{"id":642650,"date":"2024-10-26T19:50:01","date_gmt":"2024-10-26T16:50:01","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/south-africa-has-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing\/"},"modified":"2024-10-26T19:50:01","modified_gmt":"2024-10-26T16:50:01","slug":"south-africa-has-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/south-africa-has-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing\/","title":{"rendered":"#South Africa has amended its research guidelines to allow for heritable human genome editing"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a3f97a829126\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #dd3333;color:#dd3333\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #dd3333;color:#dd3333\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a3f97a829126\" checked aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/buradabiliyorum.com\/en\/south-africa-has-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing\/#Controversial_research\" >Controversial research<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/buradabiliyorum.com\/en\/south-africa-has-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing\/#New_criteria\" >New criteria<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/buradabiliyorum.com\/en\/south-africa-has-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing\/#Alignment_with_the_law\" >Alignment with the law<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/buradabiliyorum.com\/en\/south-africa-has-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing\/#Ethical_concerns\" >Ethical concerns<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/buradabiliyorum.com\/en\/south-africa-has-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing\/#Implications_for_future_research\" >Implications for future research<\/a><\/li><\/ul><\/nav><\/div>\n<div>\n<div class=\"article-gallery lightGallery\">\n<div data-thumb=\"https:\/\/scx1.b-cdn.net\/csz\/news\/tmb\/2024\/gene-editing-2.jpg\" data-src=\"https:\/\/scx2.b-cdn.net\/gfx\/news\/hires\/2024\/gene-editing-2.jpg\" data-sub-html=\"Credit: Unsplash\/CC0 Public Domain\">\n<figure class=\"article-img\">\n            <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/scx1.b-cdn.net\/csz\/news\/800a\/2024\/gene-editing-2.jpg\" alt=\"gene-editing\" title=\"Credit: Unsplash\/CC0 Public Domain\" width=\"800\" height=\"450\"\/><figcaption class=\"text-darken text-low-up text-truncate-js text-truncate mt-3\">\n                Credit: Unsplash\/CC0 Public Domain<br \/>\n            <\/figcaption><\/figure>\n<\/p><\/div>\n<\/div>\n<p>A little-noticed change to <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.health.gov.za\/wp-content\/uploads\/2024\/05\/NDoH-2024-Health-Research-Guidelines-3rdEdition-v0.1.pdf\">South Africa&#8217;s national health research guidelines<\/a>, published in May of this year, has put the country on an ethical precipice. The newly added language <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/download-scripts-themes-apps\/\" data-internallinksmanager029f6b8e52c=\"9\" title=\"Download Scripts &amp; Themes &amp; Apps\" target=\"_blank\" rel=\"noopener\">app<\/a>ears to position the country as the first to explicitly permit the use of genome editing to create genetically modified children.<\/p>\n<p>                                                                                                                                    Heritable human genome editing has long been <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/doi.org\/10.1038\/519410a\">hotly contested<\/a>, in large part because of its <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/doi.org\/10.1016\/j.tibtech.2019.12.022\">societal and eugenic implications<\/a>. As experts on the global policy landscape who have observed the high stakes and ongoing controversies over this <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/technology\/\" data-internallinksmanager029f6b8e52c=\"4\" title=\"Technology\" target=\"_blank\" rel=\"noopener\">technology<\/a>\u2014one from an academic standpoint (Fran\u00e7oise Baylis) and one from public interest advocacy (Katie Hasson)\u2014we find it surprising that South Africa plans to facilitate this type of research.<\/p>\n<p>In November 2018, the <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/social-mediaa\/\" data-internallinksmanager029f6b8e52c=\"1\" title=\"Social Media\" target=\"_blank\" rel=\"noopener\">media<\/a> reported on a <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/impactethics.ca\/2018\/11\/26\/first-crispr-babies-where-are-our-ethics\/\">Chinese scientist who had created the world&#8217;s first gene-edited babies<\/a> using CRISPR technology. He said his goal was to <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.science.org\/content\/article\/crispr-bombshell-chinese-researcher-claims-have-created-gene-edited-twins\">provide children with resistance to HIV<\/a>, the virus that causes AIDS. When his experiment became public knowledge, twin girls had already been born and a third child was born the following year.