WP6: Ethics and Regulatory activities

The EPIICAL Consortium recognises the need to ensure that all project activities, including those related with clinical studies, are compliant with the applicable legal, ethical and regulatory provisions.

This is particularly relevant because the project is focused on paediatric research and should be carried out under conditions affording the best possible protection for children because the paediatric population represents a “vulnerable population” entitled to receive special protection via ad hoc ethical rules and guarantees.

Work Package 6 coordinates the activities related to regulatory and ethical issues of the project.

EPIICAL foresees the use of paediatric data and biological samples collected previously. This will mainly account for multiplying the necessary paediatric data without exposing children to interventional clinical studies. Moreover when prospective studies are needed these will be performed in the best interest of the child.

In particular these aspects will be addressed in the WP:
1) Data sharing across countries: Paediatric studies are usually multi-national and data are often shared among many excellence clinical centres that work together networking different countries. To allow safe and ethic data use, ad hoc data sharing agreements will be implemented.

2) Data protection and confidentiality: To use the critical mass of information produced within EPIICAL, ad hoc procedures to ensure privacy and confidentiality of patients’ data exchanged among clinical centres will be adopted. A special attention will be dedicated to children’s right to privacy and confidentiality.

3) Ethical and regulatory requirements for conducting clinical studies: this issue has gained a great interest among the scientific and lay communities. Both in EU and worldwide the attention is focused on defining procedures for paediatric agreement and assent, paediatric risk-benefit and paediatric expertise in performing trials. All these aspects will be implemented by EPIICAL.