"Evaluation of Legislation and Related Guidelines .. (TISS.EU)
"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"
Start date: 01 Apr 2008,
End date: 31 Mar 2011
"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."
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