Current international,^1,2 European,^3,4 and UK^5,6 research frameworks require all competent participants in research to give an informed consent. An informed consent can be defined as a decision made by a competent individual, free of any undue influence, on the basis of all of the relevant information.⁷ Evidence exists that difficulties in obtaining an informed consent are leading to recruitment failure in essential paediatric research.⁸ Clinical research is vital to ensure that patients receive the best possible treatments. Such research either improves the quality of care or saves lives. For example, clear benefits can be shown from the results of childhood cancer trials.⁹ Research is especially important in relation to children, given the poor evidence base for much of paediatrics.^3,5 It is therefore necessary to use all possible means to improve the ability of parents and children to come to an informed position regarding research proposals, so that recruitment into such research is maintained. This review outlines a series of potential impediments to realising this objective in relation to paediatric research, provides a number of recommendations for improvements in practice, as well as suggesting some future avenues for research.

CHILDREN, PARENTS, AND COMPETENCE

Obtaining informed consent is particularly challenging for research involving children and parents because of the issue of competence. Where a child can be deemed competent to understand the nature and implications of research, he/she must be fully involved in the consent process.⁵ There is a great deal of empirical evidence to suggest that many children are capable of much greater participation than was thought possible in the past.^10,11 This has resulted in the present consensus position that where a competent child is able to give an informed consent, this is acceptable, although …