volume: 6 start-page: 363 issue: 5 year: 2015 ident: ref6 article-title: CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes publication-title: Protein & cell doi: 10.1007/s13238-015-0153-5 |
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Snippet | The announcement of He Jiankui's germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and... The announcement of He Jiankui’s germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and... |
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Title | Getting serious about the challenge of regulating germline gene therapy |
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