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
Person photo Dr Claudio Tamburrini
Practical Philosophy (Department of Philosophy)

Funding source: EU Seventh Framework Programme - Health
Period: 4/1/08 - 3/31/11
Funding: 797672 EUR
Description:
The Tiss.EU project will analyse the impact of current EU legislation and guidelines on biomedical research which is based on the procurement, storage and transfer of human tissues and cells in and across the European Union. The importance of tissue derived from the human body for biomedical research is ever increasing. In the Theme "Translating research for human health" of FP7, the EU actively encourages the networking of human sample biobank initiatives. National differences in the regulation of the handling of these tissues and cells, however, represent a serious barrier for biomedical research in the Member States and associated countries. EU legislation has dealt with these topics but covers mainly clinical application. A EU biobanking directive is still missing. This is a major handicap for translational research involving human samples. The project will evaluate the consequences of current EU legislation and related guidelines, as well as the way they are implemented at a national level, on translational research activities. It will identify regulation deficits and inconsistencies, and create an evidence base for the revision of legislation, if necessary. The project work relies on the assumption that similar ethical and legal standards of quality of research with human tissues and cells are a decisive precondition for the fostering of scientific cooperation in the European Union. The range of the project work will cover practical as well as theoretical issues to secure the impact of the project's results for scientists in the field as well as regulating bodies and policy makers. Four focal themes have been identified as decisive ethical and legal issues in the field: the regulation of (A) procurement, storage and transfer of tissues and cells for non-clinical research purposes, (B) rights, interests and entitlements involved, (C) anonymization and pseudonymization as means of privacy protection, and (D) biobanking. A network of ten renowned academic partners from nine different countries all over the EU will report national law, ethical guidelines and case reports to assess the current situation in all Member States. The Tiss.EU project is organized in a two-layer structure: each partner institution is responsible for a defined country group, and, together with one or two other partners, for one of four focal themes. The first layer serves to collect all relevant national laws and ethical guidelines for the procurement and storage of human tissues and cells in the single member states. This information will be provided by external experts in the different countries. The second layer serves for scientific analysis of the four focal themes. Public workshops and conferences with external experts from all over Europe and from different academic disciplines will guarantee a comprehensive picture of the ethical and legal landscape in Europe. A publicly accessible on-line database with the relevant documents collected in the first layer of the project and a project websites with reports on the four focal themes will serve as a comprehensive information source for scientists in the field as well as policy-makers and the general public. The collected information will provide an evidence base for commonly developed policy recommendations aiming at the harmonisation and convergence of future EU legislation in this area.
  
Researchers (2)
Partner Org. (8)
Research fields (1)
  
Prof Gustaf Arrhenius
Prof Torbjörn Tännsjö