tag:theconversation.com,2011:/uk/topics/human-embryos-23051/articlesHuman embryos – The Conversation2024-03-11T12:24:14Ztag:theconversation.com,2011:article/2251262024-03-11T12:24:14Z2024-03-11T12:24:14ZI’m a political scientist, and the Alabama Supreme Court’s IVF ruling turned me into a reproductive-rights refugee<figure><img src="https://images.theconversation.com/files/580509/original/file-20240307-26-mc43ro.jpg?ixlib=rb-1.1.0&rect=1095%2C1199%2C1403%2C1892&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Spencer and Gabby Goidel hadn't planned to become activists.</span> <span class="attribution"><span class="source">Spencer and Gabby Goidel</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span></figcaption></figure><p>The day before the Alabama Supreme Court ruled that <a href="https://apnews.com/article/alabama-supreme-court-from-embryos-161390f0758b04a7638e2ddea20df7ca">frozen embryos created and used for in vitro fertilization</a> are children, my wife, Gabby, and I were greenlighted by our doctors to begin the IVF process. We live in Alabama.</p>
<p>That Friday evening, Feb. 16, 2024, unaware of the ruling, Gabby started taking her stimulation medications, worth roughly US$4,000 in total. We didn’t hear about the decision until Sunday morning, Feb. 18. By then, she had taken four injections – or two doses – of each of the stimulation medications.</p>
<p>For those who don’t know, the <a href="https://theconversation.com/what-is-ivf-a-nurse-explains-the-evolving-science-and-legality-of-in-vitro-fertilization-224476">IVF process is a winding journey</a> full of tests, bloodwork and bills. An IVF patient takes hormones for eight to 14 days to stimulate their ovaries to produce many mature eggs. The mature eggs are then retrieved via a minor surgical procedure and fertilized with sperm in a lab. The newly created embryos are monitored, sometimes biopsied and frozen for genetic testing, and then implanted, usually one at a time, in the uterus. From injection to implantation, one round of IVF takes four to eight weeks. </p>
<p>IVF can be as stressful as it is exciting. However, the potential of having a successful pregnancy and our own child at the end of the process, we hoped, would make it all worth it. The decision by the Alabama Supreme Court threw our dreams up in the air.</p>
<p>I <a href="https://scholar.google.com/citations?user=ow6DhIQAAAAJ&hl=en&oi=ao">study politics</a> – I don’t practice it. I’m not involved in state or local government. I’m a scholar, not an activist or an advocate. But now one of the most intimate, personal events of our lives had been turned into a political event by the state’s highest court. As a result, I became something else, too, which I had not been before: an activist.</p>
<h2>Making sense of the ruling</h2>
<p>Throughout the process of creating, growing and testing embryos in a lab, as many as <a href="https://www.illumefertility.com/fertility-blog/ivf-attrition-rate">50% to 70%</a> of embryos <a href="https://theconversation.com/most-human-embryos-naturally-die-after-conception-restrictive-abortion-laws-fail-to-take-this-embryo-loss-into-account-187904">can be lost</a>. Similarly, in the preimplantation stage of natural pregnancies, <a href="https://doi.org/10.12688%2Ff1000research.22655.1">many embryos don’t survive</a>.</p>
<p>If embryos are children, as the court ruled, then fertility clinics and patients would be exposed to an immense amount of potential legal liability. Under this new framework, patients would be able to bring wrongful death suits against doctors for the normal failures of embryos in the testing or implantation phase. Doctors would either have to charge more for an already expensive procedure to cover massive legal-insurance costs or avoid IVF altogether.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/580233/original/file-20240306-30-vi57hp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A screen shows a microscope's view of a needle and cells." src="https://images.theconversation.com/files/580233/original/file-20240306-30-vi57hp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/580233/original/file-20240306-30-vi57hp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/580233/original/file-20240306-30-vi57hp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/580233/original/file-20240306-30-vi57hp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/580233/original/file-20240306-30-vi57hp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/580233/original/file-20240306-30-vi57hp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/580233/original/file-20240306-30-vi57hp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Lab staff at an in vitro fertilization lab extract cells from embryos that are then checked for viability.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/FrozenEmbryos/ebbb52ebd68b4ab691798f90b3319f05/photo">AP Photo/Michael Wyke</a></span>
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<p>The decision and its implication – that IVF could not continue in the state of Alabama – felt like a personal affront to us. We were infuriated to have this uncertainty injected into the process three days into injecting IVF medication. </p>
<p>While the decision clearly imperiled the future of IVF in Alabama, it was not clear to us whether we would be allowed to continue the process we had begun. We were left completely in the dark for the next four days. Gabby and I had no choice but to continue daily life and IVF as though nothing was happening. </p>
<p>For me, that meant teaching my <a href="https://bulletin.auburn.edu/coursesofinstruction/poli/">political participation course at Auburn University</a>.</p>
<h2>Teaching politics when it gets personal</h2>
<p>I’ll never forget walking into class on Monday, Feb. 19, and telling the students about the court’s ruling and how it – maybe? – was going to jeopardize Gabby’s and my IVF process. </p>
<p>Before starting IVF, Gabby and I had gone through three miscarriages together.</p>
<p>IVF doesn’t always work. Approximately <a href="https://nccd.cdc.gov/drh_art/rdPage.aspx?rdReport=DRH_ART.ClinicInfo&rdRequestForward=True&ClinicId=9999&ShowNational=1">55% of IVF patients</a> under the age of 35 – Gabby is 26 – have a successful pregnancy after one egg retrieval. We couldn’t imagine the pain of telling friends and family that our attempt at having a child had once again failed. So we had agreed we were going to tell as few people as possible about starting IVF. </p>
<p>Yet, here I was now, telling my entire class what we were going through and how the Alabama Supreme Court ruling could affect us. </p>
<p>I wasn’t alone in sharing our story. The night before my Monday morning class, Gabby published an <a href="https://www.al.com/opinion/2024/02/guest-opinion-alabama-supreme-court-embryo-ruling-may-make-it-difficult-for-us-to-have-children.html">opinion column</a> on our local news site about the ruling and our resulting fears and anxieties, which really resonated with people.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Clear batches of containers of eggs and embryos in a large, frozen circular container" src="https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=360&fit=crop&dpr=1 600w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=360&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=360&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=452&fit=crop&dpr=1 754w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=452&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=452&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Cryopreservation gives prospective parents more time to pursue pregnancy.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/frozen-embryos-and-eggs-in-nitrogen-cooled-royalty-free-image/520157312">Ted Horowitz Photography/The Image Bank via Getty Images</a></span>
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<p>I was, that day and throughout the next few weeks, fixated on the conceptual gulf between the court’s ruling and public opinion. I wondered aloud, “Who’s against IVF? Surely, only 5% to 10% of the public agrees with this ruling.”</p>
<p>The actual numbers aren’t far off my in-class guess. <a href="https://d3nkl3psvxxpe9.cloudfront.net/documents/econTabReport_XLG2Z6p.pdf">Only 8% of Americans</a> say that IVF is immoral or should be illegal. But the story is more nuanced than that. Approximately <a href="https://www.ipsos.com/sites/default/files/ct/news/documents/2024-02/Axios%20Ipsos%20Alabama%20IVF%20Topline%20PDF%202.28.24.pdf">31% of Americans and 49% of Republicans</a> support “considering frozen embryos as people and holding those who destroy them legally responsible.” </p>
<p>In an attempt to tie our personal political experience into the class topic, I remarked that this court decision was a surefire way to get people involved in politics. I had no clue at the time how prophetic my comment would be.</p>
<h2>Fleeing to Texas for reproductive rights?</h2>
<p>On Wednesday, Feb. 21, the <a href="https://www.al.com/news/2024/02/uab-pauses-in-vitro-fertilization-due-to-fear-of-prosecution-officials-say.html">University of Alabama Birmingham’s fertility clinic</a> paused IVF treatments. That wasn’t our clinic, but the move sent us into a total panic. Our clinic’s closure seemed inevitable – and within 24 hours <a href="https://www.nbcnews.com/health/health-news/university-alabama-pauses-ivf-services-court-rules-embryos-are-childre-rcna139846">it had paused IVF treatments as well</a>. </p>
<p>We didn’t know what we were going to do, but we knew we were likely leaving the state to continue IVF. I needed to tell my department chair what was going on.</p>
<p>I was walking out of my department chair’s office when my phone rang. Gabby told me, “We got in, we’re going to Temple.” I ran back into my department chair’s office, told her we were going to Temple, Texas, and then rushed home. </p>
<p><a href="https://www.cnn.com/2024/02/22/us/alabama-embryos-ruling-ivf-treatment-leaving-state/index.html">A reporter from CNN</a> beat me there. It was one of <a href="https://www.washingtonpost.com/nation/2024/02/24/alabama-ivf-treatment-ruling-abortion/">several</a> <a href="https://www.nbcnews.com/health/health-news/ivf-doctors-patients-fearful-alabama-court-rules-embryos-are-children-rcna139636">interviews</a> with <a href="https://apnews.com/video/alabama-assisted-reproductive-technology-courts-legislation-gabby-goidel-8990ee5efaab450b940da1e6a39bf8d1">major</a> <a href="https://www.msnbc.com/katy-tur/watch/-thoughtless-ivf-patients-speak-out-on-alabama-embryo-decision-204655173631">media</a> <a href="https://www.theguardian.com/us-news/2024/feb/22/alabama-fertility-pause-ivf-embryo-ruling">outlets</a> Gabby did in the wake of her opinion column. After the interview, we threw clothes in a suitcase, dropped our dogs off at the vet and drove to the Atlanta airport. We flew to Texas that night.</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/9MCbgW7i2I0?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">One of the Goidels’ many media interviews in the wake of the Alabama ruling.</span></figcaption>
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<p>The thought of not completing the egg retrieval never seriously entered our minds. We were confident that we could get in with another IVF clinic somewhere, anywhere. But we’re affluent. We’re privileged. What if we weren’t so well off? We wouldn’t have wanted to give up, but we wouldn’t have been able to afford the fight.</p>
<p>We spent exactly one week at my parents’ house in Texas. Thankfully, my parents live an hour and a half away from the Temple clinic. We met our new doctor, <a href="https://www.bswhealth.com/physician/gordon-bates">Dr. Gordon Wright Bates</a>, and were immediately reassured. His cool expertise and confidence were calming to a stressed-out couple. The Alabama Supreme Court may have upended our lives, but we felt weirdly lucky to be in such a comfortable place.</p>
<p>The egg retrieval was Wednesday morning, Feb. 28. By all indications, it went well. IVF, however, is full of uncertainties. Now we are waiting on the results from preimplantation genetic testing. After that, there’s implantation and hoping the embryo continues to grow. We’re not in the clear: IVF is a stressful process even without a state court getting in the way. But today we are in a situation more like an average couple going through IVF than we have been in the past few weeks.</p>
<p>Late Wednesday night, March 6, <a href="https://www.nytimes.com/2024/03/06/us/politics/alabama-ivf-law.html">Alabama Gov. Kay Ivey signed into law a bill</a> providing legal protection to IVF clinics in the state. Gabby and I rejoiced at the news. Hopefully, we’re the last Alabamian couple to flee the state for IVF.</p>
<h2>A mobilizing moment</h2>
<p>When state politics directly interferes with your life, it feels like a gut punch, as if the community that you love is saying you’re not loved back. It’s easy to see how such an experience could either discourage or motivate you. Research shows that traumatic events, for the most part, <a href="https://doi.org/10.1017/S0003055422001010">depress voter turnout</a> in the following presidential election. By contrast, families and friends of 9/11 victims <a href="https://doi.org/10.1073/pnas.1315043110">became and remained more politically engaged</a> than their peers. </p>
<p>In this case, the Alabama Supreme Court ruling mobilized Gabby and <a href="https://www.democracynow.org/2024/3/4/alabama_ivf_patients_warning_to_others">other</a> <a href="https://www.today.com/health/news/alabama-ivf-ruling-embryo-transfer-canceled-rcna140029">women</a> going through the IVF process. For better or worse, the women, couples and families mobilized by this decision will likely always be more engaged because of it.</p>
<p>“Oh, God,” I remarked to my dad, “we’re going to be activists now, aren’t we?”</p>
<p>“So?” he asked.</p>
<p>“No one likes activists,” I responded in jest. But if we’re going to have and raise the family we want, this is just the first of many decisions we’re going to make that someone’s not going to like.</p><img src="https://counter.theconversation.com/content/225126/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Spencer Goidel does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>I’m a scholar, not an activist or an advocate. But now one of the most intimate, personal events of our lives had been turned into a political event by the state’s highest court.Spencer Goidel, Assistant Professor of Political Science, Auburn UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2247212024-03-07T13:36:07Z2024-03-07T13:36:07ZWhat is a frozen embryo worth? Alabama’s IVF case reflects bigger questions over grieving and wrongful death laws<figure><img src="https://images.theconversation.com/files/579978/original/file-20240305-16-b0u7k5.jpg?ixlib=rb-1.1.0&rect=8%2C8%2C2986%2C1985&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">An embryologist uses a microscope to view an embryo, visible on a monitor.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/AlabamaFrozenEmbryos/e6f3454e8ba144ccadc7e0a21532fb6c/photo?Query=alabama%20supreme%20court&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=508&currentItemNo=22">AP Photo/Richard Drew, File</a></span></figcaption></figure><p>In the weeks since the Alabama Supreme Court held that <a href="https://thehill.com/homenews/state-watch/4477607-alabama-supreme-court-rules-frozen-embryos-are-children/">embryos are “unborn children</a>” under one state law, most attention has been focused on in vitro fertilization – whether the decision imperils parents’ attempts to create a family. On March 6, 2024, Gov. Kay Ivey signed legislation to <a href="https://apnews.com/article/alabama-ivf-frozen-embryos-ruling-cab8171e80c88a088778dc7a187b7b5a">shield IVF providers from legal liability</a>, though the new law does not address frozen embryos’ legal status.</p>
<p>As <a href="https://health.usf.edu/publichealth/overviewcoph/faculty/katherine-drabiak">a health law professor</a>, I believe it’s also important to understand the laws that shaped the court’s decision: not only Alabama’s laws about “unborn children,” but wrongful death laws. This is a legal claim where family members can bring a civil lawsuit against a person who intentionally or carelessly caused the family member’s death, which is different from any criminal charges.</p>
<p>Over the past 100 years, laws have evolved to reflect a wider sense of what it means to lose a loved one, and how to “compensate” their family. Courts have been asked to interpret how wrongful death laws should apply to situations before a child is born.</p>
<h2>What happened in the clinic?</h2>
<p>The Alabama case, <a href="https://law.justia.com/cases/alabama/supreme-court/2024/sc-2022-0579.html">LePage v. Center for Reproductive Medicine</a>, was brought by three couples who had used IVF at a fertility clinic. They sued the clinic after a patient who wandered into the “cryogenic nursery,” where frozen embryos are stored, picked some up and accidentally dropped them on the floor, destroying them.</p>
<p>In the language of the court, this killed the embryos, since they might have developed into a healthy fetus if implanted in the uterus. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/580020/original/file-20240305-18-hv069o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A steel vat, with icy condensation inside, open to reveal white packets inside at the bottom of the container." src="https://images.theconversation.com/files/580020/original/file-20240305-18-hv069o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/580020/original/file-20240305-18-hv069o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=406&fit=crop&dpr=1 600w, https://images.theconversation.com/files/580020/original/file-20240305-18-hv069o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=406&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/580020/original/file-20240305-18-hv069o.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=406&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/580020/original/file-20240305-18-hv069o.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=510&fit=crop&dpr=1 754w, https://images.theconversation.com/files/580020/original/file-20240305-18-hv069o.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=510&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/580020/original/file-20240305-18-hv069o.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=510&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Containers holding frozen embryos and sperm are stored in liquid nitrogen at a fertility clinic in Fort Myers, Fla., in 2018.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/AlabamaFrozenEmbryos/25b27e79f3e14fb6910ff3de3ebc7dae/photo?Query=alabama%20supreme%20court&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=508&currentItemNo=32">AP Photo/Lynne Sladky, File</a></span>
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<p>The three sets of parents filed a lawsuit based on a claim for <a href="https://www.law.cornell.edu/wex/wrongful_death">wrongful death</a>. Like <a href="https://www.bu.edu/bulawreview/files/2020/03/LENS.pdf">about 40 other states</a>, Alabama allows parents to bring a claim for <a href="https://law.justia.com/codes/alabama/2022/title-6/chapter-5/article-22/section-6-5-391/">wrongful death</a> of an unborn child.</p>
<p>The court said the question in this case centered around whether the term “unborn child” in state laws only refers to an embryo or fetus in utero, or whether there is an “unwritten exception” for embryos that have not yet been transferred to the womb.</p>
<h2>The court’s decision</h2>
<p>Alabama Supreme Court cases in 2011 and 2012 had already held that the state’s wrongful death law <a href="https://casetext.com/case/mack-v-carmack">allows expectant parents to bring a claim</a> following a death at <a href="https://casetext.com/case/hamilton-v-scott-2">any stage of the embryo’s or fetus’s development</a>.</p>
<p>In addition, Alabama <a href="https://ballotpedia.org/Alabama_Amendment_2,_State_Abortion_Policy_Amendment_(2018)">amended its state constitution</a> in 2018 to affirm that public policy of the state should protect “the rights of the unborn child.”</p>
<p><a href="https://law.justia.com/cases/alabama/supreme-court/2024/sc-2022-0579.html">Combining the previous cases</a>, the state constitution and even dictionary definitions, the court said nothing in the current wrongful death law would exempt “extrauterine children – that is, unborn children who are located outside of a biological uterus at the time they are killed.”</p>
<p>This ruling does not mean that the parents won a wrongful death lawsuit, but that a court will be able to hear the parents’ claim for wrongful death.</p>
<h2>The legal ‘value’ of an embryo</h2>
<p>This is significant because in <a href="https://doi.org/10.1016/j.xfre.2020.06.007">other cases</a> where embryos were destroyed, the law generally has treated embryos as <a href="https://www.nbcnews.com/health/health-news/university-hospitals-fertility-clinic-faces-new-lawsuits-after-tank-failures-n962341">parents’ property</a>, or allege negligence by the clinic. Only a <a href="https://doi.org/10.1016/j.fertnstert.2022.12.038">handful of other states</a> – including Illinois, Missouri and Georgia – allow wrongful death lawsuits for embryos.</p>
<p>IVF <a href="https://www.nytimes.com/article/ivf-treatment-costs-guide.html">is a significant investment</a> of time and money, and involves a variety of <a href="https://www.mayoclinic.org/tests-procedures/in-vitro-fertilization/about/pac-20384716">medical risks</a>. In a case where fertility treatment goes wrong, couples could try to recoup those costs through civil lawsuits that sometimes treat frozen embryos as property.</p>
<p>However, that does not account for each embryo’s biological and emotional uniqueness. Before the Alabama ruling, other cases had tried to classify embryos as <a href="https://www.courthousenews.com/would-be-parents-want-embryos-deemed-people-after-clinic-meltdown/">living people</a> to signify their <a href="https://abcnews.go.com/US/families-sue-cleveland-clinic-malfunction-possibly-destroyed-embryos/story?id=53683517">irreplaceable value</a>. </p>
<p>Some <a href="https://vanderbiltlawreview.org/lawreview/2022/11/abortion-pregnancy-loss-subjective-fetal-personhood/">legal experts</a> assert that embryos only have “subjective and relational value.” In other words, only parents can decide whether or not they are important and have meaning.</p>
<p>Other <a href="https://contemporarythinkers.org/robert-george/book/embryo-defense-human-life/">experts suggest</a> that embryos have inherent value because they are each genetically distinct, unique human life at the earliest stage. They argue that allowing protection for some stages of human development but not others violates human rights principles.</p>
<h2>How wrongful death laws work</h2>
<p>How the value of an embryo is defined also shapes whether wrongful death laws would apply.</p>
<p>Wrongful death laws were originally designed to compensate family members for the loss of that person’s <a href="https://heinonline.org/HOL/Page?handle=hein.journals/wsulr5&div=17&g_sent=1&casa_token=&collection=journals">services and contributions</a>. Damages from a lawsuit could pay medical bills, funeral expenses and lost earnings from that person’s job, for example.</p>
<p>Each state has its own wrongful death law. <a href="https://www.bu.edu/bulawreview/files/2020/03/LENS.pdf">Since the 1850s</a>, these laws have allowed parents to bring claims to recover damages from a person who causes their child’s death. Initially, these laws were designed as an economic tool because parents expected their children to work.</p>
<p>Now, according to some <a href="https://www.bu.edu/bulawreview/files/2020/03/LENS.pdf">legal scholars</a>, many states recognize that losing a child means much more: a moral injury, pain and <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1286251">the anguish</a> from losing the child’s company and affection. Some states allow the family to <a href="https://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=2059&ChapterID=57">recover damages for suffering and grief</a> – recognizing a person’s inherent value, not only their economic value.</p>
<p><a href="https://casetext.com/case/stinnett-v-kennedy-1">Awarding damages</a> to a grieving family is meant to deter risky actions that could result in loss of life.</p>
<p>By the mid-1900s, courts began to allow wrongful death claims for children that died before birth as a result of another person’s negligence or carelessness. Some states specify that <a href="https://nebraskalegislature.gov/laws/statutes.php?statute=30-809">this includes at any stage of gestation</a>. </p>
<p>Some laws, including in <a href="https://nebraskalegislature.gov/laws/statutes.php?statute=30-809">Nebraska</a> and <a href="https://statutes.capitol.texas.gov/Docs/CP/htm/CP.71.htm#:%7E:text=71.003.,inside%20or%20outside%20this%20state.">Texas</a>, prevent families from suing the pregnant woman, or from suing her medical provider, if she opts to have a medical procedure that results in unintended fetal loss. Others specify that the law <a href="https://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=2059&ChapterID=57#:%7E:text=Whenever%20the%20death%20of%20a,then%20and%20in%20every%20such">does not apply</a> in cases of abortion. </p>
<h2>What the case means moving forward</h2>
<p>Some policymakers have <a href="https://time.com/6835548/lawmakers-ivf-embryos-alabama-legislation/">expressed concern</a> that Alabama’s decision “criminalizes” parents from trying to grow their family, or that they would face <a href="https://www.cnn.com/2024/02/27/us/ivf-ruling-impact-other-states/index.html">prosecution</a>. However, this is not accurate, since this case only relates to civil lawsuits, not criminal law.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/580222/original/file-20240306-28-lwkhnd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A woman in a long white sweater, holding a pink sign that says 'I just want to be a mom,' speaks with another blonde woman in a doctor's coat." src="https://images.theconversation.com/files/580222/original/file-20240306-28-lwkhnd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/580222/original/file-20240306-28-lwkhnd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=800&fit=crop&dpr=1 600w, https://images.theconversation.com/files/580222/original/file-20240306-28-lwkhnd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=800&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/580222/original/file-20240306-28-lwkhnd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=800&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/580222/original/file-20240306-28-lwkhnd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1005&fit=crop&dpr=1 754w, https://images.theconversation.com/files/580222/original/file-20240306-28-lwkhnd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1005&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/580222/original/file-20240306-28-lwkhnd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1005&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Patients and doctors gathered outside the Alabama Statehouse in Montgomery on Feb. 28, 2024, urging lawmakers to protect IVF services in the state.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/AlabamaIVFAffectedGroups/e3ec159eb74c437297b40e73d8835780/photo?Query=ivf&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=110&currentItemNo=4">Kim Chandler/AP</a></span>
</figcaption>
</figure>
<p>Nor does the decision prohibit using IVF. The Alabama attorney general has stated that he <a href="https://www.cnn.com/2024/02/23/us/alabama-ivf-embryos-supreme-court-ruling-legislation/index.html">does not intend</a> to use this decision to prosecute either parents or IVF providers. However, several fertility clinics announced that they would <a href="https://www.nytimes.com/2024/02/23/us/politics/alabama-ivf-treatment-law.html">pause their IVF services</a> while assessing the law.</p>
<p>Based on the U.S. Constitution, courts can only <a href="https://www.ncsl.org/about-state-legislatures/separation-of-powers-legislative-judicial-relations">interpret what the law is</a>, not decide what they think it should be. </p>
<p>In response, state legislators rapidly proposed <a href="https://www.cnn.com/2024/02/27/us/ivf-ruling-impact-other-states/index.html">a variety of bills</a> aimed at preserving IVF. The bill signed into law on March 6, 2024 <a href="https://www.newsfromthestates.com/article/alabama-legislature-passes-bills-aimed-protecting-vitro-fertilization?emci=9460e6e7-4cd7-ee11-85f9-002248223794&emdi=a8a94336-c3d7-ee11-85f9-002248223794&ceid=519099">gives broad immunity</a> to IVF clinics, shielding providers from prosecution and lawsuits “for the damage to or death of an embryo.” However, it provides more protection than is standard, which may create unintended consequences – for example, potentially making it more difficult to sue for negligence or breach of contract.</p>
<p>As Alabama legislators discuss next steps, they need to incorporate the state constitution while considering how to reflect the will of their voters.</p><img src="https://counter.theconversation.com/content/224721/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Katherine Drabiak does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Alabama’s case began when three couples sued an IVF clinic where their frozen embryos had accidentally been dropped.Katherine Drabiak, Professor of Health Law, Public Health Law and Medical Ethics, University of South FloridaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2244762024-02-29T13:40:25Z2024-02-29T13:40:25ZWhat is IVF? A nurse explains the evolving science and legality of in vitro fertilization<figure><img src="https://images.theconversation.com/files/578412/original/file-20240227-28-67xx7p.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1024%2C683&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Some of the eggs and sperm in these tubes stored in liquid nitrogen may go on to form an embryo.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/january-2024-berlin-eggs-and-sperm-are-stored-in-a-liquid-news-photo/1954098470">Jens Kalaene/picture alliance via Getty Images</a></span></figcaption></figure><p><em>Since the <a href="https://www.npr.org/2022/06/24/1102305878/supreme-court-abortion-roe-v-wade-decision-overturn">overturning of Roe v. Wade in June 2022</a> ended the federal right to abortion, legislative attention has extended to many other aspects of reproductive rights, including access to assisted reproductive technologies such as in vitro fertilization, or IVF, after an Alabama Supreme Court ruling in February 2024.</em></p>
