Help with parent and child paediatric clinical trial information sheets and consent- assent forms
European Clinical Trials Direcive 2001/20/EC states in Article 4 that: "a cliincial trial on minors may only be undertaken if ... the minor has received information according to its capacity of understanding...." Any parent/child information sheet that is too long, full of scientific jargon and hard for them to understand is a waste of company time and money and is in breach of this law. It will result in un-informed consent, zero/poor trial recruitment – and is usually thrown away.
Paediatric clinical trial information sheets that are age-appropriate and meet the study needs of the child and family result in better recruitment and compliance as long as the protocol itself is workable for a paediatric population. Testing medicines for children is a complex process and the easier that companies can make it for parents and children, the better.
If you require assistance with your child/parent information sheets, consent or assent forms, please click here
Children: Clinical trial information should be easy to read and factual without being frightening. The European research guidance ICH E11 Reference 8 states that “All participants should be informed to the fullest extent possible…in language and terms they are able to understand”. This is now a legal requirement in the UK References 9,10.
Pharmaceutical companies and medical researchers testing paediatric medicines are therefore required to write information for children at a level appropriate for the reading age/ability of the population to be tested. It is very important that the information makes it clear that taking part is completely voluntary and nobody will be angry with the child if they don’t want to take part. They can say “no” at any time before or during the research without having to give a reason.
A child's consent/assent to research is especially important now the new European Paediatric Regulation is in force. Pharmaceutical Companies will receive financial rewards to compensate them for the expensive process of testing medicines with children. It is therefore an ethical "must" that children are happy to take part in the research. Parents: are extremely protective of their children. Information needs to be jargon free, factual and concise without being patronising or frightening. Great care is needed in the translation of global paediatric trial information to avoid cross-cultural misunderstandings and recruitment failure!
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