He Jiankui (贺建奎)Incident
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Shock Greets Claim of CRISPR-Edited Babies Apparent Germline Engineering by Chinese Researcher Prompts Outrage and Investigations
IN DEPTH Downloaded from BIOETHICS Shock greets claim of CRISPR-edited babies http://science.sciencemag.org/ Apparent germline engineering by Chinese researcher prompts outrage and investigations By Dennis Normile, in Hong Kong, China pears to have skipped the profound ethical and other gene-editing techniques as treat- debate that participants at the 2015 summit, ments for genetic diseases, such as muscular he idea that humanity can rewrite its and many meetings since, agreed should take dystrophy and sickle cell anemia. So far, clini- own genetic code long seemed the stuff place before such experiments began. (He did cal trials have only modified somatic cells— of a science fiction novel—and a pretty not responds to requests for an interview.) not sperm or eggs, the germ line. But He on December 30, 2020 scary one at that. But rapid advances Fueling the outcry was the fact that He altered the genome in early stage embryos, in techniques such as CRISPR have didn’t produce any data, let alone a paper, creating edits that may be heritable. Many made it possible, at least in principle, to back up his claim. The biologist was scientists and ethicists don’t rule out making Tto make precise changes to the genome of scheduled to speak at the International such changes to the germ line, but recent re- a human embryo that could help rid fami- Summit on Human Genome Editing here ports from the United States’s National Acad- lies of crippling genetic diseases—or lead to this week, but whether he would show up emies of Sciences, Engineering, and Medicine “designer” babies, gene edited to be smarter was unclear as Science went to press. -
Gene Editing in HIV Research
TREATMENT ACTION GROUP ISSUE BRIEF MARCH 2019 www.treatmentactiongroup.org Gene Editing in HIV Research INTRODUCTION the Southern University of Science and Technology in Shenzhen and placed under investigation by Chinese The term “gene therapy” refers to a broad variety of authorities. approaches that aim to provide therapeutic benefit by manipulating genetic code (DNA or RNA). The strategy Amidst the controversy about He Jiankui, it’s important takes advantage of the fact that DNA acts as a blueprint to appreciate that there is a substantial amount of for manufacturing proteins, via an intermediate step legitimate and responsible gene editing research in HIV. of translation into RNA. Multiple research groups and The best-known example is an experimental therapy biotechnology companies have explored the possibility called SB-728, developed by the company Sangamo of treating HIV with gene therapy, but so far evidence of Therapeutics. SB-728 is designed to edit the gene that efficacy has been limited, and no candidates have been encodes the CCR5 receptor, with the aim of creating submitted to the U.S. Food and Drug Administration cells impervious to infection by HIV. Several other gene (FDA) for possible approval. Importantly, no major editing approaches that may have benefits in HIV are safety issues have emerged to date. also under investigation. Initially, these The purpose of this The purpose of this issue brief is to provide background experimental information on gene editing in HIV research, and issue brief is to provide gene context for the news about He’s misuse of the background information therapies technology to alter embryos. -
CRISPR Twins Might Have Shortened Lives
NEWS IN FOCUS REPRODUCIBILITY One paper, two discussions Anaesthesia journal asks independent experts to draw their own conclusions on studies. BY DAVID ADAM Some reproducibility researchers welcome the same time as the peer-reviewed original, the the approach and say that other fields should journal hopes to accelerate the self-correcting ow deeply an anaesthetist should sedate do the same. Efforts to improve reproduc- nature of the literature. “If independent discus- an elderly person before surgery is a ibility have so far focused on methods and sion authors find a fatal flaw, then we’ll have a controversial issue — some studies link results, and need to extend to inferences and bit of a problem. But it won’t be the first time,” Hstronger doses of anaesthetic with earlier deaths. conclusions, says John Ioannidis at Stanford says Hemmings. So it should reassure clinicians to see a study1 University, California, who is one of the The original paper’s lead author praises in the British Journal of Anaesthesia that inves- authors of the independent discussion and the approach. “We’re all biased and this gives tigates and rules out such a link — the paper’s an advocate for bet- a second pair of eyes,” says Frederick Sieber, a discussion section says so explicitly. ter reproducibility in “We’re all researcher in anaesthesiology and critical-care But another paper2 in the journal that dis- science. From simi- biased and this medicine at Johns Hopkins Bayview Medical cusses the clinical trial analyses the same results lar results, people gives a second Center in Baltimore, Maryland. -
Breaking the Germline Barrier in a Moral Vacuum