<\/p>\n<p>The fate of these three children, and whether they have experienced any negative long-term consequences from the embryonic genome editing, remains a closely guarded secret.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Controversial_research\"><\/span>Controversial research<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/issues.org\/how-should-science-respond-to-crisprd-babies\/\">Considerable criticism<\/a> followed the original birth announcement. Some argued that genetically modifying embryos to alter the traits of future children and generations <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.sciencenews.org\/article\/chinese-scientists-raise-ethical-questions-first-crispr-gene-edited-babies\">should never be done<\/a>.<\/p>\n<p>Many pointed out that the rationale in this case was medically unconvincing\u2014and indeed that <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/doi.org\/10.1016\/j.tibtech.2019.12.022\">safe reproductive procedures to avoid transmitting genetic diseases are already in widespread use<\/a>, belying the justification typically given for heritable human genome editing. Others condemned his secretive approach, as well as the absence of any robust public consultation, considered a prerequisite for embarking on such a socially consequential path.<\/p>\n<p>In the immediate aftermath of the 2018 revelation, the organizing committee of the Second International Summit on Human Genome Editing joined the global uproar with a <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.nationalacademies.org\/news\/2018\/11\/statement-by-the-organizing-committee-of-the-second-international-summit-on-human-genome-editing\">statement condemning this research<\/a>.<\/p>\n<p>At the same time, however, the committee called for a &#8220;responsible translational pathway&#8221; toward clinical research. Safety thresholds and &#8220;additional criteria&#8221; would have to be met, including &#8220;independent oversight, a compelling medical need, an absence of reasonable alternatives, a plan for long-term follow-up, and attention to societal effects.&#8221;<\/p>\n<p>Notably, the additional criteria no longer included the earlier standard of &#8220;<a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.nationalacademies.org\/news\/2015\/12\/on-human-gene-editing-international-summit-statement\">broad societal consensus<\/a>.&#8221;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"New_criteria\"><\/span>New criteria<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Now, it appears that South Africa has amended its <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.health.gov.za\/wp-content\/uploads\/2024\/05\/NDoH-2024-Health-Research-Guidelines-3rdEdition-v0.1.pdf\">Ethics in Health Research Guidelines<\/a> to explicitly envisage research that would result in the birth of gene-edited babies.<\/p>\n<p>Section 4.3.2 of the guidelines on &#8220;Heritable Human Genome Editing&#8221; includes a few brief and rather vague paragraphs enumerating the following criteria: (a) scientific and medical justification; (b) transparency and informed consent; (c) stringent ethical oversight; (d) ongoing ethical evaluation and adaptation; (e) safety and efficacy; (f) long-term monitoring; and (g) legal compliance.<\/p>\n<p>While these criteria seem to be in line with those laid out in the 2018 summit statement, they are far less stringent than the frameworks put forth in subsequent reports. This includes, for example, the World Health Organization&#8217;s report <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.who.int\/publications\/i\/item\/9789240030060\">Human Genome Editing: Framework for Governance<\/a> (co-authored by Fran\u00e7oise Baylis).<\/p>\n<figure class=\"mb-4\" itemscope=\"\" itemtype=\"http:\/\/schema.org\/VideoObject\">\n    <meta itemprop=\"name\" content=\"South Africa amended its research guidelines to allow for heritable human genome editing\"\/><br \/>\n    <meta itemprop=\"url\" content=\"https:\/\/www.youtube.com\/watch\/?v=XAhFoaT6Kik\"\/><br \/>\n    <meta itemprop=\"description\" content=\"Nobel laureate David Baltimore, chair of the organizing committee for the Second International Summit on Human Genome Editing, talks about the importance of public global dialogue on gene editing.\"\/><br \/>\n    <meta itemprop=\"uploadDate\" content=\"2024-10-25T06:12:52-04:00\"\/><br \/>\n        <meta itemprop=\"embedUrl\" content=\"https:\/\/www.youtube.com\/embed\/XAhFoaT6Kik\"\/><br \/>\n    <meta itemprop=\"thumbnailUrl\" content=\"https:\/\/img.youtube.com\/vi\/XAhFoaT6Kik\/maxresdefault.jpg\"\/><\/p>\n<p>             <iframe loading=\"lazy\" title=\"Second International Summit on Human Genome Editing - David Baltimore\" width=\"640\" height=\"360\" src=\"https:\/\/www.youtube.com\/embed\/XAhFoaT6Kik?