Designer Babies. Selected Law and Ethical Issues
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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. -
CRISPR and the Future of Fertility Innovation
Science and Technology Law Review Volume 23 Number 1 Article 3 2020 CRISPR and the Future of Fertility Innovation June R. Carbone University of Minnesota Law School, [email protected] Follow this and additional works at: https://scholar.smu.edu/scitech Part of the Health Law and Policy Commons, and the Science and Technology Law Commons Recommended Citation June R Carbone, CRISPR and the Future of Fertility Innovation, 23 SMU SCI. & TECH. L. REV. 31 (2020) https://scholar.smu.edu/scitech/vol23/iss1/3 This Article is brought to you for free and open access by the Law Journals at SMU Scholar. It has been accepted for inclusion in Science and Technology Law Review by an authorized administrator of SMU Scholar. For more information, please visit http://digitalrepository.smu.edu. CRISPR and the Future of Fertility Innovation June Carbone* In 2018, Dr. He Jiankui announced that he had used CRISPR, a gene- editing tool, to produce newborn twin girls with the gene for HIV resistance.1 The announcement caused a global uproar. Dr. He appeared to have tried the procedure without advance testing.2 He did so without assurance the proce- dure was safe; indeed, unintended side effects could affect not only the twins but the twins’ own offspring.3 And he did it to otherwise healthy embryos.4 While the twins risked exposure to the HIV virus their father carried, less risky treatments exist that reduce the risk of transmission.5 Dr. He also tried the technique without following appropriate Chinese protocols.6 As a result of the outcry that followed his announcement, use of the procedure in China has been effectively shut down.7 This leaves open the question: if CRISPR is to be used again in the reproductive context, how and why is it to occur? CRISPR creates new possibilities for genetic engineering, which alters a person’s—or an embryo’s—genetic inheritance in ways that alter the germline, in turn passing on the alterations to subsequent generations. -
CRISPR Technology; Advantages, Limitations and Future Direction
nd Ph l a arm Omodamilola and Ibrahim, J Biomed Pharm Sci 2018, 1:2 a a ic c d e e u m t i o c Journal of i a B l S f o c l i e a n n c r e u s o J Biomedical and Pharmaceutical Sciences Review Article Open Access CRISPR Technology: Advantages, Limitations and Future Direction Omoyayi Ibrahim Omodamilola* and Abdullahi Umar Ibrahim Department of Biomedical Engineering, Near East University, Mersin 10, Turkey Abstract The evolutionary discovery of CRIPRS technology has paved the way for researchers in various fields’ genetics, medicine, pharmacy and computer science. Its potential application is limitless spanning from therapy of disease such as cancer and immunotherapy with gene silencing, gene knock down, gene KO, to the food production of genetically modified foods, the potential possibility of genetically designing baby using CRSIPR technology with enhanced trait and potential of eradicating Malaria and HIV-AIDS. The review thereby focuses on Off-targets limitation of the technology which is explained as one of the major constraint for application in clinical procedure with its hope of eradication through machine learning (ML). Further application of crisper technology was also discussed. Keywords: CRISPR; Designer Baby; Machine Learning; Off Targets; of an adaptive immune system and the discovery of Cas9 and PAM by Gene Knock out Bolotin. The process where bacterial CRISPR transcribed a guide RNA and form CRISPR-Cas9 Complex which not only store a record of Introduction invading bacteriophages and other viral DNA but also to destroy the The word “smart” has been the recent trend in almost all viruses upon second attack [6]. -
1 Designer Babies
Designer Babies: The Ethical and Societal Effects Andy Kromer College of Saint Benedict/Saint John’s University April 17, 2018 It’s a process; It dates back to 12,000 BC when human beings started domesticating animals. Unknowingly, at the time, we participated in an act of science: genetic modification. It is a process in which humans influence the genes of another specie. Many believe this process is the same as genetic engineering; however, there is a difference. Genetic engineering is defined as the artificial modification or manipulation of an organism’s nucleic acids or DNA. The difference is the matter in which the genes are manipulated. Through genetic modification, natural changes are made to a specie, while through genetic engineering, tools or technologies are used to modify or manipulate a certain gene. The process of genetic engineering isn’t natural. This is a key component that set these two terms apart, but they are very similar nonetheless. Background: Genetic Engineering Genetic engineering was first introduced nearly fifty years ago by Herbert Boyer and Stanley Cohen. At first, this technology was used on plants to increase the yield values of certain farm crops. Undoubtedly, it has provided a great advancement in the economy. Brookes and Barfoot (2014) found that since the first significant amounts of genetically modified crops were planted in 1996, there has been more than one hundred and sixty-six billion dollars generated from the agriculture industry. The production levels have also increased substantially. The success of GMOs and genetic engineering has sparked curiosity in the United States. -