<p><em>University of Massachusetts Lowell associate professor and department chair of the school of nursing <a href="https://scholar.google.com/citations?user=6rrHhmUAAAAJ&hl=en">Heidi Collins Fantasia</a> explains how this decades-old procedure works and what its tenuous legal status means for prospective parents.</em></p>
<h2>What is IVF?</h2>
<p>IVF is a type of artificial reproductive technology that allows people with a range of fertility issues to conceive a child. It involves fertilizing an egg with sperm <a href="https://medlineplus.gov/ency/article/007279.htm">outside the body</a> to form an embryo that is then transferred into the uterus to develop.</p>
<p>IVF is used as a treatment <a href="https://asrmcongress.org/asrm-publishes-a-new-more-inclusive-definition-of-infertility/">for infertility</a>, which the <a href="https://asrmcongress.org/asrm-publishes-a-new-more-inclusive-definition-of-infertility/">American Society for Reproductive Medicine</a> defines as an inability to achieve pregnancy “based on a patient’s medical, sexual, and reproductive history, age, physical findings, diagnostic testing” or the “need for medical intervention.” </p>
<p>While originally developed as a fertility treatment for <a href="https://www.ncbi.nlm.nih.gov/books/NBK562266/">blocked fallopian tubes</a>, IVF is currently used for other conditions such as low sperm count or when the cause for infertility can’t be determined. <a href="https://www.usatoday.com/story/money/2023/06/13/ivf-cost-higher-for-lgbtq-couples/11135417002/">LGBTQ people</a> and <a href="https://www.nytimes.com/2020/05/05/parenting/single-moms-by-choice-photos.html">single parents</a> can also use IVF and other reproductive technologies to grow their families.</p>
<h2>How does IVF work?</h2>
<p>Typically during IVF, a patient takes hormones to stimulate the ovaries to produce eggs. Once a health professional retrieves the eggs using an ultrasound and a thin needle, they either incubate the sperm with the egg or <a href="https://www.ncbi.nlm.nih.gov/books/NBK562266/">inject the sperm into the egg</a> in the lab to fertilize it. Which specific type of IVF procedure a patient undergoes is determined on an individual basis with a health care provider.</p>
<p>Scientists began to develop IVF in the 1930s, beginning with the <a href="https://doi.org/10.1387/ijdb.180364mj">live birth of rabbits and mice</a> through the procedure. This research eventually led to the birth of the <a href="https://time.com/5344145/louise-brown-test-tube-baby/">first “test-tube baby”</a> in 1978. Physiologist Robert Edwards received the <a href="https://www.nobelprize.org/prizes/medicine/2010/press-release/">2010 Nobel Prize in physiology or medicine</a> for his research on IVF.</p>
<p>The technology has rapidly expanded since the first live human birth from IVF. The <a href="https://doi.org/10.1016/j.bbagen.2011.05.001">development of cryopreservation</a>, or the freezing of human eggs and embryos, has enabled people to pursue pregnancy later in life. <a href="https://doi.org/10.1016/j.bbagen.2011.05.001">Genetic screening</a> of cells from a developing embryo can identify genetic diseases and abnormalities.</p>
<p>The chance of a successful live birth through assisted reproductive technologies varies. <a href="https://www.cdc.gov/art/artdata/index.html">Success rates</a> depend on many factors, such as underlying cause of infertility, age and type of technology used.</p>
<h2>Who currently has access to IVF?</h2>
<p>Use of IVF has steadily increased since it was first introduced. In 2015, about <a href="http://dx.doi.org/10.15585/mmwr.ss6703a1">2% of all infants</a> in the U.S. were conceived as a result of IVF, and <a href="https://doi.org/10.1007/s10815-022-02687-7">public support for IVF is high</a> overall.</p>
<p>Approximately <a href="https://www.pewresearch.org/short-reads/2023/09/14/a-growing-share-of-americans-say-theyve-had-fertility-treatments-or-know-someone-who-has/">10% of women in the U.S.</a> have used some type of <a href="https://www.kff.org/womens-health-policy/issue-brief/coverage-and-use-of-fertility-services-in-the-u-s/">fertility service</a> to achieve a pregnancy. This includes fertility advice, medications to increase ovulation, fertility testing, surgery and IVF. </p>
<p>Because infertility increases with age, <a href="https://www.cdc.gov/nchs/fastats/infertility.htm">women older than 35</a> typically use these services more often than younger women. Women in the U.S. who <a href="https://doi.org/10.1016/j.fertnstert.2019.04.044">access infertility care the least</a> are often non-U.S. citizens and uninsured, and they typically have lower income and less education than women who do.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Clear batches of containers of eggs and embryos in a large, frozen circular container" src="https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=360&fit=crop&dpr=1 600w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=360&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=360&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=452&fit=crop&dpr=1 754w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=452&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/578418/original/file-20240227-26-7ak5sq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=452&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Cryopreservation gives prospective parents more time to pursue pregnancy.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/frozen-embryos-and-eggs-in-nitrogen-cooled-royalty-free-image/520157312">Ted Horowitz Photography/The Image Bank via Getty Images</a></span>
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</figure>
<p><a href="https://www.cdc.gov/art/state-specific-surveillance/2021/figures.html#figure5">Differences in geography</a> also affect IVF access. In 2021, over 5% of all infants in Massachusetts were conceived from IVF, but this dropped to less than 1% in New Mexico, Arkansas and Mississippi.</p>
<p>Service availability and insurance coverage for IVF procedures differ by state, which could account for some of the differences in use. Only a <a href="https://resolve.org/learn/financial-resources-for-family-building/insurance-coverage/insurance-coverage-by-state/">small number of states</a> mandate that private insurers cover IVF. <a href="https://reproductiverights.org/fact-sheet-infertility-and-ivf-access-in-the-united-states-a-human-rights-based-policy-approach/">Public insurance coverage</a> for infertility services is even lower. </p>
<p>The <a href="https://doi.org/10.1186/s12958-022-00984-5">cost of IVF</a> has been the greatest barrier to infertility care. <a href="https://doi.org/10.1186/s12958-022-00984-5">Out-of-pocket costs</a> for people without insurance coverage can range from over US$10,000 to $25,000 per cycle, with rising costs per cycle.</p>
<h2>How do debates about when life begins affect IVF?</h2>
<p>Political views vary around reproductive rights, and <a href="https://www.cbsnews.com/news/republicans-senate-ivf-alabama-ruling/">access to IVF</a> is likely to become an issue in upcoming election cycles.</p>
<p>The <a href="https://www.washingtonpost.com/nation/2024/02/20/alabama-supreme-court-ivf-embryos/">Alabama Supreme Court ruled</a> in February 2024 that frozen embryos created during the process of IVF were people. While the ruling currently applies only to Alabama, it has caused <a href="https://www.theguardian.com/society/2024/feb/23/fertility-doctors-reaction-alabama-embryo-ruling">shock, confusion and concern</a> among health care providers. </p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/OsbGVgnHLBM?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Clinicians and people relying on IVF to expand their families are concerned about U.S. legislation around reproduction.</span></figcaption>
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<p>As a result of the ruling, two major <a href="https://www.pbs.org/newshour/health/a-2nd-alabama-ivf-provider-pauses-parts-of-its-program-after-court-ruling-on-frozen-embryos">IVF providers in Alabama</a> have paused infertility care because of potential legal risk to health care providers. The main concern is whether providers can be held <a href="https://www.cnn.com/2024/02/24/health/alabama-ivf-roe-v-wade/index.html">liable for wrongful death</a> if frozen embryos don’t survive the thawing process. </p>
<p>Since the elimination of federal protection of abortion in 2022 with the overturning of Roe v. Wade, individual states have made their <a href="https://www.americanprogress.org/article/a-year-after-the-supreme-court-overturned-roe-v-wade-trends-in-state-abortion-laws-have-emerged/">own laws regarding abortion access</a>. Many patients, health care providers, researchers and legislators see the Alabama decision regarding IVF as a continuation of the increasing <a href="https://www.pbs.org/newshour/show/how-an-alabama-supreme-court-ruling-that-frozen-embryos-are-children-impacts-ivf">erosion of women’s reproductive rights</a>.</p><img src="https://counter.theconversation.com/content/224476/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Heidi Collins Fantasia is the editor for Nursing for Women's Health. </span></em></p>IVF is a decades-old procedure that has allowed increasing numbers of prospective parents to have children. Evolving legislation may put it under threat.Heidi Collins Fantasia, Associate Professor of Nursing, UMass LowellLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2243652024-02-27T04:06:50Z2024-02-27T04:06:50ZAlabama ruling frozen embryos are equivalent to living children has worrying implications for IVF<figure><img src="https://images.theconversation.com/files/578118/original/file-20240227-28-8t4spu.jpg?ixlib=rb-1.1.0&rect=49%2C0%2C5472%2C3637&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/dewar-liquid-nitrogen-straws-frozenn-embryos-1225485064">Ekaterina Georgievskaia/Shutterstock</a></span></figcaption></figure><p>In <a href="https://static01.nyt.com/newsgraphics/documenttools/4b56014daa6dda84/a039b1d9-full.pdf">December 2020 in Alabama</a>, a hospital patient gained unauthorised access to an adjoining IVF storage facility, which was not adequately secured. The patient is said to have removed several frozen embryos, which they then dropped on the floor, owing to a freeze-burn to their hand. The embryos were destroyed.</p>
<p>In Alabama, the <a href="https://casetext.com/statute/code-of-alabama/title-6-civil-practice/chapter-5-actions/article-22-injury-and-death-of-minor/section-6-5-391-wrongful-death-of-minor">Wrongful Death of a Minor Act</a> allows parents of a deceased child to recover punitive damages for their child’s death, and <a href="https://www.abc.net.au/news/2024-02-25/ivf-frozen-embryo-alabama-supreme-court-ruling/103501872">three couples affected</a> by the incident subsequently brought lawsuits against the clinic under this legislation.</p>
<p>When this case was heard recently in the Supreme Court of Alabama, the majority of justices opined this statute <a href="https://static01.nyt.com/newsgraphics/documenttools/4b56014daa6dda84/a039b1d9-full.pdf">applies to frozen embryos</a> because:</p>
<blockquote>
<p>an unborn child is a genetically unique human being whose life begins at fertilization and ends at death.</p>
</blockquote>
<p>This essentially means frozen embryos are protected under Alabama law to the same extent as any living child. While this was a civil matter, it’s not inconceivable that, based on this interpretation, anyone who destroys a frozen embryo in Alabama – accidentally or on purpose – could face criminal penalties, such as manslaughter or even murder charges. </p>
<p>Likely for fear it’s too risky, clinics in the state are now limiting their IVF services, leaving patients having to <a href="https://www.today.com/video/more-clinics-in-alabama-stop-ivf-treatments-after-court-ruling-204773957818">seek treatment elsewhere</a>.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/considering-using-ivf-to-have-a-baby-heres-what-you-need-to-know-108910">Considering using IVF to have a baby? Here's what you need to know</a>
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<p>Ascribing personhood to frozen embryos is not a novel idea, but such a conviction is held only by the very fringes of the religious and conservative spectrum. There are clear political dimensions to this ruling, which appears to be an extension of a radical agenda on the altar of which the <a href="https://www.supremecourt.gov/opinions/21pdf/19-1392_6j37.pdf">Supreme Court of the United States</a> recently sacrificed the right to abortion. </p>
<p>This ruling from the Supreme Court of Alabama reflects a profound ignorance about how the process of IVF works.</p>
<h2>Creating multiple embryos is essential for overall IVF success</h2>
<p>The process of in vitro fertilisation, or IVF, begins with a “stimulated” cycle, where hormones are injected into a woman to stimulate an ovary to produce multiple eggs. These eggs are then collected and combined with sperm, forming embryos that are placed in an incubator to grow. </p>
<p>Five days later, the embryos are assessed. Some develop into “good quality” embryos suitable for transfer into a woman’s uterus. The hope is that following the transfer, the embryo will implant and result in a viable pregnancy, ultimately leading to the birth of a healthy child. Any good-quality embryos not used in a stimulated cycle are usually frozen for future attempts.</p>
<p>Unfortunately, IVF is somewhat inefficient, with attrition a prominent feature at every stage. Not all collected eggs are suitable for fertilisation, not all fertilise, not all embryos fertilise normally, and not all normally-fertilised embryos are of good quality. Poor-quality eggs, abnormally-fertilised embryos and poor-quality embryos are routinely discarded.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1760408483688534266"}"></div></p>
<p>The practical implications of this process and the heartbreaking reality for individuals and couples undergoing IVF is that it takes, on average, three to five eggs to produce <a href="https://npesu.unsw.edu.au/sites/default/files/npesu/data_collection/Assisted%20Reproductive%20Technology%20in%20Australia%20and%20New%20Zealand%202021.pdf">one good-quality embryo</a>. However, this number is age-dependent and significantly higher for older women. </p>
<p>The chance of achieving pregnancy from one embryo transfer is also significantly influenced by <a href="https://npesu.unsw.edu.au/sites/default/files/npesu/data_collection/Assisted%20Reproductive%20Technology%20in%20Australia%20and%20New%20Zealand%202021.pdf">the woman’s age</a>, being as high as 50% in younger women but decreasing exponentially as a woman gets older. At the age of 46, it can be as low as 1-2%. </p>
<p>So it’s vital to be able to safely produce as many good-quality embryos as possible from one stimulated IVF cycle in case multiple sequential embryo transfers are needed to achieve a healthy pregnancy. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-business-of-ivf-how-human-eggs-went-from-simple-cells-to-a-valuable-commodity-119168">The business of IVF: how human eggs went from simple cells to a valuable commodity</a>
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<p>Should the initial embryo transfer fail to produce a viable pregnancy, and frozen embryos are available, those can be thawed and transferred into a woman’s uterus in a “thaw” cycle. These cycles usually don’t require the use of injectable hormones or an egg collection and, in most instances, require only monitoring (including ultrasounds and blood tests), and timed embryo transfer.</p>
<p>The risks associated with IVF, such as bleeding and infections, are mostly confined to the stimulated cycles, while thaw cycles <a href="https://npesu.unsw.edu.au/sites/default/files/npesu/data_collection/Assisted%20Reproductive%20Technology%20in%20Australia%20and%20New%20Zealand%202021.pdf">pose minimal risk</a>. Notably, the most labour-intensive, and, therefore, costly portion is the stimulated cycle, while a thaw cycle can be around three to four times cheaper. </p>
<p>Should embryo freezing become unavailable, all people undergoing IVF would have to rely solely on stimulated cycles to achieve pregnancy, significantly increasing the risks and radically escalating the costs.</p>
<h2>The judge’s error in interpreting Australian practice</h2>
<p>Tom Parker, the Chief Justice of the Supreme Court of Alabama, made the following statement in his judgement:</p>
<blockquote>
<p>in Australia and New Zealand, prevailing ethical standards dictate that physicians usually create only one embryo at a time.</p>
</blockquote>
<p>He implied that in Australia, the only IVF cycles ethically permitted are stimulated cycles, where just one embryo is created and transferred, with no embryos being frozen. </p>
<figure class="align-center ">
<img alt="A pregnant woman holding her stomach." src="https://images.theconversation.com/files/578120/original/file-20240227-24-koxpao.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/578120/original/file-20240227-24-koxpao.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/578120/original/file-20240227-24-koxpao.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/578120/original/file-20240227-24-koxpao.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/578120/original/file-20240227-24-koxpao.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/578120/original/file-20240227-24-koxpao.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/578120/original/file-20240227-24-koxpao.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Many women need the help of IVF to become pregnant.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/image-pregnant-woman-touching-her-belly-147978782">10 FACE/Shutterstock</a></span>
</figcaption>
</figure>
<p>However, this assertion is demonstrably false. There are no guidelines or regulations in Australia that discourage the creation of multiple embryos, as this practice enhances overall pregnancy rates, while making IVF safer and more cost-effective. </p>
<p>What is discouraged is the <em>transfer</em> of multiple embryos at one time, as this increases the likelihood of multiple births, which carry <a href="https://www.fertilitysociety.com.au/wp-content/uploads/20211124-RTAC-ANZ-COP.pdf">heightened medical risks</a> for both mothers and babies.</p>
<p>It seems the Chief Justice has fundamentally misunderstood the Australian regulatory framework. Ironically, the <a href="https://www.varta.org.au/sites/default/files/2023-11/VARTA_AR2023.pdf">excellent IVF outcomes</a> and very low rates of multiple births in Australia are largely attributable to the widespread use of frozen embryo transfer cycles – a practice now <a href="https://www.today.com/video/more-clinics-in-alabama-stop-ivf-treatments-after-court-ruling-204773957818">under threat</a> in Alabama.</p><img src="https://counter.theconversation.com/content/224365/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>I am a fertility specialist and a Medical Director of Genea Fertility Melbourne, a private IVF unit.</span></em></p>A recent ruling from the Supreme Court of Alabama implies frozen embryos are legally equivalent to living children. This creates risks for IVF providers, and therefore problems for patients.Alex Polyakov, Medical Director, Genea Fertility Melbourne; Clinical Associate Professor, Faculty of Medicine, Dentistry & Health Sciences, The University of MelbourneLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2141862024-02-07T13:11:13Z2024-02-07T13:11:13ZSynthetic human embryos let researchers study early development while sidestepping ethical and logistical hurdles<figure><img src="https://images.theconversation.com/files/570406/original/file-20240119-29-b5qw5g.png?ixlib=rb-1.1.0&rect=0%2C0%2C2323%2C1285&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Studying embryogenesis is key to unraveling the mysteries of early life.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/human-morula-cell-solid-ball-of-cells-resulting-royalty-free-image/1327013568">luismmolina/iStock via Getty Images Plus</a></span></figcaption></figure><p>Embryonic development, also known as <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC156973/pdf/090989.pdf">embryogenesis</a>, is a cornerstone in understanding the origins of life. But studying this marvel of intricate and layered biological processes in people faces <a href="https://doi.org/10.1242%2Fdev.201797">considerable challenges</a>. Early-stage human embryos are difficult to obtain. Then there are ethical issues surrounding their use. This has made it difficult for scientists to understand early human development.</p>
<p>However, advances in genetic engineering and molecular and cellular biology have catalyzed the emergence of <a href="https://doi.org/10.1016%2Fj.ydbio.2021.03.007">synthetic embryology</a>, a subfield dedicated to replicating and studying embryonic development in a petri dish using human stem cells. By offering new tools to explore the enigmatic earliest stages of human development, synthetic embryology can help researchers overcome the challenges of using real human embryos.</p>
<p>As a reproductive and developmental biologist, I develop stem cell models for embryogenesis. With these new models, researchers can also better understand conditions that affect human reproduction and development as well as maternal-fetal health, potentially leading to new therapies.</p>
<h2>Making human embryos from stem cells</h2>
<p><a href="https://doi.org/10.1105/tpc.9.7.989">Embryogenesis</a> begins with the fertilization of an egg. This triggers the egg to rapidly divide into embryonic cells that soon form an inner cell mass that eventually develops into the fetus and a outer layer of cells that will give rise to the placenta.</p>
<p>Upon implantation in the uterus, the inner cell mass develops into the <a href="https://opentextbc.ca/biology/chapter/13-2-development-and-organogenesis/">three layers</a> that will create all the tissues and organs of the human body. Concurrently, the placenta begins to form as the embryo attaches itself to the uterine wall, a crucial step for maternal-fetal connection. This attachment enables the transfer of nutrients, oxygen and waste between mother and fetus. </p>
<p>Synthetic embryology artificially recreates these developmental stages using human <a href="https://doi.org/10.1155%2F2016%2F9451492">pluripotent stem cells</a> derived from human embryos or induced from adult human cells. Like early embryonic cells, these cells have the ability to develop into any type of cell in the human body. In carefully engineered lab environments, researchers can coax these cells to form multicellular structures that mimic various embryonic developmental stages, including early organ formation.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/570395/original/file-20240119-15-l7kh2l.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram depicting the first 23 days of embryogenesis, from fertilization to enlargement of the amniotic sac" src="https://images.theconversation.com/files/570395/original/file-20240119-15-l7kh2l.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/570395/original/file-20240119-15-l7kh2l.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=479&fit=crop&dpr=1 600w, https://images.theconversation.com/files/570395/original/file-20240119-15-l7kh2l.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=479&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/570395/original/file-20240119-15-l7kh2l.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=479&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/570395/original/file-20240119-15-l7kh2l.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=602&fit=crop&dpr=1 754w, https://images.theconversation.com/files/570395/original/file-20240119-15-l7kh2l.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=602&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/570395/original/file-20240119-15-l7kh2l.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=602&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">This diagram shows the first few weeks of human embryogenesis, which begins with fertilization.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Human_embryogenesis_-2.png">Jrockley/Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>Researchers created the <a href="https://doi.org/10.1038/nmeth.3016">first human embryo model</a> from embryonic stem cells in 2014. This pioneering model, also called a gastruloid, captured key aspects of early human development and showed that scientists can drive pluripotent stem cells to form patterned layers echoing the three germ layers and the outer layers of the embryo. </p>
<p>Gastruloids are easy to replicate and measure when studying early events in development. These 2D gastruloids can also help researchers precisely identify and image embryonic cells. However, this model lacks the complex 3D structure and spatial cell interactions seen in natural embryogenesis.</p>
<h2>Advancements in human embryo models</h2>
<p>Since the first gastruloid, the field has made substantial advancements.</p>
<p>Over the years, various models have been able to replicate different facets of human embryogenesis, <a href="https://doi.org/10.1038/s41467-017-00236-w">such as</a> <a href="https://doi.org/10.1038/s41586-019-1535-2">amniotic sac development</a>, <a href="https://doi.org/10.1016/j.reprotox.2021.08.003">germ layer formation</a> and <a href="https://doi.org/10.1038/s41556-019-0349-7">body plan organization</a>. Researchers have also developed organ-specific models for early organ development, such as a model that captures <a href="https://doi.org/10.1038/nprot.2014.158">key events of</a> <a href="https://doi.org/10.1038/s41587-019-0237-5">neural development</a> and <a href="https://doi.org/10.1016/j.stem.2022.11.013">fetal lung organoids</a> <a href="https://doi.org/10.1016%2Fj.stemcr.2023.03.015">that mimic</a> the process of lung formation.</p>
<p>However, none of these models fully captures the entire process of a single cell type developing into the complete structure of a whole embryo.</p>
<p>A significant breakthrough occurred in 2021 when several research groups successfully used human pluripotent stem cells with <a href="https://doi.org/10.1038/s41586-021-03356-y">higher developmental potential to</a> <a href="https://doi.org/10.1038/s41586-021-04267-8">create blastoids</a>, which resemble early-stage embryos prior to implantation. Blastoids form in a similar way to human embryos, starting from just a few cells that proliferate and organize themselves. </p>
<p>The developmental and structural similarity of blastoids to embryos make them useful for studying the early steps of how embryos form, especially before they attach to the womb. Blastoids can adhere to <a href="https://doi.org/10.1016/j.stemcr.2023.11.005">lab dishes</a> and <a href="https://doi.org/10.1016/j.stem.2023.08.005">undergo further growth</a>. They can also mimic embryo implantation in the uterus by integrating with maternal endometrial cells and developing into later embryonic stages <a href="https://www.sciencedirect.com/science/article/pii/S1934590923002850?via%3Dihub">after implantation</a>. </p>
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<figcaption><span class="caption">Embryo models allow researchers to study key developmental processes, such as the formation of the spine.</span></figcaption>
</figure>
<p>Recently, researchers have successfully created more complex models in the lab that mimic what happens after embryos attach to the womb. Two research teams have used specially <a href="https://doi.org/10.1038/s41586-023-06368-y">engineered cells</a> <a href="https://doi.org/10.1038/s41586-023-06604-5">to create structures</a> similar to those of human embryos at about one week postimplantation. These models are also able to form the cells that eventually turn into sperm and eggs in humans, mirroring what happens in natural development.</p>
<p>Another research group was also able to <a href="https://doi.org/10.1016/j.cell.2023.07.018">create a similar model</a> from pluripotent stem cells without needing to genetically engineer them. This model is able to mimic even later development stages and the beginning of nervous system formation.</p>
<h2>Choosing the right models</h2>
<p>In the evolving field of synthetic embryology, no single model can perfectly capture all aspects of embryogenesis. Consequently, the objective isn’t to play God, creating life in a petri dish, but rather to enhance our understanding of ourselves. This goal underscores the importance of carefully choosing the model best suited to the specific research objectives at hand. </p>
<p>For example, my previous work focused on <a href="https://doi.org/10.1038/s41556-021-00660-7">chromosomal abnormalities</a> in early human development. <a href="https://theconversation.com/chromosome-errors-cause-many-pregnancies-to-end-before-they-are-even-detected-39844">Aneuploidy</a>, or cells with an abnormal number of chromosomes, is a leading cause of pregnancy loss. But scientific knowledge about how these abnormal cells affect pregnancy and fetal development is very limited. </p>
<p>Since gastruloids can effectively model these aspects of early development, this system could be ideal for studying aneuploidy in early development. It allows researchers to precisely track and analyze how aneuploid cells behave and how they affect developmental processes.</p>
<p>Using this model, <a href="https://doi.org/10.1038/s41556-021-00660-7">my team and I discovered</a> that cells with chromosomal abnormalities are more likely to mature into placental cells and are likely eliminated during the development of fetal cells. This finding offers significant insight into why babies with normal chromosome numbers can be born healthy even with aneuploidy detected during pregnancy. Such discoveries are valuable for improving diagnostic and prognostic methods in prenatal care.</p>
<p>Future models that more completely replicate embryonic structures and more closely mirror biological events will not only advance understanding of the fundamentals of early development but also hold great potential in addressing clinical problems. Researchers can use them to model diseases and develop drugs for early life or genetic conditions. These models are also invaluable for studying tissue formation in regenerative medicine. Creating embryo models from a patient’s own cells could also allow researchers to study the genetics of development and aid in personalizing treatments.</p>
<p>Key to progress in the field of synthetic embryology is unwavering <a href="https://doi.org/10.1016/j.stem.2023.06.007">adherence to ethical standards</a> and regulation.
