Footnotes

• Contributors Members of the RCPCH Working Party held a series of face-to-face meetings and corresponded by email. The first draft of the paper was prepared by NM; all authors contributed to subsequent revisions. The final draft was reviewed and approved by representatives of RCPCH Council and all authors. The full RCPCH Guidance is available at http://www.rcpch.ac.uk/research-ethics.

• Funding Royal College of Paediatrics and Child Health.

• Competing interests NM was RCPCH Science and Research Vice-President 2009–2014, is current President of the Neonatal Society, and Chair of the BMJ Ethics Committee; in the last 5 years. NM has held research grants awarded by the National Institute of Health Research, Welcome Trust, Medical Research Council, Acton Medical Research, Child Growth Foundation, Department of Health, Westminster Medical School Research Trust, Healthcare Quality Improvement Partnership, HCA International and Bliss, and has participated in academic meetings supported by Danone, Nestle, and Ferring Pharmaceuticals. AG is current RCPCH Science and Research Vice-President; in the last 5 years. AG has held grants from the National Institute of Health Research, Department of Health, National Institutes of Health and Asthma UK, and has held grants and received honoraria from various ventilator manufacturers. VL provides ethics advice as a member of a Data Monitoring Committee that reviews information from an international trial of long acting β agonists in asthma. The trial involves four sponsors co-ordinated by a company who convened the Data Monitoring Committee at the request of the US Food and Drug Administration.

• Provenance and peer review Not commissioned; internally peer reviewed.