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Abstract

Even as research with children has increasingly been recognized as urgently needed for generating effective treatments for childhood diseases, drug formulations for infants and young children, and dosages appropriate for children, it has remained controversial. Scholars have engaged in heated debates over whether non-beneficial research with children is morally and legally justified. On one point, however, there has been agreement: Whether they support or criticize pediatric research, commentators generally assume that pediatric research should be justified under the “best interests of the child” legal standard. This assumption not only threatens important research and public health interventions, but it is also incorrect. This Article challenges conventional wisdom by arguing that research does not have to be in a child’s best interests to be legally permissible.

The best interests standard is generally understood as the governing principle for legal decisions about children, particularly in the medical context. Nevertheless, the best interests standard operates in two different ways that have very different implications—treating a child’s best interests as paramount versus as a primary consideration. Both versions of the standard fail to account adequately for the interests of others. Yet, the history of best interests standard reveals that the child’s best interests were rarely considered in isolation of other the interests. In a variety of contexts, moreover, legal scholars have criticized the best interests standard for failing to take account of the interests of people other than the child. This concern applies with special urgency to certain medical and public health decisions. An empirical analysis reveals that the history and criticisms have not been effective in changing how courts oversee medical decision making involving children.

Insofar as it places the interests of the child above all other interests, the best interests standard is a legal fiction that should not be applied to public health decisions in general and pediatric research in particular. Attempts to fix the current standard are unlikely to work, largely because of the confusion already engendered by the different versions of the standard. Instead, legislators should adopt a new legal standard, the “secure child standard,” for public health decision making: Parents should be given discretion to make decisions for children unless their decisions are likely to cause unjustified harm to the child. The secure child standard will lead to more transparency and prevent poor decision making in the contexts of public health and biomedical research, and is also a legal standard that may have broad applicability to decisions and policies involving children.

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