Crucially, these embryo models are neither synthetic nor actual embryos. The <a href="https://www.isscr.org/isscr-news/isscr-statement-on-new-research-with-embryo-models#">International Society for Stem Cell Research</a> strictly prohibits transferring these embryo models into the uterus of a human or an animal. Although these models mimic certain features of early developmental stages, they cannot and will not develop into the equivalent of a human baby after birth. Grounding research in solid justifications and oversight will help ensure that scientific exploration into the fabric of life is conducted with the utmost respect and responsibility.</p>
<p>By embracing the complexities and potential of synthetic embryology, researchers stand on the brink of a new era in biological understanding and are poised to unravel the mysteries of life itself.</p><img src="https://counter.theconversation.com/content/214186/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Min (Mia) Yang receives funding from University of Washington</span></em></p>Early human development is a complex, multistep process that’s even more complicated to study in the lab. Models made from stem cells avoid some of the trouble with using real human embryos.Min Yang, Assistant Professor of Obstetrics and Gynecology, School of Medicine, University of WashingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2079582023-07-25T18:08:07Z2023-07-25T18:08:07ZSynthetic human embryos could allow for research beyond the 14-day limit, but this raises ethical questions<figure><img src="https://images.theconversation.com/files/538789/original/file-20230721-17-akn0iy.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C8192%2C4608&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Synthetic human embryos mimic the development of “natural human embryos,” those created by fertilization. </span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/synthetic-human-embryos-could-allow-for-research-beyond-the-14-day-limit-but-this-raises-ethical-questions" width="100%" height="400"></iframe>
<p>On June 14, 2023, developmental biologist Magdalena Żernicka-Goetz presented her research on creating human embryos using stem cells at the <a href="https://www.isscr2023.org/plenary-sessions">2023 annual meeting of the International Society for Stem Cell Research</a> (ISSCR). </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/scientists-have-created-synthetic-human-embryos-now-we-must-consider-the-ethical-and-moral-quandaries-207911">Scientists have created synthetic human embryos. Now we must consider the ethical and moral quandaries</a>
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</em>
</p>
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<p>This research could <a href="https://www.theguardian.com/science/2023/jun/14/synthetic-human-embryos-created-in-groundbreaking-advance">increase our understanding of human development and genetic disorders</a>, help us learn how to prevent early miscarriages, lead to improvements in fertility treatment, and — perhaps — <a href="https://www.aljazeera.com/news/2023/6/15/scientists-say-first-synthetic-human-embryo-created">eventually allow for reproduction without using sperm and eggs</a>.</p>
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<figcaption><span class="caption">EuroNews reports on the synthetic embryos.</span></figcaption>
</figure>
<h2>Beyond the limits</h2>
<p>Synthetic human embryos — also called embryoid bodies, embryo-like structures or embryo models — mimic the development of “natural human embryos,” those created by fertilization. Synthetic human embryos include the “<a href="https://www.pdn.cam.ac.uk/news/model-post-implantation-human-embryo-derived-pluripotent-stem-cells">cells that would typically go on to form the embryo, placenta and yolk sac, and develop to form the precursors of germ cells (that will form sperm and eggs)</a>.”</p>
<p>Though research involving natural human embryos is legal in many jurisdictions, it remains controversial. For some people, research involving synthetic human embryos is less controversial because these embryos cannot “develop to the equivalent of postnatal stage humans.” In other words, these embryos are non-viable and cannot result in live births.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/creating-and-implanting-synthetic-monkey-embryos-could-pave-the-way-to-stem-cell-babies-203648">Creating and implanting synthetic monkey embryos could pave the way to stem-cell babies</a>
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<p>In addition, some maintain that the creation of synthetic human embryos would allow for <a href="https://doi.org/10.1038/d41586-023-01992-0">research beyond the 14-day limit</a> that typically applies to natural human embryos.</p>
<p>But would it?</p>
<h2>Laws in the United Kingdom</h2>
<p>The <a href="https://doi.org/10.1038/s41586-023-06368-y">research presented by Żernicka-Goetz</a> at the ISSCR meeting took place in the United Kingdom. It was conducted in accordance with the <a href="https://www.legislation.gov.uk/ukpga/1990/37/contents">Human Fertilization and Embryology Act, 1990</a>, with the approval of the U.K. <a href="https://www.ukri.org/councils/mrc/guidance-for-applicants/policies-and-guidance-for-researchers/uk-stem-cell-bank-steering-committee/">Stem Cell Bank Steering Committee</a>.</p>
<p>U.K. law limits the research use of human embryos to <a href="https://www.legislation.gov.uk/ukpga/1990/37/section/3/enacted">14 days of development</a>. An embryo is defined as “<a href="https://www.legislation.gov.uk/ukpga/1990/37/section/1/enacted">a live human embryo where fertilisation is complete, and references to an embryo include an egg in the process of fertilisation</a>.” </p>
<p>Synthetic embryos are not created by fertilization and therefore, by definition, the 14-day limit on human embryo research does not apply to them. This means that synthetic human embryo research beyond 14 days can proceed in the U.K. </p>
<p>The door to the touted potential benefits — and ethical controversies — seems wide open in the U.K.</p>
<h2>Canadian law</h2>
<p>While the law in the U.K. does not apply to synthetic human embryos, the law in Canada clearly does. This is because the legal definition of an embryo in Canada is not limited to embryos created by fertilization.</p>
<p>The Assisted Human Reproduction Act (the AHR Act) defines an embryo as “<a href="https://laws-lois.justice.gc.ca/eng/acts/a-13.4/page-1.html#h-6012">a human organism during the first 56 days of its development following fertilization or creation</a>, excluding any time during which its development has been suspended.”</p>
<p>Based on this definition, the AHR Act applies to embryos created by reprogramming human embryonic stem cells — in other words, synthetic human embryos — provided such embryos qualify as human organisms.</p>
<p>A synthetic human embryo is a human organism. It is of the species Homo sapiens, and is thus human. It also qualifies as an organism — a life form — alongside other organisms created by means of fertilization, asexual reproduction, parthenogenesis or cloning. </p>
<p>The definition of an organism does not stipulate a specific means of creation and so can include creation by means of reprogramming embryonic stem cells.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/538794/original/file-20230721-37780-kr1bxy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="a cluster of microscopic cells" src="https://images.theconversation.com/files/538794/original/file-20230721-37780-kr1bxy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/538794/original/file-20230721-37780-kr1bxy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=397&fit=crop&dpr=1 600w, https://images.theconversation.com/files/538794/original/file-20230721-37780-kr1bxy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=397&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/538794/original/file-20230721-37780-kr1bxy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=397&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/538794/original/file-20230721-37780-kr1bxy.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=499&fit=crop&dpr=1 754w, https://images.theconversation.com/files/538794/original/file-20230721-37780-kr1bxy.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=499&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/538794/original/file-20230721-37780-kr1bxy.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=499&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A human embryo for IVF selection.</span>
<span class="attribution"><a class="source" href="https://wellcomecollection.org/works/kprrpcyd">(K. Hardy/Wellcome Collection)</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<h2>Limitations</h2>
<p>Given that the AHR Act applies to synthetic human embryos, there are legal limits on their creation and use in Canada.</p>
<p>First, human embryos — including synthetic human embryos – can only be created for the purposes of “<a href="https://laws-lois.justice.gc.ca/eng/acts/A-13.4/page-1.html#h-6002">creating a human being, improving or providing instruction in assisted reproduction procedures</a>.” </p>
<p>Given the state of the science, it follows that synthetic human embryos could legally be created for the purpose of improving assisted reproduction procedures.</p>
<p>Second, “spare” or “excess” human embryos — including synthetic human embryos — originally created for one of the permitted purposes, but no longer wanted for this purpose, can be used for research. This research must be done in accordance with the <a href="https://laws-lois.justice.gc.ca/eng/regulations/SOR-2007-137/page-1.html#h-734501">consent regulations</a> which specify that consent must be for a “specific research project.”</p>
<p>Finally, all research involving human embryos — including synthetic human embryos — is subject to the 14-day rule. The law stipulates that: “<a href="https://laws-lois.justice.gc.ca/eng/acts/A-13.4/page-1.html#h-6052">No person shall knowingly… maintain an embryo outside the body of a female person after the fourteenth day of its development following fertilization or creation</a>, excluding any time during which its development has been suspended.”</p>
<p>Putting this all together, the creation of synthetic embryos for improving assisted human reproduction procedures is permitted, as is research using “spare” or “excess” synthetic embryos originally created for this purpose — provided there is specific consent and the research does not exceed 14 days. </p>
<p>This means that while synthetic human embryos may be useful for limited research on pre-implantation embryo development, they are not available in Canada for research on post-implantation embryo development beyond 14 days.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/538792/original/file-20230721-19-qd52p5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="two gloved hands positioning a slide under a microscope" src="https://images.theconversation.com/files/538792/original/file-20230721-19-qd52p5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/538792/original/file-20230721-19-qd52p5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/538792/original/file-20230721-19-qd52p5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/538792/original/file-20230721-19-qd52p5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/538792/original/file-20230721-19-qd52p5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/538792/original/file-20230721-19-qd52p5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/538792/original/file-20230721-19-qd52p5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">It is morally preferable to use non-viable rather than viable human embryos for research.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<h2>Prospects for expansion</h2>
<p>Proponents of synthetic human embryo research beyond 14 days may argue for a different interpretation of the law and insist that synthetic human embryos are not “human embryos” as defined in the AHR Act. But this looks to be an impossible task.</p>
<p>Alternatively, they may insist there is an important moral distinction between natural and synthetic human embryos because synthetic human embryos lack the potential to become live born humans. This means they fall into the category of non-viable human embryos. </p>
<p>It is not the case, however, that all natural embryos are viable embryos, and that all synthetic embryos are non-viable embryos. There are non-viable natural embryos such as <a href="https://doi.org/10.1111/j.1469-1809.1978.tb00930.x">tri-pronuclear embryos</a>, where more than one sperm enters the egg during fertilization. </p>
<p>And one day, synthetic human embryos may be viable embryos. In any case, in Canada, viable and non-viable embryos are legally equivalent. They are subject to the same rules, including the 14-day limit. </p>
<p>This leaves proponents of synthetic human embryo research beyond 14 days with the need for an alternative argument. But any argument will have to overcome the political reality that the federal government is unlikely to open up the Pandora’s box of amending the AHR Act.</p>
<p>It therefore seems likely that synthetic human embryo research will remain limited in Canada for the foreseeable future.</p><img src="https://counter.theconversation.com/content/207958/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Françoise Baylis is affiliated with the International Science Council. </span></em></p><p class="fine-print"><em><span>Jocelyn Downie does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>In June, the possibility of synthetic embryos was announced at a conference. This allows some research to extend beyond the 14-day rule, which restricts experimentation on embryos beyond this period.Françoise Baylis, Distinguished Research Professor, Emerita, Dalhousie UniversityJocelyn Downie, Professor, Faculties of Law and Medicine, Dalhousie UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2082762023-07-13T12:37:38Z2023-07-13T12:37:38ZPromising assisted reproductive technologies come with ethical, legal and social challenges – a developmental biologist and a bioethicist discuss IVF, abortion and the mice with two dads<figure><img src="https://images.theconversation.com/files/534595/original/file-20230628-23-se3fkd.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2000%2C1500&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A few days after successful fertilization, an embryo becomes a rapidly dividing ball of cells called a blastocyst.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/blastocyst-embryo-illustration-royalty-free-illustration/1498384521">Juan Gaertner/Science Photo Library via Getty Images</a></span></figcaption></figure><p><em>Assisted reproductive technologies are medical procedures that help people experiencing difficulty having or an inability to have biological children of their own. From in vitro fertilization to genetic screening to creation of viable eggs from the <a href="https://doi.org/10.1038/s41586-023-05834-x">skin cells of two male mice</a>, each new development speaks to the potential of reproductive technologies to expand access to the experience of pregnancy.</em> </p>
<p><em>Translating advances from the lab to the clinic, however, comes with challenges that go far beyond the purely technical.</em></p>
<p><em>Conversations around the ethics and implications of cutting-edge research often happen after the fact, when the science and technology have advanced beyond the point at which open dialogue could best protect affected groups. In the spirit of starting such cross-discipline conversations earlier, we invited developmental biologist <a href="https://scholar.google.com/citations?user=i6SghEMAAAAJ&hl=en">Keith Latham</a> of Michigan State University and bioethicist <a href="https://www.researchgate.net/profile/Mary-Faith-Marshall">Mary Faith Marshall</a> of the University of Virginia to discuss the ethical and technological potential of <a href="https://www.npr.org/sections/health-shots/2023/05/27/1177191913/sperm-or-egg-in-lab-breakthrough-in-reproduction-designer-babies-ivg">in vitro gametogenesis</a> and assisted reproductive technology post-Roe.</em></p>
<h2>How new are the ethical considerations raised by assisted reproductive technologies?</h2>
<p><strong>Keith</strong></p>
<p>Every new technology raises many of the same questions, and likely new ones. On the safety and risk-benefit side of the ethical conversation, there’s nothing here that we haven’t dealt with since the 1970s with other reproductive technologies. But it’s important to keep asking questions, because the benefits are hugely dependent on the success rate. There are potential biological costs, but also possible social costs, financial costs, societal costs and many others.</p>
<p><strong>Mary Faith</strong> </p>
<p>It’s probably been that way even longer. One of my mentors, Joseph Francis Fletcher, a pioneering bioethicist and Episcopal priest, wrote a book called “<a href="https://press.princeton.edu/books/hardcover/9780691635224/morals-and-medicine">Morals and Medicine</a>” in 1954. It was the first non-Roman Catholic treatment of bioethics. And he raised a lot of these issues there, including the <a href="https://theconversation.com/jurassic-world-scientists-still-havent-learned-that-just-because-you-can-doesnt-mean-you-should-real-world-genetic-engineers-can-learn-from-the-cautionary-tale-184369">technological imperative</a> – the idea that because we can develop the technology to do something, we therefore should develop it.</p>
<p>Fletcher also said that the use of artifice, or human-made creations, is supremely human. That’s what we do: We figure out how things work and we develop new technologies like vaccines and heart-lung machines based on evolving scientific knowledge.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Microscopy image of mouse ovum being fertilized by mouse sperm" src="https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=388&fit=crop&dpr=1 600w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=388&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=388&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=487&fit=crop&dpr=1 754w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=487&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/534596/original/file-20230628-30-nfjlun.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=487&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Scientists were able to create a mouse egg from the skin cells of male mice.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/fertilization-of-mouse-ovum-royalty-free-image/523741410">Clouds Hill Imaging Ltd./Corbis Documentary via Getty Images</a></span>
</figcaption>
</figure>
<p>I think that in most cases, scientists should be involved in thinking about the implications of their work. But often, researchers focus more on the direct applications of their work than the potential indirect consequences. </p>
<p>Given the evolution of assisted reproductive technology, and the fact that its evolution is going to continue, I think one of the central questions to consider is, what are the goals of developing it? For assisted reproduction, it’s to help infertile people and people in nontraditional relationships have children.</p>
<h2>What are some recent developments in the field of assisted reproductive technology?</h2>
<p><strong>Keith</strong></p>
<p>One recent advance in assisted reproductive technology is the expansion of <a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/03/preimplantation-genetic-testing">pre-implantation genetic testing</a> methods, particularly DNA sequencing. Many genes come in different variants, or alleles, that can be inherited from each parent. Providers can determine whether an embryo bears a “bad” allele that may increase the risk of certain diseases and select embryos with “healthy” alleles.</p>
<p>Genetic screening <a href="https://doi.org/10.1016/j.fertnstert.2022.03.017">raises several ethical concerns</a>. For example, the parents’ genetic profiles could be unwillingly inferred from that of the embryo. This possibility may deter prospective parents from having children, and such knowledge may also have potential effects on any future child. The cost of screening and potential need for additional cycles of IVF may also increase disparities.</p>
<p>There are also considerations about the <a href="https://doi.org/10.1016/j.fertnstert.2022.03.019">accuracy of screening predictions</a> without accounting for environmental effects, and what <a href="https://doi.org/10.1007/s12687-021-00573-w">level of genetic risk</a> is “serious” enough for an embryo to be excluded. More extensive screening also raises concerns about possible misuse for purposes other than disease prevention, such as production of “<a href="https://theconversation.com/an-american-company-will-test-your-embryos-for-genetic-defects-but-designer-babies-arent-here-just-yet-126833">designer babies</a>.”</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/uhb5gd5B-7g?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">In vitro gametogenesis involves making egg or sperm cells from other adult cells in the body.</span></figcaption>
</figure>
<p>At a <a href="https://www.nationalacademies.org/news/2023/02/agenda-for-third-international-summit-on-human-genome-editing-march-6-8">genome-editing conference</a> in March 2023, researchers announced that they were able to <a href="https://doi.org/10.1038/s41586-023-05834-x">delete and duplicate whole chromosomes</a> from the skin cells of male mice to make eggs. This method is one potential way to make eggs that do not carry genetic abnormalities. </p>
<p>They were very upfront that this was done at 1% efficiency in mice, which could be lower in humans. That means something bad happened to 99% of the embryos. The biological world is not typically binary, so a portion of that surviving 1% could still be abnormal. Just because the mice survived doesn’t mean they’re OK. I would say at this point, it would be unethical to try this on people.</p>
<p>As with some forms of genetic screening, using this technique to reduce the risk of one disease could inadvertently increase the risk of another. Determining that it is absolutely safe to duplicate a chromosome would require knowing every allele of every gene on that chromosome, and what each allele could do to the health of a person. That’s a pretty tall order, as that could involve identifying hundreds to thousands of genes, and the effects of all their variants may not be known. </p>
<p><strong>Mary Faith</strong></p>
<p>That raises the issue of efficacy and costs to yet another order of magnitude.</p>
<p><strong>Keith</strong> </p>
<p>Genome editing with <a href="https://theconversation.com/human-genome-editing-offers-tantalizing-possibilities-but-without-clear-guidelines-many-ethical-questions-still-remain-200983">CRISPR technology</a> in people carries similar concerns. Because of potential limitations in how precise the technology can be, it may be difficult for researchers to say they are absolutely 100% certain there won’t be off-target changes in the genome. Proceeding without that full knowledge could be risky. </p>
<p>But that’s where bioethicists need to come into play. Researchers don’t know what the full risk is, so how do you make that risk-benefit calculation?</p>
<p><strong>Mary Faith</strong></p>
<p>There’s the option of a voluntary global moratorium on using these technologies on human embryos. But somebody somewhere is <a href="https://theconversation.com/did-he-jiankui-make-people-better-documentary-spurs-a-new-look-at-the-case-of-the-first-gene-edited-babies-196714">still going to do it</a>, because the technology is just sitting there, waiting to be moved forward.</p>
<h2>How will the legal landscape affect the development and implementation of assisted reproductive technologies?</h2>
<p><strong>Mary Faith</strong></p>
<p>Any research that involves human embryos is in some ways politicized. Not only because the <a href="https://doi.org/10.1038/d41586-020-00127-z">government provides funding</a> to the basic science labs that conduct this research, but because of the wide array of beliefs that members of the public at large have about <a href="https://theconversation.com/defining-when-human-life-begins-is-not-a-question-science-can-answer-its-a-question-of-politics-and-ethical-values-165514">when life begins</a> or <a href="https://theconversation.com/what-is-personhood-the-ethics-question-that-needs-a-closer-look-in-abortion-debates-182745">what personhood means</a>.</p>
<p>The <a href="https://theconversation.com/roe-overturned-what-you-need-to-know-about-the-supreme-court-abortion-decision-184692">Dobbs decision</a>, which overturned the constitutional right to an abortion, has implications for assisted reproduction and beyond. Most people who are pregnant don’t even know they’re pregnant at the earliest stages, and somewhere around <a href="https://theconversation.com/most-human-embryos-naturally-die-after-conception-restrictive-abortion-laws-fail-to-take-this-embryo-loss-into-account-187904">60% of those pregnancies end naturally</a> because of genetic aberrations. Between 1973 and 2005, <a href="https://doi.org/10.1215/03616878-1966324">over 400 women were arrested for miscarriage in the U.S.</a>, and I think that number is going to grow. The implications for reproductive health care, and for assisted reproduction in the future, are challenging and frightening.</p>
<p>What will abortion restrictions mean for people who have <a href="https://www.cdc.gov/art/key-findings/multiple-births.html">multiple-gestation pregnancies</a>, in which they carry more than one embryo at the same time? In order to have one healthy child born from that process, the other embryos often need to be removed so they don’t all die. In the past 40 years, the number of twin births doubled and triplet and higher-order births quadrupled, primarily because of fertility treatments. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Needle touching eggs in petri dish under microscope in IVF" src="https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/534477/original/file-20230628-27-v0r0uc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">IVF may involve transferring more than one embryo at a time.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/in-vitro-fertilization-royalty-free-image/1272954210">Antonio Marquez lanza/Moment via Getty Images</a></span>
</figcaption>
</figure>
<p><strong>Keith</strong> </p>
<p>IVF may transfer one, two, or sometimes three embryos at a time. The <a href="https://doi.org/10.1016/j.jpeds.2022.11.038">cost of care for preterm birth</a>, which is one possible outcome of multiple-gestation pregnancies, can be high. That’s in addition to the <a href="https://doi.org/10.1016/j.ajog.2013.10.005">cost of delivery</a>. IVF clinics are increasingly transferring just one embryo to mitigate such concerns.</p>
<p>The life-at-conception bills that have been put forth in some U.S. state legislatures and Congress may contain language claiming they are not meant to prevent IVF. But the language of the bills could be extended to affect procedures such as IVF with pre-implantation genetic testing to detect chromosomal abnormalities, particularly when single-embryo transfer is the goal. Pre-implantation genetic testing has been increasing, with one study estimating that <a href="https://doi.org/10.1001/jama.2022.1892">over 40% of all IVF cycles</a> in the U.S. in 2018 involved genetic screening. </p>
<p>Could life-at-conception bills criminalize clinics that don’t transfer embryos known to be genetically abnormal? Freezing genetically abnormal embryos could avoid destroying them, but that raises questions of, to what end? Who would pay for the storage, and who would be responsible for those embryos?</p>
<h2>How can we determine whether the risks outweigh the benefits when so much is unknown?</h2>
<p><strong>Keith</strong></p>
<p>Conducting studies in animal models is an important first step. In some cases, it either hasn’t been done or hasn’t been done extensively. Even with animal studies, you have to recognize that mice, rabbits and monkeys are not human. Animal models may reduce some risks before a technology is used in people, but they won’t eliminate all risks, because of biological differences between species.</p>
<p><strong>Mary Faith</strong> </p>
<p>We could look to the example of <a href="https://www.genome.gov/25520302/online-education-kit-1972-first-recombinant-dna">early recombinant DNA research in the U.S.</a> The federal government created the <a href="https://doi.org/10.1089%2Fhum.2013.2524">Recombinant DNA Advisory Committee at the National Institutes of Health</a> to oversee animal and early-phase human research involving synthetic or hybrid genetic material. </p>
<p>The <a href="https://doi.org/10.1126/science.307.5712.1028b">death of Jesse Gelsinger</a>, who was a participant in a gene therapy clinical trial in 1999, led to a halt in all gene therapy clinical trials in the U.S. for a time. When the Food and Drug Administration investigated what went wrong, they found huge numbers of adverse events in both humans and animals that should have been reported to the advisory committee but weren’t. Notably, the principal investigator of the trial was also the <a href="https://sciencehistory.org/stories/magazine/the-death-of-jesse-gelsinger-20-years-later/">primary shareholder</a> of the biotech company that made the drug being tested. That raises questions about the reality of oversight.</p>
<p>I think something like that earlier NIH advisory committee but for reproductive technologies would still be advisable. But researchers, policymakers and regulators need to learn from the lessons of the past to try to ensure that – especially in early-phase research – we’re very thoughtful about the potential risks and that research participants really understand what the implications are for participation in research. That would be one model for translating research from the animal into the human.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Child looking into a slip lamp microscope for an eye exam with a doctor" src="https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/534481/original/file-20230628-30590-2nwhy8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The FDA approved a gene therapy for a form of congenital vision loss in 2017. The child in this photo, then 8, first received gene therapy at age 4.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/BlindnessTreatmentPrice/c567cc3a2b244cac8afc2b5ae2c62ca3">Bill West/AP Photo</a></span>
</figcaption>
</figure>
<p><strong>Keith</strong></p>
<p>A process to make sure that the people conducting studies don’t have a conflict of interest, like having the potential to commercially profit from the technology, would be useful. </p>
<p>Caution, consensus and cooperation should not take second place to profit motives. Altering the human genome in a way that allows human-made genetic changes to be <a href="https://doi.org/10.1089/crispr.2020.0096">propagated throughout the population</a> has a potential to alter the genetics of the human species as a whole. </p>
<p><strong>Mary Faith</strong></p>
<p>That raises the question of how long it will take for long-term effects to show. It’s one thing for an implanted egg not to survive. But how long will it take to know whether there are effects that aren’t obvious at birth?</p>
<p><strong>Keith</strong> </p>
<p>We’re still collecting long-term outcome data for people born using different reproductive technologies. So far there have been no obviously horrible consequences. But some abnormalities could take decades to manifest, and there are many variables to contend with. </p>
<p>One can arguably say that there’s substantial good in helping couples have babies. There can be a benefit to their emotional well-being, and reproduction is a natural part of human health and biology. And a lot of really smart, dedicated people are putting a lot of energy into making sure that the risks are minimized. We can also look to some of the practices and approaches to oversight that have been used over the past several decades.</p>
<p><strong>Mary Faith</strong></p>
<p>And thinking about international guidelines, such as from the <a href="https://cioms.ch">Council for International Medical Science</a> and other groups, could provide guidance on protecting human research subjects.</p>
<p><strong>Keith</strong></p>
<p>You hate to advocate for a world where the automatic response to anything new is “no, don’t do that.” My response is, “Show me it’s safe before you do it.” I don’t think that’s unreasonable.</p>
<p>Some people have a view that scientists don’t think about the ethics of research and what’s right and wrong, advisable or inadvisable. But we do think about it. I co-direct a research training program that includes teaching scientists how to responsibly and ethically conduct research, including speakers who specifically address the ethics of reproductive technologies. It is valuable to have a dialogue between scientists and ethicists, because ethicists will often think about things from a different perspective. </p>
<p>As people go through their scientific careers and see new technologies unfold over time, these discussions can help them develop a deeper appreciation and understanding of the broader impact of their research. It becomes our job to make sure that each generation of scientists is motivated to think about these things. </p>
<p><strong>Mary Faith</strong></p>
<p>It’s also really important to include stakeholders – people who are nonscientists, people who experience barriers to reproduction and people who are opposed to the idea – so they have a voice at the table as well. That’s how you get good policies, right? You have everyone who should be at the table, at the table.</p><img src="https://counter.theconversation.com/content/208276/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Scientists can create viable eggs from two male mice. In the wake of CRISPR controversies and restrictive abortion laws, two experts start a dialogue on ethical research in reproductive biology.Keith Latham, Professor of Animal Science, Adjunct Professor of Obstetrics, Gynecology and Reproductive Biology, Michigan State UniversityMary Faith Marshall, Professor of Biomedical Ethics, University of VirginiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1655142021-09-01T23:18:07Z2021-09-01T23:18:07ZDefining when human life begins is not a question science can answer – it’s a question of politics and ethical values<figure><img src="https://images.theconversation.com/files/418958/original/file-20210901-21-5hg6d6.jpg?ixlib=rb-1.1.0&rect=25%2C33%2C5572%2C4154&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Science can observe these various phases of fetal development but cannot determine when human life begins.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/pregnancy-ultrasound-royalty-free-image/168415756">UrsaHoogle/E+ via Getty Images</a></span></figcaption></figure><p>Now that the U.S. Supreme Court has <a href="https://theconversation.com/a-revolutionary-ruling-and-not-just-for-abortion-a-supreme-court-scholar-explains-the-impact-of-dobbs-185823">given states final say</a> over if and when abortions are legal, the <a href="https://www.cnn.com/2022/06/27/media/supreme-court-abortion-reliable-sources/index.html">political debates over abortion rights</a> will intensify in legislatures and <a href="https://theconversation.com/state-courts-from-oregon-to-georgia-will-now-decide-who-if-anyone-can-get-an-abortion-under-50-different-state-constitutions-184298">courthouses</a> around the nation. Many of those discussions will hinge on the question of when, exactly, is the beginning of a human life that could – or should – be protected by law.</p>
<p>A <a href="https://www.supremecourt.gov/DocketPDF/19/19-1392/185346/20210729162737297_19-1392%20BRIEF%20OF%20BIOLOGISTS%20AS%20AMICI%20CURIAE%20IN%20SUPPORT%20OF%20NEITHER%20PARTY.pdf">friend of the court filing</a> in the Supreme Court case implicitly claimed that biology – and therefore biologists – can tell when human life begins. The filing then went on to claim explicitly that a vast majority of biologists agree on which particular point in fetal development actually marks the beginning of a human life.</p>
<p>Neither of those claims is true.</p>
<h2>The role of science</h2>
<p>As a <a href="https://scholar.google.com/citations?user=wQsQxFoAAAAJ&hl=en&oi=ao">biologist and philosopher</a>, I have been watching players in the national abortion debate make claims about biology for many years. </p>
<p>Abortion rights opponents know that Americans have widely differing values and religious beliefs about abortion and the protection of human life. So they <a href="https://www.nytimes.com/2019/01/22/opinion/abortion-roe-science.html">seek to use science as an absolute standard</a> in any discussion of abortion’s constitutionality, setting a definition of human life that they hope will be immune to any counterargument.</p>
<p>While possibly well-intentioned, this appeal to scientific authority and evidence over discussions of people’s values is based on faulty reasoning. Philosophers such as the late <a href="https://plato.stanford.edu/entries/williams-bernard/">Bernard Williams</a> have long pointed out that understanding what it is to be human <a href="https://philpapers.org/rec/WILMSO">requires a lot more than biology</a>. And <a href="https://cup.columbia.edu/book/fear-wonder-and-science-in-the-new-age-of-reproductive-biotechnology/9780231170949">scientists can’t establish</a> when a fertilized cell or embryo or fetus becomes a human being.</p>
<iframe width="100%" height="480" frameborder="0" allowfullscreen="" src="https://archive.org/embed/COM_20121113_070000_The_Daily_Show_With_Jon_Stewart?start=1370&end=1412.2" webkitallowfullscreen="true" mozallowfullscreen="true"></iframe>
<h2>Political claims about science</h2>
<p>Public figures have, in recent years, prominently claimed that scientific knowledge on the topic of human life is definitive.</p>
<p>In 2012, for instance, former Arkansas Gov. Mike Huckabee, who was running for president, claimed on “The Daily Show with Jon Stewart: ”<a href="https://lincmad.blogspot.com/2012/11/transcript-huckabee-on-daily-show.html">Biologically, life begins at conception</a>. That’s irrefutable from a biological standpoint.“</p>
<p>Similarly, in his 2015 presidential bid, Florida Sen. Marco Rubio declared, ”<a href="https://www.cnn.com/2015/08/07/politics/marco-rubio-abortion-republican-debate-gop/index.html">I believe that science is clear</a> … when there is conception that that is a human life in the early stages of its development.“</p>
<p>The most recent high-profile example of this claim is in that <a href="https://www.supremecourt.gov/DocketPDF/19/19-1392/185346/20210729162737297_19-1392%20BRIEF%20OF%20BIOLOGISTS%20AS%20AMICI%20CURIAE%20IN%20SUPPORT%20OF%20NEITHER%20PARTY.pdf">amicus brief filed with the Supreme Court</a> in the Mississippi case.</p>
<p>The brief, coordinated by a University of Chicago graduate student in comparative human development, Steven Andrew Jacobs, is based on a problematic piece of research Jacobs conducted. He now seeks to enter it into the public record to influence U.S. law.</p>
<p>First, Jacobs carried out a survey, supposedly representative of all Americans, by seeking potential participants on the <a href="https://doi.org/10.1177%2F1948550619875149">Amazon Mechanical Turk crowdsourcing marketplace</a> and accepting all 2,979 respondents who agreed to participate. He found that <a href="https://papers.ssrn.com/sol3/papers.Cfm?Abstract_id=3211703">most of these respondents trust biologists over others</a> – including religious leaders, voters, philosophers and Supreme Court justices – to determine when human life begins.</p>
<p>Then, he sent 62,469 biologists who could be identified from institutional faculty and researcher lists a separate survey, offering several options for when, biologically, human life might begin. He got 5,502 responses; 95% of those self-selected respondents said that life began at fertilization, when a sperm and egg merge to form a single-celled zygote. </p>
<p>That result is not a proper survey method and does not carry any statistical or scientific weight. It is like asking 100 people about their favorite sport, finding out that only the <a href="https://news.gallup.com/poll/4735/sports.aspx">37 football fans</a> bothered to answer, and declaring that 100% of Americans love football.</p>
<p>In the end, just 70 of those 60,000-plus biologists supported Jacobs’ legal argument enough to sign the amicus brief, which makes a companion argument to the main case. That may well be because there is neither scientific consensus on the matter of when human life actually begins nor agreement that it is a question that biologists can answer using their science.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/418960/original/file-20210901-15-10pj2s7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="An image of a fetus" src="https://images.theconversation.com/files/418960/original/file-20210901-15-10pj2s7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/418960/original/file-20210901-15-10pj2s7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=402&fit=crop&dpr=1 600w, https://images.theconversation.com/files/418960/original/file-20210901-15-10pj2s7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=402&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/418960/original/file-20210901-15-10pj2s7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=402&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/418960/original/file-20210901-15-10pj2s7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=505&fit=crop&dpr=1 754w, https://images.theconversation.com/files/418960/original/file-20210901-15-10pj2s7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=505&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/418960/original/file-20210901-15-10pj2s7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=505&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A human fetus at six to seven weeks of gestation.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/lunarcaustic/3233482244">lunarcaustic via Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<h2>Several possible options</h2>
<p><a href="https://www.swarthmore.edu/profile/scott-gilbert">Scott Gilbert</a>, the Howard A. Schneiderman Professor of Biology emeritus at Swarthmore College, is the author of the <a href="https://global.oup.com/ushe/product/developmental-biology-9781605358246?cc=us&lang=en&">standard textbook</a> of developmental biology. He has identified <a href="https://www.swarthmore.edu/news-events/when-does-personhood-begin">as many as five developmental stages</a> that, from a biological perspective, are all plausible beginning points for human life. Biology, as science knows it now, can tell these stages apart, but cannot determine at which one of these stages life begins.</p>
<p>The first of these stages is fertilization in the egg duct, when a zygote is
formed with the full human genetic material. But <a href="https://www.nytimes.com/2018/05/21/science/mosaicism-dna-genome-cancer.html">almost every cell in everyone’s body contains that person’s complete DNA sequence</a>. If genetic material alone makes a potential human being, then when we shed skin cells – as we do all the time – we are severing potential human beings.</p>
<p>The second plausible stage is called gastrulation, which happens about two weeks after fertilization. At that point, <a href="https://dx.doi.org/10.1187%2Flse.7.1.cbe12">the embryo loses the ability to form identical twins</a> – or triplets or more. The embryo therefore becomes a biological individual but not necessarily a human individual. </p>
<p>The third possible stage is at 24 to 27 weeks of pregnancy, when the characteristic <a href="https://doi.org/10.7312/gilb17094">human-specific brain-wave pattern emerges in the fetus’s brain</a>. Disappearance of this pattern is part of <a href="https://dx.doi.org/10.1007%2Fs11571-008-9047-z">the legal standard for human death</a>; by symmetry, perhaps its appearance could be taken to mark the beginning of human life.</p>
<p>The fourth possible stage, which is <a href="https://www.worldcat.org/title/abortion-medicine-and-the-law/oclc/563961118">the one endorsed in the Roe v. Wade decision</a> legalizing abortion in the United States, is viability, when a fetus typically becomes viable outside the uterus with the help of available medical technology. With the technology that we have today, <a href="https://www.rcog.org.uk/en/guidelines-research-services/guidelines/sip41/">that stage is reached at about 24 weeks</a>.</p>
<p>The final possibility is birth itself.</p>
<p>[<em>Over 100,000 readers rely on The Conversation’s newsletter to understand the world.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=100Ksignup">Sign up today</a>.]</p>
<p>The overall point is that biology does not determine when human life begins. It is a question that can only be answered by appealing to our values, examining what we take to be human. </p>
<p>Perhaps biologists of the future will learn more. Until then, when human life begins during fetal developments is a question for philosophers and theologians. And policies based on an answer to that question will remain up to politicians – and judges.</p>
<p><em>This is an updated version of an article originally published Sept. 1, 2021.</em></p><img src="https://counter.theconversation.com/content/165514/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sahotra Sarkar does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Some people seeking to influence public opinion about abortion rights claim the science is clear. It’s not, and that means abortion remains a political question – not a biological one.Sahotra Sarkar, Professor of Philosophy and Integrative Biology, The University of Texas at AustinLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1637922021-08-23T18:37:26Z2021-08-23T18:37:26ZThe fertility industry is poorly regulated – and would-be parents can lose out on having children as a result<figure><img src="https://images.theconversation.com/files/416106/original/file-20210813-22-wv89iu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Louise Brown, who was the world's first baby to be born from in vitro fertilization (IVF) in 1978, poses with equipment used in early IVF treatments.