Accountability in Research Policies and Quality Assurance ISSN: 0898-9621 (Print) 1545-5815 (Online) Journal homepage: https://www.tandfonline.com/loi/gacr20 Breaking the germline barrier in a moral vacuum Sheldon Krimsky To cite this article: Sheldon Krimsky (2019): Breaking the germline barrier in a moral vacuum, Accountability in Research, DOI: 10.1080/08989621.2019.1644171 To link to this article: https://doi.org/10.1080/08989621.2019.1644171 Accepted author version posted online: 15 Jul 2019. Published online: 26 Jul 2019. Submit your article to this journal Article views: 37 View Crossmark data Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=gacr20 ACCOUNTABILITY IN RESEARCH https://doi.org/10.1080/08989621.2019.1644171 Breaking the germline barrier in a moral vacuum Sheldon Krimsky Department of Urban & Environmental Policy & Planning, Tufts University, Medford, MA, USA ABSTRACT KEYWORDS In November 2018 a Chinese scientist claimed to have used CRISPR/Cas9; gene editing; CRISPR/Cas 9 technology to genetically modify two human human embryos; AIDS; embryos that were then gestated in one adult woman through CCR5; HIV an IVF pregnancy and brought to term. The twin girls are allegedly the first babies born with their prenatal genomes edited. Using both English language and Chinese supporting documents, this paper discusses the background of this human experiment, the social context of Chinese science, and the alleged ethical transgressions of its principal scientist. Introduction The international science community was caught off guard in late November 2018 when Chinese scientist Dr. He Jiankui announced through the media that he had used CRISPR/Cas9 editing technology to modify the genes of two human embryos, which were subsequently implanted in a Chinese woman by IVF techniques and brought to term as fraternal twin girls. -
S Human Reproductive Cloning
9/15/2020 Cloning humans is technically possible. It's curious no one has tried - STAT 1 Human reproductive cloning: The curious incident of the dog in the night-time By Henry T. Greely February 21, 2020 Reprints2 Seven-month-old Dolly poses for photographs in 1997 at the University of Edinburgh's Roslin Institute, where she was cloned and raised. Paul Clements/AP Gregory: Is there any other point to which you would wish to draw my attention? Holmes: To the curious incident of the dog in the night-time. Gregory: The dog did nothing in the night-time. Holmes: That was the curious incident. — Arthur Conan Doyle, “The Adventure of Silver Blaze”3 Sometimes what doesn’t happen is as interesting as what does. Cloning human embryos has been possible for nearly seven years. Yet as far as I know, during that time no one has made a cloned baby or, apparently, has tried to make one. And what I find most surprising is that no one has announced they intend to make one. https://www.statnews.com/2020/02/21/human-reproductive-cloning-curious-incident-of-the-dog-in-the-night-time/ 1/7 9/15/2020 Cloning humans is technically possible. It's curious no one has tried - STAT Why is this surprising? Let’s go back almost 23 years to Feb. 23, 1997. On that day, news leaked out that the scientific journal Nature was about to publish a report of the birth of the first mammal cloned from adult cells — a sheep named Dolly4. -
Ethical Reflections on the Conditions Surrounding the First Genome-Edited Babies [Version 1; Peer Review: 2 Approved with Reservations]
Wellcome Open Research 2020, 5:216 Last updated: 04 AUG 2021 OPEN LETTER Making sense of it all: Ethical reflections on the conditions surrounding the first genome-edited babies [version 1; peer review: 2 approved with reservations] Qi Chen1, Yonghui Ma 1, G Owen Schaefer2, Vicki Xafis 2, Markus Labude2, Peter Mills 3 1Centre for Bioethics, Medical School, Xiamen University, Xiamen, 361102, China 2Centre for Biomedical Ethics, National University of Singapore, Singapore, 117597, Singapore 3Nuffield Council on Bioethics, London, WC1B 3JS, UK v1 First published: 16 Sep 2020, 5:216 Open Peer Review https://doi.org/10.12688/wellcomeopenres.16295.1 Latest published: 23 Jun 2021, 5:216 https://doi.org/10.12688/wellcomeopenres.16295.2 Reviewer Status Invited Reviewers Abstract In November 2018 the birth of the first genome-edited human beings 1 2 was announced. The ensuing ethical controversy, institutional investigations and legal proceedings led to the revision of standards, version 2 rules and procedures at many levels. Arguably, however, these (revision) report developments have not fundamentally changed the conditions or the 23 Jun 2021 culture that nourished He Jiankui’s vaulting ambition in the first place and enabled it to find expression. In this paper we explore the clinical, version 1 regulatory and societal circumstances of the ‘gene-edited baby’ case, 16 Sep 2020 report report the political, cultural and economic conditions that created a radical and dangerous climate for biotechnology innovation, and the responsibilities of the international research community, many of 1. Giulia Cavaliere , King's College London, whose members were apprised of Dr He’s intentions. -
Russian Biologist Plans More CRISPR-Edited Babies the Proposal Follows the Birth of Twins from Embryos Edited by a Chinese Scientist Last Year