Are We Ready for Designer Babies? Analysis of Law, Policy and Ethics Surrounding Germline Genetic Engineering
MUMBAI SILICON VALLEY BANGALORE SINGAPORE MUMBAI BKC NEW DELHI MUNICH NEW YORK Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering Strategic, Legal, Tax and Ethical issues June 2019 © Copyright 2019 Nishith Desai Associates www.nishithdesai.com Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering Strategic, Legal, Tax and Ethical Issues June 2019 [email protected] DMS Code: No 480049v2 © Nishith Desai Associates 2019 Are we ready for Designer Babies? Analysis of law, policy and ethics surrounding germline genetic engineering About NDA At Nishith Desai Associates, we have earned the reputation of being Asia’s most Innovative Law Firm – and the go-to specialists for companies around the world, looking to conduct businesses in India and for Indian companies considering business expansion abroad. In fact, we have conceptualized and created a state-of-the-art Blue Sky Thinking and Research Campus, Imaginarium Aligunjan, an international institution dedicated to designing a premeditated future with an embedded strategic foresight capability. We are a research and strategy driven international firm with offices in Mumbai, Palo Alto (Silicon Valley), Bangalore, Singapore, New Delhi, Munich, and New York. Our team comprises of specialists who provide strategic advice on legal, regulatory, and tax related matters in an integrated manner basis key insights carefully culled from the allied industries. As an active participant in shaping India’s regulatory environment, we at NDA, have the expertise and more importantly – the VISION – to navigate its complexities. Our ongoing endeavors in conducting and facilitating original research in emerging areas of law has helped us develop unparalleled proficiency to anticipate legal obstacles, mitigate potential risks and identify new opportunities for our clients on a global scale. -
He Jiankui (贺建奎)Incident
The “He JianKui (贺建奎) Incident”: Summary of Facts and Concerns Olivia Ngan Post-doctoral Fellow CUHK Centre for Bioethics The Chinese University of Hong Kong CUHK Centre for Bioethics, Seminar on Germline Genome Editing 03.28.2019 1 2 Outline • Key events after He JianKui’s breaking the news of his work • Reaction and current consensus from the scientific community, professional society in germline genome editing 3 CRISPR Technology CRISPR is a simple yet powerful tool for editing genomes. It allow genetic material to be added, removed, or altered at particular locations in the genome. Potential applications include correcting genetic defects, treating and preventing the spread of diseases and improving crops. Timeline of “CRISPR-related events” Scientists showed that Produce customized dogs with CRISPR could be used to double the amount of muscle edit the genomes of mass by deleting a gene cultured mouse cells or human cells 2012 2014 2016 2013 2015 First monkeys engineered with CRISPR to edit targeted mutations the genes of using CRISPR various crops to make them CRISPR was discovered more nutritious 4 Timeline of “CRISPR-related events” • Gene editing in embryos intended for pregnancy has not previously been reported. • CRISPR is remarkably accurate at editing the genes that it is supposed to edit, but it can also cause off- target mutations. 2018 • No one has previously tried editing embryos that develop into humans, because the science is not yet precise enough to guarantee the results. 2018 • He shocked the world by making the world’s -
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. -
Pencil Template
www.xplora.org Xplora Thematic dossier: DNA by Alexa Joyce – [email protected] Every month, Xplora will release a new thematic dossier on an important topic in science, complete with background information, recommended resources, experiments, training opportunities and more. This month the focus is DNA – it includes top tips for extracting DNA from bananas, animations for illustrating key aspects and more. Until just over 50 years ago, nobody knew what deoxyribonucleic acid (DNA) was. Now, DNA is one of the hottest topics in science and hits the headlines every day. Researchers James Watson, Francis Crick, Maurice Wilkins and Rosalind Franklin each contributed essential work to discover this special molecule, which is found in the nucleus of every living cell. DNA is the template for cells to produce the proteins and other molecules that make the cell machinery work smoothly. Without DNA, no cells would even exist, whether plants, animals or humans. Profiling the DNA of an organism helps us to understand how it works, by getting an insight into the kinds of proteins that the organism builds and uses. It can also help to understand disease, by comparing healthy genes with those that cause health problems. However DNA profiling techniques will challenge our society in new ways. For instance, if a DNA profile shows that a patient will die young because of a disease, should the patient be informed? And who else should receive DNA profile information – for instance the police, health insurance companies or others? DNA profiles could encourage discrimination – a company boss might reject a new applicant for a job if she has a gene for mental illness, even if the person has never suffered from the problem. -
Is Germline Gene Editing Exceptional?
