{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:13:06Z","timestamp":1772169186376,"version":"3.50.1"},"reference-count":30,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T00:00:00Z","timestamp":1733356800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["226801\/Z\/22\/Z"],"award-info":[{"award-number":["226801\/Z\/22\/Z"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns3:p>\n                    Since the inception of transplantation, it has been crucial to ensure that organ or tissue donations are made with valid informed consent to avoid concerns about coercion or exploitation. This issue is particularly challenging when it comes to infants and younger children, insofar as they are unable to provide consent. Despite their vulnerability, infants' organs and tissues are considered valuable for biomedical purposes due to their size and unique properties. This raises questions about the conditions under which it is permissible to remove and use these body parts for transplantation, research, or commercial purposes. The aim of this protocol is to establish a foundation for a scoping review that will identify, clarify, and categorise the main ethical arguments regarding the permissibility of removing and using organs or tissues from infants. The scoping review will follow the methodology outlined by the Joanna Briggs Institute (JBI), consisting of five stages: (1) identifying the research question, (2) developing the search strategy, (3) setting inclusion criteria, (4) extracting data, and (5) presenting and analysing the results. We will include both published and unpublished materials that explicitly discuss the ethical arguments related to the procurement and use of infant organs or tissues in the biomedical context. The search will cover various databases, including the National Library of Medicine, Web of Science, EBSCO, and others, as well as grey literature sources. Two raters will independently assess the eligibility of articles, and data from eligible studies will be extracted using a standardised form. The extracted data will then be analysed descriptively through qualitative content analysis. Background There has been debate about how to respect the rights and interests of organ and tissue donors since the beginning of transplantation practice, given the moral risks involved in procuring parts of their bodies and using them for transplantation or research. A major concern has been to ensure that, at a minimum, donation of organs or other bodily tissues for transplantation or research is done under conditions of valid informed consent, so as to avoid coercion or exploitation among other moral harms. In the case of infants and younger children, however, this concern poses special difficulties insofar as infants and younger children are deemed incapable of providing valid consent. Due to their diminutive size and other distinctive properties, infants\u2019 organs and tissues are seen as valuable for biomedical purposes. Yet, the heightened vulnerability of infants raises questions about when and whether it is ever permissible to remove these body parts or use them in research or for other purposes. The aim of this protocol is to form the basis of a systematic scoping review to identify, clarify, and systematise the main ethical arguments for and against the permissibility of removing and using infant or newborn (hereafter, \u201cinfant\u201d) organs or tissues in the biomedical context (i.e. for transplantation, research, or commercial purposes). Methods Our scoping review will broadly follow the well-established methodology outlined by the Joanna Briggs Institute (Peters\n                    <ns3:italic>et al.<\/ns3:italic>\n                    , 2020). We will follow a five-stage review process: (1) identification of the research question, (2) development of the search strategy, (3) inclusion criteria, (4) data extraction, and (5) presentation and analysis of the results. Published and unpublished bibliographic material (including reports, dissertations, book chapters, etc.) will be considered based on the following inclusion criteria: the presence of explicit (bio)ethical arguments or reasons (concept) for or against the procurement and use of organs or tissues from infants, defined as a child from birth until 1 year old (population), in the biomedical domain, including transplantation, research, and commercial development (context). We will search for relevant studies in the National Library of Medicine (including PubMed and MEDLINE), Virtual Health Library, Web of Science, Google Scholar, EBSCO, Google Scholar, PhilPapers, The Bioethics Literature Database (BELIT), EthxWeb as well as grey literature sources (e.g., Google, BASE, OpenGrey, and WorldCat) and the reference lists of key studies to identify studies suitable for inclusion. A three-stage search strategy will be used to determine the eligibility of articles, as recommended by the JBI methodological guidelines. We will exclude sources if (a) the full text is not accessible, (b) the main text is in a language other than English, or (c) the focus is exclusively on scientific, legal, or religious\/theological arguments. All articles will be independently assessed for eligibility between two raters (MB &amp; XL); data from eligible articles will be extracted and charted using a standardised data extraction form. The extracted data will be analysed descriptively using basic qualitative content analysis. Ethics and dissemination Ethical review is not required as scoping reviews