Children (minors)
Information and resources specifically applicable to research involving children and young people.
The Children Act (or equivalent)
The Children Act (2004) covers the whole of the UK, though much of the act covers England and Wales only. The Children (Scotland) Act (1995) covers Scotland. The Children (Northern Ireland) Order (1995) covers Northern Ireland.
CTIMPs
The Medicines for Human Use (Clinical Trials) Regulations (2004) include requirements for the conduct of CTIMPs involving children.
Paediatric Regulations (EC/1901/2006) European Regulations apply directly in all the Member States without requiring a national act to transpose them. The Paediatric Regulations (EC/1901/2006) are applicable to, and enforceable within, the UK without the need to transpose them into an Act or a Statutory Instrument. Further information about the EU Paediatric Regulations is available on the NIHR Medicines for Children Research Network (MCRN) website.
Useful resources
The 'Research Governance Framework for Health and Social Care (Second Edition)' (2005) provides a helpful scenario of a parent and child’s perspective of clinical trials and informed consent (pages 10 – 12, Box A: Protecting Research Participants’ Rights).
The EudraLex resource detailing ‘The rules governing medicinal products in the European Union’ Volume 10 (Chapter V: Additional Information) includes ‘Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric Population’ (2008).
Articles
Clinical trials in neonates: ethical issues
Peter Allmark, Michael Spedding (2007) Science Direct
Obtaining consent for neonatal research
P Allmark, S Mason, A B Gill and C Megone Arch. Dis. Child. Fetal Neonatal Ed. doi:10.1136/fn.88.3.F166 2003;88;166-167
What motivates British parents to consent for research? A questionnaire study
Helen M Sammons, Maria Atkinson, Imti Choonara and Terence Stephenson
