Consent requirements are not harmonised in Europe and vary according to national laws and regulations. These discrepancies can present challenges for paediatric clinical trials, especially as many are conducted as multinational trials.
The Enpr-EMA working group on ethics, of which Viviana Giannuzzi and Cristina Manfredi are members representing the TEDDY Network, has published the “Assent / informed consent guidance for paediatric clinical trials with medicinal products in Europe”. The document is intended to be used as a tool for all stakeholders (such as patients, sponsors, and investigators) which provides practical recommendations for the contents for assent and informed consent forms to support the conduct of paediatric clinical trials in Europe.
For more information please visit the following webpage.