A 4-year-old boy with a serious metabolic disorder is eligible for a trial of a new enzyme replacement, the first potential option to treat this disease. His parents have little understanding of the disease or trial, even with careful explanation, but eventually they consent to entry in the trial. The treating clinician doubts whether their consent is valid.

This and similar dilemmas face pediatricians in research every day. Many of the therapeutic options for children have not been tested with the rigor applied to similar treatments in adults. This highlights the need for research to improve the evidence base of children's medicine, for more pediatricians to undertake research, and for more children and families to participate. Each of these components is more challenging when research is proposed in vulnerable participants, such as children. Well-designed consent procedures are vital for ethically sound recruitment.

This article highlights some of the...

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