{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,6]],"date-time":"2026-04-06T08:54:54Z","timestamp":1775465694079,"version":"3.50.1"},"reference-count":19,"publisher":"Wiley","issue":"13","license":[{"start":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T00:00:00Z","timestamp":1761868800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Prenatal Diagnosis"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To analyze the legal consent requirements and customary procedures in clinical trials of fetal therapy with continuing neonatal interventions across four European countries using the BOOSTB4 trial as a case study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study of country\u2010specific legal consent requirements and the actual consent procedures in the BOOSTB4 trial, incorporating surveys with the trial's principal investigators.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Prenatal consent was obtained solely from the pregnant women in all participating countries, in line with legal requirements. However, in all countries both prospective parents were engaged in prenatal counseling. In Sweden, the Netherlands and Germany obtaining consent from both parents for continuing neonatal interventions is mandatory. In the United Kingdom, officially only the consent of one parent is required. Nevertheless, researchers there are cautious of including pregnant women or neonates if parents disagree to trial participation, a concern echoed by Dutch, German and Swedish researchers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>While the pregnant woman's autonomy is paramount for prenatal trial participation, trials involving continuing neonatal interventions should adopt a two\u2010step prenatal counseling approach. This approach allows a distinction between consent for fetal and neonatal procedures and allows researchers to comprehend parental perspectives without undermining the pregnant woman's individual rights.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pd.70012","type":"journal-article","created":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T13:11:17Z","timestamp":1761916277000},"page":"1810-1815","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Clinical Trials of Fetal Therapy With Continuing Neonatal Interventions: Legal Requirements and Customary Procedures Regarding Parental Consent.\n                    <i>The BOOSTB4 Trial as a Case Study<\/i>"],"prefix":"10.1002","volume":"45","author":[{"given":"Esther J.","family":"Oldekamp","sequence":"first","affiliation":[{"name":"Department of Medical Ethics and Health Law Leiden University Medical Centre  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martine C.","family":"de Vries","sequence":"additional","affiliation":[{"name":"Department of Medical Ethics and Health Law Leiden University Medical Centre  Leiden the Netherlands"},{"name":"Department of Pediatrics Leiden University Medical Centre  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0199-6140","authenticated-orcid":false,"given":"Anna L.","family":"David","sequence":"additional","affiliation":[{"name":"Elizabeth Garrett Anderson Institute for Women's Health University College London  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Oliver","family":"Semler","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Faculty of Medicine and University Hospital Cologne University of Cologne  Cologne Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Magnus","family":"Westgren","sequence":"additional","affiliation":[{"name":"Department of Clinical Science, Intervention and Technology Division of Obstetrics and Gynecology Karolinska Institutet  Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cecilia","family":"G\u00f6therstr\u00f6m","sequence":"additional","affiliation":[{"name":"Department of Clinical Science, Intervention and Technology Division of Obstetrics and Gynecology Karolinska Institutet  Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E. J. T. (Joanne)","family":"Verweij","sequence":"additional","affiliation":[{"name":"Department of Obstetrics Division of Fetal Therapy Leiden University Medical Centre  Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,31]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"EU CTR 536\/20140."},{"key":"e_1_2_11_3_1","unstructured":"Article 7 International Covenant on Civil and Political Rights.article 3 European Charter of Fundamental Rights; Article 6 Universal Declaration on Bioethics and Human Rights (UNESCO); Article 4 and 7 General Data Protection Regulation; Article 5 Jo. 16 Oviedo Convention; Article 25 26 Declaration of Helsinki (World Medical Association); Guideline 9 and 15 International Ethical Guidelines for Health\u2010related Research Involving Humans(Council for international Organizations of Medical Sciences."},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2015-310001"},{"key":"e_1_2_11_5_1","unstructured":"European Network Paediatric Research at the European Medicines Agency. \u201cToolkit: Informed Consent for Paediatric Clinical Trials in Europe 2015 \u201d (2023). Accessed November 17 2024 https:\/\/www.ema.europa.eu\/en\/documents\/other\/informed\u2010consent\u2010paediatric\u2010clinical\u2010trials\u2010europe\u20102015_en.pdf."},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/GRF.0000000000000656"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/uog.25062"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen\u20102023\u2010079767"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/17411343241303843"},{"key":"e_1_2_11_10_1","unstructured":"Article 21 Dutch Embryo Act."},{"key":"e_1_2_11_11_1","unstructured":"Article 6\u20101 Under D Dutch Medical Research With Humans Act."},{"key":"e_1_2_11_12_1","unstructured":"Clinical Trials Regulations.2004 part 1\u20102."},{"key":"e_1_2_11_13_1","unstructured":"Clinical Trials Regulations Part 4. (2004): Principle 13."},{"key":"e_1_2_11_14_1","unstructured":"National Health Service. \u201cHealth Research Authority. Research Involving Children \u201d (December 2023). Accessed November 17 2024 https:\/\/www.hra.nhs.uk\/planning\u2010and\u2010improving\u2010research\/policies\u2010standards\u2010legislation\/research\u2010involving\u2010children\/."},{"key":"e_1_2_11_15_1","unstructured":"Ethical Review Act (Lag om etikpr\u00f6vning av forskning som avser m\u00e4nniskor 2003:460) & Medicinal Product Act (L\u00e4kemedelslagen 2015:315). Chapter 7 Section 3."},{"key":"e_1_2_11_16_1","unstructured":"Article 40 3 under b Provisions 40 to 42 under b AMG"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1163\/157180908x322950"},{"key":"e_1_2_11_18_1","unstructured":"W. J.Dondorp M. C.Ploem G. M. W. R.de Wert andD. E.Embryowet et\u00a0al. Den Haag: Zonmw Februari Vol.50 (2021) 136\u2013140."},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1163\/15718182\u201002601006"},{"key":"e_1_2_11_20_1","doi-asserted-by":"crossref","unstructured":"JohanssonM. Hermer\u00e9nG. SahlinN. E. Paternal Consent in Prenatal Research: Ethical Aspects Medicin Health Care and Philosophy (2019).","DOI":"10.1007\/s11019-019-09919-1"}],"container-title":["Prenatal Diagnosis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pd.70012","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,10]],"date-time":"2025-12-10T14:56:37Z","timestamp":1765378597000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1002\/pd.70012"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,31]]},"references-count":19,"journal-issue":{"issue":"13","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["10.1002\/pd.70012"],"URL":"https:\/\/doi.org\/10.1002\/pd.70012","archive":["Portico"],"relation":{},"ISSN":["0197-3851","1097-0223"],"issn-type":[{"value":"0197-3851","type":"print"},{"value":"1097-0223","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,31]]},"assertion":[{"value":"2025-05-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-24","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-31","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}