German Ethics Council calls for clear statutory provisions on research using biobanks
Human biobanks are collections of samples of human body substances (e.g. tissue, blood, DNA), which are electronically linked to personal data and in particular to health information on the donors. They play a central role in research on the causes and mechanisms of a large number of illnesses and their treatment and are a vital resource for biomedical research. The increasing dynamism in this research area prompted the German Ethics Council to address the topic again, after both the former National Ethics Council and the Study Commission “Ethics and Law of Modern Medicine” of the German Bundestag, issued earlier opinions on biobanks.
Biobanks raise ethical and legal questions which extend from the protection of individual rights to the global control of research infrastructures. The Gendiagnostikgesetz [Gene Diagnostics Act], which entered into force in February 2010, does not deal with these questions. At present, therefore, research biobanks are governed only by general legal provisions. In view of the growing challenges, the German Ethics Council regards it as necessary to create specific provisions for human biobanks.
Previous concepts to protect the interests of donors were essentially based on the donors’ informed consent. However, biobanks have special structural features that mean an individual’s consent can give only limited protection, since it is given against the background of limited information. The concept of consent should therefore be supplemented by institutional and procedural rules which both set objective limits and also permit flexibility for research with biobanks.
In its Opinion, the German Ethics Council proposes a five-pillar concept for biobank regulation. It includes recommendations on introducing biobank secrecy, on defining permissible use, on involving ethics commissions, on quality assurance and on transparency. It is the aim of the recommendations to provide a suitable legal framework for the interests and rights of personality of the donors, to achieve more legal certainty for biobank research and at the same time to facilitate research.
The first and most important pillar of this concept is the introduction of biobank secrecy. This should restrict the processing and transmission of samples and related data for the duration of their existence to the purposes of scientific research and guarantee that they are inaccessible to all non-research third-parties. The core of biobank secrecy should be provisions corresponding to those applying to doctors: a duty of professional discretion and a right to refuse to give evidence for the operators, personnel and users of biobanks and a prohibition of access to samples and data for all persons and institutions outside science, including the state.
The second pillar of the concept relates to defining permissible use of biobank materials and data. As now, the consent of the donors should continue to be the essential requirement for the use of samples and data in biobanks. However, donors should also have the possibility of making their samples and data available for scientific research for an indefinite period of time, without restriction to a specific research project or a specific field of research.
As the third pillar of the concept, the Ethics Council recommends involving ethics commissions, firstly, to provide for the case where personal samples and data are to be used or there is an intention to recontact donors, and secondly in order to periodically evaluate the activities of biobanks which are not restricted in subject and duration.
The fourth pillar relates to quality assurance. Donors’ rights should be protected by appropriate organisational structures and procedures and a system evaluation of all biobanks not narrowly restricted in subject and duration.
As the fifth pillar of its legislative concept, the Ethics Council calls for a number of measures to guarantee the transparency of the goals and procedures of a biobank. These include in particular complete documentation and regular publication of the activities of the biobank, and setting up a publicly accessible biobank register.
The Ethics Council also recommends that internationally binding standards of protection should be introduced. In its Opinion, the Council presents a number of proposals for safeguarding biobank secrecy when samples and data are exchanged with cooperation partners abroad.
In a supplementary position statement, four members of the Council recommend that the proposed provisions should not apply to thematically and temporally narrowly restricted collections, where it is not planned to transmit samples and data for other use, as in the case of academic projects for university dissertations and theses. They fear that otherwise there could be a legislative and administrative burden for such projects. Thus, these Council members are also in favour of increased regulation of large-scale biobanks, although they believe that for thematically and temporally narrowly restricted collections the existing provisions for the protection of data and donors when samples are taken are sufficient.
Opinion: Human biobanks for research