Objective Although few clinical applications for pharmacogenomic tests currently exist, pharmacogenomic research has the potential to generate clinically relevant information, whose applicability and utility will doubtless grow over time. Current guidelines will be critically assessed and recommendations will be proposed.

Methods We undertook a comprehensive review of literature as well as of international, regional and national norms and guidelines addressing pharmacogenomic research in pediatrics.

Results/Conclusions We identified three major ethical issues that have implications for paediatric research: 1) consent and assent: how the assent of child should be obtained taking account of both age and maturity; and how complex information should be communicated to ensure that parental consent is properly informed; 2) the return of research results to participants: when, if ever; general or individual; ancillary results; and when the child becomes mature; and 3) the future secondary uses of samples: reconsent; risks and benefits.