Work package 5: Legal and Ethical framework
Brief description and aims of work
This project needs a legal and ethical framework. This framework will be developed in WP 5. The WP continuesthe developments of the ACGT project and extends it to the access to biobanks, patient empowerment and thedealing with a data warehouse.
In ACGT a data protection and data security framework was designed that is fully ready for use. The drivingprinciples are published and are frequently positively evaluated. However the framework needs furtherdevelopment and refinement, mainly in four areas: First, the implications of the Directive 2001/20/EC on clinicaltrials for the infrastructure provided in p-medicine need to be systematically analysed. Second, the frameworkneeds to be adapted for the exchange of biomaterial and the systematic use of biobanks. Third the securityinfrastructure needs to be refurbished and adapted for usage of data and specimen in biobanks. Finally the implementation of the ethical and legal framework into a clinical day to day scenario needs to be achieved. As p-medicine is clinically driven the expertise of UDUS on behalf of ECRIN participating in this work package will guarantee the usability of the developed legal and ethical framework.
On the one hand it will guarantee that p-medicine is fully compliant with alllegal and ethical rules applicable. It will develop – using the achievements developed in ACGT as a starting point– a legal and security framework guaranteeing compliance with the relevant norms. Specific attention will begiven to all security and data protection related issues.
On the other hand WP5 do systematic in depth research on legal and ethical rules of sharing data and biologicalmaterial on a European level with the final objective of empowering patients. Empowering patients means thatpatients are aware of the privacy related and ethical aspects of the research done with their data and theirbiological material. WP 5 will provide all relevant stakeholders (the project, the European Commission, PatientGroups, Regulatory bodies and the general public) with insight in legal and ethical possibilities and constraints ofsharing information in full respect of privacy rights.