Evaluation of risk in research with children – it’s time to clear the misconceptions

Abstract

French and German abstracts see p. 77 & 78 The current discussion on research with persons incapable of consent and consequently on research with children is obscured by four misconceptions. The «therapeutic misconception», by maintaining the notion that the primary goal of a research project does either include direct benefit to participants or not, obscures the fact that the primary purpose of research is not to benefit participants but to generate knowledge, and the ethical postulate that research must never put children at risk of serious harm, irrespective of whether it is performed in a context of patient care or not. Avoiding this and three additional misconceptions allows a uni- fied and pragmatic approach to risk evaluation in all types of research involving children. Its cornerstone is the comparison of the likely outcome for participating children with the outcome for eligible non-partici- pants in the light of the following conditions: research participation must not place the child at a net risk of serious harm, and the physical and psychological discomfort entailed by the study has to be readily tolerable according to the judgement of reasonable parents.