Objectives
CONTRACT seeks to understand the way the European Data Protection Directive and the Clinical Trials Directive have had and continue to have an impact on the success of translational research.
To achieve this CONTRACT:
- Analyses the state of affairs to understand:
- What are the main issues and hurdles concerning informed consent faced by clinical projects
- What is the level of awareness about legal obligations for informed consent among the relevant stakeholders (clinical staff, ethics committees, patients…)
- Produces a two-fold study of informed consent legislation focusing on:
- Differences between legal requirements for care, for clinical trials and for data protection
- Differences between legal requirements for informed consent in different national legislations
- Will offer support for ongoing and upcoming research projects in issues concerning informed consent by:
- Offering legal advice
- Proposing novel approaches for clinical handling and it-solutions
- Will provide the European legislator with a proposal for harmonisation and improvements in the regulation of informed consent
The CONTRACT support action has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement nο. 261412.
The second CONTRACT Newsletter is OUT.
Click the image below to download the pdf document.
JOINT CONFERENCE: The Impact of EU legislation on Therapeutic Advance
A joint conference will be hosted in Brussels by CONTRACT and Academic GMP (Grant Agreement No: 260773), both projects running within the research area HEALTH.2010.4.2-6, Impact of EU legislation on health
What change do we need in informed consent?
CONTRACT final Workshop - Hanover, 6 September 2012.The final Workshop of the CONTRACT project is the second meeting, organized by the CONTRACT consortium, bringing together specialist stakeholders who are interested in the topics
Open research questions
In order to be able to propose certain legal recommendations to the EU legislators, the CONTRACT Consortium has specified ten research questions, the outcome of which should provide possible solutions or improvements to existing gaps in the current
CONTRACT co-organizes together with other key FP7 projects a Special Session on Computational solutions to large-scale data management and analysis in translational, personalized and predictive medicine at the 12th IEEE International Conference on BioInformatics and BioEngineering, November 11-13 | Larnaca,
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