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Guidance on clinical research involving infants, children and young people
This is an excellent update of relevance to clinicians, researchers and research ethics committees.
There is no disagreement that research in children is important and should be supported and encouraged with the need to strengthen child health research in the UK. This is highlighted in a recent Royal College report1 and in the National Institute of Health Research (UK) call for research into the management of children with long term conditions. The research environment is complex and regulated with processes and procedures in place to support research participants, researchers and organisations. These ‘processes’ can be quite difficult to work through. There are specific issues relating to children and this paper provides practical guidance on the ethical issues in relation to research involving children. This includes discussion of children's rights, research risk, and the complex issues of consent, assent and dissent. There are sections on research involving pregnant women, emergency situations and vulnerable children. There are useful summary discussions on sedation for practical procedures, dealing with unexpected findings, commercial sponsorship and payment for participation in research. It is clear from the document that the ethical principles underpinning …
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