William & Mary Law School William & Mary Law School Scholarship Repository Faculty Publications Faculty and Deans 2021 Is Germline Gene Editing Exceptional? Myrisha S. Lewis William & Mary Law School, [email protected] Follow this and additional works at: https://scholarship.law.wm.edu/facpubs Part of the Bioethics and Medical Ethics Commons, Food and Drug Law Commons, Health Law and Policy Commons, and the Science and Technology Law Commons Repository Citation Lewis, Myrisha S., "Is Germline Gene Editing Exceptional?" (2021). Faculty Publications. 2028. https://scholarship.law.wm.edu/facpubs/2028 Copyright c 2021 by the authors. This article is brought to you by the William & Mary Law School Scholarship Repository. https://scholarship.law.wm.edu/facpubs Is Germline Gene Editing Exceptional? Myrisha S. Lewis' Advances in gene editing have recently received significantscientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable,gene editinggenerates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross. ThisArticle addressesseveral interrelatedethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, ifgermline gene editing needs to be regulated, whether it can be regulated under existing law. Ultimately, this Article finds thatgermline gene editing should and can be regulated under existing law; however, the currentfederal-centric regime is not the optimal way to regulate this subset ofgene editing. -
Science and Bioethics of CRISPR-Cas9 Gene Editing: an Analysis Towards Separating Facts and Fiction
YALE JOURNAL OF BIOLOGY AND MEDICINE 90 (2017), pp.625-634. Review Science and Bioethics of CRISPR-Cas9 Gene Editing: An Analysis Towards Separating Facts and Fiction Adam P. Cribbsa,c,* and Sumeth M. W. Pererab,c aComputational Genomics and Training Centre (CGAT), MRC Weatherall Institute of Molecular Medicine, University of Oxford, John Radcliffe Hospital, Headington, Oxford, UK;b Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK; cCampion Hall, Oxford, UK Since its emergence in 2012, the genome editing technique known as CRISPR-Cas9 and its scientific use have rapidly expanded globally within a very short period of time. The technique consists of using an RNA guide molecule to bind to complementary DNA sequences, which simultaneously recruits the endonuclease Cas9 to introduce double-stranded breaks in the target DNA. The resulting double- stranded break is then repaired, allowing modification or removal of specific DNA bases. The technique has gained momentum in the laboratory because it is cheap, quick, and easy to use. Moreover, it is also being applied in vivo to generate more complex animal model systems. Such use of genome editing has proven to be highly effective and warrants a potential therapy for both genetic and non-genetic diseases. Although genome editing has the potential to be a transformative therapy for patients it is still in its infancy. Consequently, the legal and ethical frameworks are yet to be fully discussed and will be an increasingly important topic as the technology moves towards more contentious issues such as modification of the germline. Here, we review a number of scientific and ethical issues which may potentially influence the development of both the technology and its use in the clinical setting.