Paediatric Research Consultancy

  Helps optimise paediatric trial planning to improve recruitment and compliance

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  • Consent/assent - the key to successful recruitment

    Consent and Assent in paediatric clinical trials

        Consent and assent needs to be an on-going process throughout the research project, not just a signature at the beginning.

    This is a particular area of interest and expertise for PRC. Jane Lamprill is co-author of a book chapter “Consent and assent in paediatric clinical trials” published in 2006 by Karger Medical Publishing, Basel: Guide to paediatric clinical research.

    The correct management of the consent/assent process for paediatric clinical trials is essential to ensure and comply with a solid ethico-legal framework in a very vulnerable population. A well managed assent process can make the difference between success or failure of a paediatric clinical trial. As more and more medicines are to be tested on children, it is imperative that potential  child volunteers are given every opportunity to “have their say” to make sure they and their parents/guardians are happy to take part.

    One could imagine that the girl’s mother in this picture may have consented for her daughter’s research participation - but the girl may not be assenting as she doesn’t look very sure about it!

    Consent and assent needs to be an on-going process throughout the research project, not just a signature at the beginning. Children need to be empowered to dissent should they wish, to ensure that the research is conducted ethically.

    Please click here if you would like help with consent/assent aspects of your paediatric clinical trial or require paediatric information sheets that are age appropriate and comply to ICH/GCP.

    Help with Consent/assent

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