</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/louise-brown-who-in-1978-became-the-worlds-first-baby-to-be-news-photo/1004176610?adppopup=true"> Daniel Leal-Olivas/ Getty</a></span></figcaption></figure><p>When embryologist <a href="https://www.courthousenews.com/lab-workers-were-devastated-by-tank-failure-that-destroyed-human-embryos/">Joseph Conaghan arrived at work</a> at San Francisco’s Pacific Fertility Center on March 4, 2018, nothing seemed awry. He did routine inspections of the facility’s cryogenic tanks, which store frozen embryos and eggs for clients who hope to someday have biological children. </p>
<p>But what he found was not routine; it was an emergency. Almost all of the liquid nitrogen inside Tank 4 had drained out. Conaghan and his staff tried to save 80 metal boxes of frozen reproductive material, but it was too late. The contents had warmed, damaging or destroying 1,500 eggs and 2,500 embryos. </p>
<p>Some belonged to a couple who traveled cross-country from their farm in Ohio, hoping to build their family from frozen embryos. A single woman in her early 40s was hoping to soon use her preserved eggs with “Mr. Right.”</p>
<p>For many, infertility is a significant challenge: In 2018, 12.7% of American women sought infertility services, according to a <a href="https://www.cdc.gov/nchs/nsfg/key_statistics/i_2015-2017.htm#infertilityservices">U.S. Centers for Disease Control and Prevention report</a>. As experts on regulation of the fertility industry, we are concerned about protecting those who need these interventions. There is little oversight in the U.S. of the industry, with <a href="https://www.fertstertreports.org/action/showPdf?pii=S2666-3341%2820%2930039-8">no requirement</a> that clinics report problems – including tank failures. As Professor Dov Fox of the University of San Diego Law School told a reporter: “<a href="https://www.washingtonpost.com/health/2021/06/11/fertility-clinic-egg-embryo-verdict/">These tanks specifically, they’re not regulated any better than kitchen appliances or farm tools</a>.”</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/P27waC05Hdk?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The science behind making a baby in a lab.</span></figcaption>
</figure>
<h2>Reproductive innovations</h2>
<p>The current age of reproductive technology dates to 1944, when lab technician <a href="https://www.bbc.com/future/article/20200103-the-female-scientist-who-changed-human-fertility-forever">Miriam Menkin</a> successfully fertilized a human egg in a petri dish. She made history, creating a new method of human conception.</p>
<p>That year, 30 fertility experts founded the <a href="https://www.asrm.org/about-us/history-of-asrm/">American Society for Reproductive Medicine</a>. Today it is a global organization of <a href="https://www.asrm.org/news-and-publications/news-and-research/announcements/asrm-task-force-on-diversity-equity-and-inclusion-issues-statement-recommendations/">about 8,000</a>, including doctors, nurses, health care professionals and others.</p>
<p>But it wasn’t until 1978 that in vitro fertilization emerged as a groundbreaking and controversial technology. That year marked the birth of <a href="https://time.com/5344145/louise-brown-test-tube-baby/">Louise Brown</a>, the first “test tube baby.”</p>
<p>Since then, the procedure has produced more than <a href="https://www.sciencedaily.com/releases/2018/07/180703084127.htm">8 million children</a> worldwide. Some <a href="https://www.cdc.gov/art/artdata/index.html">80,000 children</a> are born yearly in the U.S. through IVF, accounting for <a href="https://www.cdc.gov/art/artdata/index.html">1.9% of births.</a></p>
<h2>Little regulation</h2>
<p>Assisted reproduction is now a multibillion-dollar industry, with more than <a href="https://www.cdc.gov/art/nass/index.html">440 U.S. clinics</a>. In other industrialized nations, including the U.K., fertility treatment is <a href="https://www.hfea.gov.uk/about-us/">monitored</a> by independent, comprehensive regulators. In the U.S., government regulation is so light that the U.S. fertility industry has been called the “<a href="https://www.nytimes.com/roomfordebate/2011/09/13/making-laws-about-making-babies/fertility-industry-is-a-wild-west">Wild West</a>.” U.S. lawmakers have largely steered clear: The contentious battle over abortion has created a political minefield around any issue concerning conception or embryos.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1422369124827557888"}"></div></p>
<p>Minimal <a href="https://www.asrm.org/globalassets/asrm/asrm-content/about-us/pdfs/oversiteofart.pdf">regulations</a> are scattered among <a href="https://www.today.com/health/lack-oversight-regulations-may-lead-ivf-mishaps-t157872">federal, state and professional entities</a>. Meanwhile, the U.S. Centers for Disease Control and Prevention offers limited oversight, <a href="https://www.cdc.gov/art/nass/index.html">auditing or inspecting</a> only a sample of clinics each year, mostly to validate data. </p>
<p>Under a 1992 <a href="https://www.govinfo.gov/content/pkg/STATUTE-106/pdf/STATUTE-106-Pg3146.pdf">U.S. federal law</a>, clinics must <a href="https://www.cdc.gov/art/nass/index.html">report assisted reproduction success rates</a> to the CDC. Labs can be <a href="https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2015/3/18/states-not-eager-to-regulate-fertility-industry">certified</a> by <a href="https://www.cap.org/laboratory-improvement/accreditation/reproductive-accreditation-program">one</a> of <a href="https://www.jointcommission.org">two</a> <a href="https://www.cdc.gov/art/nass/policy.html">accrediting, nonprofit organizations</a>. While some states <a href="https://www.washingtonpost.com/news/to-your-health/wp/2018/03/14/faq-are-my-frozen-embryos-safe-everything-you-need-to-know-given-two-fertility-clinics-recent-problems/">require fertility labs to be accredited,</a> others do not; certification <a href="https://www.asrm.org/globalassets/asrm/asrm-content/news-and-publications/practice-guidelines/for-non-members/cryostorage_of_reproductive_tissues.pdf">requires the monitoring of tanks</a>.</p>
<p>Without comprehensive monitoring, there is little known about problems within this industry. Some of the most complete information on frozen embryo mishaps comes from a <a href="https://www.google.com/url?sa=D&q=https://www.fertstertreports.org/action/showPdf%3Fpii%3DS2666-3341%252820%252930039-8&ust=1627324440000000&usg=AOvVaw3blyWRCntiDd2el33sY9SB&hl=en&source=gmail">study</a> analyzing lawsuits from 2009 through 2019. </p>
<p>The authors reported 133 cases of embryo loss. More than half were related to two catastrophic freezer failures, including the San Francisco event and another that occurred, in a bizarre coincidence, on the same day at Ohio’s <a href="https://www.cleveland.com/news/2019/09/uh-freezer-malfunction-update-more-than-150-families-settle-lawsuits-in-loss-of-embryos.html">Ahuja Medical Center</a>. The Ohio malfunction thawed 4,000 eggs, affecting more than 900 women or families.</p>
<p>But this study only includes cases that can be tracked because of legal filings. Clinics often require patients to sign arbitration agreements that keep cases out of court and out of the public eye. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"972945298115956741"}"></div></p>
<h2>The Pacific Fertility Center case</h2>
<p>Cryogenic tank failures should never happen. Although they store often irreplaceable genetic material, this equipment is minimally regulated. </p>
<p>The <a href="https://www.ecfr.gov/cgi-bin/text-idx?SID=13f55385af12d02f3c7cf85f833911fb&mc=true&node=se21.8.884_16120&rgn=div8">U.S. Food and Drug Administration</a> categorizes these tanks as Class II devices and exempts them from <a href="https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k">premarket</a> scientific and regulatory <a href="https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma">review</a> on safety and effectiveness. </p>
<p>There is also little oversight on the equipment while it’s in use. The American Society for Reproductive Medicine issued <a href="https://www.asrm.org/globalassets/asrm/asrm-content/news-and-publications/practice-guidelines/for-non-members/cryostorage_of_reproductive_tissues.pdf">guidance</a> on best practices for cryopreservation in 2020, noting that a “known” source of potential mishaps included “human errors,” such as a “lack of quality control including liquid nitrogen filling schedule” and “inadequate inventory records.”</p>
<p>Basic federal standards for the manufacturing and use of cryopreservation tanks would prevent future storage tank failures and the loss of frozen eggs and embryos. In lieu of federal action, New Jersey became the <a href="https://abovethelaw.com/2020/03/new-jersey-is-the-first-state-to-regulate-the-storage-of-human-embryos/">first state</a> to regulate embryo storage through a law enacted in December 2019. </p>
<p>But ultimately, we believe only federal regulations can ensure uniformity so that standards don’t vary from state to state. Clinics also need greater government oversight to ensure prompt communication about errors. </p>
<p>Many who hope to someday have a genetically related child — like the couple from Ohio and that single woman looking for the right partner — must place their trust in fertility specialists, clinics and equipment manufacturers that provide needed services and devices. Even minimal regulation would help ensure that others are spared from devastating losses in the future. </p>
<p>[<em>Get our best science, health and technology stories.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-best">Sign up for The Conversation’s science newsletter</a>.]</p><img src="https://counter.theconversation.com/content/163792/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dena Sharp's law firm, Girard Sharp, worked on the cases relating to the tank failure at Pacific Fertility that are discussed in this article. </span></em></p><p class="fine-print"><em><span>Naomi Cahn does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>An unknown number of people have lost their dreams of parenthood because of storage disasters at fertility clinics. These experts note poor government oversight and the need for stronger regulation.Naomi Cahn, Professor of Law, University of VirginiaDena Sharp, Guest lecturer, University of California College of the Law, San FranciscoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1623052021-06-30T15:16:59Z2021-06-30T15:16:59ZLimits for human embryo research have been changed: this calls for public debate<figure><img src="https://images.theconversation.com/files/407647/original/file-20210622-24-o9o6ri.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Human embryo research allows us to understand normal and abnormal human development. </span> <span class="attribution"><span class="source">Anusorn Nakdee/Shutterstock</span></span></figcaption></figure><p>For 40 years, research into early human development has been guided by the principle that after 14 days, an embryo should not be used for research and must be destroyed. This rule has been part of the law of more than 12 countries. But <a href="https://www.cell.com/stem-cell-reports/fulltext/S2213-6711(21)00263-0">new guidelines</a> released by the <a href="https://www.isscr.org/">International Society for Stem Cell Research</a> have removed this rule. This makes it possible to conduct research on human embryos that are at more advanced stages of development. </p>
<p>Now, countries must revise their laws, policies and guidelines to reflect this change. But first, public debate is crucial to determine the limits of what sort of research should be allowed.</p>
<p>Over the decades <a href="https://pediatrics.aappublications.org/content/108/3/813">human embryo research</a> has allowed us to understand normal and abnormal human development, as well as early genetic diseases and disorders. Studying human embryos, as the earliest forms of human life, can give us insight into why miscarriages occur, and how our complex body systems develop. Human embryos are also important for <a href="https://www.healthline.com/health/stem-cell-research">stem cell research</a>, where researchers try and create cell-based therapies to treat human diseases. </p>
<p>Often, extra embryos are created during <a href="https://www.mayoclinic.org/tests-procedures/in-vitro-fertilization/about/pac-20384716#:%7E:text=In%20vitro%20fertilization%20(IVF)%20is,by%20sperm%20in%20a%20lab.">in vitro fertilisation</a> procedures. These extra embryos may be donated for research. They are cultured (or grown) in a laboratory and can be studied until they reach day 14 post-creation. </p>
<p>The 14-day rule has served as an international standard since 1990 when it was included in the <a href="https://www.legislation.gov.uk/ukpga/1990/37/contents">Human Fertilisation and Embryology Act</a> in the UK. At the time that it was introduced, it was not possible to keep human embryos alive in a laboratory for more than a few days. However, scientists have been recently been able to keep embryos alive for longer periods, between 12 and 13 days. The ethical, legal and social consequences of such research were also important considerations. </p>
<h2>The 14-day rule and the new guidelines</h2>
<p>Although the 14-day rule has been criticised as being arbitrarily decided, there are a number of reasons for the time frame. </p>
<p>After an egg cell is fertilised by a sperm cell, the resulting embryo consists of a few identical cells. Most embryos will implant in the uterus after the 14th day. After this point, the <a href="https://www.sciencedirect.com/topics/biochemistry-genetics-and-molecular-biology/primitive-streak">‘primitive streak’</a> appears, which is the first sign of an embryo’s developing nervous system. The rule also identified the point at which the embryo shows signs of individuation, because it is no longer possible for the embryo to <a href="https://www.vcrmed.com/fertility-treatment/monozygotic-twins/">split into twins</a> after 14 days. Some people reason that due to these events, it is at this stage that a moral being comes into existence, and it would not be ethical to perform research on embryos after this time. </p>
<p>There has been increasing pressure from some researchers to <a href="https://link.springer.com/article/10.1007/s40778-018-0135-7">remove the 14-day rule</a>, or at least <a href="https://www.bmj.com/company/newsroom/extend-14-day-human-embryo-research-limit-to-28-days-urges-ethicist/">extend it,</a> as it prevents critical research from being undertaken. Extending the rule would allow important research into early human development to be done. <a href="https://www.cell.com/stem-cell-reports/fulltext/S2213-6711(21)00263-0">The new guidelines</a> make it possible to do research on embryos older than 14 days if the approval processes of the relevant ethics committees are followed. </p>
<p>A significant problem, however, is that there is no longer any limit on the time frame for research. Would it be permissible to do research on human embryos that are 20 days old or 40 days old? The guidelines specify no limit. The longer a human embryo is allowed to grow, the more recognisably human it becomes. At what point would we regard the research unethical, and at what point does the moral cost outweigh the benefits of research? </p>
<h2>What the law says</h2>
<p>Countries around the world take a <a href="https://www.futuremedicine.com/doi/10.2217/rme-2019-0138">variety of approaches</a> to human embryo research. Some – like Italy and Germany – don’t allow it at all. Others, like the UK, allow research to continue until the embryo is 14 days old, after which it must be destroyed. There are also some which permit embryo research without identifying a limit. Some, like the US, do not have any law regulating it (but there are <a href="http://www.sciencepolicyjournal.org/uploads/5/4/3/4/5434385/wallace_2017.pdf">guidelines</a> which contain reference to the 14-day rule). </p>
<p>In South Africa, reference to the rule is found in the <a href="https://www.up.ac.za/media/shared/12/ZP_Files/health-act.zp122778.pdf">National Health Act (2003)</a>, which states that human embryo research may only be done with permission of the minister, and that the embryos must not be older than 14 days. </p>
<p>International guidelines are not legally binding. But the effect of the revised guidelines is that the international standard for best practice in scientific research has now changed. This means that countries which have implemented the rule in their laws will need to revise them so that they are in line with best practice in science. </p>
<h2>The future of human embryo research</h2>
<p>Human embryo research is a sensitive topic because people are divided on the <a href="https://www.rbmojournal.com/article/S1472-6483(10)61722-1/pdf">moral status of the human embryo</a>. Some people believe that the embryo, as the earliest form of human life, should be protected and not subjected to research at all. Others believe that while an embryo has some moral status, it cannot be protected in the same way as humans are, and may be used for some important research which could ultimately benefit people. </p>
<p>The decision to discard the 14-rule appears to have been made without public input. That does not encourage the public to trust in science, and public engagement should have come before such an an important rule was changed. </p>
<p>There are a number of approaches to working with the revised guidance. Bioethicist Françoise Baylis has suggested that <a href="https://theconversation.com/stem-cell-research-community-drops-14-day-limit-on-human-embryo-research-161616">project-specific time limits should be identified</a>, based on the minimum amount of time required to address the stated research objectives. This would mean that some research would still be subject to the 14-day limit, while other studies would be permitted to exceed it. Another approach would be to keep the 14-day limit as the norm, and consider applications to exceed it <a href="https://www.nature.com/articles/d41586-018-05586-z">case by case</a>. Or the limit could be <a href="https://dx.doi.org/10.15252/emmm.201809437">extended to 28 days</a>. </p>
<p>The coming conversations surrounding embryo research will prove to be very important. The proverbial genie is out of the bottle, and public debate is crucial.</p><img src="https://counter.theconversation.com/content/162305/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sheetal Soni does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The rule, which previously acted as the upper time limit on human embryo research, has been dropped, paving the way for research on older human embryos.Sheetal Soni, Researcher, Lecturer, Attorney, University of KwaZulu-NatalLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1616112021-05-27T10:38:23Z2021-05-27T10:38:23ZGrowing human embryos in the lab and why scientists just tweaked the rules – podcast<figure><img src="https://images.theconversation.com/files/402947/original/file-20210526-21-1u5rsa0.jpg?ixlib=rb-1.1.0&rect=0%2C52%2C4865%2C3540&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Illustration of an early stage human embryo. </span> <span class="attribution"><span class="source">nobeastsofierce via Shutterstock</span></span></figcaption></figure><p>In this week’s episode of <a href="https://theconversation.com/uk/topics/the-conversation-weekly-98901">The Conversation Weekly</a>, as new scientific guidelines are released on embryo research and the use of stem cells, we talk to experts about what’s changed – including a recommendation to relax the 14-day time limit for human embryo research. And we hear about a wave of romantic comedy films emerging from South Africa that are re-imagining the city of Johannesburg. </p>
<iframe src="https://embed.acast.com/60087127b9687759d637bade/60af6da2a7e7e20012444626?cover=true" frameborder="0" allow="autoplay" width="100%" height="110"></iframe>
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<p>It’s been five years since the last set of guidelines from the International Society for Stem Cell Research (ISSCR) were published. Since then, scientists have made significant developments in stem cell and embryo research – including the creation of <a href="https://theconversation.com/researchers-have-grown-human-embryos-from-skin-cells-what-does-that-mean-and-is-it-ethical-157228">human embryo models</a> and the <a href="https://theconversation.com/first-human-monkey-embryos-created-a-small-step-towards-a-huge-ethical-problem-159355">first human-monkey embryos</a>. </p>
<p>Now, <a href="https://www.isscr.org/policy/guidelines-for-stem-cell-research-and-clinical-translation">new ISSCR guidelines</a> have just been published. One of the most significant shifts concerns what’s called the 14-day rule. This has prohibited researchers – by law in some countries, <a href="https://www.legislation.gov.uk/ukpga/2008/22">such as the UK</a> – from growing human embryos in the lab for more than 14 days. The revised guidelines no longer strictly prohibit this, rather they recommend that a panel of experts should approve research proposals on a case-by-case basis. And they also call on countries to start national conversations about the issue and whether such research should be allowed.</p>
<p>The ISSCR guidelines are not international law, but their recommendations are used by countries around the world to guide their own national regulations and legislation. And also by countries that don’t have laws governing this kind of research using embryos and stem cells. </p>
<p>For this episode, we talk to Megan Munsie, deputy director for the Centre for Stem Cell Systems at the University of Melbourne and one of the scientists who sat on the panel that reviewed the guidelines. She tells us there have been advances that mean that we can now grow sperm-egg embryos for more than 14 days, “and the guideline is calling for consideration about whether we should”. She says that in a very small number of cases there may be justification for doing so.</p>
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Read more:
<a href="https://theconversation.com/new-global-guidelines-for-stem-cell-research-aim-to-drive-discussions-not-lay-down-the-law-161578">New global guidelines for stem cell research aim to drive discussions, not lay down the law</a>
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<p>The guidelines stress that doing research using human embryos should be a last resort – only turned to if there is no other way to get the same information. And this is where human embryo models come in. We speak to Jun Wu, assistant professor in molecular biology at the University of Texas Southwestern Medical Center, whose lab recently <a href="https://www.nature.com/articles/s41586-021-03356-y%C2%A0">made a breakthrough</a> by creating a human embryo model, called a blastoid, using human pluripotent stem cells. He explains how he did it and why this kind of research is so important to help understand what happens in the earliest stages of pregnancy, when the embryo implants into the womb lining. “This process of implantation is essentially a black box,” Wu says. “We don’t know much about it.” </p>
<p>And we speak to César Palacios-González senior research fellow in practical ethics at the Uehiro Centre for Practical Ethics at the University of Oxford, about some of the moral dilemmas that the 14-day rule and research using human embryos provoke. “Philosophers like myself love thinking about these things,” he told us. “The main ethical question that people have in mind is the moral value that human embryos have, and if actually we should even be carrying out this particular type of research.” He explains the arguments on both sides. </p>
<p>In our second story (at 25:20), we head to South Africa, where a wave of romantic comedies has hit the big screen in recent years. Many of these films are set in Johannesburg – a city that’s had a violent portrayal in film. Pier Paolo Frassinelli, professor of communication and media studies at the University of Johannesburg has <a href="https://www.tandfonline.com/doi/abs/10.1080/02533952.2021.1899734?journalCode=rsdy20">just published new research</a> looking at the way Black South African filmmakers are now portraying Joburg in a different light through these romcoms. “Even though the films try to present a certain image of upper-middle-class Johannesburg, the films cannot quite push away the tensions, the contradictions, the complexities of the city,” Frassinelli tells us. </p>
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Read more:
<a href="https://theconversation.com/south-africas-romcom-revolution-and-how-it-reimagines-joburg-159255">South Africa's romcom revolution and how it reimagines Joburg</a>
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<p>And Wale Fatade, commissioning editor at The Conversation in Lagos, Nigeria, gives us his recommended reading. </p>
<p>The Conversation Weekly is produced by Mend Mariwany and Gemma Ware, with sound design by Eloise Stevens. Our theme music is by Neeta Sarl. You can find us on Twitter <a href="https://twitter.com/TC_Audio">@TC_Audio</a>, on Instagram at <a href="https://www.instagram.com/theconversationdotcom/?hl=en">theconversationdotcom</a>. or via email on podcast@theconversation.com. You can also sign up to <a href="https://theconversation.com/newsletter?utm_campaign=PodcastTCWeekly&utm_content=newsletter&utm_source=podcast">The Conversation’s free daily email here</a>.</p>
<p>A transcript of this episode will be available soon. </p>
<p>News clips in this episode are from <a href="https://www.youtube.com/watch?v=GF1ZoSLMZVo">ABC News Australia</a>, <a href="https://www.youtube.com/watch?v=C9V3mqswbv0">AP News</a>, <a href="https://www.youtube.com/watch?v=oBMDMXDftnM">Rififi Pictures Trailer: Tell me Sweet Something</a>, <a href="https://www.youtube.com/watch?v=teS_BiLulVs">Showmax, Trailer: Happiness is a Four Letter Word</a>, <a href="https://www.youtube.com/watch?v=9gcty69_R74">Mrs Right Guy Official, Trailer: Mrs Right Guy</a>, <a href="https://www.youtube.com/watch?v=DyLUwOcR5pk">Sony Picture Entertainment: District 9 - Official Trailer</a> and <a href="https://www.youtube.com/watch?v=t6EohBg3QoY">Movieclips Classic Trailers, Trailer: Jerusalema</a>. </p>
<p><em>You can listen to The Conversation Weekly via any of the apps listed above, our <a href="https://feeds.acast.com/public/shows/60087127b9687759d637bade">RSS feed</a>, or find out how else to <a href="https://theconversation.com/how-to-listen-to-the-conversations-podcasts-154131">listen here</a>.</em></p><img src="https://counter.theconversation.com/content/161611/count.gif" alt="The Conversation" width="1" height="1" />
Plus, how a new wave of South African romcoms is reimagining Johannesburg. Listen to episode 17 of The Conversation Weekly podcast.Gemma Ware, Head of AudioDaniel Merino, Associate Breaking News Editor and Co-Host of The Conversation Weekly PodcastLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1615782021-05-27T02:32:53Z2021-05-27T02:32:53ZNew global guidelines for stem cell research aim to drive discussions, not lay down the law<figure><img src="https://images.theconversation.com/files/403016/original/file-20210527-23-n1k71z.jpg?ixlib=rb-1.1.0&rect=16%2C0%2C5339%2C3420&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Paul Sakuma/AP</span></span></figcaption></figure><p>The International Society for Stem Cell Research (ISSCR) today <a href="https://www.isscr.org/policy/guidelines-for-stem-cell-research-and-clinical-translation">released updated guidelines</a> for stem cell research and its translation to medicine. </p>
<p>Developed in response to recent scientific and clinical advances, the revised guidelines provide a series of detailed and practical recommendations that set out global standards for how these emerging technologies should be harnessed.</p>
<p>Stem cell research has <a href="https://www.closerlookatstemcells.org/from-lab-to-you/stem-cells-and-research/">huge potential</a> — it could help pave the way for new therapies for ailments ranging from Parkinson’s disease to childhood kidney failure. But scientific advances in this field can present unique ethical and policy issues beyond that seen in other areas of medical research.</p>
<p>The science is advancing at breakneck pace. Just in the past couple of months, we have seen <a href="https://theconversation.com/researchers-have-grown-human-embryos-from-skin-cells-what-does-that-mean-and-is-it-ethical-157228">model human embryos grown from skin cells</a>, and the creation of <a href="https://theconversation.com/as-scientists-move-closer-to-making-part-human-part-animal-organisms-what-are-the-concerns-159049">human-monkey embryos</a> for use in research. </p>
<p>The ISSCR has long recognised the need to set clear ethical boundaries for stem cell research. Previous guidelines have provided advice on techniques such as the use of human embryos to create stem cells, and set the required standards when using these technologies to create new medicines. </p>
<p>They have also explicitly banned certain practices, such as <a href="https://theconversation.com/dolly-the-sheep-and-the-human-cloning-debate-twenty-years-later-63712">reproductive cloning</a> and the <a href="https://theconversation.com/private-clinics-peddling-of-unproven-stem-cell-treatments-is-unsafe-and-unethical-80608">sale of unproven therapies that claim to be made of stem cells</a>. </p>
<p>The 2021 guidelines — an update on the previous version, released in 2016 — aim to set standards for the many recent advances in stem cell and human embryo research. These include “chimeric” embryos containing cells from humans and other animals, “organoids” grown from stem cells to create tissue that resembles particular human organs, and “models” of human embryos — arrangements of human cells that mimic the early stages of embryo development. </p>
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<p><a href="https://theconversation.com/growing-human-embryos-in-the-lab-and-why-scientists-just-tweaked-the-rules-podcast-161611"><img src="https://images.theconversation.com/files/403160/original/file-20210527-15-1crjmoe.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=212&fit=crop&dpr=1" alt="Promotional image for podcast" width="100%"></a>
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<h2>So what’s new?</h2>
<p>The guidelines contain a clear requirement for certain new stem cell research approaches only to be conducted after a specialised review process. This review should be independent of the researchers, and include community members as well as people with expertise in the relevant science, ethics and law. </p>
<p>This is beyond what is typically required by a university or research institute where medical research is conducted. Besides evaluating the merit of the proposed research, the new reviews should also consider whether there are alternative ways to do the research, the source of stem cells and how they were obtained, and the minimum time required to reach the research goals, particularly in relation to human embryo and related research.</p>
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<img alt="Human embryos" src="https://images.theconversation.com/files/403024/original/file-20210527-13-gn1h3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/403024/original/file-20210527-13-gn1h3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=422&fit=crop&dpr=1 600w, https://images.theconversation.com/files/403024/original/file-20210527-13-gn1h3j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=422&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/403024/original/file-20210527-13-gn1h3j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=422&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/403024/original/file-20210527-13-gn1h3j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=530&fit=crop&dpr=1 754w, https://images.theconversation.com/files/403024/original/file-20210527-13-gn1h3j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=530&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/403024/original/file-20210527-13-gn1h3j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=530&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The new guidelines call for a debate on whether to extend the current 14-day limit for experimentation on human embryos.</span>
<span class="attribution"><span class="source">Oregon Health Sciences/AP</span></span>
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<p>Specialised review is not a new concept. The previous guidelines required it when researchers made stem cells from human embryos or sought to culture human embryos in the lab. But now researchers will now also be required to seek higher review when they create model embryos such as <a href="https://theconversation.com/researchers-have-grown-human-embryos-from-skin-cells-what-does-that-mean-and-is-it-ethical-157228">blastoids</a>, or study the development of animal-human embryos in animal wombs. </p>
<p>Researchers developing <a href="https://theconversation.com/3-parent-ivf-could-prevent-illness-in-many-children-but-its-really-more-like-2-002-parent-ivf-126591">new therapies for mitochondrial disease</a> will also be required to seek higher-level review before attempting to transfer to the uterus of a woman human embryos in which affected mitochondria (a part of the cell’s energy-production apparatus) have been replaced.</p>