NEWS IN FOCUS PALAEONTOLOGY French court CONSERVATION Largest plant ASTROPHYSICS The first map BIOLOGY Mouse lemurs are orders return of fossil survey reveals alarming of the Universe in high- getting a closer look from bounty to Brazil p.147 extinction rates p.148 energy X-rays p.149 geneticists p.151 Molecular biologist Denis Rebrikov is planning controversial gene-editing experiments in women diagnosed with HIV. GENE EDITING Russian biologist plans more CRISPR-edited babies The proposal follows the birth of twins from embryos edited by a Chinese scientist last year. BY DAVID CYRANOSKI gene-edited embryos into women, possibly into women who have been diagnosed with before the end of the year if he can get approval HIV, reducing the risk of them passing on Russian scientist says he is planning by then. Chinese scientist He Jiankui prompted the virus to the baby in utero. By contrast, He to produce gene-edited babies, an act an international outcry when he announced modified the gene in embryos from fathers that would make him only the second last November that he had made the world’s with HIV, which many geneticists said provided Aperson known to have done this. It would first gene-edited babies — twin girls. little clinical benefit because the risk of a father also fly in the face of the scientific consensus The experiment will target the same gene, passing on HIV to his children is minimal. that such experiments should be banned called CCR5, as He did, but Rebrikov claims Rebrikov heads a genome-editing lab at Rus- until an international ethical framework has his technique will offer greater benefits, pose sia’s largest fertility clinic, the Kulakov National been agreed on the circumstances and safety fewer risks and be more ethically acceptable to Medical Research Center for Obstetrics, Gyne- measures that would justify them. -
To the State Secretary for Infrastructure and Water Management Mrs S. Van Veldhoven-Van Der Meer P.O. Box 20901 2500 EX the Hague
To the state secretary for Infrastructure and Water Management Mrs S. van Veldhoven-van der Meer P.O. Box 20901 2500 EX The Hague DATE 31 January 2019 REFERENCE CGM/190131-02 SUBJECT Update to policy report ‘Editing human DNA’ Dear Mrs Van Veldhoven, At the end of November 2018 the Chinese scientist Dr He Jiankui claimed to have created the first gene-edited (GM) humans. The twin girls are said to have been born at the beginning of November and have an alteration to their DNA that can confer resistance to HIV. This announcement injected new urgency into the international debate about human genome editing. The news has been confirmed by the Chinese authorities. Using recent gene editing techniques such as CRISPR-Cas it is relatively simple and easy to make precisely targeted and specific alterations to DNA sequences.1 This opens up possibilities to alter human DNA sequences in such a way that these modifications are passed on to subsequent generations, for example to prevent genetic disorders. Human genome editing is prohibited by law in most countries, including the Netherlands, and the technology raises technical, legal and ethical issues. In 2017 COGEM and the Health Council of the Netherlands published a joint report on this topic.2 In this letter COGEM informs you about the developments that have taken place since that earlier report and revises its recommendations in the light of these developments. 1 Scientist claims to have created first gene-edited humans Earlier research in 2015 into gene editing of non-viable human embryos in the lab (in vitro) put the discussion about human genome editing onto the international agenda, although at the time clinical use seemed a long way off. -
HIV Cure Research Ethics Update Considerations for Cell and Gene Therapiesconsiderations for Cell and Gene Therapies
HIV Cure Research Ethics Update HIV Cure Research Ethics Update Considerations for Cell and Gene TherapiesConsiderations for Cell and Gene Therapies Karine Dubé, DrPH, UNC Gillings School of Global Public Health Michael Louella, defeatHIV Community Advisory Board 2019 Pre-CROI Community HIV Cure Research Workshop Sunday, March 3, 2019 What Happened with the Chinese Gene-Edited Babies? • He Jiankui, Assistant Professor South University of Science and Technology (China) • Use of CRISPR/Cas9 technology to edit genes for the HIV co-receptor CCR5 in human embryos for implementation • Public announcement at the Start of the Second He Jiankui International summit on Human Genome Editing (Hong Kong, November 2018) • Male partner HIV-positive à HIV-negative offspring • Led to birth of twins who were mutated for CCR5 genes Why Was This Event So Controversial? SOMATIC GERMLINE medicine He Jiankui’s HERAPY & research experiments T Plastic Designer surgery babies NHANCEMENT E How Did Our Community React? “TAG joins with the scientists and the ethicists who are condemning the work as unethical, unjustified, and potentially dangerous” – Richard Jefferys http://www.treatmentactiongroup.org/content/treatment-action-group-statement-reported-birth-twins-edited-ccr5-genes How Did the Risks Outweigh the Benefits? • There are safe, effective and easier options to prevent mother-to- child transmission and treat HIV • Alteration of germ line • Incomplete ability of CCR5 gene deletion to prevent HIV acquisition • Safety of experimenting with CRISPR/Cas-9 in human -
