Clear strategies and recommendations needed for biomaterials banks for research

3 May 2011

Two German Senate Commissions have concluded that: biomaterial banks are an indispensable resource for biomedical research; they are of great importance to the quality and competitiveness of German research; and it is important that clear strategies and recommendations exist for Germany.

They say that at present, however, no general comprehensive statutory regulations, in the form of a research biobank act, should be introduced.

This conclusion comes in a joint statement by two Senate Commissions of the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation): the Senate Commission on Clinical Research and the Senate Commission on Genetic Research. The statement was initiated with regard to the current debate on legal regulations of human biobanks and represents the DFG’s contribution to and commentary on the statement by the German Ethics Council Human Biobanks for Research.

The DFG Senate Commissions propose that, instead of an overarching set of legal regulations, observance of the principles contained in the recommendations of the Ethics Council, based on the existing legal framework for large biobanks, is to be encouraged.

These principles include the specification of permissible usage, the involvement of ethics committees, quality assurance in data protection and transparency of the goals and operating procedures of a biobank. The DFG Senate Commissions further propose that the observance of these principles should be made a prerequisite for the funding of biobanks by the DFG and other public funding bodies. In the opinion of the DFG Senate Commissions, there should be no tightening of the requirements for smaller biomaterial banks.

To the DFG Senate Commissions, separate secrecy protection for biobanks does not appear to be necessary at present and would be unique internationally. Any new relevant legislation could prevent international cooperation and hinder biomedical research in Germany.

Further information

Deutscher Ethikrat. Human biobanks for research. Berlin, 2010
http://www.ethikrat.org/files/der_opinion_human-biobanks.pdf
(translation from the German: Humanbiobanken für die Forschung)