are a form of secondary data analysis that synthesise data from publicly available sources. Our dissemination strategy includes peer review publication, presentation at conferences, and outreach to relevant stakeholders. Results The results will be reported according to the PRISMA-ScR guidelines. An overview of the general data from the included studies will be presented in the form of graphs or tables showing the distribution of studies by year or period of publication, country of origin, and key ethical arguments. These results will be accompanied by a narrative summary describing how each included study or article relates to the aims of this review. Research gaps will be identified and limitations of the review will also be highlighted. Conclusions A paper summarising the findings from this review will be published in a peer-reviewed journal. In addition, a synthesis of the key findings will be disseminated to biomedical settings (e.g., conferences or workshops, potentially including ones linked to university hospitals) in the UK, USA, T\u00fcrkiye, and Singapore. They will also be shared with the academic community and policy makers involved in the organ procurement organisations (OPO), which will potentially consider our recommendations in their decision-making processes regarding infant tissue\/organ donation practice in these countries. Strengths and limitations of this study The use of a rigorous, well-established methodological framework will ensure the production of a high-quality scoping review that will contribute to the bioethics literature. A comprehensive search of disciplinary and cross-disciplinary databases will be undertaken to ensure coverage of all possible sources that meet the inclusion criteria for the review. This review will focus exclusively on infant tissue\/organ procurement\/use in biomedical contexts, providing a comprehensive and reliable source of ethical arguments for future debates on this sensitive topic. The review will be limited to articles published in English, which increases the risk of missing relevant sources published in other languages. The review will be limited to articles for which the full text is available, which increases the risk of missing relevant sources that otherwise may have been included in the scoping review had the full text been accessible.\n                  <\/ns3:p>","DOI":"10.12688\/wellcomeopenres.23235.1","type":"journal-article","created":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T06:55:10Z","timestamp":1733381710000},"page":"717","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":4,"title":["Ethics of Procuring and Using Organs or Tissue from Infants and Newborns for Transplantation, Research, or Commercial Purposes: Protocol for a Bioethics Scoping Review"],"prefix":"10.12688","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7445-4599","authenticated-orcid":false,"given":"Maide","family":"Bar\u0131s\u0327","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiu","family":"Lim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2448-4866","authenticated-orcid":false,"given":"Melanie","family":"T Almonte","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Shaw","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joe","family":"Brierley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastian","family":"Porsdam Mann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Trung","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jerry","family":"Menikoff","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3958-8633","authenticated-orcid":false,"given":"Dominic","family":"Wilkinson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julian","family":"Savulescu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9691-2888","authenticated-orcid":false,"given":"Brian D.","family":"Earp","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2024,12,5]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"289-302","DOI":"10.1007\/s10561-020-09822-7","article-title":"Neonatal organ and tissue donation for research: options following death by natural causes.","volume":"21","author":"M Anderson","year":"2020","journal-title":"Cell Tissue Bank."},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"19-32","DOI":"10.1080\/1364557032000119616","article-title":"Scoping studies: towards a methodological framework.","volume":"8","author":"H Arksey","year":"2005","journal-title":"Int J Soc Res Methodol."},{"key":"ref-3","doi-asserted-by":"publisher","DOI":"10.1111\/petr.14486","article-title":"Potential of neonatal organ donation and outcome after transplantation.","volume":"27","author":"E Bluhme","year":"2023","journal-title":"Pediatr Transplant."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"469-477","DOI":"10.1007\/s10561-020-09833-4","article-title":"Ethical and deontological aspects of pediatric biobanks: the situation in Italy.","volume":"21","author":"N Cannovo","year":"2020","journal-title":"Cell Tissue Bank."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"119-140","DOI":"10.1111\/j.1467-8519.1987.tb00022.x","article-title":"Should foetuses or infants be utilized as organ donors?","volume":"1","author":"A Caplan","year":"1987","journal-title":"Bioethics."},{"key":"ref-6","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2022.917615","article-title":"Paediatric biobanking for health: the ethical, legal, and societal landscape.","volume":"10","author":"S Casati","year":"2022","journal-title":"Front Public Health."