Ethics of Procuring and Using Organs or Tissue from Infants and Newborns for Transplantation, Research, or Commercial...

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 We will include both published and unpublished materials that explicitly discuss the ethical arguments related to the procurement and use of infant organs or tissues in the biomedical context.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.

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' 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, "infant") organs or tissues in the biomedical context (i.e. for transplantation, research, or commercial purposes).

Our scoping review will broadly follow the well-established methodology outlined by the Joanna Briggs Institute ( Peters et al., 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 & 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.

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.

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.

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, Türkiye, 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.

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.