Towards an Alternative Account for Defining Acceptable Risk in Non-beneficial Paediatric Research

The purpose of this paper is to propose an alternative account by which the ethical threshold of acceptable risk in paediatric research can be assessed. Three popular interpretations of the minimal risk threshold and the problems they raise when applied in the research context are presented. First, the “risks of daily life” standard and the “routine examinations” standard are addressed. It is argued here that neither of them can provide a satisfactory morally justified framework within which risks during paediatric non-therapeutic research should be assessed. The alternative view of the “charitable participation” standard is then discussed and the argument advanced that despite its advantages, it generates unavoidable difficulties when considered in the context of medical research. Finally, the author argues that consideration of the risk to which parents are willing to expose their children in a vaccination programme in the case of an infectious disease, which does not constitute a significant threat to them, can facilitate the definition of this threshold. Although the proposed account shares some of its strong points with those already existing, it does not lead to inconsistencies when applied in research context.