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Table 4 Requests for changes on material for the informed consent and assent process from EU Ethics Committees

From: Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project

Request type CY GR IT UK
Inclusion of more details about Sponsor    x  
Inclusion of details on contraceptive methods    x x
Inclusion of details on volume of blood sample    x  
Inclusion of information on anaesthesia and MRI x   x  
Inclusion of information in risk and on insurance policy x   x  
Inclusion of privacy of data (data will be remained confidential) x    
Inclusion of information on the custody holder in the consent form x    
Inclusion of detail on the taste of the new formulation     x
Inclusion of more information on pregnancy (test and management possible occurrence)     x
Removal of “thump prints” of participants and guardians from consent and assent forms   x   x
Replacing the booklets prepared by the sponsor with information sheets, rewording the information for 6–10 years old age group considered too complicated and splitting the Young Person Information Sheet for the 11 to 17 into two     x