Ethics of Genome Editing
#EthicsGroup_EU Ethics of Genome Editing European Group on Ethics in Science and New Technologies Research and Innovation European Group on Ethics in Science and New Technologies Ethics of Genome Editing European Commission Directorate-General for Research and Innovation Unit 03 Contact Jim DRATWA Email [email protected] [email protected] European Commission B-1049 Brussels Manuscript completed in March 2021. The European Commission is not liable for any consequence stemming from the reuse of this publication. The contents of this opinion are the sole responsibility of the European Group on Ethics in Science and New Technologies (EGE). The views expressed in this document reflect the collective view of the EGE and may not in any circumstances be regarded as stating an official position of the European Commission. More information on the European Union is available on the internet (http://europa.eu). Print ISBN 978-92-76-30141-7 doi:10.2777/763 KI-01-21-062-EN-C PDF ISBN 978-92-76-30140-0 doi:10.2777/659034 KI-01-21-062-EN-N Luxembourg: Publications Office of the European Union, 2021 © European Union, 2021 The reuse policy of European Commission documents is implemented based on Commission Decision 2011/833/EU of 12 December 2011 on the reuse of Commission documents (OJ L 330, 14.12.2011, p. 39). Except otherwise noted, the reuse of this document is authorised under a Creative Commons Attribution 4.0 International (CC-BY 4.0) licence (https://creativecommons.org/licenses/by/4.0/). This means that reuse is allowed provided appropriate credit is given and any changes are indicated. -
Regulating Genome Editing Under International Human Rights Law
© The Author(s) 2020. Published by Cambridge University Press for the British Institute of International and Comparative Law. This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work. REGULATING GENOME EDITING UNDER INTERNATIONAL HUMAN RIGHTS LAW RUMIANA YOTOVA* Abstract This article offers a critical assessment of the role of international human rights law in the regulation of genome editing. Given the rapid scientific developments in the field of genetics, it is important to explore the implications of the human rights framework for the research into and the clinical application of genome editing. The broader normative question is whether the existing human rights standards are sufficient to address the challenges posed by this new technology. It will be argued that while international human rights law does not prohibit genome editing, it imposes important restrictions upon it. However, existing human rights are arguably insufficient to regulate germline genome editing as there are significant loopholes in the protection of embryos. Nor do they fully address the wide-ranging implications of the new technology for society and humankind. It will be suggested that new standards are needed, ideally set out in a new international instrument and supported by an institutional framework, which address the specific challenges posed by this new technology. -
Genetic Modification: the Ethical and Societal Implications of Crispr Technology
NYU SCHOOL OF MEDICINE HIGH SCHOOL BIOETHICS PROJECT GENETIC MODIFICATION: THE ETHICAL AND SOCIETAL IMPLICATIONS OF CRISPR TECHNOLOGY OVERVIEW CONTENTS This module aims to build an understanding 1. Key Terms of the moral and ethical implications of genetic 2. Introduction to the Topic modification, specifically regarding the use of 3. Goals and Applications of CRISPR CRISPR technology for germline (heritable) and 4. Problems with the Technology somatic (non heritable) genetic editing. The module 5. Ethical Concerns will incorporate a study of recent scientific 6. Recent Developments discoveries, breakthroughs, and controversies 7. References and Additional Resources through ethical and conceptual lenses. While 8. Concluding Assignment CRISPR has a variety of potential applications, this module explores the genetic modification of human LEARNING OUTCOMES DNA and the consequences of these edits. CRISPR is a technology adapted from a naturally 1. Gain a solid understanding of how CRISPR occurring genome editing system in bacteria that is technology functions. a more accurate, effective, and cost efficient way to 2. Learn the difference between germline and alter DNA than techniques used previously. It somatic editing. allows geneticists and medical researchers to edit 3. Be able to participate in thoughtful parts of the genome by removing, adding, or discussions regarding the ethical concerns altering parts of the DNA sequence. What is of genetic modification. CRISPR and how does it work? Why have 4. Come to a conclusion about how CRISPR scientists currently called for a moratorium on the technology should be regulated and/or clinical use of CRISPR for germline modification? controlled. What is the future of CRISPR, how will it be regulated, and how will it affect the world in which we live? This module will delve into these questions PROCEDURES AND ACTIVITIES and leave the classroom with a newfound understanding of the ethical implications behind the This module is a student led exploration of the use of this technology.