{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T22:03:21Z","timestamp":1790892201168,"version":"4.1.0"},"reference-count":34,"publisher":"BMJ","issue":"10","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Med Ethics"],"accepted":{"date-parts":[[2025,10,14]]},"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:p>Advances in stem cell research have enabled the creation of embryo models that challenge existing definitions and regulatory boundaries in embryo research. The scientific community has struggled to establish a coherent nomenclature for these models, leading to confusion and sensationalism about their nature and applications. Moreover, recent publications by the Nuffield Council on Bioethics and the Ethics Committee of the European Society of Human Reproduction and Embryology have argued that embryonic models derived from stem cells are ineligible to be included in the definition of an embryo. However, some countries had already enacted legislation addressing the classification of certain models derived from stem cells as embryos prior to the issuance of these guidelines. This discrepancy engenders considerable tension among the scientific viewpoints of the countries safeguarded by these laws, with suggestions emerging from authoritative agencies. This research seeks to recognise the regulatory and ethical void created by inconsistent definitions of embryo-like entities and to advocate for a framework fostering interdisciplinary agreement in response to recent advancements. Alternatively, we aim to promote a bioethics that not only supports legislative decisions but also guarantees their validation before their implementation. We argue that without a unified interdisciplinary framework, legal structures may become fragmented, jeopardising both research integrity and public trust.<\/jats:p>","DOI":"10.1136\/jme-2025-111132","type":"journal-article","created":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T09:25:16Z","timestamp":1762507516000},"page":"678-682","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Embryo models and the regulatory void: ethical imperatives before legal action"],"prefix":"10.1136","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-8733-2274","authenticated-orcid":false,"given":"Mart\u00ed","family":"Vila-P\u00e9rez","sequence":"first","affiliation":[{"name":"Institut Borja de Bio\u00e8tica URL, Barcelona, Spain"},{"name":"Blanquerna Universitat Ramon Llull, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Lorenzo-Izquierdo","sequence":"additional","affiliation":[{"name":"Institut Borja de Bio\u00e8tica URL, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Montserrat","family":"Esquerda-Arest\u00e9","sequence":"additional","affiliation":[{"name":"Institut Borja de Bio\u00e8tica URL, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,11,7]]},"reference":[{"key":"2026092202201054000_52.10.678.1","doi-asserted-by":"crossref","first-page":"669","DOI":"10.3325\/cmj.2014.55.669","article-title":"What is a human embryo? A new piece in the bioethics puzzle","volume":"55","author":"de Miguel Beriain","year":"2014","journal-title":"Croat Med J"},{"key":"2026092202201054000_52.10.678.2","doi-asserted-by":"crossref","first-page":"2387","DOI":"10.1093\/humrep\/deae228","article-title":"Ethical considerations on the moral status of the embryo and embryo-like structures\u2020","volume":"39","author":"Pennings","year":"2024","journal-title":"Hum Reprod"},{"key":"2026092202201054000_52.10.678.3","unstructured":"Nuffield Council on Bioethics . Human stem cell-based embryo models: a review of ethical and governance questions. 2024."