DFG Senate Commissions propose statement on biobanks' legal regulations

Biomaterial banks are an indispensable resource for biomedical research. They are of great importance to the quality and competitiveness of German research. Therefore, it is important that clear strategies and recommendations exist for Germany. At present however, no general comprehensive statutory regulations, in the form of a research biobank act, should be introduced.

This is the conclusion of 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.

Wording of the Statement by the DFG Senate Commissions

Biomaterial banks are an indispensable resource for biomedical research; coordinated, quality-assured and sustainable biomaterial banking is a long-term scientific structural objective, which is essential to the quality and competitiveness of German research. Therefore, it is important for Germany that clear strategies and recommendations for biobanks exist. The DFG, as a substantial funder of biomedical research, is taking an active part in discussions on the future structure of biobanking in Germany and on the regulations that are relevant to it.

1. 1.     The DFG Senate Commission on Clinical Research and the DFG Senate Commission on Genetic Research expressly welcome the statement by the German Ethics Council "Human Biobanks for Research". On many issues it represents the "gold standard" for biomaterial banks and is a suitable approach for placing research biomaterial banks on a sustainable and coordinated basis in the long term that is accepted by all stakeholders.

1. 2.     Already, large existing and planned biomaterial banks can fulfil the requirements of the German Ethics Council without legal regulation (for example National Cohort, PopGen, tissue bank of the Nationales Centrum für Tumorerkrankungen (National Centre for Tumour Diseases, NCT), tissue banks of the Network of Comprehensive Cancer Centres). In principle however, these requirements place a considerable, not to mention financial, constraint on the biomaterial banks, which has not been adequately represented in the available structural funding up to now.

1. 3.     For many relevant biomaterial banks which do not have the necessary resources at their disposal, the formal requirements in the statement by the German Ethics Council are very high and thereby threaten their continued existence. On the other hand, in the interests of all stakeholders - the donors, the host institutions and research - there is a general need to optimise these biomaterial banks for scientific use as well.

1. 4.     Project-specific collections that are relatively small, for example those of doctoral and postdoctoral researchers, are of specific importance for university-based research. If they were to be subject to a biobank law, that would surely overstretch their organisational capacity. However, if these collections are excluded from the regulatory scope of such a law, this runs counter to sustainability considerations in relation to biobanks. To ensure that the samples and data remain accessible for further use after completion of the project, they should ideally be included in a larger biomaterial bank that is structurally and technically well equipped. In this case the samples and data would again fall under the regulatory scope of a biobank law, and this at a time when most of the requirements of such a law could no longer be satisfied. From this immediately follows the necessity to draw up a strategy that is tailored to the needs of project-specific collections, before committing to a fixed legal framework.

1. The biobank secrecy being discussed in Germany takes a very specific aspect of the operation of biobanks into account. Since in general no comparable protection regulations exist in other countries, such a move could have negative consequences with regard to the increasing number of international collaborations and joint research programmes, as well as competitive disadvantages in comparison to research carried out abroad. Furthermore, the extensive regulations on data protection and medical privacy in the context of biobanks already guarantee a very high level of protection for research in international comparison.

1. 6.     Proposal by the Senate Commissions 

-       At present no general and comprehensive statutory regulation, in the form of a research biobank act, should be introduced. Instead, observance of the principles contained in the recommendations of the Ethics Council is to be encouraged on the basis of the existing legal framework for large biobanks. This could be implemented effectively by making the observance of these principles a prerequisite for the funding of biobanks by the DFG and other public funding bodies. In addition data protection authorities and ethics commissions should require and monitor the observance of the guidelines.

-       Conversely, it is necessary to provide sufficient funds for biomaterial banks in order to ensure over the long term both a high-quality biobanking facility as well as the implementation of the current rules. Unified strategies are necessary at the various participating institutions to ensure this.

-       For smaller biomaterial banks there should be no tightening of the requirements - in accordance with the minority statement by the German Ethics Council. Strategies are to be developed that also tie these smaller biobanks into secure structures for the purpose of optimising their usage 

-       Separate secrecy protection for biobanks does not appear necessary at present and would be unique internationally. Any new relevant legislation risks jeopardising international cooperation and biomedical research in Germany.