CONTRACT

CONTRACT’s acronym stands for “Consent in a Trial and Care Environment” and consent will be the main focus of the project. The Consortium - involving five partners of which three belong to the ACGT project[LUH (project coordinator), USAAR and Custodix]will focus on analyzing how the legal concepts of informed consent in the European Directives: on data protection and clinical trials differ from each other and from the regulations of informed consent for care in chosen Member States of European Union. The project will analyse consent issues in vulnerable patient groups, with the paediatric population in the central point. The outcome should be an assessment how far those different understanding of informed consent have an impact on the success of translational research. The concept will be analyzed from a legal, ethical, IT-related and clinical point of view.

CONTRACT will support translational research projects – both ongoing and upcoming. It will develop a multidisciplinary approach in delivering facts and figures on different approaches to informed consent. To achieve this the consortium will circulate a questionnaire directed to the partner projects, which are, or were working with vulnerable patients. At the end of the project a helpdesk will be established, it will offer advice to projects on issues of informed consent, it will also offer a ready to run data-protection-framework and will provide a help forum for informed consent and data protection in translational research.