},{"key":"2026092202201054000_52.10.678.4","doi-asserted-by":"crossref","first-page":"102514","DOI":"10.1016\/j.stemcr.2025.102514","article-title":"Stem cell-based embryo models: The 2021 ISSCR stem cell guidelines revisited","volume":"20","author":"Clark","year":"2025","journal-title":"Stem Cell Reports"},{"key":"2026092202201054000_52.10.678.5","unstructured":"Determining whether an embryo model is regulated by the ERLC. National Health and Medical Research Council; 2023. Available: https:\/\/www.nhmrc.gov.au\/research-policy\/embryo-research-licensing\/commonwealth-and-state-legislation\/determining-whether-embryo-model-regulated-erlc"},{"key":"2026092202201054000_52.10.678.6","unstructured":"The 14-day rule in the dutch embryo act. Health Council of the Netherlands; 2023. Available: https:\/\/www.healthcouncil.nl\/documents\/advisory-reports\/2023\/10\/31\/the-14-day-rule-in-the-dutch-embryo-act"},{"key":"2026092202201054000_52.10.678.7","doi-asserted-by":"crossref","first-page":"231","DOI":"10.3390\/organoids2040018","article-title":"Stem Cell-Derived Organoids, Embryoids, and Embryos: Advances in Organismic Development In Vitro Force Us to Re-Focus on Ethical and Legal Aspects of Model Choice","volume":"2","author":"Denker","year":"2023","journal-title":"Organoids"},{"key":"2026092202201054000_52.10.678.8","doi-asserted-by":"publisher","DOI":"10.1242\/dev.144915"},{"key":"2026092202201054000_52.10.678.9","doi-asserted-by":"crossref","first-page":"1290","DOI":"10.1016\/j.stem.2023.09.006","article-title":"Human embryo models made from pluripotent stem cells are not synthetic; they aren\u2019t embryos, either","volume":"30","author":"Landecker","year":"2023","journal-title":"Cell Stem Cell"},{"key":"2026092202201054000_52.10.678.10","doi-asserted-by":"crossref","DOI":"10.7554\/eLife.20674","article-title":"Addressing the ethical issues raised by synthetic human entities with embryo-like features","volume":"6","author":"Aach","year":"2017","journal-title":"Elife"},{"key":"2026092202201054000_52.10.678.11","first-page":"147","article-title":"The 14-Day Embryo Rule: A Modest Proposal","volume":"22","author":"Greely","year":"2022","journal-title":"Houst J Health Law Policy"},{"key":"2026092202201054000_52.10.678.12","doi-asserted-by":"crossref","DOI":"10.1093\/jlb\/lsaf008","article-title":"Advocating distinct regulatory paths for embryos and embryo-like structures","volume":"12","author":"Cave","year":"2025","journal-title":"J Law Biosci"},{"key":"2026092202201054000_52.10.678.13","unstructured":"Warnock M . Report of the committee of inquiry into human fertilisation and embryology. Vol. 9314. HM Stationery Office, 1984."},{"key":"2026092202201054000_52.10.678.14","doi-asserted-by":"crossref","first-page":"1398","DOI":"10.1016\/j.stemcr.2021.05.012","article-title":"ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update","volume":"16","author":"Lovell-Badge","year":"2021","journal-title":"Stem Cell Reports"},{"key":"2026092202201054000_52.10.678.15","doi-asserted-by":"publisher","DOI":"10.1038\/s12276-023-01097-8"},{"key":"2026092202201054000_52.10.678.16","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1038\/s41586-021-03416-3","article-title":"Ex utero mouse embryogenesis from pre-gastrulation to late organogenesis","volume":"593","author":"Aguilera-Castrejon","year":"2021","journal-title":"Nature New Biol"},{"key":"2026092202201054000_52.10.678.17","doi-asserted-by":"publisher","DOI":"10.1016\/J.CELL.2022.07.028"},{"key":"2026092202201054000_52.10.678.18","doi-asserted-by":"crossref","first-page":"584","DOI":"10.1038\/s41586-023-06368-y","article-title":"Pluripotent stem cell-derived model of the post-implantation human embryo","volume":"622","author":"Weatherbee","year":"2023","journal-title":"Nature New Biol"},{"key":"2026092202201054000_52.10.678.19","doi-asserted-by":"crossref","first-page":"562","DOI":"10.1038\/s41586-023-06604-5","article-title":"Complete human day 14 post-implantation embryo models from naive ES cells","volume":"622","author":"Oldak","year":"2023","journal-title":"Nature New Biol"},{"key":"2026092202201054000_52.10.678.20","unstructured":"Cambridge Reproduction, Progress Educational Trust . Code of practice for the generation and use of human stem cell-based embryo models. 