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"314-317","DOI":"10.1542\/peds.95.2.314","article-title":"Informed consent, parental permission, and assent in pediatric practice.","volume":"95","year":"1995","journal-title":"Pediatrics."},{"key":"ref-8","first-page":"1284-1290","article-title":"Policy statement: brain death in infants and children.","volume":"131","year":"2013","journal-title":"Pediatrics."},{"key":"ref-9","doi-asserted-by":"publisher","first-page":"312-317","DOI":"10.1136\/medethics-2015-103224","article-title":"An analysis of heart Donation after Circulatory Determination of Death.","volume":"42","author":"A Dalle Ave","year":"2016","journal-title":"J Med Ethics."},{"key":"ref-10","doi-asserted-by":"publisher","first-page":"921-939","DOI":"10.1093\/oxfordjournals.bmb.a011659","article-title":"The ethics of organ donation.","volume":"53","author":"G Dunstan","year":"1997","journal-title":"Br Med Bull."},{"key":"ref-11","doi-asserted-by":"publisher","first-page":"s42-43","DOI":"10.1016\/S0140-6736(04)17637-X","article-title":"Beyond organ retention: the new human tissue bill.","volume":"364 Suppl 1","author":"I Ellis","year":"2004","journal-title":"Lancet."},{"key":"ref-12","doi-asserted-by":"publisher","first-page":"1-16","DOI":"10.1542\/peds.2016-1485","article-title":"Informed consent in decision-making in pediatric practice.","volume":"138","author":"A Katz","year":"2016","journal-title":"Pediatrics."},{"key":"ref-13","doi-asserted-by":"publisher","first-page":"276-282","DOI":"10.11613\/BM.2012.031","article-title":"Interrater reliability: the kappa statistic.","volume":"22","author":"M McHugh","year":"2012","journal-title":"Biochem Med (Zagreb)."},{"key":"ref-14","doi-asserted-by":"publisher","DOI":"10.1186\/s12874-018-0611-x","article-title":"Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach.","volume":"18","author":"Z Munn","year":"2018","journal-title":"BMC Med Res Methodol."},{"key":"ref-15","doi-asserted-by":"publisher","first-page":"e720-e740","DOI":"10.1542\/peds.2011-1511","article-title":"Clinical report\u2014Guidelines for the determination of brain death in infants and children: an update of the 1987 task force recommendations.","volume":"128","author":"T Nakagawa","year":"2011","journal-title":"Pediatrics."},{"key":"ref-16","doi-asserted-by":"publisher","first-page":"1261-1271","DOI":"10.1016\/S0140-6736(23)00878-4","article-title":"National, regional, and global estimates of preterm birth in 2020, with trends from 2010: a systematic analysis.","volume":"402","author":"E Ohuma","year":"2023","journal-title":"Lancet."},{"key":"ref-17","doi-asserted-by":"publisher","first-page":"385-394","DOI":"10.1177\/2051415818761526","article-title":"Human foreskin fibroblasts: from waste bag to important biomedical applications.","volume":"11","author":"T Oliveira","year":"2018","journal-title":"J Clin Urol."},{"key":"ref-18","doi-asserted-by":"publisher","first-page":"2119-2126","DOI":"10.11124\/JBIES-20-00167","article-title":"Updated methodological guidance for the conduct of scoping reviews.","volume":"18","author":"M Peters","year":"2020","journal-title":"JBI Evid Synth."},{"key":"ref-19","doi-asserted-by":"publisher","first-page":"92-97","DOI":"10.1177\/1751143718777171","article-title":"Is presumed consent an ethically acceptable way of obtaining organs for transplant?","volume":"20","author":"P Prabhu","year":"2019","journal-title":"J Intensive Care Soc."},{"key":"ref-20","doi-asserted-by":"publisher","first-page":"100","DOI":"10.3389\/fped.2015.00100","article-title":"Neonatal and pediatric organ donation: ethical perspectives and implications for policy.","volume":"3","author":"A Sarnaik","year":"2015","journal-title":"Front Pediatr."},{"key":"ref-21","doi-asserted-by":"publisher","first-page":"105613","DOI":"10.1016\/j.earlhumdev.2022.105613","article-title":"The clinical burden of extremely preterm birth in a large medical records database in the United States: mortality and survival associated with selected complications.","volume":"171","author":"C Siffel","year":"2022","journal-title":"Early Hum Dev."},{"key":"ref-22","doi-asserted-by":"publisher","first-page":"110-119","DOI":"10.1093\/bmb\/ldac038","article-title":"Children and bioethics: clarifying consent and assent in medical and research settings.","volume":"145","author":"M Spriggs","year":"2023","journal-title":"Br Med Bull."},{"key":"ref-23","doi-asserted-by":"publisher","first-page":"3554-3561","DOI":"10.1111\/ajt.13868","article-title":"Living organ donation by minors: an analysis of the regulations in European Union member states.","volume":"16","author":"K Thys","year":"2016","journal-title":"Am J Transplant."},{"key":"ref-24","doi-asserted-by":"publisher","first-page":"467-473","DOI":"10.7326\/M18-0850","article-title":"PRISMA extension for Scoping Reviews (PRISMA-ScR): checklist and explanation.","volume":"169","author":"A Tricco","year":"2018","journal-title":"Ann Intern Med."},{"key":"ref-25","doi-asserted-by":"publisher","first-page":"58-93","DOI":"10.1177\/0968533216660877","article-title":"Living tissue and organ donation by minors: suggestions to improve the regulatory framework in Europe.","volume":"16","author":"K Van Assche","year":"2016","journal-title":"Med Law Int."},{"key":"ref-27","doi-asserted-by":"publisher","first-page":"789","DOI":"10.3390\/ijms18040789","article-title":"Advances in skin regeneration using tissue engineering.","volume":"18","author":"K Vig","year":"2017","journal-title":"Int J Mol Sci."