CONTRACT

• CUSTODIX NV(short name: CUSTODIX) – Belgium
• Universitaet des Saarlandes (short name: USAAR)
• Katholieke Universiteit Leuven(short name: KU Leuven) – Belgium
• Technological Educational Institute of Crete (short name: TEI-C)- Greece

CONTRACT is about consent. The project focuses on analysing how the legal (and underlying ethical) concepts of informed consent in the European Data Protection Directive and in the Clinical Trials Directive have had and continue to have an impact on the success of translational research. The project predominantly deals with vulnerable patients as their consent is of utmost complexity. The concept of informed consent in the two mentioned Directives will be analysed from a legal, ethical, IT-related and clinical point of view. The European approach on the matter will be compared with national concepts of informed consent for care purposes in the Member States. CONTRACT will support the European Commission and other policymakers in achieving a clear Community framework by providing clarity on different concepts of informed consent on European and national level.