The Article “European Pediatric Informed Consent and AF: Current Status of Country Requirements” , released by the Paediatric Working Group of EUCROF, the European CRO Federation, has been published in Applied Clinical Trials October 2016.
EUCROF is a non-profit organisation aimed to promote clinical research by improving the knowledge, competence/expertise and skills of clinical researchers in Europe by networking activities and information exchange in congresses, meeting and other ways of communication.
The Paediatric Working Group of EUCROF was founded in 2007 and is aimed to improve clinical research in children, to improve the relationships between CROs, pharmaceutical industry and competent authorities and to make society aware about the importance of paediatric research in order to get better medicines for children.
The article has been prepared following the pan-European survey launched in 2014 by the Paediatric Working Group, regarding national legislation and requirements governing Informed Consent Form (ICF) and Assent Forms (AF) documents.
The article shows that although, in general, the requirements for the ICF and AFs in pediatric clinical trials within European countries are similar and in accordance with the ICH GCP, there is a difference within individual countries, and in some cases there is a lack of clarity in national legislations. The observed differences are not critical, but still make pediatric clinical trials performed across different European countries more challenging.
There is a clear need for further harmonization of the documents and consent/assent process requirements, as this would facilitate the conduct of clinical trials in children and would increase the quality of trials, thus contributing to the development of better medicines for children.
The Paediatric Working Group will continue to update information around the current state of the Informed Consent Forms (ICF) and Assent Forms (AFs) and related procedures with the final goal to develop standardized general templates for the ICF and AF that can be used in paediatric clinical trials within the European Union as a starting point.
The article is available at this link.