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><figcaption class=\"text-darken text-low-up mt-4\" itemprop=\"caption\">Nobel laureate David Baltimore, chair of the organizing committee for the Second International Summit on Human Genome Editing, talks about the importance of public global dialogue on gene editing.<\/figcaption><\/figure>\n<h2><span class=\"ez-toc-section\" id=\"Alignment_with_the_law\"><\/span>Alignment with the law<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Further, there is a significant problem with the seemingly permissive stance on heritable human genome editing entrenched in these research guidelines. The guidelines clearly require the research to comply with all laws governing heritable human genome research. Yet, the law and the research guidelines in South Africa are not aligned, which entails a significant inhibition on any possible research.<\/p>\n<p>This is because of a stipulation in section 57(1) of the <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.gov.za\/sites\/default\/files\/gcis_document\/201409\/a61-03.pdf\">South African National Health Act 2004<\/a> on the &#8220;Prohibition of reproductive cloning of human beings.&#8221; This stipulates that a &#8220;person may not manipulate any genetic material, including genetic material of human <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/game\/\" data-internallinksmanager029f6b8e52c=\"7\" title=\"Game\" target=\"_blank\" rel=\"noopener\">game<\/a>tes, zygotes, or embryos\u2026 for the purpose of the reproductive cloning of a human being.&#8221;<\/p>\n<p>When this act came into force in 2004, it was not yet possible to genetically modify human embryos and so it&#8217;s not surprising there&#8217;s no specific reference to this technology. Yet the statutory language is clearly wide enough to encompass it. The objection to the manipulation of human genetic material is therefore clear, and imposes a prohibition on heritable human genome editing.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Ethical_concerns\"><\/span>Ethical concerns<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>The question that concerns us is: Why are South Africa&#8217;s ethical guidelines on research apparently pushing the envelope with heritable human genome editing?<\/p>\n<p>In 2020, we published alongside our colleagues a global review of <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/doi.org\/10.1089\/crispr.2020.0082\">policies on research involving heritable human genome editing<\/a>. At the time, we identified policy documents\u2014legislation, regulations, guidelines, codes and international treaties\u2014prohibiting heritable genome editing in more than 70 countries. We found no policy documents that explicitly permitted heritable human genome editing.<\/p>\n<p>It&#8217;s easy to understand why some of South Africa&#8217;s ethicists might be disposed to clear the way for somatic human genome editing research. Recently, <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/doi.org\/10.1080\/23294515.2020.1818876\">an effective treatment for sickle cell disease has been developed using genome editing technology<\/a>. Many children die of this disease before the age of five and somatic genome editing\u2014which does not involve the genetic modification of embryos\u2014promises a cure.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Implications_for_future_research\"><\/span>Implications for future research<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>But that&#8217;s not what this is about. So, what is the interest in forging a path for research on heritable human genome editing, which involves the genetic modification of embryos and has implications for subsequent generations? And why the seemingly quiet modification of the guidelines?<\/p>\n<p>How many people in South Africa are aware that they&#8217;ve just become the only country in the world with research guidelines that envisage accommodating a highly contested technology? Has careful attention been given to <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.hup.harvard.edu\/books\/9780674976719\">the myriad potential harms<\/a> associated with this use of CRISPR technology, including harms to women, prospective parents, children, society and the gene pool?<\/p>\n<p>Is it plausible that scientists from other countries, who are interested in this area of research, are patiently waiting in the wings to see whether the law in South Africa prohibiting the manipulation of human genetic material will be an insufficient impediment to creating genetically modified children? Should the research guidelines be amended to accord with the 2004 statutory prohibition?<\/p>\n<p>Or if, instead, the law is brought into line with the guidelines, would the result be a wave of scientific tourism with labs moving to South Africa to take advantage of permissive research guidelines and laws?<\/p>\n<p>We hope the questions we ask are alarmist, as now is the time to ask and answer these questions.