European Academy of Paediatrics Position Paper: A Response to the 2024 Declaration of Helsinki Update

The European Academy of Paediatrics welcomes the recent update to the overarching international ethical norm for research with humans, the Declaration of Helsinki [1]. The Declaration is a statement of ethical principles for medical research involving humans, including research on identifiable human material and data. Developed in 1964 by the World Medical Association (WMA), the Declaration is regarded as the most crucial document in the history of research ethics. It is revised regularly to ensure that it continues to address evolving global ethical challenges and the evolution in values and the language surrounding research. The history of abuse of what were previously termed research subjects but are finally called participants in the updated Declaration, including children, remains troubling [2]. This change of language from the arguably dehumanising subject to participant is a crucial change that certainly improves the fundamental ethical norms of research in the Declaration, but here the WMA has been reactive rather than proactive. This illustrates one challenge for the WMA: the concept that the DOH as a supranational ethical norm has primacy over national norms, including law. Some countries are perhaps further along the healthcare journey of involving people (not patients) in medical research. However, in countries perhaps at such a different stage, the WMA must remain relevant as compliance may have legal as well as professional implications. How can any such international ethical document truly be operationally nuanced? The revision strengthens the informed consent process for minors. It stipulates that when a minor is capable of providing assent, their preferences and values must be considered alongside the consent of their legally authorised representative. This approach respects the developing autonomy of children and ensures that their voices are heard in decisions about research participation, which the EAP has always promoted. However, we do query why restrictions on children with the capacity to consent to their medical treatment remain in place for research in some countries. A good example is the recent ethical argument in JAMA about ‘Making the Ethical Oversight of All Clinical Trials Fit for Purpose’, which calls for proportionality in the often-arduous process of gaining ethical approval for research. Though this call seems morally incontestable, given the history of research abuses such change remains a challenge for many countries. A new concept in the new Declaration is expanded informed consent, allowing for the secondary use of health data and biological samples under certain conditions, which EAP unreservedly supports. Children have long suffered from inadequately researched treatments, a continuing issue especially in the rare disease space. The need for consent must be proportionate, and at present, despite the ascribing of vulnerability to children, which EAP contends, it can often be a barrier to improving child health [3]. Research studies with deferred consent, or even without consent if no medical decision is to be made, with children and families involved in the design and research governance/REC review, seem morally incontestable and ought to feature in the Declaration's next iteration. Another helpful clarification is that consent is not simply a one-time event at the beginning of a research project. Consent is an iterative and ongoing process with children and their parents with the provision of information throughout involvement in the study. This information must include any new (potential) risks/harms discovered and the eventual outcome and impact. This norm also highlights the need for reconsent when minors reach adulthood, ensuring ongoing respect for the autonomy and privacy of individuals as they mature. Other changes in the newest Declaration of Helsinki include increased protection for vulnerable populations in research, including children, improved transparency in clinical trials and more substantial commitments to fairness and equity in research. Previous versions of the Declaration tended to exclude vulnerable groups, including children, from research to protect them from potential harm. The 2024 revision acknowledges that such exclusions have led to significant gaps in medical knowledge about these populations. It emphasises that vulnerability is contextual and dynamic, and that excluding these groups can perpetuate disparities. Therefore, the updated Declaration encourages the inclusion of children in research, provided that appropriate safeguards are in place. EAP, however, remains concerned about children being automatically termed vulnerable, sharing the UK Nuffield Council on Bioethics' view, derived from its working group that included the voices of children and parents, that children are not automatically vulnerable [3]. It is more how children are treated that can make them vulnerable. Children and their families should, and must, be meaningfully involved at every stage of the research process—commissioning, design, ethical reviews, participation and dissemination. Such engagement helps ensure that research is responsive to the needs and perspectives of paediatric populations and mitigates vulnerability. Furthermore, we argue that this means that calls for diversity in the REC/ethical bodies that review research ought to include the voices of children and their families, together with those of different cultures, faiths and value groups. As the Declaration suggests, and EAP agrees, RECs should represent the community they serve. However, this should surely include representatives of the very group the research is being performed on, specifically in paediatric research, children and their parents. The new Declaration is stronger in stating that social value is the true primary purpose of research. EAP strongly advocates for children not just being, by definition, the future of society, but a fundamental current component. Diversity in all aspects of research is welcome, but must surely include children as a group, and specifically children from different ethnic, cultural, and socio-economic groups. Only by achieving this will research contribute to reducing the dreadful health inequalities affecting European children. The DOH inclusion of both global justice and meaningful engagement with research participants and their communities is a laudable aim, but EAP argues that we must all work to make the former a reality and that no research ought to be permitted without the latter. The WMA's new Declaration of Helsinki's inclusion of the term ‘promotes sustainability’, alongside minimising possible harm to the environment, means its research norms are now consistent with the language used in the WMA's International Code of Medical Ethics. EAP welcomes this recognition that every human activity, including medical research, must understand and mitigate its impact on the planet's future. The climate emergency is causing worldwide weather-based catastrophes in which children are frequently the worst affected group, and the worsening of air quality represents a devastating risk to European children [4]. The new DOH is stronger with regards to the right of participants who benefit from an interventional therapy in a study to be provided with it at the end of the study period; an important consideration for children who may survive for many decades following a research study. The World Medical Association has significantly improved the latest 2024 iteration of the Declaration of Helsinki. The challenge of composing an international ethical norm notwithstanding, the European Academy of Paediatrics supports and endorses many of the changes, as we highlight above. However, EAP also identifies improvements that ought to be made in future iterations of the Declaration, and we argue sooner by national and other bodies to facilitate clinical research with children, which is clearly a fundamental method of improving the health of humanity. The authors declare no conflicts of interest. The authors have nothing to report.