Press release 03/2003
October 2, 2003

Joint declaration on biobanks by the National Ethics Councils of Germany and France

A legal framework must be laid down at national and international level for the establishment of biobanks. This is the view expressed by the National Ethics Council of the Federal Republic of Germany (NER) and the French Comité consultatif national d’éthique (CCNE) in a joint declaration issued today.

The subject of this declaration and of the Opinions of both organizations on which it is based are biobanks for biomedical research – i.e. privately or publicly maintained institutions for the long-term storage of samples of human body materials such as cells, tissue, blood or DNA and for holding personal records of donors (genetic data on the one hand and information on health and lifestyle on the other).

The problems and issues raised by biobanks are outlined in the joint declaration.

The large-scale collection and comparison of body materials and the data derived from them make it possible to establish correlations that may in the long term yield a valuable diagnostic and therapeutic return. However, there is a risk that the data and samples could be used for purposes other than that to which the donor has consented or be passed on to third parties.

The following aspects are of paramount importance in the regulation of biobanks:

• the existence of a guaranteed continuous chain of responsibility in relation to the derivation, storage, handling and use of body materials and personal data;
• a clear definition of the donor’s free and informed consent; and
• issues of solidarity, altruism and justice.

The conclusion is that a new regulatory framework must be established in both countries to reconcile the development and utilization of research with protection of the individual. This is not only a task confronting Germany and France, but must also be addressed internationally.

The French Ethics Committee’s Opinion on biobanks is published simultaneously with the joint NER-CCNE declaration. The NER’s Opinion will be presented at the end of the year.

(back to the top)