Consent in a Trial and Care environment (CONTRACT)
Consent in a Trial and Care environment
Date du début: 1 oct. 2010,
Date de fin: 30 sept. 2012
"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. CONTRACT’s approach will be based on facts and figures by delivering an empirical survey about the handling of consent in European and national translational trials. CONTRACT will identify good practices in obtaining and administering informed consent in translational research and will give recommendations on possible harmonization of and common approaches to the legal framework.CONTRACT has already built a target community for its services, the “partner projects”, which will be significantly enlarged after the project’s start. CONTRACT will offer a help desk for its target audience on consent issues and will constantly support partner projects and other relevant stakeholders in balancing patient’s and research interests by a proper management of consent.In achieving these objectives the project has put together an internationally recognised interdisciplinary team of individuals and organisations with significant expertise and know-how on all areas of relevance to the project, it has drawn-up a ambitious – yet achievable - workplan, and has made every effort to identify and minimize potential risks."
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