The ethics of risk in clinical research with children
A research subject’s participation in a trial is usually justified, in part, by informed consent. But children’s limited cognitive abilities and experiences complicate their ability to make informed choices. This gives rise to a problem: It is unclear what, if anything, justifies their participation in research. One necessary part of the justification for research with children is that participation must offer a child a reasonable balance between research risks and potential benefits. It is widely agreed that ensuring a reasonable balance between risks and potential benefits requires that the risks of research procedures administered without the prospect of direct benefit, that is non-therapeutic research procedures, should be restricted. But it is not clear how these risks should be restricted.
This project focuses on identifying a justifiable threshold for non-therapeutic research procedures with children. It focuses (1) on establishing that the risks of daily life is a morally relevant threshold. The project examines whether, and in what sense, the risks of daily life can replace (rather than adding to) the risks a child would ordinarily face. Further, it proposes that the risks of daily life are morally relevant because they may be understood as part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. (2) This project also focuses on identifying a group of children whose daily lives are morally relevant. It rejects arguments identifying healthy children or the subjects of the research (including healthy and sick children) as the appropriate groups. It then proposes that the referent for minimal risk should be children who are not unduly burdened by their daily lives. It argues that children are not unduly burdened when they fare well and defends the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood.