Guidance on clinical research involving infants, children and young people: an update for researchers and research ethics committees.

BACKGROUND The British Paediatric Association, the forerunner of the Royal College of Paediatrics and Child Health (RCPCH), first published guidance in relation to research involving children in 1980. Prior to this time, little clinical research involved children. The 1980 guidance initiated a sea change, stating ‘research involving children is important’, ‘should be supported and encouraged’ and ‘research which involves a child and is of no benefit to that child (non-therapeutic research) is not necessarily either unethical or illegal’. Updated guidance was issued by the RCPCH in 2000. Both documents have been cited extensively.