Ethics

The d-LIVER project declares to follow all required ethical guidelines and applicable laws:

All European Legislation relevant to ethical issues will be adhered to and enforced through local regulatory bodies.

All of the clinical work proposed to be carried out by d-LIVER will take place in EU member state countries. Research performed within d-LIVER will meet the relevant national regulations as well as international regulations such as the Helsinki Declaration in its latest version. Biomaterials will be collected and used according to procedures that have been approved by local ethics committees. Clinical studies will be performed in accordance with the National regulations and with the international Good Clinical Practice (GCP) Guidelines as well as the European Directive 2001/20/EC for the conduct of clinical studies in Europe.

The Consortium Management will ensure that all processes for handling personal data conform to relevant standards and that proper anonymity or confidentiality procedures are in place.

Within the project, patient samples may be transferred among the participants. Each participating country has its own national regulations related to the transfer of biomaterials. All national regulations for transfer of samples will be followed and the application of these regulations will be monitored by the Project Coordinator and a Project Ethics Committee.