The article “Informed consent and assent guide for paediatric clinical trials in Europe” has been recently published. Viviana Giannuzzi from Fondazione Gianni Benzi, also member of the ethics working group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), cooperated in this work.

This is the first work to extensively collate all the current legal, regulatory and ethical documentation on the informed consent (IC) process, considering also input from children as members of the European Young Person’s Advisory Groups.

Although the new EU Clinical Trial Regulation will harmonise clinical trial application practices in Europe, it does not contain specific guidance for the paediatric clinical trial consent process. Moreover, there are still many national legal differences in the requirements for consent and assent documents.

Therefore, the aim of this new guide was to provide more practical easy-to-use tool for designing the content of IC and assent documents to enhance the high-quality ethical standards of paediatric clinical trials.

This guide can be adapted to all types of paediatric clinical trials on a case-by-case basis and it can also be used to promote the involvement of children in the consent process.

Specific elements, both general and trial specific ones, were considered for four paediatric age groups, according to the EU Ethical considerations published in 2017.

Read the full article here to discover more on these elements as well as the information to be included in the IC/assent document.