Abstract

The principles which can justify significantly risky nontherapeutic research on children are a combination of: (1) direct or indirect benefits to the child participants now and/or in the future (and these benefits need not necessarily be medical, they can also be socioeconomic or otherwise non-medical); (2) a high standard of informed consent that fundamentally focuses on the child participant's understanding (and capacity for understanding) of relevant features of informed consent. Researchers, parents and guardians, as well as child participants themselves, have different roles and obligations towards one another. This is not an issue of seeking to find excuses to expose children to risk, but rather an issue of seeking the least risky and most ethical way to do so if and when required by public health emergencies or to achieve directly beneficial scientific breakthroughs.