Consent in paediatric research: An evaluation of the guidance provided in the 2007 NHMRC National statement on ethical conduct in human research

Abstract

• In 2007, the National Health and Medical Research Council (NHMRC) released a revised National statement on ethical conduct in human research. • Public submissions in the review process leading to the 2007 statement highlighted four main areas of concern: children's competence to consent, mature minors and the requirement for parental consent, whether children can refuse to participate, and the provision of information to children. • A useful addition to the statement is the concept of levels of maturity, which help determine whether a child or young person's consent is necessary and/or sufficient for participation in research. • Changes in terminology ("capacity" instead of "competence" an..