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The Principle of the Primacy of the Human Subject and Minimal Risk in Non-Beneficial Paediatric 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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Notes

  1. I omit here the insightful question of whether developing dispositions for helping others or being altruistic towards others constitutes a developmental benefit for the child herself at all or whether it is instead a benefit for a society (Wendler 2010).

  2. Feinberg describes these interests in the following way: “In this category are the interests in the continuance for a foreseeable interval of one’s life, and the interests in one’s own physical health and vigor, the integrity and normal functioning of one’s body, the absence of absorbing pain and suffering or grotesque disfigurement, minimal intellectual acuity, emotional stability, the absence of groundless anxieties and resentments, the capacity to engage normally in social intercourse and to enjoy and maintain friendships, at least minimal income and financial security, a tolerable social and physical environment, and a certain amount of freedom from interference and coercion ... they are the very most important interests a person has, and cry out for protection, for without their fulfillment, a person is lost. But in another way, they are relatively trivial goods, necessary but grossly insufficient for a good life” (1984, 37).

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This analysis was supported by a grant of the National Science Centre, Poland, no. 2014/15/B/HS1/03829.

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Correspondence to Joanna Różyńska.

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Różyńska, J. The Principle of the Primacy of the Human Subject and Minimal Risk in Non-Beneficial Paediatric Research. Bioethical Inquiry 19, 273–286 (2022). https://doi.org/10.1007/s11673-022-10179-7

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Keywords

  • Ethics of non-beneficial paediatric research
  • The primacy of the human being
  • Instrumentalization
  • Minimal risk standard