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    Jane Lamprill RN RSCN FICR
    Paediatric Research Consultant
    Specialist Medical Writer for Parents and Children
    Member, FP7 ethics panel European Commission

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    • PRC address and telephone number available on request
    • Your query and contact details will be treated in strict confidence

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    Help with parent and child paediatric clinical trial information sheets and consent- assent forms

      Paediatric Research Consultancy™  can provide age-appropriate child-friendly information. This mother and chlld clearly enjoy reading together - but a more child-friendly version would be better.

    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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    “Bobby compliant” website designed by Creative Eye Photographs of children are "model released" I.e. written parental permission obtained. They are embedded to prevent unauthorised persons downloading.

    © Copyright Jane Lamprill 2006. Paediatric Research Consultant is the owner of copyright on this website and its original contents. No part of this website may be published, distributed, extracted, re-utilised, or reproduced in any material form except in accordance with the permissions set out below or as permitted by the Copyright Designs and Patents Act 1988. The following permissions DO NOT APPLY to content supplied by third parties. For permitted use of third party content apply to the relevant content owner. You are welcome to use material from this website on the condition you acknowledge Jane Lamprill and the Paediatric Research Consultancy website or the relevant journal reference as the source of the material and you recopy the extracted material in complete and unmodified form.

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