2024. Available: https:\/\/www.repro.cam.ac.uk\/scbemcode"},{"key":"2026092202201054000_52.10.678.21","doi-asserted-by":"crossref","first-page":"810","DOI":"10.1038\/385810a0","article-title":"Viable offspring derived from fetal and adult mammalian cells","volume":"385","author":"Wilmut","year":"1997","journal-title":"Nature New Biol"},{"key":"2026092202201054000_52.10.678.22","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1080\/15265161.2010.546474","article-title":"The distinction between parthenotes and embryos is not easily made","volume":"11","author":"Schwartz","year":"2011","journal-title":"Am J Bioeth"},{"key":"2026092202201054000_52.10.678.23","unstructured":"Oliver br\u00fcstle v greenpeace eV. 2011. Available: https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A62010CJ0034 [Accessed 30 Oct 2024]."},{"key":"2026092202201054000_52.10.678.24","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1016\/j.stem.2023.06.007","article-title":"Human stem cell-derived embryo models: Toward ethically appropriate regulations and policies","volume":"30","author":"Blasimme","year":"2023","journal-title":"Cell Stem Cell"},{"key":"2026092202201054000_52.10.678.25","unstructured":"Nuffield Council on Bioethics . Next steps for the regulation of stem cell-based embryo models. Available: https:\/\/www.nuffieldbioethics.org\/news-blog\/next-steps-for-the-regulation-of-stem-cell-based-embryo-models\/ [Accessed 07 Aug 2025]."},{"key":"2026092202201054000_52.10.678.26","doi-asserted-by":"publisher","DOI":"10.1136\/medethics-2018-105253"},{"key":"2026092202201054000_52.10.678.27","doi-asserted-by":"crossref","unstructured":"Jasanoff S . Technologies of humility: citizen participation in governing science. In: Bogner A , Torgersen H , eds. Wozu experten? Ambivalenzen der beziehung von wissenschaft und politik. Wiesbaden: VS Verlag f\u00fcr Sozialwissenschaften, 2005: 370\u201389. Available: https:\/\/doi.org\/10.1007\/978-3-322-80692-5_17","DOI":"10.1007\/978-3-322-80692-5_17"},{"key":"2026092202201054000_52.10.678.28","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1080\/15265161.2017.1284933","article-title":"Participation of Citizen Scientists in Clinical Research and Access to Research Ethics Consultation","volume":"17","author":"Collier","year":"2017","journal-title":"Am J Bioeth"},{"key":"2026092202201054000_52.10.678.29","doi-asserted-by":"crossref","first-page":"1682","DOI":"10.1038\/s44319-025-00409-5","article-title":"Regulating stem cell\u2013based embryo model research in Japan","volume":"26","author":"Sawai","year":"2025","journal-title":"EMBO Rep"},{"key":"2026092202201054000_52.10.678.30","doi-asserted-by":"crossref","first-page":"102479","DOI":"10.1016\/j.stemcr.2025.102479","article-title":"What does \u201cappropriate scientific justification\u201d mean for the review of human pluripotent stem cell, embryo, and related research?","volume":"20","author":"Jonlin","year":"2025","journal-title":"Stem Cell Reports"},{"key":"2026092202201054000_52.10.678.31","unstructured":"Jasanoff S . The ethics of invention. New York W.W. Norton&Company; 2016.116\u201347."},{"key":"2026092202201054000_52.10.678.32","unstructured":"Jasanoff S . The ethics of invention. New York W.W. Norton&Company; 2016.146."},{"key":"2026092202201054000_52.10.678.33","unstructured":"Medicine National Academies of Sciences E . Second international summit on human genome editing: continuing the global discussion: proceedings of a workshop\u2013in brief. National Academies of Sciences, Engineering, and Medicine; 2019."},{"key":"2026092202201054000_52.10.678.34","doi-asserted-by":"publisher","DOI":"10.1136\/jme-2023-109605"}],"container-title":["Journal of Medical Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/jme-2025-111132","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T09:22:48Z","timestamp":1790068968000},"score":1,"resource":{"primary":{"URL":"https:\/\/jme.bmj.com\/lookup\/doi\/10.1136\/jme-2025-111132"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,7]]},"references-count":34,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2026,9,22]]},"published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1136\/jme-2025-111132"],"URL":"https:\/\/doi.org\/10.1136\/jme-2025-111132","relation":{},"ISSN":["0306-6800","1473-4257"],"issn-type":[{"value":"0306-6800","type":"print"},{"value":"1473-4257","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,7]]}}}