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The Principle of the Primacy of the Human Subject and Minimal Risk in Non-Beneficial Paediatric Research
1Center for Bioethics and Biolaw, Faculty of Philosophy, University of Warsaw, Krakowskie Przedmiescie 3, 00-047, Warsaw, Poland. j.rozynska@uw.edu.pl.
Insights
Ethical challenges in non-beneficial pediatric research are addressed. This study proposes a new framework for the principle of the primacy of the human subject, ensuring children
Area of Science:
- Pediatric Research Ethics
- Clinical Trial Ethics
- Child Welfare in Research
Background:
- Non-beneficial pediatric research, while crucial for healthcare advancement, presents significant ethical dilemmas.
- Children in such studies cannot provide consent and face risks without direct clinical benefit, raising concerns about instrumentalization.
Purpose of the Study:
- To analyze existing literature on reconciling non-beneficial pediatric research with the principle of the primacy of the human subject (PP).
- To propose a novel approach to resolve the ethical conflict between pediatric research ethics and the PP.
Main Methods:
- Critical analysis of ethical frameworks and proposed solutions in existing literature.
- Development of a revised principle of the primacy of the human subject (PP).
Main Results:
- Existing solutions for ethical dilemmas in non-beneficial pediatric research were found to be insufficient.
- A new formulation of the PP is proposed, offering a way to ethically conduct such research.
Conclusions:
- The proposed new formula for the PP necessitates a specific non-comparative definition of the minimal risk threshold.
- This approach aims to protect child participants while enabling vital pediatric research.
Abstract:
Non-beneficial paediatric research is vital to improving paediatric healthcare. Nevertheless, it is also ethically controversial. By definition, subjects of such studies are unable to give consent and they are exposed to risks only for the benefit of others, without obtaining any clinical benefits which could compensate those risks. This raises ethical concern that children participating in non-beneficial research are treated instrumentally; that they are reduced to mere instruments for the benefit of science and society. But this would make the research incompatible with the widely endorsed principle of the primacy of the human subject (henceforth PP), which stipulates that the interests of the participating individual should prevail over the interests of science and society. This paper deals with this conflict. It analyses solutions to this problem developed in the literature, and shows that they are unsuccessful. Finally, it offers a new idea of how to reconcile the conduct of non-beneficial paediatric research with the PP. The paper argues for a new formula of the PP, and shows that it implies a specific non-comparative definition of the minimal risk threshold.
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