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 1980.1 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 2000.2 Both documents have been cited extensively.

The need for updating

There are now many sources of detailed information for researchers, and the purpose of this paper is not to duplicate this material. The principles that underpin previous guidance remain valid, but there have been changes in their interpretation, scope and application. Since the last RCPCH guidance, the National Institute for Health Research (NIHR) has transformed the UK research environment. Changes in European Union regulations have facilitated children's research, including medicines studies.3 ,4 There have been significant changes in the UK regulation and governance of research, with the involvement of a number of agencies, most recently the Health Research Authority.5 There is a greater focus on involving children and their parents more actively in the design, review and conduct of studies. The ways in which society views clinical research have also continued to evolve. The Declaration of Helsinki that sets out the ethical principles that underpin medical research involving all human subjects has had two notes of clarification and seven amendments, the most recent in 2013.6

In recognition of these changes, a working party led by the RCPCH was established with representatives from the Royal College of Nursing, Ethics and the Law Advisory Committee of the RCPCH, National Research Ethics Service, Medicines & …