<p>Importantly, the revised guidelines also clearly rule out certain activities. These continue to include reproductive cloning and attempts to form a pregnancy in a woman from <a href="https://theconversation.com/chinas-failed-gene-edited-baby-experiment-proves-were-not-ready-for-human-embryo-modification-128454">genetically “edited” human embryos</a> or from model embryos made from stem cells. Prohibited activities also now include using eggs and sperm made from human stem cells for reproduction, or transferring a human-animal chimeric embryo into the uterus of a woman or an ape.</p>
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Read more:
<a href="https://theconversation.com/chinas-failed-gene-edited-baby-experiment-proves-were-not-ready-for-human-embryo-modification-128454">China's failed gene-edited baby experiment proves we're not ready for human embryo modification</a>
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<p>The guidelines also call for a public conversation about whether we should allow limited lab research on human embryos beyond the <a href="https://www.nature.com/articles/d41586-018-05586-z">existing limit of 14 days’ development</a>. Historically, it has not been possible to support human embryonic development outside the body beyond this stage. However, recent advances in human embryo culture raise the possibility that this may now be technically feasible. </p>
<p>Extending the amount of time in culture - in terms of days - could potentially yield new treatments for developmental conditions or infertility, but will also raise concerns about whether possible benefits justify this research. Any decisions to overturn this long-held signpost would need to be carefully deliberated and take into consideration existing law, community values and discussion around what the new limit should be. </p>
<p>The revised guidelines also reinforce the need for informed consent for the collection of human material and participation in stem cell clinical trials, and reiterate that no new stem cell treatment should be made available before it is tested for safety and effectiveness in well-designed and publicly visible clinical trials. The ISSCR continues to condemn the commercial use of unproven stem cell treatments.</p>
<h2>Why do these guidelines matter?</h2>
<p>While stem cell science holds much promise, it is paramount that research is scientifically and ethically rigorous, with appropriate oversight, transparency and public accountability.</p>
<p>The fact these guidelines are driven by experts – including stem cell scientists, doctors, ethicists, lawyers and industry representatives – from across 14 countries indicates a deep sense of responsibility and integrity within the research community, and a desire to ensure science remains in step with community values.</p>
<p>However, these guidelines are recommendations, not laws. </p>
<p>Researchers will need to abide by their respective national or state regulations and ethical standards. Some countries already have regulatory frameworks that are consistent with the new recommendations. In other places there is no national guidance around laboratory and clinical stem cell research at all, or existing law touches on some but not all of the emerging applications of stem cell research. </p>
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Read more:
<a href="https://theconversation.com/as-scientists-move-closer-to-making-part-human-part-animal-organisms-what-are-the-concerns-159049">As scientists move closer to making part human, part animal organisms, what are the concerns?</a>
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<p>For example, in Australia there is already an established pathway for higher-level review of embryo models created from stem cells. However, the same legislation currently bans any attempt to use mitochondrial transfer techniques to create embryos for research or to achieve a pregnancy – both of which are permissible under the new ISSCR guidelines. </p>
<p>Rather than attempting to impose a set of hard-and-fast rules on an ever-evolving research field, the new guidelines attempt to address emerging issues and drive important discussions at domestic level. Ultimately, it is the public and the regulators who will need to set the standards.</p><img src="https://counter.theconversation.com/content/161578/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Megan Munsie has received funding from the Australian Research Council and the Medical Research Future Fund. She is a non-executive director with the National Stem Cell Foundation of Australia, Vice-President of the Australasian Society for Stem Cell Research, member of the MRFF Stem Cell Therapies Mission Expert Advisory Panel and Chair of the Ethics Committee of the International Society for Stem Cell Research (ISSCR) and a member of the taskforce that produced the 2021 ISSCR Guidelines.</span></em></p><p class="fine-print"><em><span>Melissa Little currently receives funding from the NHMRC, MRFF, ARC, PKD USA, PKD Australia. She also has contract research income. She is affiliated with Murdoch Childrens Research Institute and the University of Melbourne. She is the incoming President of the International Society for Stem Cell Research. She also is a Board Member of Research Australia and the Co-Chair of the MRFF Stem Cell Therapies Mission Expert Advisory Panel.</span></em></p>The International Society for Stem Cell Research’s newly released guidelines aim to address new ethical challenges posed by stem cell advances such as model embryos and human-monkey hybrid embryos.Megan Munsie, Head Ethics, Education & Policy in Stem Cell Science and Convener of Stem Cells Australia, The University of MelbourneMelissa Little, Theme Director, Cell Biology, Murdoch Children's Research InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1572282021-03-17T18:59:28Z2021-03-17T18:59:28ZResearchers have grown ‘human embryos’ from skin cells. What does that mean, and is it ethical?<figure><img src="https://images.theconversation.com/files/390046/original/file-20210317-23-d98z9m.jpeg?ixlib=rb-1.1.0&rect=2%2C2%2C374%2C280&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A human blastocyst. Researchers have now created 'model' versions of this early embryonic structure by reprogramming human skin cells.</span> <span class="attribution"><span class="source">Harimiao/Wikimedia Commons</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>Researchers have successfully grown model versions of early human embryos by “reprogramming” cells from human skin. The breakthrough potentially opens up new ways to study the earliest phases of human development, learn more about developmental disorders, infertility and genetic diseases, and perhaps even improve the success of IVF treatment. </p>
<p>In a study <a href="https://www.nature.com/articles/s41586-021-03372-y">published in Nature today</a>, a team led by our colleague Jose Polo discovered that when skin cells are treated in a particular way, 3D structures similar to early human embryos form. A <a href="https://www.nature.com/articles/s41586-021-03356-y%C2%A0">US-Chinese research group led by Jun Wu</a> also reported a similar feat, creating structures that resemble a very early stage of the embryo called a “blastocyst”. </p>
<p>While this is an exciting scientific advance, it will also be vital to consider the ethics behind this and other emerging approaches to modelling human development.</p>
<h2>Growing ‘human organs’ in a dish</h2>
<p>Over the past 50 years, research has revealed a lot about how the different organs of our bodies are formed, and what happens at a cellular level during disease and illness.</p>
<p>Many of these insights came from recent breakthroughs in stem cell research, in which scientists can effectively create 3D models, or miniature organs from human tissue, that resemble the structure and function of particular organs in the body.</p>
<p>These structures, known as organoids, have been used to understand <a href="https://theconversation.com/kidney-failing-grow-a-new-one-48834">how kidneys form</a>, learn what happens to the developing brain <a href="https://www.npr.org/sections/health-shots/2016/11/13/501257433/minibrains-could-help-drug-discovery-for-zika-and-for-alzheimers">during a Zika infection</a>, and to test an array of therapies to find the best ways to <a href="https://www.newscientist.com/article/2219051-mini-organs-grown-from-tumour-cells-can-help-us-choose-the-best-chemo/">halt the progression of bowel or pancreatic cancers</a>.</p>
<p>These advances rely on the innate ability of stem cells to organise themselves into characteristic anatomical and functional features when given the right conditions. Researchers can use stem cells taken from a patient’s own tissue to create 3D models of the organ from which those cells were taken. Many, but not all, organs have their <a href="https://www.sciencemag.org/news/2017/08/scientist-building-miniature-guts-livers-and-lungs-could-save-your-life-one-day">own specific stem cells</a>.</p>
<p>Other approaches use a more basic type of stem cell, called “pluripotent stem cells”, obtained from human embryos or created in the lab from a skin or blood cell through a process called reprogramming. This approach means researchers can create stem cells then coax them to mimic how a particular organ forms. While these 3D structures are often referred to as mini-organs, they usually only replicate <a href="https://www.sciencemag.org/news/2017/03/lab-grown-mini-organs-help-model-disease-test-new-drugs">certain aspects of the organ’s architecture and function</a>.</p>
<h2>Exploring the developmental ‘black box’</h2>
<p>While stem cells can reveal much about how organs form, research so far has provided little insight into the complex interplay between the developing embryo and the lining of the womb required to establish and maintain a pregnancy.</p>
<p>This period, covering the first few weeks after implantation, is sometimes referred to as the “black box” of development, as it is extremely difficult to access reproductive material at this early stage. </p>
<p>What’s more, even in countries that allow research on donated IVF embryos, studies are usually limited to just the <a href="https://theconversation.com/destroying-research-embryos-within-14-days-limits-chance-of-medical-breakthroughs-71986">first 14 days</a> after fertilisation, and alternative animal models are of little value in revealing the unique process of human embryo implantation.</p>
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Read more:
<a href="https://theconversation.com/destroying-research-embryos-within-14-days-limits-chance-of-medical-breakthroughs-71986">Destroying research embryos within 14 days limits chance of medical breakthroughs</a>
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<p>With miscarriages <a href="https://theconversation.com/miscarriages-affect-1-in-6-pregnancies-we-need-better-investigations-and-treatments-120672">affecting 1 in 6 pregnancies</a>, and high rates of infertility due to failure of embryos to implant, we need better ways to understand and address these devastating outcomes.</p>
<h2>Creating 3D models could provide answers</h2>
<p>Human pluripotent stem cells have been used to create structures that <a href="https://www.genengnews.com/news/stem-cell-based-human-gastruloid-allows-peek-into-black-box-of-embryonic-development/">replicate specific aspects of development</a>, but not the entire embryo, at and immediately after implantation.</p>
<p>The new discoveries reported today offer another way to explore development around the time of implantation. <a href="https://www.the-scientist.com/news-opinion/early-embryo-models-generated-from-mouse-stem-cells-66583">Unlike animal studies</a>, in which the 3D model embryo is compiled by assembling cells from pre-established stem cell lines, this approach relied on adapting the technology used to create induced pluripotent stem cells. </p>
<p>In the approach taken by Polo’s group, skin cells from adult donors were first treated to “reprogram” them over several weeks, effectively resetting their development back to an earlier, less specialised state. </p>
<p>The researchers then grew these cells in 3D clusters for six days, after which some of them formed structures very similar to “blastocysts” — the final stage of embryonic development before implantation. These lab-grown structures are dubbed “iBlastoids”. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/390044/original/file-20210317-23-7jje8o.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Graphic of human and lab-grown blastocysts and iBlastoids" src="https://images.theconversation.com/files/390044/original/file-20210317-23-7jje8o.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/390044/original/file-20210317-23-7jje8o.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=420&fit=crop&dpr=1 600w, https://images.theconversation.com/files/390044/original/file-20210317-23-7jje8o.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=420&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/390044/original/file-20210317-23-7jje8o.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=420&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/390044/original/file-20210317-23-7jje8o.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=528&fit=crop&dpr=1 754w, https://images.theconversation.com/files/390044/original/file-20210317-23-7jje8o.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=528&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/390044/original/file-20210317-23-7jje8o.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=528&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Growth process for human blastocysts (top) and iBlastoids grown in the lab from human skin cells (bottom).</span>
<span class="attribution"><span class="source">Monash Biomedicine Discovery Institute</span></span>
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<p>The second group cultured human pluripotent stem cell lines - both embryonic stem cell lines and those created through reprogramming - in a slightly different two-step process to encourage 3D clusters to form. They called their structures “blastoids”.</p>
<p>While iBlastoids and blastoids both seem to be structurally and functionally similar to real blastocysts, it is not yet clear exactly how closely they resemble true embryos formed by a sperm and an egg. While the models were shown to share gene patterns and respond in culture in ways characteristic of actual embryos, researchers also saw significant anomalies, such as unsynchronised growth and cells that are not usually present in an embryo.</p>
<h2>Ethical issues</h2>
<p>It can be hard to decide where we should draw the ethical line between using stem cells to grow “model embryos”, and research on real human embryos created by IVF.</p>
<p>Some people may see no ethical distinction between these two processes at all. Others might support the creation of models but only for specific types of research, such as to understand the origins of infertility or genetic disease. Those people may draw the line at attempts to use these models to test gene-editing techniques to correct genetic diseases rather than simply study them.</p>
<p>When considering these ethical issues, we need to address three important questions: </p>
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<li><p>what are the likely benefits? </p></li>
<li><p>can the scientific goals be met by other means? </p></li>
<li><p>what is the appropriate oversight process?</p></li>
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<p>While 3D models are not human embryos, existing national laws around the creation and use of IVF embryos may provide useful guidance and oversight. Many countries have specialised review committees to provide independent advice to researchers and ensure ethical transparency.</p>
<p>Above all, we need to approach this issue carefully. The science is complex, and likely to trigger many of the same concerns raised 25 years ago by breakthroughs in <a href="https://theconversation.com/dolly-the-sheep-and-the-human-cloning-debate-twenty-years-later-63712">cloning technology</a>. One thing seems clear, just as it was back then: this new technology should only be used for laboratory research. Any attempt to use it to establish pregnancies in humans or animals must be strictly prohibited. </p>
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Read more:
<a href="https://theconversation.com/dolly-the-sheep-and-the-human-cloning-debate-twenty-years-later-63712">Dolly the Sheep and the human cloning debate - twenty years later</a>
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<p>The <a href="https://www.isscr.org/news-publicationsss/isscr-news-articles/article-detail/2020/01/16/isscr-statement-on-ethical-standards-for-stem-cell-based-embryo-models">International Society for Stem Cell Research will soon release a new set of guidelines</a> that are likely to provide more explicit recommendations for research in human embryo modelling. As it has done in the past for other ethically charged issues, this global approach is essential. There is too much at stake to ignore the complexities.</p><img src="https://counter.theconversation.com/content/157228/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Megan Munsie receives funding from the Australian Research Council and the Medical Research Future Fund. She is a non-executive director with the National Stem Cell Foundation of Australia, Vice-President of the Australasian Society for Stem Cell Research, Chair of the Ethics Committee of the International Society for Stem Cell Research and a member of the taskforce currently updating the ISSCR Guidelines.</span></em></p><p class="fine-print"><em><span>Helen Abud receives funding from the National Health and Medical Research Council, Cancer Australia, Cancer Council Victoria and the Australian Research Council. She is President of the Australian Society for Stem Cell Research</span></em></p>Two research groups have turned human skin cells into structures resembling an early-stage human embryo, paving the way for exciting new research avenues, and opening up some tricky ethical questions.Megan Munsie, Deputy Director - Centre for Stem Cell Systems and Head of Engagements, Ethics & Policy Program, Stem Cells Australia, The University of MelbourneHelen Abud, Professor, Head of the Department of Anatomy and Developmental Biology and Director of the Organoid Program, Monash Biomedicine Discovery Institute, Monash UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1284542019-12-06T03:52:51Z2019-12-06T03:52:51ZChina’s failed gene-edited baby experiment proves we’re not ready for human embryo modification<figure><img src="https://images.theconversation.com/files/305569/original/file-20191206-39018-1dfhe9r.jpg?ixlib=rb-1.1.0&rect=47%2C33%2C4446%2C2957&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The team used CRISPR on human embryos in a bid to render them resistant to HIV infection. But instead, they generated different mutations, about which we know nothing.</span> <span class="attribution"><span class="source">SHUTTERSTOCK</span></span></figcaption></figure><p>More than a year ago, the world was shocked by Chinese biophysicist He Jiankui’s attempt to use CRISPR technology to modify human embryos and make them resistant to HIV, which led to the birth of twins Lulu and Nana.</p>
<p>Now, crucial details have been revealed in a recent <a href="https://www.technologyreview.com/s/614764/chinas-crispr-babies-read-exclusive-excerpts-he-jiankui-paper/">release of excerpts</a> from the study, which have triggered a series of concerns about how Lulu and Nana’s genome was modified.</p>
<h2>How CRISPR works</h2>
<p>CRISPR is a technique that allows scientists to make precise edits to any DNA by altering its sequence.</p>
<p>When using CRISPR, you may be trying to “knock out” a gene by rendering it inactive, or trying to achieve specific modifications, such as introducing or removing a desired piece of DNA.</p>
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<a href="https://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">What is CRISPR gene editing, and how does it work?</a>
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<p>Gene editing with the CRISPR system relies on an association of two molecules. One is a protein, called Cas9, that is responsible for “cutting” the DNA. The other molecule is a short RNA (ribonucleic acid) molecule which works as a “guide” that brings Cas9 to the position where it is supposed to cut.</p>
<p>The system also needs help from the cells being edited. DNA damage is frequent, so cells regularly have to repair the DNA lesions. The associated repair mechanisms are what introduce the deletions, insertions or modifications when performing gene editing.</p>
<p><iframe id="tc-infographic-229" class="tc-infographic" height="580px" src="https://cdn.theconversation.com/infographics/229/1e1ccd9abbd9a92604e144561050c08a9c49d8b3/site/index.html" width="100%" style="border: none" frameborder="0"></iframe></p>
<h2>How the genomes of Lulu and Nana were modified</h2>
<p>He Jiankui and his colleagues were targeting a gene called CCR5, which is necessary for the HIV virus to enter into white blood cells (<a href="https://www.medicalnewstoday.com/articles/320987.php">lymphocytes</a>) and infect our body. </p>
<p>One variant of CCR5, called CCR5 Δ32, is missing a particular string of 32 “letters” of DNA code. This variant naturally occurs in the human population, and results in a high level of resistance to the most common type of HIV virus.</p>
<p>The team wanted to recreate this mutation using CRISPR on human embryos, in a bid to render them resistant to HIV infection. But this did not go as planned, and there are several ways they may have failed.</p>
<p>First, despite claiming in the abstract of their unpublished article that they reproduced the human CCR5 mutation, in reality the team tried to modify CCR5 <em>close</em> to the Δ32 mutation. </p>
<p>As a result, they generated different mutations, of which the effects are unknown. It may or may not confer HIV resistance, and may or may not have other consequences. </p>
<p>Worryingly, they did not test any of this, and went ahead with implanting the embryos. This is unjustifiable.</p>
<h2>The mosaic effect</h2>
<p>A second source of errors could have been that the editing was not perfectly efficient. This means that not all cells in the embryos were necessarily edited. </p>
<p>When an organism has a mixture of edited and unedited cells, it is called a “mosaic”. While the available data are still limited, it seems that both Lulu and Nana are mosaic. </p>
<p>This makes it even less likely that the gene-edited babies would be resistant to HIV infection. The risk of mosaicism should have been another reason not to implant the embryos.</p>
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Read more:
<a href="https://theconversation.com/designer-babies-wont-be-common-anytime-soon-despite-recent-crispr-twins-108342">'Designer' babies won't be common anytime soon – despite recent CRISPR twins</a>
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<p>Moreover, editing can have unintended impacts elsewhere in the genome. </p>
<p>When designing a CRISPR experiment, you choose the “guide” RNA so that its sequence is unique to the gene you are targeting. However, “off-target” cuts can still happen elsewhere in the genome, at places that have a similar sequence. </p>
<p>He Jiankui and his team tested cells from the edited embryos, and reported only one off-target modification. However, that testing required sampling the cells, which were therefore no longer part of the embryos - which continued developing. </p>
<p>Thus, the remaining cells in the embryos had not been tested, and may have had different off-target modifications. </p>
<p>This is not the team’s fault, as there will always be limitations in detecting off-target and mosaicism, and we can only get a partial picture. </p>
<p>However, that partial picture should have made them pause.</p>
<h2>A bad idea to begin</h2>
<p>Above, we have described several risks associated with the modifications made on the embryos, which could be passed on to future generations. </p>
<p>Embryo editing is only ethically justifiable in cases where the benefits clearly outweigh the risks.</p>
<p>Technical issues aside, the researchers did not even address an unmet medical need. </p>
<p>While the twins’ father was HIV-positive, there is already a well-established way to prevent an HIV-positive father from infecting embryos. This “<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4779710/">sperm washing</a>” method was actually used by the team. </p>
<p>The only benefit of the attempted gene modification, if proven, would have been a reduced risk of HIV infection for the twins later in life.</p>
<p>But there are safer existing ways to control the risk of infection, such as condoms and mandatory testing of blood donations.</p>
<h2>Implications for gene editing as a field</h2>
<p>Gene editing has endless applications. It can be used to <a href="https://www.nature.com/articles/d41586-019-02770-7">make plants such as the Cavendish banana more resistant to devastating diseases</a>. It can play an important role in the adaptation to climate change. </p>
<p>In health, we are already seeing <a href="https://www.npr.org/sections/health-shots/2019/11/19/780510277/gene-edited-supercells-make-progress-in-fight-against-sickle-cell-disease">promising results</a> with the editing of somatic cells (that is, non-heritable modifications of the patient’s own cells) in beta thalassemia and sickle cell disease.</p>
<p>However, we are just not ready for human embryo editing. Our techniques are not mature enough, and no case has been made for a widespread need that other techniques, such as preimplantation genetic testing, could not address.</p>
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Read more:
<a href="https://theconversation.com/experts-call-for-halt-to-crispr-editing-that-allows-gene-changes-to-pass-on-to-children-113463">Experts call for halt to CRISPR editing that allows gene changes to pass on to children</a>
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<p>There is also much work still needed on governance. There have been individual calls for a moratorium on embryo editing, and expert panels from the <a href="https://www.nature.com/articles/d41586-019-00942-z">World Health Organisation</a> to <a href="https://en.unesco.org/news/unesco-panel-experts-calls-ban-editing-human-dna-avoid-unethical-tampering-hereditary-traits">UNESCO</a>.</p>
<p>Yet, no consensus has emerged.</p>
<p>It is important these discussions move <a href="https://www.nature.com/articles/d41586-019-03525-0">in unison</a> to a second phase, where other stakeholders, such as patient groups, are more broadly consulted (and informed). Engagement with the public is also crucial. </p>
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<p><em>Correction: this article originally described RNA (ribonucleic acid) as a protein, rather than a molecule.</em></p><img src="https://counter.theconversation.com/content/128454/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dimitri Perrin has received funding from the Australian Research Council (ARC), the Australian-French Association for Innovation and Research (AFRAN), and the Advance Queensland programme.</span></em></p><p class="fine-print"><em><span>Gaetan Burgio receives funding from the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), the National Collaborative Research Infrastructure Strategy (NCRIS) via the Australian Phenomics Network (APN) ,Universities Australia and the Natural Science Foundation in China (NSFC).</span></em></p>A number of things may have gone wrong when researchers edited Chinese twins Lulu and Nana’s genome. Either way, the failed experiment is a cautionary tale for us all.Dimitri Perrin, Senior Lecturer, Queensland University of TechnologyGaetan Burgio, Geneticist and Group Leader, The John Curtin School of Medical Research, Australian National UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1219122019-08-15T11:14:47Z2019-08-15T11:14:47ZWhat’s the right way for scientists to edit human genes? 5 essential reads<figure><img src="https://images.theconversation.com/files/288064/original/file-20190814-136222-xtmn4o.jpg?ixlib=rb-1.1.0&rect=431%2C449%2C5290%2C3520&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Ethical frameworks, rules, laws: all try to have their say.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-prepares-special-media-growing-embryos-1447342460?src=XFXBbEV0tU5iihvrK1Vv0A-1-12">Tati9/Shutterstock.com</a></span></figcaption></figure><p>Since scientists first figured out how to edit genes with precision using a technology called CRISPR, they’ve been grappling with when and how to do it ethically. Is it reasonable to edit human genes with CRISPR? What about human genes in reproductive cells that pass the edits on to future generations?</p>
<p>The <a href="http://nationalacademies.org/gene-editing/international-commission/index.htm?_ga=2.266036175.1969896713.1565792406-1004430421.1565792406">International Commission on the Clinical Use of Human Germline Genome Editing</a> convened on Aug. 13 to hash out guidelines about editing human embryos. The goal is to provide a framework that researchers around the globe can consult to ensure their work is in line with scientific consensus.</p>
<p>An earlier U.S. National Academies committee had already released recommendations in 2017. They called for caution – but were ambiguous enough for Chinese scientist He Jiankui to suggest he’d followed them even as he produced <a href="https://theconversation.com/how-a-scientist-says-he-made-a-gene-edited-baby-and-what-health-worries-may-ensue-107764">twin girls with CRISPR-edited genomes</a> late last year.</p>
<p>Here are five stories from our archive that explore how to ethically develop and regulate a potentially risky new technology.</p>
<h2>1. A voluntary pause</h2>
<p>No one denies the power of the CRISPR editing tool. It could allow doctors to one day cure genetic diseases, whether in adults who are living with medical conditions or in embryos that have not yet even been born. But there’s a lot of lab work yet to be done, as well as many conversations to be had, about the right way to proceed.</p>
<p>In 2015, a group of prominent scientists called for a voluntary freeze on germline editing – that is, changing sperm, eggs or embryos – until ethical issues could be resolved.</p>
<p>Chemical biologist <a href="https://theconversation.com/profiles/jeff-bessen-174263">Jeff Bessen</a> wrote that this approach has precedents in the scientific community, where many think it makes sense to take things slow and place “the right emphasis on <a href="https://theconversation.com/crispr-cas-gene-editing-technique-holds-great-promise-but-research-moratorium-makes-sense-pending-further-study-43371">safety and ethics without hampering research progress</a>.”</p>
<h2>2. Stringent hurdles before proceeding</h2>
<p>The National Academies’ 2017 report was meant to provide the scientific community with definitive guidance on the issue.</p>
<p><a href="https://theconversation.com/profiles/rosa-castro-303464">Rosa Castro</a>, a scholar of science and society, explained that the report gave the green light to modifying body cells and a yellow light to modifying reproductive cells that would allow the changes to be inherited by future progeny. The report’s goal was to ensure that “germline genome editing <a href="https://theconversation.com/safe-and-ethical-ways-to-edit-the-human-genome-73110">will be used only</a> to prevent a serious disease, where no reasonable alternatives exist, and under strong supervision.”</p>
<h2>3. Science marches on</h2>
<p>By later that year, a research group announced they’d successfully used CRISPR to modify human embryos, though the edited embryos weren’t implanted in women and were never born. Bioethics and public health professor <a href="https://scholar.google.com/citations?user=eXQqA5gAAAAJ&hl=en&oi=ao">Jessica Berg</a> wrote about the importance of <a href="https://theconversation.com/editing-human-embryos-with-crispr-is-moving-ahead-nows-the-time-to-work-out-the-ethics-81732">working out the ethical issues</a> of gene editing before researchers take the critical step of allowing modified embryos to develop and be born as babies.</p>
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<p>“Should there be limits on the types of things you can edit in an embryo? If so, what should they entail? These questions also involve deciding who gets to set the limits and control access to the technology.</p>
<p>"We may also be concerned about who gets to control the subsequent research using this technology. Should there be state or federal oversight? Keep in mind that we cannot control what happens in other countries.</p>
<p>"Moreover, there are important questions about cost and access.”</p>
</blockquote>
<h2>4. Babies born with edited genomes</h2>
<p>Most of the world reacted with shock in 2018 when a Chinese researcher announced he’d <a href="https://theconversation.com/how-a-scientist-says-he-made-a-gene-edited-baby-and-what-health-worries-may-ensue-107764">edited the germline cells of embryos</a> that went on to become twin baby girls. His stated goal was to protect them from HIV infection.</p>