<\/p>\n<div class=\"d-inline-block text-medium my-4\">\n                                                Provided by<br \/>\n                                                                                                    The Conversation<br \/>\n                                                                                                        <a rel=\"nofollow noopener\" target=\"_blank\" class=\"icon_open\" href=\"https:\/\/theconversation.com\"><br \/>\n                                                        <svg>\n                                                            <use href=\"https:\/\/medx.b-cdn.net\/tmpl\/v6\/img\/svg\/sprite.svg#icon_open\" x=\"0\" y=\"0\"\/>\n                                                        <\/svg><br \/>\n                                                    <\/a><\/p><\/div>\n<p class=\"article-main__note mt-4\">\n                                                This article is republished from <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/theconversation.com\">The Conversation<\/a> under a Creative Commons license. Read the <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/theconversation.com\/south-africa-amended-its-research-guidelines-to-allow-for-heritable-human-genome-editing-241136\">original article<\/a>.<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/counter.theconversation.com\/content\/241136\/count.gif?distributor=republish-lightbox-advanced\" alt=\"The Conversation\" width=\"1\" height=\"1\"\/>\n                                            <\/p>\n<p>                                        <!-- print only --><\/p>\n<div class=\"d-none d-print-block\">\n<p>                                                 <strong>Citation<\/strong>:<br \/>\n                                                 South Africa has amended its research guidelines to allow for heritable human genome editing (2024, October 26)<br \/>\n                                                 retrieved 26 October 2024<br \/>\n                                                 from https:\/\/medicalxpress.com\/<a href=\"https:\/\/buradabiliyorum.com\/en\/category\/news\/\" data-internallinksmanager029f6b8e52c=\"2\" title=\"News\" target=\"_blank\" rel=\"noopener\">news<\/a>\/2024-10-south-africa-amended-guidelines-heritable.html<\/p>\n<p>                                            This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no<br \/>\n                                            part may be reproduced without the written permission. The content is provided for information purposes only.<\/p><\/div>\n<\/p><\/div>\n<p><script id=\"facebook-jssdk\" async=\"\" src=\"https:\/\/connect.facebook.net\/en_US\/sdk.js\"><\/script><\/p>\n<blockquote><p><strong><span style=\"color: #ff6600;\">If you liked the article, do not forget to share it with your friends. Follow us on\u00a0<span style=\"color: #ff0000;\"><a style=\"color: #ff0000;\" href=\"https:\/\/news.google.com\/publications\/CAAqBwgKMN63nwsw68G3Aw\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Google News<\/a><\/span>\u00a0too, click on the star and choose us from your favorites.<\/span><\/strong><\/p><\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\"><strong>If you want to read more Like this articles, you can visit our <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/en.buradabiliyorum.com\/sciencee\/\" target=\"_blank\" rel=\"noopener\">Science category.<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<p><span style=\"color: black;\"><a style=\"color: #ff9900;\" href=\"https:\/\/medicalxpress.com\/news\/2024-10-south-africa-amended-guidelines-heritable.html\" target=\"_blank\" rel=\"noopener\">Source<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Credit: Unsplash\/CC0 Public Domain A little-noticed change to South Africa&#8217;s national health research guidelines, published in May of this year, has put the country on an ethical precipice. The newly added language appears to position the country as the first to explicitly permit the use of genome editing to create genetically modified children. Heritable human&#8230;<\/p>\n","protected":false},"author":1,"featured_media":642651,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/scx2.b-cdn.net\/gfx\/news\/hires\/2024\/gene-editing-2.jpg","fifu_image_alt":"","footnotes":""},"categories":[16],"tags":[],"class_list":["post-642650","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sciencee"],"_links":{"self":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/642650","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/comments?post=642650"}],"version-history":[{"count":0,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/642650\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media\/642651"}],"wp:attachment":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media?parent=642650"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/categories?post=642650"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/tags?post=642650"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}