The Tiss.EU Project (Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union - an Evidence-Based Impact Analysis) is funded by the European Commission as part of the 7th Framework Programme, runs until early 2011 and will address questions of ethical and legal regulation in relation to research using human tissue.
The project is coordinated by Christian Lenk and Claudia Wiesemann (Dept. for Ethics and History of Medicine, University of Goettingen) in cooperation with Nils Hoppe (Medical Law and Bioethics Group, University of Hannover). Heather Widdows is the Tiss.EU partner from Birmingham, and Sean Cordell is the Research Fellow.
Tiss.EU is made up of four parts, the ethical and legal aspects of which are going to be looked at by the project partners:
- Procurement, storage and transfer of tissue and cells for research;
- Rights and entitlements to tissue and cells;
- Anonymisation and pseudonymisation to protect privacy rights;
- Research using biobanks.
The project's aim is to assess the impact made by European Union's regulatory activities to date on research in the member states (plus Switzerland). To this end, the project will accumulate and compare national legislative instruments and guidelines with the help of external experts and make these data available to the public. As a culmination of the project, recommendations are to be drafted for possible ethical and legal guidelines in the interests of European-wide convergence and harmonisation.
Heather and Sean are responsible, with the partner institution, for the fourth theme of the project, that of BioBanks. This work builds on previous research undertaken in the another EU project PropEur (Property Regulation in Science, Ethics and Law Project which ran from 2004-2007) which was lead by Heather Widdows and Caroline Mullen. The PropEur project identified and analysed ethical and legal issues in relation to governance in the themes of human tissue, human genomes, plant and animal genomes, and the information society (www.propeur.bham.ac.uk). PropEur gave particular focus to Biobanks, examining questions of ethical and legal status of donation, conditional gift, commodification, charitable trust, benefit sharing. Following from PropEur, we have a contract with CUP’s Cambridge Law, Medicine, and Ethics Series for an edited collection ‘The Governance of Genetic Information: Who Decides?’ Heather Widdows also serves on the Ethics and Governance Council of UK Biobank (www.ukbiobank.ac.uk).
For further information on the Tiss.EU project and to follow our progress please visit the Tiss.Eu Project website at: http://www.tisseu.uni-hannover.de