<p>This development seemed to many researchers to be in violation of at least the spirit of the 2017 guidelines around human gene editing. Biomedical ethicist <a href="https://scholar.google.com/citations?user=yebS-LIAAAAJ&hl=en&oi=ao">G. Owen Schaefer</a> described the central objection: that the procedure was simply too risky, with the potential for unexpected and harmful health effects later in the girls’ lives outweighing any benefit.</p>
<p>He wrote that the “CRISPR babies” are “part of a disturbing pattern in reproduction: <a href="https://theconversation.com/rogue-science-strikes-again-the-case-of-the-first-gene-edited-babies-107684">rogue scientists bucking international norms</a> to engage in ethically and scientifically dubious reproductive research.”</p>
<h2>5. Rules and regs don’t guarantee ethical work</h2>
<p>Whatever the outcome of the current meeting, there may be a distinction between sticking to the rules and doing what’s right. Arizona State professor of life sciences <a href="https://theconversation.com/profiles/j-benjamin-hurlbut-608394">J. Benjamin Hurlbut</a> and applied ethicist <a href="https://scholar.google.com/citations?user=hOM4hNIAAAAJ&hl=en&oi=ao">Jason Scott Robert</a> underscored this point after Chinese scientist He Jiankui claimed he checked off the boxes laid out by the 2017 guidelines.</p>
<blockquote>
<p>“Public debate about the experiment should not make the mistake of <a href="https://theconversation.com/crispr-babies-raise-an-uncomfortable-reality-abiding-by-scientific-standards-doesnt-guarantee-ethical-research-108008">equating ethical oversight with ethical acceptability</a>. Research that follows the rules is not necessarily good by definition.”</p>
</blockquote>
<p>Guidelines and expectations can help define what the scientific community finds acceptable. But complying with the routines of oversight doesn’t guarantee a project is ethical. That’s a much more complicated question.</p>
<p><em>Editor’s note: This story is a roundup of articles from The Conversation’s archives.</em></p><img src="https://counter.theconversation.com/content/121912/count.gif" alt="The Conversation" width="1" height="1" />
CRISPR technology could have momentous effects if it’s used to edit genes that will be inherited by future generations. Researchers and ethicists continue to weigh appropriate guidelines.Maggie Villiger, Senior Science + Technology EditorLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/927942018-03-22T10:42:06Z2018-03-22T10:42:06ZMitochondria mutation mystery solved: Random sorting helps get rid of duds<figure><img src="https://images.theconversation.com/files/211047/original/file-20180319-31633-1sxhx6g.jpg?ixlib=rb-1.1.0&rect=2%2C16%2C590%2C453&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">When a cell divides, mitochondria are randomly allotted to the resulting new cells.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/wellcomeimages/25937295324">Odra Noel. Wellcome Images</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc/4.0/">CC BY-NC</a></span></figcaption></figure><p>You probably know about the 23 pairs of chromosomes safely stowed in your cells’ nuclei. That’s where the vast majority of your genes can be found. But there are 37 special genes — a very tiny fraction of the human genome — located in mitochondria, the structures inside your cells that breathe and produce energy.</p>
<p>Repeated copying of mitochondrial DNA introduces errors; if not kept in check, these mutations can give rise to incurable diseases like <a href="https://ghr.nlm.nih.gov/condition/leigh-syndrome">Leigh syndrome</a> and <a href="https://ghr.nlm.nih.gov/condition/leber-hereditary-optic-neuropathy">Leber’s optic neuropathy</a>. Worldwide, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737121/">more than 1 in 10,000</a> people are affected by disorders resulting from mitochondrial genome defects.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/211067/original/file-20180319-31614-14j8noq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/211067/original/file-20180319-31614-14j8noq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/211067/original/file-20180319-31614-14j8noq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=671&fit=crop&dpr=1 600w, https://images.theconversation.com/files/211067/original/file-20180319-31614-14j8noq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=671&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/211067/original/file-20180319-31614-14j8noq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=671&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/211067/original/file-20180319-31614-14j8noq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=843&fit=crop&dpr=1 754w, https://images.theconversation.com/files/211067/original/file-20180319-31614-14j8noq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=843&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/211067/original/file-20180319-31614-14j8noq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=843&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Mitochondrial DNA is inherited only from the mother, based on what mitochondria happen to be in the egg.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Mitochondrial_DNA_lg.jpg">National Human Genome Research Institute</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>Unlike nuclear chromosomes that we get from both parents, only mothers’ mitochondria are passed on to offspring. This makes the usual process of sexual recombination, in which pieces of maternal and paternal chromosomes combine to repair genome defects, impossible. For decades, biologists predicted that without this repair mechanism, mitochondrial genes should rapidly accumulate harmful mutations and <a href="http://rspb.royalsocietypublishing.org/content/early/2009/02/09/rspb.2008.1758.short">lose their function</a>.</p>
<p>Despite these predictions, mitochondrial disorders in humans, while debilitating, are relatively rare. A <a href="https://doi.org/10.1038/s41556-017-0017-8">set of experiments</a> with human embryos has recently found low levels of mitochondrial mutations in most of the studied cells, that, strikingly, were otherwise perfectly healthy. If mitochondrial defects are so common, what keeps them from reaching dangerous disease-causing levels?</p>
<h2>Dealing out mitochondria by chance</h2>
<p>A typical human cell contains hundreds of mitochondria. Each mitochondrion in turn has many genome copies jointly responsible for <a href="https://en.wikipedia.org/wiki/Cellular_respiration">energy production</a>. If only a few of these copies become faulty, the rest of the mitochondria can still produce enough energy, and the cell does perfectly fine. In fact, some of the most severe disorders develop only when <a href="https://doi.org/10.1111/dgd.12420">60 to 90 percent</a> of mitochondria within each cell become mutated. This means that low levels of mitochondrial mutations are essentially invisible, and can lurk within human cells for generations without causing a disease. </p>
<p>Recent <a href="https://doi.org/10.1534/genetics.117.300273">theoretical work</a> by <a href="https://scholar.google.com/citations?user=yi-SnYcAAAAJ&hl=en&oi=ao">me</a> and my colleagues predicted a number of solutions that likely evolved to expose and eventually eliminate these hidden defects. The general principle we proposed is based on simple sorting of healthy and faulty mitochondria.</p>
<p>Whenever a cell within a developing embryo divides, mitochondria are partitioned into the two daughter cells more or less randomly. By chance, one of the two daughter cells inherits more mitochondrial defects than the other. Initially, this difference is barely noticeable. But repeat the process many times and a sizeable proportion of all daughter cells will have enough mutations to ensure that the cell does not survive. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/211432/original/file-20180321-165583-11ye0fl.PNG?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/211432/original/file-20180321-165583-11ye0fl.PNG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/211432/original/file-20180321-165583-11ye0fl.PNG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=277&fit=crop&dpr=1 600w, https://images.theconversation.com/files/211432/original/file-20180321-165583-11ye0fl.PNG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=277&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/211432/original/file-20180321-165583-11ye0fl.PNG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=277&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/211432/original/file-20180321-165583-11ye0fl.PNG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=348&fit=crop&dpr=1 754w, https://images.theconversation.com/files/211432/original/file-20180321-165583-11ye0fl.PNG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=348&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/211432/original/file-20180321-165583-11ye0fl.PNG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=348&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The mitochondria make copies in preparation for a cell dividing. Which version winds up in each daughter cell is essentially random. By chance, the bottom cell has even fewer of the red version than the original cell.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1371/journal.pbio.2000410">Radzvilavicius et al</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>On the opposite side of the spectrum, this leaves cells that have fewer mutations even than the original cell that started dividing. This simple mechanism of cell division and random sorting of mitochondria can therefore produce cells packed with healthy mitochondria that can then go on to divide further and to eventually produce mutation-free reproductive cells (eggs in females).</p>
<p>But there’s more. Scientists now believe that many features of the human reproductive system evolved to increase the efficiency of this random mitochondrial sorting. For instance, mutations would pile up faster if both paternal and maternal mitochondria were inherited by the offspring – mixing of two unrelated types of organelles would make it easier for rare defects to hide. It is very likely that we inherit mitochondrial genes only from our mothers precisely because it slows down the accumulation of defective genes.</p>
<p>The number of genome replication cycles also matters, because new defects are introduced each time genes are copied. In a paper published in 2016, my colleagues and I suggest this <a href="https://doi.org/10.1371/journal.pbio.2000410">could be the reason</a> why the number of cell divisions to produce an egg in females is strictly limited to 24. In males – whose mitochondria are not transmitted to the offspring – sperm are produced continually with more than 400 cell divisions by the age of 30. By capping the number of times a cell divides before an egg is made, females reduce the risk of introducing new copying errors in their mitochondrial genes.</p>
<p>Likewise, theory predicts that random sorting of healthy and sickly mitochondria works best when the number of mitochondria in a cell is low. With only a few mitochondria, even slightly defective genes cannot hide; their harmful effects are immediately obvious at the level of the cell, which can then be eliminated.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/211068/original/file-20180319-31596-p49o9j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/211068/original/file-20180319-31596-p49o9j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/211068/original/file-20180319-31596-p49o9j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/211068/original/file-20180319-31596-p49o9j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/211068/original/file-20180319-31596-p49o9j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/211068/original/file-20180319-31596-p49o9j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/211068/original/file-20180319-31596-p49o9j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/211068/original/file-20180319-31596-p49o9j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Less hearty mitochondria may already be getting weeded out in an eight-cell embryo.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Embryo,_8_cells.jpg">eked</a></span>
</figcaption>
</figure>
<h2>Observing what theory predicts</h2>
<p>Confirming these predictions, a recent study involving human embryos has indeed discovered that the <a href="https://doi.org/10.1038/s41556-017-0017-8">number of mitochondria is sharply reduced throughout development</a> – from 1 million in a fertilized egg to only around 1,500 per cell in a 4-week-old embryo. Researchers also found that cells taken from older embryos had fewer mitochondrial mutations, meaning that cells with the most defects were somehow eliminated throughout embryonic development.</p>
<p>It is not yet clear how cells with the most mitochondrial mutations are selectively removed in human embryos. But because most of the harmful mutations were eliminated at the stage of embryonic development when cells start breathing more actively, scientists think that damaged mitochondria simply fail to produce enough energy for the cell to survive. </p>
<p>Many questions remain. For instance, why do cells with high levels of defective mitochondria sometimes escape these quality-control mechanisms, resulting in incurable disorders? Ultimately, greater understanding of these mechanisms should suggest better ways of estimating the risk of mitochondrial diseases, or even develop new interventions to prevent them completely.</p><img src="https://counter.theconversation.com/content/92794/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Arunas L. Radzvilavicius receives funding from Defense Advanced Research Projects Agency.</span></em></p>The genes in our cells’ mitochondria are passed on in a different way than the vast majority of our DNA. New studies shed light on how the unique process isn’t derailed by mutations.Arunas L. Radzvilavicius, Postdoctoral Researcher of Evolutionary Biology, University of PennsylvaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/848882017-10-01T23:10:07Z2017-10-01T23:10:07ZGenome editing of human embryos broadens ethics discussions<figure><img src="https://images.theconversation.com/files/188207/original/file-20170929-21094-1qm6boi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Scientists are using a powerful gene editing technique to understand how human embryos develop.</span> <span class="attribution"><span class="source">shutterstock</span></span></figcaption></figure><p>For several years, scientists have experimented on human embryos with a powerful genome editing tool called CRISPR to see if they could correct genetic errors or reduce the risk of disease. In September, <a href="https://www.crick.ac.uk/kathy-niakan">Kathy Niakan at the Francis Crick Institute</a> in London and her colleagues reported they had <a href="https://www.nature.com/nature/journal/vaop/ncurrent/full/nature24033.html">used this tool on human embryos for a very different purpose</a> — to better understand human development.</p>
<p>The use of CRISPR (pronounced “crisper”) to modify human embryos has prompted a healthy debate on the ethics of human genetic technologies. This tool is controversial, in part, because changes that are made to the embryo could be passed down to future generations. Niakan’s recent research is novel, and less ethically fraught than some other genome-editing research.</p>
<p>Research labs around the world are using CRISPR to selectively insert, delete or replace DNA with far greater precision and at a lower cost than other genome-editing techniques. Since 2015, five reports have detailed its use in human embryos to correct disease-causing mutations or create resistance to infectious disease. </p>
<p>Scientists have <a href="https://link.springer.com/article/10.1007%2Fs13238-015-0153-5">modified the genes responsible for β-thalassemia</a> (an inherited blood disorder), <a href="https://link.springer.com/article/10.1007%2Fs00438-017-1299-z">favism</a> (a reaction to eating fava beans), and a <a href="https://www.nature.com/nature/journal/v548/n7668/full/nature23305.html">type of heart disease</a>. Another experiment used CRISPR to introduce a mutation into a protein called CCR5 in an effort to <a href="http://europepmc.org/articles/pmc4870449">prevent HIV infection</a>.</p>
<h2>A striking difference</h2>
<p>The project led by Niakan had a starkly different aim. It used CRISPR to peek at the earliest stages of human embryonic development by targeting a gene called OCT4, which is active in the cells that go on to form the embryo. </p>
<p>Niakan’s immediate objective was to better understand the early aspects of human development. But her research eventually may help reveal why some pregnancies end in miscarriages and may improve the success of <em>in vitro</em> fertilization. </p>
<p>Much of the global discussion over the ethics of modifying human embryos has focused on whether the technique might be unsafe or used for non-medical purposes. Niakan’s recent project brings other aspects of this debate to light. How do scientists acquire the embryos they use in their research, and how are their projects approved? </p>
<p>So far, these types of experiments have been done in China, the United Kingdom and the United States. With only limited data available on the experiments conducted in China, it makes sense to focus the discussion on the experiments based in the United States and in the United Kingdom. </p>
<h2>Who’s taking the risk - and why?</h2>
<p>Earlier this year, <a href="http://www.ohsu.edu/people/shoukhrat-mitalipov/2D760207FF014335B07EC30F3818652F">Shoukhrat Mitalipov</a>, a reproductive biologist at Oregon Health and Science University (OHSU), and his colleagues used CRISPR in human embryos to repair a mutation that causes heart disease. From an ethics standpoint, Mitalipov’s research is more controversial than Niakan’s. The goal of his experiments was to make changes to the human embryo that could be passed on to future generations. Niakan’s research, on the other hand, aimed to develop our understanding of human embryology. </p>
<p>To do the experiments, Mitalipov’s team had to create human embryos from donated eggs and sperm. In contrast, Niakan’s project used embryos that were left over from fertility treatments. This is an important difference. </p>
<p>For Mitalipov’s study, the women who donated their eggs for research were exposed to the risks associated with hormonal stimulation and egg retrieval. These risks include abdominal pain, vomiting, rapid weight gain, shortness of breath, and damage to the organs that are close to the ovaries. A particularly serious risk is ovarian hyperstimulation syndrome that can require hospitalization.</p>
<p>With Niakan’s study, women assumed these risks in connection with their IVF treatment, not their participation in research. These women weighed the potential harms of hormonal stimulation and egg retrieval against the potential benefits of having a child using assisted human reproduction. Embryos remaining after fertility treatment were donated to research.</p>
<h2>Looking ahead</h2>
<p>It’s also worth examining how these studies were approved. Several committees, panels and review boards from OHSU provided input and guidance prior to granting Mitalipov permission to do his experiments. OHSU is Mitalipov’s home institution. This raises the spectre of institutional conflict of interest because OHSU stands to benefit from Mitalipov’s research if his work attracts more research funding or enhances the university’s reputation. </p>
<p>In the United Kingdom, the governance and oversight of human embryo research lies in the hands of authorities that are legally regulated and are at arms length to the institutions conducting the research. Ethics review of human embryo research occurs at both the national and regional level. The Human Fertilisation and Embryology Authority and the regional research ethics committee <a href="https://www.crick.ac.uk/news/science-news/2016/02/01/hfea-decision/">reviewed Niakan’s proposal</a> before she could begin her experiments. </p>
<p>As genome editing of human embryos becomes more widespread, it is important to understand the differences between one project and the next so that we can meaningfully discuss the range of ethical, social, political and regulatory issues associated with the research.</p><img src="https://counter.theconversation.com/content/84888/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Françoise Baylis does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A new gene editing experiment explores human development. With this comes new ethical questions: How do scientists acquire embryos and how are their projects approved?Françoise Baylis, Research Professor, Philosophy, Dalhousie UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/845902017-09-26T03:22:36Z2017-09-26T03:22:36ZUK gene editing breakthrough could land an Aussie in jail for 15 years: here’s why our laws need to catch up<figure><img src="https://images.theconversation.com/files/187488/original/file-20170926-12134-16zmwow.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Altering the genomes of embryonic cells is illegal in Australia. </span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>One of the greatest mysteries in life is why <a href="https://academic.oup.com/humupd/article-lookup/doi/10.1093/humupd/8.4.333">only about one in three embryos</a> formed naturally ever go on to produce a baby. Most miscarry. By genetically engineering human embryos, scientists in the UK have identified a key gene in enabling embryos to develop.</p>
<p>Kathy Niakan, of the Francis Crick Institute in London, led a team which used gene editing technique <a href="https://theconversation.com/explainer-what-is-genome-editing-25072">CRISPR</a> to investigate the role of a particular gene in the development of embryos. The study could potentially lead to better understanding of miscarriage, and hopefully prevention of it, and improve treatment of infertility.</p>
<p>However, this ground-breaking research would be illegal in Australia. Scientists doing this in Australia could be imprisoned. It’s time to review Australia’s laws in this area, which are 15 years old.</p>
<h2>What did the study accomplish?</h2>
<p>Many aspects of early human development are still a mystery. Our bodies are composed of over 200 cell types, including different types of skin cells, blood cells and muscle cells. But we all start as a single cell – called a zygote. As we grow our cells become more and more specialised, and this process is poorly understood – particularly at the very earliest stages of life. </p>
<p>Niakan’s team showed that one particular gene, “OCT4”, plays a key role. They used the CRISPR-CAS9 system – which allows researchers to make precise changes to DNA sequences - to turn off the OCT4 gene in zygotes. These zygotes were donated by couples who had some left over after fertility treatment. </p>
<p>With OCT4 turned off, the cells of the embryo failed to mature into other cell types, showing that OCT4 is required for normal embryo development. The study suggests that OCT4 acts as a regulatory gene, controlling the expression of other genes which cause cells to mature into distinct types.</p>
<h2>Why is the study significant?</h2>
<p>The study is significant for two reasons. First, it’s the only study involving genetically engineered human embryos that has been officially sanctioned by a regulatory body. </p>
<p>The UK’s <a href="https://www.hfea.gov.uk/">Human Fertilisation and Embryology Authority</a> gave the green light for Niakan’s project last year. All previous studies using human embryos have been performed in China or the USA. China has no federal legislation governing embryo research, whereas the USA has no legislation that covers privately funded research.</p>
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<p><em><strong>Read more:</strong></em></p>
<p><em><strong><a href="https://theconversation.com/human-embryo-crispr-advances-science-but-lets-focus-on-ethics-not-world-firsts-81956">Human embryo CRISPR advances science but let’s focus on ethics, not world firsts</a></strong></em></p>
<p><em><strong><a href="https://theconversation.com/five-reasons-we-should-embrace-gene-editing-research-on-human-embryos-51474">Five reasons we should embrace gene-editing research on human embryos</a></strong></em></p>
<p><em><strong><a href="https://theconversation.com/debate-on-whether-we-should-use-gene-editing-technology-is-far-from-black-and-white-51483">Debate on whether we should use gene-editing technology is far from black and white</a></strong></em></p>
<p><em><strong><a href="https://theconversation.com/now-we-can-edit-life-itself-we-need-to-ask-how-we-should-use-such-technology-68821">Now we can edit life itself, we need to ask how we should use such technology</a></strong></em></p>
<p><em><strong><a href="https://theconversation.com/why-we-can-trust-scientists-with-the-power-of-new-gene-editing-technology-51480">Why we can trust scientists with the power of new gene-editing technology</a></strong></em></p>
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<p>Second, it was the first study to use CRISPR-CAS9 to study human development. The four previous studies that have used CRISPR on human embryos have attempted to correct mutations that cause diseases. Such research may suggest ways in which gene editing could one day be used to avoid genetic disease in children. </p>
<p>But such research is, at the very least, premature. <a href="http://www.sciencedirect.com/science/article/pii/S0002929717302471">Most experts agree</a> gene editing science is far too immature for us to be thinking about reproductive applications in humans. But the technique can today be fruitfully used to study development, as the Niakan study shows.</p>
<p>CRISPR-CAS9 is a novel way to study human development and uncover the mechanisms important in embryo development. Such research is significant for its own sake, but may also have important clinical applications. </p>
<p><a href="https://www.sciencedaily.com/releases/2010/10/101003205930.htm">Two-thirds of all human embryos</a> fail to develop successfully. We have a poor understanding of why this is. Increasing our understanding of human development may suggest ways to reduce embryo loss and improve IVF success rates.</p>
<h2>What about Australia?</h2>
<p>Despite the success of this UK study, this research couldn’t be conducted in Australia. Australia has one of the strictest regulatory environments for gene editing research in the world. Australia’s <a href="https://www.legislation.gov.au/Details/C2017C00306">Prohibition of Human Cloning Act</a> (2002) makes altering the genomes of embryonic cells illegal. If Kathy Niakan’s team had performed their study in Australia, they would face 15 years in jail.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/187330/original/file-20170925-19899-axqxh7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/187330/original/file-20170925-19899-axqxh7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/187330/original/file-20170925-19899-axqxh7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=398&fit=crop&dpr=1 600w, https://images.theconversation.com/files/187330/original/file-20170925-19899-axqxh7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=398&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/187330/original/file-20170925-19899-axqxh7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=398&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/187330/original/file-20170925-19899-axqxh7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/187330/original/file-20170925-19899-axqxh7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/187330/original/file-20170925-19899-axqxh7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Concerns have been raised gene editing will be used to pick the gender, hair and eye colour of babies.</span>
<span class="attribution"><span class="source">from www.shutterstock.com</span></span>
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<p>This law, and the punishment that comes with it, are difficult to justify. Australia already allows research using human embryos to study development. Such research is permitted if: </p>
<p>1) the embryos are never implanted into a woman</p>
<p>2) the embryos are destroyed within 14 days of development</p>
<p>3) the research is performed on embryos that have been created for use in IVF, but are no longer needed for that purpose</p>
<p>4) the research is performed on embryos whose parents consent for them to be used in research.</p>
<p>It’s difficult to see why simply using a different technique to study embryo development, that also meets these conditions, is not only banned but punishable by serious jail time. In the UK, the law permits researchers to alter the genome of embryos, provided such embryos are not allowed to develop beyond 14 days.</p>
<h2>Why are Australian laws so restrictive?</h2>
<p>Many are worried about the long-term implications of such gene editing research, and claim it sets us on a path to “designer” babies. But in the UK where the Nikian study was performed, <a href="https://www.legislation.gov.uk/ukpga/2008/22/contents">the laws make a distinction</a> between the research and reproductive applications of gene editing. </p>
<p>Under the UK’s regulatory regime all reproductive applications of gene editing are banned. Such a distinction is also made in Australian laws between the use of cloning for reproductive purposes (which is prohibited) and cloning for research (which is permitted). Making a distinction between reproductive applications and research enables clearly beneficial research to proceed while preventing controversial applications.</p>
<p>The laws that ban gene editing for research purposes in Australia were first established 15 years ago, in a different era of biotechnologies. Genetic engineering technologies at that time were crude and imprecise. However, technologies have changed vastly since this time, and it’s time for our laws to change as well. Australia should allow gene editing for research, and help solve the mysteries of early human development.</p><img src="https://counter.theconversation.com/content/84590/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Christopher Gyngell holds a position at the The Murdoch Children's Research Institute. He previously received funding from the European Union's Horizon 2020 framework program. </span></em></p><p class="fine-print"><em><span>Julian Savulescu holds a Visiting Position at the Murdoch Childrens Research Institute. </span></em></p>A landmark study in the UK discovered the gene that allows cells to form into embryos. If Australian researchers attempted this they could go to jail for 15 years.Christopher Gyngell, Research fellow in Biomedical Ethics, Murdoch Children's Research InstituteJulian Savulescu, Uehiro Chair in Practical Ethics, Visiting Professor in Biomedical Ethics, Murdoch Childrens Research Institute and Distinguished Visiting Professor in Law, Melbourne University, University of OxfordLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/824192017-08-22T01:59:38Z2017-08-22T01:59:38ZScared of CRISPR? 40 years on, IVF shows how fears of new medical technology can fade<figure><img src="https://images.theconversation.com/files/182872/original/file-20170822-8916-y977a5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">With all these 'test-tube babies' grown up, how have our reactions to the technology evolved?</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Associated-Press-International-News-United-King-/5d990e8aa9e4da11af9f0014c2589dfb/2/0">AP Photo/Alastair Grant</a></span></figcaption></figure><p>The first “test-tube baby” made headlines around the world in 1978, setting off intense debate on the ethics of researching human embryos and reproductive technologies. Every breakthrough since then has raised the same questions about “<a href="https://www.scientificamerican.com/article/regulate-designer-babies/">designer babies</a>” and “<a href="https://www.washingtonpost.com/opinions/if-were-going-to-play-god-with-gene-editing-weve-got-to-ask-some-moral-questions/2017/02/20/e4e0c396-f787-11e6-be05-1a3817ac21a5_story.html">playing God</a>” – but public response has grown more subdued rather than more engaged as assisted reproductive technologies have become <a href="https://doi.org/10.7916/D8FB5CQC">increasingly sophisticated and powerful</a>.</p>
<p>As the science has advanced, doctors are able to perform more complex procedures with <a href="https://doi.org/10.1111/ajo.12356">better-than-ever success rates</a>. This progress has made in vitro fertilization and associated assisted reproductive technologies relatively commonplace. <a href="http://www.sart.org/news-and-publications/news-and-research/press-releases-and-bulletins/SART_Data_Release_2015_Preliminary_and_2014_Final/">Over one million babies</a> have been born in the U.S. using IVF since 1985.</p>
<p>And Americans’ acceptance of these technologies has evolved alongside their increased usage, as we’ve gotten used to the idea of physicians manipulating embryos. </p>
