{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T14:02:22Z","timestamp":1789567342746,"version":"build-2803163510"},"reference-count":28,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T00:00:00Z","timestamp":1789516800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T00:00:00Z","timestamp":1789516800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Paediatrica"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>An estimated five million children under the age of five die each year, largely from preventable causes. Clinical research involving young children is essential for improving child health, but is ethically complex. The United Nations Convention on the Rights of the Child (UNCRC) provides a framework for protecting children's rights and best interests. This study explored how clinical research involving children under five can be conducted in accordance with the UNCRC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A qualitative interview study was conducted with six experienced paediatric clinical research staff at Swedish university hospitals. Semi\u2010structured interviews were used to explore how key UNCRC principles are applied in everyday research practice. Data was analysed using qualitative content analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Three themes were identified: Balance of the child's best interest, Supporting the child and the family, and organising ethical paediatric research practice. Applying the UNCRC was described as an ongoing process of ethical judgement, involving adaptation to the individual child, attention to non\u2010verbal cues, and careful communication with families.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The UNCRC provides a complementary framework to existing ethical regulations. Its application relies on professional judgement and is not consistently standardised, but may support more child\u2010centred and ethically grounded research practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apa.70768","type":"journal-article","created":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T13:03:12Z","timestamp":1789563792000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Research Staff's Experiences of Applying the UNCRC in Clinical Research Involving Young Children\u2014An Ongoing Process of Ethical Judgement"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-3525-1336","authenticated-orcid":false,"given":"Anna Karin","family":"Bernhardsson","sequence":"first","affiliation":[{"name":"Department of Women's and Children's Health Karolinska Institute  Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4451-4252","authenticated-orcid":false,"given":"Anna","family":"Gustafsson","sequence":"additional","affiliation":[{"name":"Department of Women's and Children's Health Karolinska Institute  Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,16]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"WHO \u201cChild Mortality (Under 5\u2009Years) \u201dhttps:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/child\u2010mortality\u2010under\u20105\u2010years."},{"key":"e_1_2_12_3_1","unstructured":"European Union \u201cEthical Considerations for Clinical Trials on Medicina. Products Conducted With the Paediatric Population\u2014Recommendations of the Ad Hoc Group for the Development of Implementing Guidelines for Directive 2001\/20\/EC Relating to Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use\u201d."},{"key":"e_1_2_12_4_1","volume-title":"Guidance for Best Practices for Clinical Trials","author":"World Health Organization","year":"2023"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1542\/pir.34\u20106\u2010258"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics15122652"},{"key":"e_1_2_12_7_1","volume-title":"Directorate General for Health and Food Safety. Study on Off\u2010Label Use of Medicinal Products in the European Union: Report","author":"European Commission","year":"2019"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2023.3939"},{"key":"e_1_2_12_9_1","unstructured":"Etikpr\u00f6vningsmyndigheten (Swedish Ethical Review Authority) \u201cWhat is Important to Consider When Including Children and Young People in Research?\u201dhttps:\/\/etikprovningsmyndigheten.se\/faq\/vad\u2010ar\u2010viktigt\u2010att\u2010tanka\u2010pa\u2010nar\u2010barn\u2010och\u2010unga\u2010ska\u2010inkluderas\u2010i\u2010forskning\/."},{"key":"e_1_2_12_10_1","unstructured":"UNICEF \u201cHistory of Child Rights \u201dhttps:\/\/www.unicef.org\/child\u2010rights\u2010convention\/history\u2010child\u2010rights."},{"key":"e_1_2_12_11_1","unstructured":"United Nations \u201cConvention Rights Child at Crossroad 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