title: [Current legal framework conditions for running and utilization of biobanks. Part 2: data protection and informed consent].
abstract: Informed consent of donors of biomaterials represents an essential pillar of legal conformity of business organizations even for biobanks. For the assessment of self-determination of donors and freedom of research for users of biobanks there is a general consensus on the necessity for a social and individual agreement for the participation of donors in research projects. However, demands are often made for which the legal implementation is at least contentious and can be considered as excessive and biased. In part 2 of this review series the current legal foundation of data protection and informed consent is summarized on the basis of normative and ethical principles. With respect to appropriation of data and biosamples it can be deduced that by conformation to corresponding framework conditions the informed consent of donors in particular can be constructed independent of the project.
authors.affiliation: Comprehensive Cancer Center Münster, Universitätsklinikum Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Deutschland, haier@uni-muenster.de.
authors.forename: J
authors.initials: J
authors.lastname: Haier
mesh_terms: D018070:Biological Specimen Banks / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000458:organization & administration / Q000706:statistics & numerical data*; D016494:Computer Security / Q000941:ethics / Q000331:legislation & jurisprudence*; D017041:Ethics Committees; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence*; D009313:National Health Programs / Q000941:ethics / Q000331:legislation & jurisprudence*