<p>But the ethical challenges posed by these procedures remain – and in fact are increasing along with our capabilities. While still a long way from clinical use, the recent news that scientists in Oregon had <a href="https://doi.org/10.1038/nature23305">successfully edited genes in a human embryo</a> brings us one step closer to changing the DNA that we pass along to our descendants. As the state of the science continues to advance, ethical issues need to be addressed before the next big breakthrough.</p>
<h2>Birth of the test-tube baby era</h2>
<p>Louise Brown was born in the U.K. on July 25, 1978. Known as the first “test-tube baby,” <a href="http://www.bbc.com/news/health-33599353">she was a product of IVF</a>, a process where an egg is fertilized by sperm outside of the body before being implanted into the womb. IVF opened up the possibility for infertile parents to have their own biologically related children. But Brown’s family was also subjected to <a href="http://www.telegraph.co.uk/news/health/11760004/Louise-Brown-the-first-IVF-baby-reveals-family-was-bombarded-with-hate-mail.html">vicious hate mail</a>, and groups opposed to IVF warned it would be used for <a href="http://yalebooks.yale.edu/book/9780300137156/new-eugenics">eugenic experiments</a> leading to a dystopian future where all babies would be genetically engineered. </p>
<p>The reaction in the U.S. had another layer to it when compared to other developed countries. Here, research on embryos has <a href="https://doi.org/10.1038/sj.gt.3301744">historically been linked to the debate on abortion</a>. The 1973 Supreme Court decision to make abortion legal in Roe v. Wade fueled anti-abortion groups, <a href="http://www.lifenews.com/2011/09/06/pro-life-concerns-about-ivf-include-abortion-exploitation/">who also oppose research on human embryos</a>.</p>
<p>Embryonic research and procedures offer the hope of eliminating devastating diseases, but scientists also destroy embryos in the process. Under pressure from these groups over the ethical implications of embryo creation and destruction, <a href="https://doi.org/10.1038/sj.gt.3301744">Congress issued a moratorium in 1974</a> on federally funded clinical research on embryos and embryonic tissue, including on IVF, infertility and prenatal diagnosis. To this day, federal funds are still not available for this type of work.</p>
<p>In hindsight, the sharp media attention and negative response from anti-abortion groups to IVF didn’t accurately represent overall public opinion. The majority of Americans (60 percent) were in favor of IVF <a href="http://www.gallup.com/poll/8983/gallup-brain-birth-vitro-fertilization.aspx">when polled in August 1978</a>, and 53 percent of those polled said they would be willing to try IVF if they were unable to have a child.</p>
<p>So while the intense media coverage at the time helped inform the public of this new development, the insensitive labeling of Louise Brown as a “test-tube baby” and warnings about dystopian results didn’t stop Americans from forming positive opinions of IVF.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/182873/original/file-20170822-5029-tvzs8c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/182873/original/file-20170822-5029-tvzs8c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/182873/original/file-20170822-5029-tvzs8c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=409&fit=crop&dpr=1 600w, https://images.theconversation.com/files/182873/original/file-20170822-5029-tvzs8c.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=409&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/182873/original/file-20170822-5029-tvzs8c.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=409&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/182873/original/file-20170822-5029-tvzs8c.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=514&fit=crop&dpr=1 754w, https://images.theconversation.com/files/182873/original/file-20170822-5029-tvzs8c.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=514&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/182873/original/file-20170822-5029-tvzs8c.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=514&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Opinions evolved over the years as we got to know more ‘test-tube babies’ like Louise Brown.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Watchf-Associated-Press-Domestic-News-Illinois-/c13743ff67f24383a37c047f7684e157/1/0">AP Photo/FHJ</a></span>
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<h2>Is embryonic research a moral issue?</h2>
<p>In the 40 years since IVF was introduced for use in humans, scientists have <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3799275/">developed several new technologies</a> – from freezing eggs to genetically testing embryos before implantation – that have improved patient experience as well as the chances that IVF will result in the birth of a baby. The announcement of each of these breakthroughs has resulted in flurries of media attention to the ethical challenges raised by this type of research, but there has been no consensus – social, political or scientific – on how to proceed.</p>
<p>Americans’ general opinion of assisted reproductive technologies has remained positive. Despite opposition groups’ efforts, surveys show that Americans have separated out the issue of abortion from embryonic research. <a href="http://www.pewforum.org/2013/08/15/abortion-viewed-in-moral-terms/">A Pew Research Center poll from 2013</a> revealed that only 12 percent of Americans say they personally consider using IVF to be morally wrong. That’s a significant decrease from the <a href="http://www.gallup.com/poll/8983/Gallup-Brain-Birth-Vitro-Fertilization.aspx">28 percent of respondents in 1978</a> who replied that they opposed the procedure for being “not natural.” In addition, the 2013 poll showed that twice as many Americans (46 percent) said they <a href="http://www.pewforum.org/2013/08/15/abortion-viewed-in-moral-terms/">do not personally consider using IVF to be a moral issue</a> compared to the number of Americans (23 percent) who said they personally do not consider having an abortion to be a moral issue.</p>
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<span class="caption">We’re still a little hazy on the specifics of technologies that use human embryos.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Ballot-Stem-Cell-Research/9267ae5cd8e344b9ba3fd318bcd614ad/41/0">AP Photo/Paul Sancya</a></span>
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<h2>Why we need to pay attention</h2>
<p>Although most Americans don’t think of embryonic research and procedures like IVF as a moral issue or morally wrong, the introduction of new technologies is outpacing Americans’ understanding of what they actually do.</p>
<p><a href="http://www.thenewatlantis.com/publications/public-opinion-and-the-embryo-debates">Polls from 2007-2008</a> showed that only 17 percent of respondents reported that they were “very familiar” with stem cell research, and that there was a “relative absence of knowledge about even the most prominent of the embryo-research issues.” When Americans are asked more specific questions that explain IVF, they show less support for certain procedures, like freezing and storing eggs or using embryos for scientific research.</p>
<p>In light of recent developments, surveys show that <a href="https://doi.org/10.1056/NEJMp1602010">nearly 69 percent of Americans</a> have not heard or read much or know nothing at all about gene editing. Additionally, support for gene editing depends on how the technology will be used. A majority of Americans generally accept gene editing if the purpose is to improve the health of a person, or if it will prevent a child from inheriting certain diseases. The scientists in Oregon <a href="https://doi.org/10.1038/nature23305">used a gene-editing technique</a> that allowed them to <a href="https://www.statnews.com/2017/07/26/human-embryos-edited/">correct a genetic defect in human embryos</a> that causes heart disease. This type of progress falls into the category that most Americans would support.</p>
<p>But the technique that’s used to make this correction, known as CRISPR-Cas9, can potentially be used for editing genes in other ways, not just to eliminate diseases. The success of the Oregon team opens the door to many possibilities in gene editing, including ones unrelated to health, such as changes to appearance or other physical characteristics.</p>
<p>Advancements in assisted reproductive technologies have happened rapidly over the last few decades, leading to <a href="https://www.cbsnews.com/news/report-5-million-babies-born-thanks-to-assisted-reproductive-technologies/">over five million births worldwide</a>. But as common as these procedures have become, scientists are not yet in agreement over how to integrate CRISPR and gene editing to the IVF toolkit. There are concerns about changing the genomes of human embryos destined to be babies, particularly since any modifications would be passed on to future generations. <a href="https://www.theguardian.com/science/2015/dec/03/gene-editing-summit-rules-out-ban-on-embryos-destined-to-become-people-dna-human">Scientific committees have noted</a> that decisions on whether and how to use gene editing should be revisited on a regular basis. The newest breakthrough with CRISPR is providing us with one of those opportunities.</p>
<p>We should focus our attention on answering the ethical questions that have long gone unanswered: What are the boundaries to this type of research? Who decides what is an ethical use of CRISPR? What responsibility do we have to people affected by genetic conditions? Who pays for these medical procedures? How will this research and potential clinical use be regulated? </p>
<p>The successful use of assisted reproductive technologies has skyrocketed in the last decade, making Americans complacent about some of the ethical concerns that these procedures raise. It’s important that we engage with these issues now, before gene editing becomes as familiar to us as IVF.</p><img src="https://counter.theconversation.com/content/82419/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Patricia Stapleton does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Americans have moved on from worrying about ‘test-tube babies’ – but there are still ethical challenges to resolve as reproductive technologies continue to advance.Patricia Stapleton, Assistant Professor of Political Science, Worcester Polytechnic InstituteLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/819562017-08-03T00:03:14Z2017-08-03T00:03:14ZHuman embryo CRISPR advances science but let’s focus on ethics, not world firsts<figure><img src="https://images.theconversation.com/files/180712/original/file-20170802-14264-134cwo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Just because we can edit genes in human embryos, should we? </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/cell-embryo-mitosis-under-microscope-3d-458057029?src=EElBZbGjhfiHGrrW3cFSAA-1-1">Andrii Vodolazhskyi/shutterstock </a></span></figcaption></figure><p>Following <a href="http://abcnews.go.com/Technology/wireStory/oregon-scientists-human-gene-embryo-editing-us-48882536">early reports</a> last week that scientists had edited the DNA of human embryos, American researchers have now published their <a href="https://www.nature.com/articles/doi:10.1038/nature23305">much anticipated paper</a> in the journal Nature. </p>
<p>The human embryos used in the research were created using eggs collected from healthy women and sperm from a man carrying a DNA error. Thus some of the embryos carried the DNA error, and some were “healthy”. </p>
<p>Led by Hong Ma of Oregon Health and Science University, the researchers then used the <a href="https://theconversation.com/beyond-just-promise-crispr-is-delivering-in-the-lab-today-77596">gene-editing technology known as CRISPR</a> in the embryos to try to correct the error, which causes catastrophic genetic heart disease in adults.</p>
<p>In more than half of the embryos, the DNA mutation was replaced with “healthy” DNA, and these embryos appeared to grow normally to the blastocyst stage (the point at which they would normally be transferred back into the woman’s uterus during the IVF process - in this study, the blastocysts were destroyed during analysis). </p>
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Read more:
<a href="https://theconversation.com/editing-human-embryos-with-crispr-is-moving-ahead-nows-the-time-to-work-out-the-ethics-81732">Editing human embryos with CRISPR is moving ahead – now's the time to work out the ethics</a>
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<p>Simply put, CRISPR is like a sat-nav-guided pair of molecular scissors. It is directed to a specific location in the DNA and performs a cut-and-paste function, not unlike word-processing software. </p>
<p>Genetic diseases are a significant cause of <a href="http://www.who.int/genomics/public/geneticdiseases/en/index2.html">healthcare spending and death globally</a>, and many research groups are using CRISPR as a tool to try to combat them. </p>
<p>This latest paper is not the first time human embryos have been <a href="https://link.springer.com/article/10.1007%2Fs13238-015-0153-5">genetically modified</a>, and is one of <a href="https://link.springer.com/article/10.1007%2Fs10815-016-0710-8">many</a> <a href="http://www.nature.com/nprot/journal/v9/n8/full/nprot.2014.134.html?foxtrotcallback=true">examples</a> of CRISPR being successfully applied to remove a target gene. </p>
<p>But it is the first time a disease-causing mutation has been repaired in a significant number of healthy human embryos, created specifically for research. And, for me, this advance is both notable and problematic all at once. It creates a leap forward in several key aspects of science. On the other hand, it highlights ethical dilemmas that we regularly grapple with in reproductive health.</p>
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<p><em><strong>Read more:</strong> <a href="https://theconversation.com/worlds-first-genetically-modified-human-embryo-raises-ethical-concerns-40766">World’s first genetically modified human embryo</a></em> </p>
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<h2>Science win: we know more about embryos</h2>
<p>From a purely research perspective, this paper is an exciting advance. </p>
<p>CRISPR gives us the ability to edit embryos one gene at a time, to learn about the events that happen in the first five days of life, and to tease apart how the sperm and egg come together to form a ball of cells, which ultimately go on to form a healthy baby. </p>
<p>It may also help us to understand more about infertility, miscarriage and stillbirth, plus many diseases and disorders, by making better and new animal models of disease. </p>
<h2>Science win: the right timing improves CRISPR</h2>
<p>Building on previous research from other groups, in the new research Ma and colleagues improve the success rates of DNA editing by changing the timing. </p>
<p>By using CRISPR to alter the DNA just as the sperm and egg came together, they improved the frequency at which the editing happened, and also how often it was correct. The issue of timing presented challenges in previous attempts, where <a href="https://link.springer.com/article/10.1007%2Fs13238-015-0153-5">mistakes were frequent</a>. </p>
<p>There is still room for improvement though, with small mistakes still incorporated, meaning these embryos would never be suitable to transfer to a patient. We are by no means at the point where this technology is ready for use. </p>
<h2>Ethical quandary: editing healthy embryos</h2>
<p>Unlike research groups before them – which worked on embryos that were <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4417674/">not capable of ever becoming a baby</a> – this study involved the creation of healthy human embryos specifically for research purposes. </p>
<p>Scientific research is sometimes faced with these catch-22 moments where advancement is not likely without facing enormous moral and ethical challenges. Some of science’s greatest breakthroughs have used <a href="http://www.nature.com/ng/journal/v45/n9/abs/ng.2714.html">animal models</a> or <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2661189/">questionable experiments on humans</a>. </p>
<p>As detailed in the paper’s research methods, the scientists adhered to strict ethical guidelines, and were monitored closely by committees of individuals including not just scientists and doctors, but also members of the general public.</p>
<p>Research using human embryos is highly regulated, and is different between countries. In Australia, the National Health and Medical Research Council has a <a href="https://www.nhmrc.gov.au/guidelines-publications/e78">strict set of guidelines</a>, meaning that all research performed on human embryos is monitored very closely, and many limitations exist.</p>
<h2>Ethical quandary: multiple opinions matter</h2>
<p>Science is not as simple as just being able to perform a biological technique successfully in a laboratory setting. Research must proceed only with extreme caution. </p>
<p>Concurrent with advances in benchtop biology, multidisciplinary teams of biologists, IVF specialists, psychologists, bioethicists, social scientists, policy makers and advisers, disability advocates, and most importantly consumers (as well as many others) must work together. </p>
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<p><em><strong>Read more:</strong> <a href="https://theconversation.com/human-genome-editing-we-should-all-have-a-say-81797">Human genome editing: We should all have a say</a></em> </p>
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<p>If one day scientists are positioned to perform genome editing safely in humans, this should only happen if society considers it useful, appropriate and desirable. </p>
<h2>Ethical quandary: where to from here?</h2>
<p>As a biologist, understanding if this technology is safe, and whether a healthy human baby can be born from a genetically modified human embryo seems unanswerable right now. </p>
<p>So many questions remain. When and how will we know that it is time to create a living, breathing human from a modified embryo? Should we take the risk of proceeding with the first full term human pregnancy, not knowing if the technology will have unexpected adverse consequences? </p>
<p>Seeing more experiments being performed in larger animal models (agricultural species like cow and pig) and in non-human primates will be essential. This step should – in my opinion – be a research priority, before more healthy human embryos are used for research purposes.</p><img src="https://counter.theconversation.com/content/81956/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Hannah Brown receives funding from NHMRC and ARC for research not directly related to this piece. </span></em></p>A world first study shows CRISPR can remove a target gene from early stage human embryos. But with the advance in science come weighty ethical dilemmas.Hannah Brown, Post-doctoral Fellow; Reproductive Epigenetics, University of AdelaideLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/817972017-08-01T22:36:56Z2017-08-01T22:36:56ZHuman genome editing: We should all have a say<figure><img src="https://images.theconversation.com/files/180420/original/file-20170731-22134-1s9uda.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Controversial gene editing should not proceed without citizen input and societal consensus.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Shoukhrat Mitalipov, a reproductive biologist at Oregon Health and Science University, is nothing if not a pioneer. In 2007, his team published proof-of-principle research in primates showing it was possible to <a href="https://dx.doi.org/10.1038/nature06357">derive stem cells from cloned primate embryos</a>. In 2013, his team was the first to <a href="https://theconversation.com/human-embryonic-stem-cells-grown-from-skin-tissue-14339">create human embryonic stem cells by cloning</a>. Now, in 2017, <a href="https://dx.doi.org/10.1038/nature23305">his team has reported safely and effectively modifying human embryos with the MYBPC3 mutation (which causes myocardial disease)</a> using the gene editing technique <a href="https://theconversation.com/explainer-crispr-technology-brings-precise-genetic-editing-and-raises-ethical-questions-39219">CRISPR</a>. </p>
<p>Mitalipov’s team is not the first to genetically modify human embryos. This was first accomplished in 2015 by <a href="http://www.nature.com/news/chinese-scientists-genetically-modify-human-embryos-1.17378">a group of Chinese scientists led by Junjiu Huang</a>. Mitalipov’s team, however, may be the first to demonstrate basic safety and efficacy using the CRISPR technique. </p>
<p>This has serious implications for the ethics debate on human germline modification which involves inserting, deleting or replacing the DNA of human sperm, eggs or embryos to change the genes of future children. </p>
<h2>Ethically controversial</h2>
<p>Those who support human embryo research will argue that Mitalipov’s research to alter human embryos is ethically acceptable because the embryos were not allowed to develop beyond 14 days (the widely accepted international limit on human embryo research) and because the modified embryos were not used to initiate a pregnancy. They will also point to the future potential benefit of correcting defective genes that cause inherited disease. </p>
<p>This research is ethically controversial, however, because it is a clear step on the path to making heritable modifications - genetic changes that can be passed down through subsequent generations.</p>
<h2>Beyond safety and efficacy</h2>
<p>Internationally, <a href="http://en.unesco.org/news/unesco-panel-experts-calls-ban-editing-human-dna-avoid-unethical-tampering-hereditary-traits">UNESCO has called for a ban</a> on human germline gene editing. And the “Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine” – the <a href="http://www.coe.int/en/web/conventions/full-list/-/conventions/rms/090000168007cf98">Oviedo Convention</a> – specifies that “an intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.”</p>
<p>In a move away from the positions taken by UNESCO and included in the Oviedo Convention, in 2015 the 12-person Organizing Committee of the first <a href="http://nationalacademies.org/gene-editing/Gene-Edit-Summit/">International Summit on Human Gene Editing</a> (of which I was a member) <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12032015a">issued a statement</a> endorsing basic and preclinical gene editing research involving human embryos. </p>
<p>The statement further stipulated, however, that: “It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application.”</p>
<p>Mitalipov’s research aims to address the first condition about safety and efficacy. But what of the second condition which effectively recognizes that the human genome belongs to all of us and that it is not for scientists or other elites to decree what should or should not happen to it?</p>
<h2>Modification endorsed</h2>
<p>Since the 2015 statement was issued, many individuals and groups have tried to set aside the recommendation calling for a broad societal consensus. </p>
<p>For example, in February 2017, the U.S. National Academy of Sciences and National Academy of Medicine <a href="https://www.nap.edu/catalog/24623/human-genome-editing-science-ethics-and-governance">published a report</a> endorsing germline modification. It states unequivocally that “clinical trials using heritable germline genome editing should be permitted” provided the research is only for compelling reasons and under strict oversight limiting uses of the technology to specified criteria.</p>
<h2>Seeds of change in Canada</h2>
<p>In Canada, it is illegal to modify human germ cells. Altering “the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants” is among the activities prohibited in the 2004 <a href="http://laws-lois.justice.gc.ca/eng/acts/a-13.4/FullText.html">Assisted Human Reproduction Act</a>. </p>
<p>Worried that “Canadian researchers may fall behind on the international scene” and that “restrictive research policies may lead to medical tourism,” the Canadian Institutes for Health Research (with input from the <a href="http://stemcellnetwork.ca/about-scn/">Canadian Stem Cell Network</a>) has begun to plant the seeds of change. </p>
<p>In its <a href="http://www.cihr-irsc.gc.ca/e/50158.html">Human Germline Gene Editing</a> report, CIHR hints at the benefits of changing the legislation. It also suggests professional self-regulation and research funding guidelines could replace the current federal statutory prohibition.</p>
<h2>Future of the species</h2>
<p>With Mitalipov’s technological advances and increasing suggestions from researchers that heritable modifications to human embryos be permitted, it is essential that citizens be given opportunities to think through the ethical issues and to work towards broad societal consensus. </p>
<p>We are talking about nothing less than the future of the human species. No decisions about the modification of the germline should be made without broad societal consultation. </p>
<p>Nothing about us without us!</p><img src="https://counter.theconversation.com/content/81797/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Françoise Baylis has received past funding from the Canadian Institutes for Health Research and the Stem Cell Network.</span></em></p>A team in the U.S. is said to have safely and effectively altered human embryos. The news is a reminder that citizens must be consulted on developments potentially affecting the future of the species.Françoise Baylis, Research Professor, Philosophy, Dalhousie UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/817322017-07-28T15:40:07Z2017-07-28T15:40:07ZEditing human embryos with CRISPR is moving ahead – now’s the time to work out the ethics<figure><img src="https://images.theconversation.com/files/180229/original/file-20170728-15340-1460v93.jpg?ixlib=rb-1.1.0&rect=35%2C73%2C1173%2C805&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">There's still a way to go from editing single-cell embryos to a full-term 'designer baby.'</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/zeissmicro/27771482282">ZEISS Microscopy</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span></figcaption></figure><p>The announcement by researchers in Portland, Oregon that they’ve successfully modified the genetic material <a href="https://www.technologyreview.com/s/608350/first-human-embryos-edited-in-us/">of a human embryo</a> took some people by surprise.</p>
<p>With headlines referring to “<a href="https://www.businesslive.co.za/bd/world/americas/2017-07-27-us-university-edits-embryo-genes-in-experiment-hailed-as-groundbreaking/">groundbreaking</a>” research and “<a href="http://www.dailymail.co.uk/sciencetech/article-4734364/First-editing-human-embryos-carried-United-States.html">designer babies</a>,” you might wonder what the scientists actually accomplished. This was a big step forward, but hardly unexpected. As this kind of work proceeds, it continues to raise questions about ethical issues and how we should we react.</p>
<h2>What did researchers actually do?</h2>
<p>For a number of years now we have had the ability to alter genetic material in a cell, using a technique called CRISPR.</p>
<p>The DNA that makes up our genome comprises long sequences of base pairs, each base indicated by one of four letters. These letters form a genetic alphabet, and the “words” or “sentences” created from a particular order of letters are the genes that determine our characteristics.</p>
<p>Sometimes words can be “misspelled” or sentences slightly garbled, resulting in a disease or disorder. Genetic engineering is designed to correct those mistakes. CRISPR is a tool that enables scientists to target a specific area of a gene, working like the search-and-replace function in Microsoft Word, to remove a section and insert the “correct” sequence. </p>
<p>In the last decade, CRISPR has been the primary tool for those seeking to modify genes – human and otherwise. Among other things, it has been used in experiments to make <a href="https://doi.org/10.1038/nbt.3439">mosquitoes resistant to malaria</a>, genetically <a href="http://www.genengnews.com/gen-exclusives/crispr-applications-in-plants/77900846">modify plants to be resistant to disease</a>, explore the possibility of <a href="https://doi.org/10.1038/nature.2015.18448">engineered pets</a> and <a href="https://www.sciencenews.org/blog/science-ticker/crispr-used-cows-help-fight-tuberculosis">livestock</a>, and potentially treat some human diseases (including <a href="http://sites.tufts.edu/crispr/applications/hiv-treatment/">HIV</a>, <a href="https://doi.org/10.15252/emmm.201606325">hemophilia</a> and <a href="https://doi.org/10.1016/j.omtn.2016.12.012">leukemia</a>).</p>
<p>Up until recently, the focus in humans has been on changing the cells of a single individual, and not changing eggs, sperm and early embryos – what are called the “germline” cells that pass traits along to offspring. The theory is that focusing on non-germline cells would limit any unexpected long-term impact of genetic changes on descendants. At the same time, this limitation means that we would have to use the technique in every generation, which affects its potential therapeutic benefit.</p>
<p>Earlier this year, an international committee convened by the National Academy of Sciences <a href="https://doi.org/10.17226/24623">issued a report</a> that, while highlighting the concerns with human germline genetic engineering, laid out a series of <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=24623">safeguards and recommended oversight</a>. The report was widely regarded as opening the door to embryo-editing research.</p>
<p>That is exactly what happened in Oregon. Although this is the first study reported in the United States, similar research has been <a href="https://doi.org/10.1007/s13238-015-0153-5">conducted in China</a>. This new study, however, apparently avoided previous errors we’ve seen with CRISPR – such as changes in other, untargeted parts of the genome, or the desired change not occurring in all cells. Both of these problems had made scientists wary of using CRISPR to make changes in embryos that might eventually be used in a human pregnancy. Evidence of more successful (and thus safer) CRISPR use may lead to additional studies involving human embryos.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/180203/original/file-20170728-5295-1tgc36j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/180203/original/file-20170728-5295-1tgc36j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/180203/original/file-20170728-5295-1tgc36j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=402&fit=crop&dpr=1 600w, https://images.theconversation.com/files/180203/original/file-20170728-5295-1tgc36j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=402&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/180203/original/file-20170728-5295-1tgc36j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=402&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/180203/original/file-20170728-5295-1tgc36j.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=505&fit=crop&dpr=1 754w, https://images.theconversation.com/files/180203/original/file-20170728-5295-1tgc36j.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=505&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/180203/original/file-20170728-5295-1tgc36j.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=505&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">We have a ways to go before ordering up desired traits in a future baby. Researchers at Oregon Health and Science University say they worked with single-cell embryos, inserting CRISPR chemicals at the time of fertilization.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/lunarcaustic/3233482244">lunar caustic</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<h2>What didn’t happen in Oregon?</h2>
<p>First, this study did not entail the creation of “designer babies,” despite some news headlines. The research involved only early stage embryos, outside the womb, none of which was allowed to develop beyond a few days.</p>
<p>In fact, there are a number of existing limits – both policy-based and scientific – that will create barriers to implanting an edited embryo to achieve the birth of a child. There is a <a href="https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos">federal ban on funding</a> gene editing research in embryos; in some states, there are also <a href="https://nyscf.org/scmapus">total bans on embryo research</a>, regardless of how funded. In addition, the implantation of an edited human embryos would be regulated under the <a href="https://humansubjects.nih.gov/pregnant-women-human-fetuses-neonates">federal human research regulations</a>, the <a href="https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/">Food, Drug and Cosmetic Act</a> and potentially the federal rules regarding <a href="https://wwwn.cdc.gov/CLIA/Regulatory/default.aspx">clinical laboratory testing</a>.</p>
<p>Beyond the regulatory barriers, we are a long way from having the scientific knowledge necessary to design our children. While the Oregon experiment focused on a single gene correction to inherited diseases, there are few human traits that are controlled by one gene. Anything that involves multiple genes or a gene/environment interaction will be less amenable to this type of engineering. Most characteristics we might be interested in designing – such as intelligence, personality, athletic or artistic or musical ability – are much more complex.</p>
