[Experience with establishment and operation of a biobank].

Tissue specimens taken in pathology for diagnostic or therapeutic interventions have been collected for decades, archived and used for local research projects. Meanwhile there is an increasing need of this material for academic and non-academic biomedical research. Many questions in the field of translational research can only be addressed with a sufficient number of high quality tissue samples especially when combined with comprehensive clinical data. Although biobanks represent an indispensable basis for medical research, this might be in conflict with the rights of patients. Currently there are no specific regulations for biobanks leading to substantial legal uncertainties. However, interpretation of existing regulations by the National Ethics Committee or the Telematic Platform for Medical Research Network are important for ethical and legal solutions. Irrespective of future (national or European) regulations, the informed consent of the patients including a secure data protection concept is a prerequisite for establishment and operation of biobanks.