Children are a unique population with marked developmental and physiological differences from adults. Clinical trials in children are essential to develop age-specific, empirically-verified therapies and interventions to determine and improve the best medical treatment available. Children are also an exceptional population with specific ethical and clinical concerns. Clinical research is of paramount importance in developing safe medications, paediatric formulations, clinical interventions, vaccines and best practice guidelines. The vulnerable nature of this population must be considered when balancing the risks of research with the need for safe and validated therapies. Currently there are no international standards or guidelines at all for medical research involving children. The committee should create standards and guidelines.