When is it possible to conduct a paediatric clinical trial?
• the informed consent of the parents or legal representative has been obtained; consent must represent the minor’s presumed will and may be revoked at any time, without detriment to the minor; • the minor has received information regarding the trial, the risks and the benefits, according to its capacity of understanding and from staff with experience with minors; • the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the investigator, or where appropriate the principal investigator; • no incentives or financial inducements are given except compensation; • some direct benefit for the group of patients is obtained from the clinical trial and only where such research is essential to validate data obtained in clinical trials on persons able to give informed consent or by other research methods; additionally, such research should either relate directly