<p>Second, while this is a significant step forward in the science regarding the use of the CRISPR technique, it is only one step. There is a long way to go between this and a cure for various disease and disorders. This is not to say that there aren’t concerns. But we have some time to consider the issues before the use of the technique becomes a mainstream medical practice.</p>
<h2>So what should we be concerned about?</h2>
<p>Taking into account the cautions above, we do need to decide when and how we should use this technique.</p>
<p>Should there be limits on the types of things you can edit in an embryo? If so, what should they entail? These questions also involve deciding who gets to set the limits and control access to the technology.</p>
<p>We may also be concerned about who gets to control the subsequent research using this technology. Should there be state or federal oversight? Keep in mind that we cannot control what happens in other countries. Even in this country it can be difficult to craft guidelines that restrict only the research someone finds objectionable, while allowing other important research to continue. Additionally, the use of assisted reproductive technologies (IVF, for example) is <a href="http://www.rockinst.org/pdf/health_care/2009-07-States_Regulation_ART.pdf">largely unregulated in the U.S.</a>, and the decision to put in place restrictions will certainly raise objections from both potential parents and IVF providers.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/180211/original/file-20170728-18243-1g5vqx3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/180211/original/file-20170728-18243-1g5vqx3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/180211/original/file-20170728-18243-1g5vqx3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/180211/original/file-20170728-18243-1g5vqx3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/180211/original/file-20170728-18243-1g5vqx3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/180211/original/file-20170728-18243-1g5vqx3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/180211/original/file-20170728-18243-1g5vqx3.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/180211/original/file-20170728-18243-1g5vqx3.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Who should be able to use this technology? And who should decide?</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/j2dread/5595599661">Johnathan D. Anderson</a>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>Moreover, there are important questions about cost and access. Right now most assisted reproductive technologies are available only to higher-income individuals. A handful of <a href="http://www.ncsl.org/research/health/insurance-coverage-for-infertility-laws.aspx">states mandate infertility treatment coverage</a>, but it is very limited. How should we regulate access to embryo editing for serious diseases? We are in the midst of a <a href="https://theconversation.com/us/topics/us-health-care-reform-40185">widespread debate</a> about health care, access and cost. If it becomes established and safe, should this technique be part of a basic package of health care services when used to help create a child who does not suffer from a specific genetic problem? What about editing for nonhealth issues or less serious problems – are there fairness concerns if only people with sufficient wealth can access?</p>
<p>So far the promise of genetic engineering for disease eradication has not lived up to its hype. Nor have many other milestones, like the 1996 <a href="https://theconversation.com/20-years-after-dolly-everything-you-always-wanted-to-know-about-the-cloned-sheep-and-what-came-next-72655">cloning of Dolly the sheep</a>, resulted in the feared apocalypse. The announcement of the Oregon study is only the next step in a long line of research. Nonetheless, it is sure to bring many of the issues about embryos, stem cell research, genetic engineering and reproductive technologies back into the spotlight. Now is the time to figure out how we want to see this gene-editing path unfold.</p><img src="https://counter.theconversation.com/content/81732/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jessica Berg does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The news may have come as a surprise, but it probably shouldn’t have. A bioethics expert walks through how big a deal this announcement is – and what we should be considering now.Jessica Berg, Law Dean; Professor of Law; and Professor of Bioethics & Public Health, Case Western Reserve UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/815392017-07-28T03:07:20Z2017-07-28T03:07:20ZWhat marsupials taught us about embryo implantation could help women using IVF<figure><img src="https://images.theconversation.com/files/180078/original/file-20170727-8525-iej152.jpg?ixlib=rb-1.1.0&rect=188%2C89%2C1671%2C1229&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">She must have had a successful pregnancy.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/ryansnyder/1164717250">Ryan Snyder</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>What do a swollen sprained ankle and a new pregnancy have in common? Believe it or not, they’re both closely tied to the body’s inflammation response.</p>
<p>Inflammation is usually the first reaction of the immune system to the presence of injury or infection. It’s characterized by local swelling, fever and pain. </p>
<p>Interestingly, inflammation is also key to how a pregnancy begins and ends. It facilitates the implantation of the embryo in the mother’s uterus and then eventually the baby’s birth. (Inflammation at the time of implantation might be one of the <a href="https://doi.org/10.1111/j.1749-6632.2010.05938.x">causes of morning sickness</a>.)</p>
<p>But scientists have typically thought of pregnancy as an anti-inflammatory process. The mother’s immune system must be suppressed so it doesn’t attack and destroy the developing fetus as an unwanted intruder. After all, it contains the father’s foreign DNA. Inflammation through the middle of gestation is a major risk to the pregnancy, and can <a href="https://dx.doi.org/10.3109/14767058.2010.547963">result in miscarriage</a>. </p>
<p>It’s been a medical paradox: Why does the body use inflammation to regulate normal physiological processes of pregnancy when it’s also one of the biggest threats to the maintenance of pregnancy?</p>
<p>In our research published in the <a href="https://doi.org/10.1073/pnas.1701129114">Proceedings of the National Academy of Sciences</a>, my collaborators at Yale University and the <a href="https://www.nichd.nih.gov">Eunice Kennedy Shriver National Institute of Child Health and Human Development</a> used an evolutionary perspective to identify why inflammation is used to facilitate implantation in humans. Our close look at opossums could have medical implications for women struggling to conceive, including better success rates using IVF. </p>
<h2>An evolutionary perspective on the paradox</h2>
<p>The first mammals on Earth laid eggs. Eventually <a href="https://theconversation.com/lizards-help-us-find-out-which-came-first-the-baby-or-the-egg-29954">live birth evolved</a> more than 160 million years ago in a common ancestor of humans and marsupials.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/179633/original/file-20170725-13256-2b9l37.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/179633/original/file-20170725-13256-2b9l37.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/179633/original/file-20170725-13256-2b9l37.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=294&fit=crop&dpr=1 600w, https://images.theconversation.com/files/179633/original/file-20170725-13256-2b9l37.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=294&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/179633/original/file-20170725-13256-2b9l37.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=294&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/179633/original/file-20170725-13256-2b9l37.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=370&fit=crop&dpr=1 754w, https://images.theconversation.com/files/179633/original/file-20170725-13256-2b9l37.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=370&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/179633/original/file-20170725-13256-2b9l37.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=370&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Relationship between the major groups of mammals alive today. Monotremes lay eggs. Marsupials give birth to live young but have very short pregnancies, with embryo and maternal tissues separated by an eggshell for most of the time. A short-lived placenta does form, however. Eutherian mammals have an extended pregnancy including a placenta, and give birth to relatively well developed young.</span>
<span class="attribution"><span class="source">Oliver Griffith</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>Marsupial pregnancy shares common features with both egg-laying mammals (<a href="https://en.wikipedia.org/wiki/Monotreme">monotremes</a>, including the platypus) and eutherian mammals (formerly referred to as placental mammals). Since it’s partway between those two, we think marsupial pregnancy likely reflects the reproductive biology of the first live-bearing mammals. </p>
<p>Our research looked at pregnancy in the <a href="https://en.wikipedia.org/wiki/Gray_short-tailed_opossum">grey short-tailed opossum</a> as a model for the ancestral condition. Specifically, we wanted to know if they had any hints of inflammation during pregnancy. </p>
<p>Opossum pregnancy is short, lasting only 14 days. For 12 of those days the embryo is separated from the maternal tissue by an eggshell.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/180063/original/file-20170727-9209-li11pj.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/180063/original/file-20170727-9209-li11pj.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/180063/original/file-20170727-9209-li11pj.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=495&fit=crop&dpr=1 600w, https://images.theconversation.com/files/180063/original/file-20170727-9209-li11pj.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=495&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/180063/original/file-20170727-9209-li11pj.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=495&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/180063/original/file-20170727-9209-li11pj.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=622&fit=crop&dpr=1 754w, https://images.theconversation.com/files/180063/original/file-20170727-9209-li11pj.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=622&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/180063/original/file-20170727-9209-li11pj.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=622&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Healthy opossum babies are the end result.</span>
<span class="attribution"><span class="source">João Francisco Botelho</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>To break out of the eggshell, the embryo produces digestive enzymes which essentially dissolve the shell from the inside out. But even once the shell is gone, the embryo continues secreting these enzymes, causing damage to the lining of the uterus.</p>
<p>We found that the loss of the eggshell, and <a href="https://theconversation.com/using-the-placenta-to-understand-how-complex-organs-evolve-70107">formation of a placenta</a>, coincides with a massive inflammatory reaction by the mother to the presence of the fetus. </p>
<p>An extended period of inflammation is not compatible with pregnancy, so for a longer pregnancy to evolve (like our own) something needed to change. During the evolution of an extended pregnancy, rather than prevent inflammation during the period of embryo attachment, the body’s inflammation response has been repurposed – possibly as a way for the female to respond quickly to the presence of an embryo. </p>
<h2>A new use for inflammation</h2>
<p>The inflammation that results from maternal-fetal interaction in the opossum provides a clue for why inflammation is used during implantation in eutherian mammals like ourselves.</p>
<p>We suggest that inflammation has been repurposed as a way for the mother and fetus to communicate. Inflammation is one of the first changes that occurs following attachment of the embryo to the uterine wall in women. This inflammation signals to the rest of the uterus to prepare itself for pregnancy. </p>
<p>Rather than evolving a whole new way for the embryo to tell the uterus to get ready for an extended pregnancy, evolution has modified the inflammation response to be a method of communication. Now it’s a way for the mother to detect the presence of the embryo, allowing her to support implantation and establish pregnancy.</p>
<p>Once the inflammation gets started in humans, it’s readily controlled and the uterus switches to an anti-inflammatory state. We think the ability to make this shift during gestation was a key innovation in eutherian mammals, allowing for an extended pregnancy.</p>
<p>Our findings not only explain the paradox of why inflammation is used to regulate implantation and giving birth, but also provide a paradigm for understanding inflammation as a normal component of pregnancy. It’s not only a response to injury – it’s become a method of communication.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/180093/original/file-20170727-10836-1mjqxm6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/180093/original/file-20170727-10836-1mjqxm6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/180093/original/file-20170727-10836-1mjqxm6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=225&fit=crop&dpr=1 600w, https://images.theconversation.com/files/180093/original/file-20170727-10836-1mjqxm6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=225&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/180093/original/file-20170727-10836-1mjqxm6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=225&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/180093/original/file-20170727-10836-1mjqxm6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=282&fit=crop&dpr=1 754w, https://images.theconversation.com/files/180093/original/file-20170727-10836-1mjqxm6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=282&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/180093/original/file-20170727-10836-1mjqxm6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=282&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Grey short-tailed opossums provided a great model for how our own long pregnancies evolved.</span>
<span class="attribution"><span class="source">Oliver Griffith</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<h2>Evolutionary view could increase IVF success</h2>
<p>Historically doctors have thought of implantation as the process of the very early embryo attaching and embedding itself into the uterine wall. From this perspective, it looks like the success of implantation is primarily the embryo’s responsibility – that is, how adept is this embryo at attaching and embedding?</p>
<p>With this idea in mind, reproductive technologies have traditionally invested resources into improving embryo viability as a way to facilitate implantation. Researchers have focused less on the mother’s receptivity to implantation.</p>
<p>But in reality, implantation is a complex process regulated by both the fetus and the mother. </p>
<p>Our research provides a new framework to think about implantation as an evolved reaction of the mother’s body to the presence of a fetus. Now we can start to build a bigger picture of how the molecular changes that support implantation fit together, adding to how researchers have typically relied on their understanding of individual genes and proteins as pieces of the puzzle.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/180100/original/file-20170727-10773-1wgcxqq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/180100/original/file-20170727-10773-1wgcxqq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/180100/original/file-20170727-10773-1wgcxqq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/180100/original/file-20170727-10773-1wgcxqq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/180100/original/file-20170727-10773-1wgcxqq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/180100/original/file-20170727-10773-1wgcxqq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/180100/original/file-20170727-10773-1wgcxqq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/180100/original/file-20170727-10773-1wgcxqq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Much of IVF focuses on the embryos, but maybe the mother’s body can be better supported.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Britain-Cheap-IVF/574c4d6aba984a68930b9a92af646949/3/0">AP Photo/Sang Tan</a></span>
</figcaption>
</figure>
<p>We can now start to understand why doctors have observed for some time that suppressing inflammation (including by taking the anti-inflammatory drug ibuprofen) during implantation <a href="https://doi.org/10.1136/bmj.327.7411.368">decreases the implantation success rate</a>. Also, it might have seemed counterintuitive that scratching the uterus – inducing uterine inflammation – can actually <a href="https://dx.doi.org/10.3109/09513590.2014.994603">increase implantation success</a> for women. But now we have a new way to understand the job inflammation is doing.</p>
<p>In addition, IVF doctors use several molecular changes to detect a woman’s receptivity to implantation in the clinic; we showed that opossums experience the same molecular changes during embryo attachment. These molecular changes that are vital to both opossum attachment and human implantation must be fundamental to the process – if they occur in both species, they’ve remained unchanged for more than 160 million years. These processes that have lasted throughout evolution must be essential for reproductive fitness.</p>
<p>Our research allows us to identify important molecules for assessing uterine receptivity and potential drug targets for treating implantation disorders and provides a new way to think about implantation as a modified reaction of the uterus to the presence of a fetus.</p><img src="https://counter.theconversation.com/content/81539/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Oliver Griffith receives funding from the Yale Institute for Biospheric studies. </span></em></p>A new evolutionary perspective on what’s been a medical paradox: Why does the body use inflammation to regulate aspects of pregnancy when inflammation is also a big threat to pregnancy?Oliver Griffith, Postdoctoral Associate in Ecology and Evolutionary Biology, Yale UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/719862017-01-29T19:02:11Z2017-01-29T19:02:11ZDestroying research embryos within 14 days limits chance of medical breakthroughs<p>Californian scientists recently grew the <a href="http://www.nature.com/news/hybrid-zoo-introducing-pig-human-embryos-and-a-rat-mouse-1.21378#/b1">first human-pig embryos</a>, and Japanese scientists say they’ve <a href="http://www.abc.net.au/radionational/programs/breakfast/science-with-chris-smith-growing-organs/8216406">grown a replacement pancreas</a> for a mouse inside a rat. </p>
<p>Scientists envision these grown organs herald a new era for drug testing and can help understand early human development. The developments pave the way for a future where transplant organs for humans can be grown inside hybrid animals.</p>
<p>These innovations have sprung from stem-cell science, a controversial but rapidly growing area of research. The recent Australian of the Year award given to biomedical scientist <a href="http://www.abc.net.au/news/2017-01-25/australian-of-the-year-2017-winners-alan-mackay-sim/8212694">Professor Alan Mackay-Sim</a>, who dedicated his life to researching stem cells implicated in groundbreaking treatment of spinal cord injuries, highlights stem-cell science’s potential for breakthroughs in the area of regenerative medicine, among others.</p>
<p>Yet, primarily due to moral considerations, stem-cell scientists have to work within many limitations placed on their research. One of these is the 14-day rule that outlaws research on pure human embryos over two weeks old. It is <a href="http://www.nature.com/news/embryology-policy-revisit-the-14-day-rule-1.19838#/agreement">encoded in laws</a> in at least 12 countries, including the US, UK, Australia and New Zealand.</p>
<p>Having extra time would permit researchers to investigate the causes of miscarriages and develop methods to create stem cells to cure many diseases. Given the potential therapeutic benefits, there is now a strong case to consider revising the restrictive two-week limit.</p>
<h2>Why 14 days?</h2>
<p>The 14-day limit was <a href="http://www.nature.com/news/embryology-policy-revisit-the-14-day-rule-1.19838">first proposed in 1979</a>, in the early days of IVF, by the Ethics Advisory Board of the US Department of Health, Education, and Welfare. It was then endorsed in 1984 by the <a href="http://www.hfea.gov.uk/2068.html">Warnock committee</a> – established to inquire into the technologies in-vitro fertilisation (IVF) and embryology – in the United Kingdom, and in 1994 by the US National Institutes of Health’s Human Embryo Research Panel.</p>
<p>This time limit was recommended because it precedes the appearance of something called “the primitive streak”. This represents the earliest point at which an embryo’s biological individuation is assured. Before this point, embryos can split in two (twins) or fuse together. Some people reason a morally significant individual comes into being at this stage. </p>
<p>This is also the earliest development of the human’s nervous system (brain and spinal cord), at which there is risk of the embryo suffering pain. In short, termination of the embryo at day 14 was a compromise between reaping the benefits of research and alleviating society’s ethical concerns.</p>
<p>The Warnock report’s recommendations were subsequently adopted in the UK law and around the world, <a href="http://www.austlii.edu.au/au/legis/cth/consol_act/rihea2002347/">including Australia</a>. The rule is embodied in many reports commissioned by governments and in guidelines for embryo and assisted-reproduction research. </p>
<p>Researchers <a href="http://www.nature.com/news/embryology-policy-revisit-the-14-day-rule-1.19838">called for a revision of the 14-day rule last year</a> after scientists in the UK and US <a href="http://www.nature.com/nature/journal/v533/n7602/full/nature17948.html">devised a method</a> to enable a human embryo to survive outside the womb longer than before. </p>
<p>They did this by successfully creating a chemical environment that tricked the embryo into thinking it was in a womb while it was still in a petri dish. The cells they used were obtained from stem-cell lines derived from early (four- to five-day-old) embryos, donated through fertility clinics. </p>
<p>Scientists had to destroy the embryos on the thirteenth day of their survival in the petri dish to avoid violating the law. Before the destruction, the UK and US teams discovered a cluster of cells emerged on the tenth day of the embryos’ development, suggesting a previously unknown biological process was occurring. </p>
<p>Having more time with the embryos would allow scientists to study all aspects of early human development with unprecedented precision.</p>
<p>One of the study’s researchers, <a href="http://www.abc.net.au/news/2016-05-05/human-embryos-grown-in-the-lab-up-to-14-days/7384002">Marta Shahbazi, said</a> the ability to observe embryonic development in the laboratory offered a</p>
<blockquote>
<p>unique opportunity not only to learn how the embryo develops in this period, but to understand why pregnancies fail at this critical junction in development.</p>
</blockquote>
<p>Until then, the 14-day rule presented few obstacles to researchers as an embryo had only been able to survive nine days in a laboratory. In the case of IVF, the outside embryo is <a href="https://academic.oup.com/humrep/article/18/2/283/639212/An-in-vitro-model-for-stromal-invasion-during">usually implanted into a womb</a> in the first seven days. </p>
<h2>Redrawing the boundaries</h2>
<p>Prior to the publications of the recent studies, there appeared to be few valid reasons to amend the 14-day law. But scientific progress has brought us to a point where we have a reason to revisit the moral boundary line.</p>
<p>According to the bioethicist, John Harris, the <a href="https://www.theguardian.com/commentisfree/2016/may/06/extend-14-day-limit-embryo-research">consensus of scientific opinion</a> is that scientists can learn much by augmenting the 14-day limit to 21 days. He notes, by comparison, abortion in many nations is legally permitted up to 24 weeks’ gestation – a threshold substantially beyond the 21-day limit.</p>
<p>The 14-day rule has survived for more than three decades and to amend it would require careful evaluation. If we maintain a status quo that prevents meaningful research from proceeding, we risk forgoing therapeutic benefits owed to society and future generations.</p>
<p>But revising the rule requires a careful, deliberative approach, which would include conducting an inquiry into Australian public attitudes and open, democratic debate. </p>
<p>Meanwhile, <a href="http://nuffieldbioethics.org/news/2016/council-hold-workshops-ageing-research-global-health-emergencies/">the Nuffield Council of Bioethics</a>, the body that decides on contentious scientific research in the UK, has announced it will review the present experiment limits. Here in pluralist Australia, we should begin to have the difficult conversation about this sensitive, complex and important topic.</p><img src="https://counter.theconversation.com/content/71986/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Patrick Foong is affiliated with the International Society for Stem Cell Research (ISSCR)
</span></em></p>Stem-cell scientists have to work within many limitations placed on their research. One of these is the 14-day rule that outlaws research on pure human embryos over two weeks old.Patrick Foong, Lecturer, Law, Swinburne University of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/514762015-12-01T19:13:14Z2015-12-01T19:13:14ZGene editing in embryos is fraught with scientific and ethical issues<figure><img src="https://images.theconversation.com/files/103840/original/image-20151201-26549-tgy4q1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Genetic changes to embryos will not only affect the person that embryo becomes but also all their descendants.</span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/anniferrr/5190095551/">anna gutermuth/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span></figcaption></figure><p>Recent technological advances have revolutionised our ability to manipulate the genetic code, allowing us to specifically edit individual genes. Gene editing offers exciting potential for disease therapies but application of the technology in embryos also raises many ethical and scientific issues.</p>
<p>Humans - and all other mammals - reproduce through sperm and eggs (germ cells) that transmit a single copy of each parent’s chromosomes to the offspring. When an embryo forms at conception, it has a mix of genes from both germs cells, producing a child who’s a biological reflection of the parents.</p>
<p>Sometimes, harmful mutations or changes in a gene sequence are transmitted by the germ cells and have deleterious effects in the embryo or in later life. In recent decades, genetic screening has allowed detection of particular genetic aberrations in early embryos. This has allowed us to avoid some of the harmful consequences of specific damaging mutations through pregnancy termination. </p>
<p>While genetic screening poses complex ethical questions, it’s safe and doesn’t introduce changes to genes that affect the baby or the baby’s future children. By contrast, gene editing affects both.</p>
<h2>Risking off-target effects</h2>
<p>Gene-editing technologies have introduced the possibility of altering individual genes in eggs or sperm, or immediately after fertilisation in the earliest human embryos. This has the potential to correct gene mutations that underlie inherited disease. </p>
<p>But such germline gene therapy doesn’t only affect the individual germ cells or embryo that has been treated; any changes will be transmitted to the future children of that individual. </p>
<p>This is highly controversial as it raises major safety concerns and the spectre of introducing “designer” mutations, in which specific genetic traits could be modified according to parents’ requirements. </p>
<p>Clearly, there are fundamental social and ethical considerations involved that preclude the use of gene editing in the human germline or in human embryos. But critical questions also surround safety and the potential biological impacts of gene editing if it were to be applied in humans.</p>
<p>The most obvious risk of editing embryo genes is the potential for errors or of introducing off-target genetic effects. Off-target effects occur when gene technology mistakenly hits a DNA sequence that’s not the intended target. </p>
<p>While gene editing can be very specific, even minor errors or off-target effects are unacceptable in human embryos as they could harm the developing fetus or cause disease in adulthood. Off-target sites can also include the surprisingly large proportion of DNA sequence that lies between genes and plays important roles in gene regulation. </p>
<p>Critically, changes to any of these sequences will then be inherited by future generations.</p>
<h2>The epigenetic black box</h2>
<p>Other concerns surround potential effects on the way genes are regulated in the embryo. Although we’ve made unprecedented advances in biotechnology, we’re only beginning to understand the complex biological systems that regulate fetal formation and influence lifelong health. </p>
<p>While gene sequence is paramount, additional information provided around the DNA is also crucial for development. One such example is the epigenetic code, which controls whether the thousands of genes contained in each cell are switched on and off in the correct combination, in the correct tissue, over a lifetime. </p>
<p>Epigenetic information contained in each cell type is passed to each new cell as it divides to maintain or renew each tissue. This code ensures the long-term identity of cell types and the proper function of the tissue and organs they constitute. </p>
<p>Two important epigenetic issues arise in the context of editing embryo genes. First, environmental stimuli, such as chemicals, drugs or even diet, can alter epigenetic mechanisms. Second, disruptions in this code can lead to disease, a concept that is best illustrated in cancer development. </p>
<p>Importantly, both the sperm and egg transmit epigenetic information to the newly fertilised embryo. This epigenetic information affects development, health and even behaviour in the offspring. </p>
<p>Growing evidence indicates certain environmental stimuli alter epigenetic state in the germline and significantly affect outcomes not only in children, but also in grandchildren. Despite this, we have little understanding of how these effects are mediated in the developing embryo.</p>
<h2>Cause for caution</h2>
<p>While gene editing may be designed to correct a very specific genetic mutation, the change must be made in an embryo culture environment – that is, in the lab. Although embryo culture conditions are carefully controlled, we still have no way of properly measuring the potentially complex impacts of the gene-editing process on the embryo</p>
<p>Importantly, any negative effects may not be limited to the actual edit; they may also result from the gene-editing process, which requires the use of specific enzymes, chemicals and reagents in an artificial culture environment. These too may alter epigenetic state and other mechanisms in the embryo. </p>
<p>Despite the rapid progress and undeniable power of gene-editing technologies, we’re still in the early stages of understanding the impacts of these processes on the genetic and epigenetic state of embryos and the future health and development of the person they become. The ethical issues surrounding germline gene therapy in humans are also enormous (more on that in The Conversation tomorrow). </p>
<p>If such technology were ever to be applied to the human germline for medical purposes, these issues would need to be addressed with the greatest stringency.</p><img src="https://counter.theconversation.com/content/51476/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Patrick Western receives funding from the National Health and Medical Research Council of Australia. </span></em></p>While gene editing offers the exciting potential for disease therapies, using it on human embryos opens up a can of worms.Patrick Western, Research Group Head, Germ Cell Development and Epigenetics, Hudson InstituteLicensed as Creative Commons – attribution, no derivatives.