},{"key":"ref-26","doi-asserted-by":"publisher","first-page":"2402-2408","DOI":"10.1111\/apa.15241","article-title":"Lack of knowledge and experience highlights the need for a clear paediatric organ and tissue donation protocol in the Netherlands.","volume":"109","author":"A Vileito","year":"2020","journal-title":"Acta Paediatr."},{"key":"ref-28","first-page":"58-61","article-title":"Establishing the possibility of neonatal and paediatric organ tissue donation.","volume":"2","author":"C Watts","year":"2006","journal-title":"Infant."},{"key":"ref-29","doi-asserted-by":"publisher","first-page":"e87-e108","DOI":"10.1097\/PCC.0000000000000602","article-title":"Pediatric donation after circulatory determination of death: a scoping review.","volume":"17","author":"M Weiss","year":"2016","journal-title":"Pediatr Crit Care Med."},{"key":"ref-30","doi-asserted-by":"publisher","first-page":"1723-30","DOI":"10.1542\/peds.2012-3992","article-title":"Pediatric organ donation and transplantation.","volume":"131","author":"J Workman","year":"2013","journal-title":"Pediatrics."}],"container-title":["Wellcome Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-717\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-717\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-717\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T02:05:11Z","timestamp":1737338711000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-717\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12,5]]},"references-count":30,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.23235.1","relation":{"has-review":[{"id-type":"doi","id":"10.21956\/wellcomeopenres.25595.r114860","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.25595.r116866","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.25595.r116870","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.25595.r116866","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.25595.r114860","asserted-by":"object"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12,5]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-717\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.25595.r114860, Sanwar Siraj, The University of Hong Kong, Hong Kong, 24 Dec 2024, version 1, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-717\/v1#referee-response-114860","order":0,"name":"referee-response-114860","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Maide Bar\u0131\u015f<\/b>; \n<i>Posted: 01 Jan 2025<\/i>; \n<b>Reviewer comment: The authors will carry out the screening process of literature with two members (for example, MB &amp; XL) to test the inclusion and exclusion criteria in a random sample of 10% of the uploaded sources. I suggest authors include details about the activities carried out and research team members will be involved in each phase of the literature search strategy, literature analysis, and report on findings.<\/b> \n<b><u>Authors\u2019 response:<\/u><\/b> We thank the Dr Siraj for raising this point. Here is a preliminary list of the activities of team members in different stages* of the project, to be added to the protocol:  Maide Bar\u0131s\u0327: Stage-1; Stage-2; Stage-3; Stage-4; Stage-5 Xiu Lim: Stage-1; Stage-2; Stage-3; Stage-4; Stage-5 Melanie T Almonte: Stage-3; Stage-4; Stage-5 David Shaw: Stage-4; Stage-5 Joe Brierley: Stage-4; Stage-5 Sebastian Porsdam Mann: Stage-4; Stage-5 Trung Nguyen: Stage-3; Stage-4; Stage-5 Jerry Menikoff: Stage-4; Stage-5 Dominic Wilkinson: Stage-3; Stage-4; Stage-5 Julian Savulescu: Stage-4; Stage-5 Brian D. Earp: Stage-1; Stage-2; Stage-3; Stage-4; Stage-5  *Stage 1: Determining the research question; Stage 2: Search strategy; Stage 3: Inclusion criteria; Stage 4: Data extraction; Stage 5: Data analysis and presentation &nbsp;  \n<b>Reviewer comment: The authors disseminate their findings to potentially including ones linked to university hospitals) in the UK, USA, T&uuml;rkiye, and Singapore. I suggest authors to offer justifications supporting their arguments about the selection.<\/b> \n<b><u>Authors' response: <\/u><\/b>We thank Dr Siraj for raising this point. We have chosen the UK, USA, T&uuml;rkiye and Singapore because the university hospitals to which our authors are affiliated in these countries are easily accessible. &nbsp;  \n<b>Reviewer comment: The authors consider their dissemination strategy to include peer review publication, presentation at conferences, and outreach to relevant stakeholders. What if the authors consider school-going students and colleges and social gathering parties where parents and families present to make them aware of the research findings?<\/b> \n<b><u>Authors\u2019 response:<\/u><\/b> We thank Dr Siraj for raising this point. Unfortunately, we do not have any share in the grant for school outreach or contact with schools. Nevertheless, given the significance of such an outreach and contact, it is something we will consider for the future work.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-717\/v1#referee-comment-5995","order":1,"name":"referee-comment-5995","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.25595.r116866, Evie Kendal, Swinburne University of Technology, Melbourne, Victoria, 20 Jan 2025, version 1, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/9-717\/v1#referee-response-116866","order":2,"name":"referee-response-116866","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by the Wellcome Trust [Grant number: 226801] for Discovery Research Platform for Transformative Inclusivity in Ethics and Humanities Research (ANTITHESES). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}