Why the debate over minimal risk needs to be reconsidered

Abstract

Minimal risk is a central concept in the ethical analysis of research with children. It is defined as the risks ". . . ordinarily encountered in daily life . . . ." But the question arises: who is the referent for minimal risk? Commentators in the research ethics literature often answer this question by endorsing one of two possible interpretations: the uniform interpretation (which is also known as the absolute interpretation) or the relative interpretation of minimal risk. We argue that describing the debate over minimal risk as a disagreement between the uniform and the relative interpretation impedes progress on the identification of a justifiable referent for minimal risk. There are two main problems with this approach: (1) constructing the debate over minimal risk as a disagreement between a uniform and a relative interpretation misconstrues the main difference between competing interpretations and (2) neither the uniform nor the relative interpretation identifies one unique and consistent group of children as the referent for minimal risk. We conclude that progress on the debate over minimal risk requires that we abandon the uniform and relative interpretations and address the main moral problem at stake: whether healthy children or the subjects of the research should be the referent for minimal risk.

Keywords: harm-benefit assessment; minimal risk; research with children.