Gegenwärtige rechtliche Rahmenbedingungen für den Betrieb und die Nutzung von Biobanken. Teil 2
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TY - JOUR
T1 - Gegenwärtige rechtliche Rahmenbedingungen für den Betrieb und die Nutzung von Biobanken. Teil 2
T2 - Datenschutz und informierte Einwilligung
AU - Haier, J
PY - 2013/10
Y1 - 2013/10
N2 - 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.
AB - 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.
KW - Biological Specimen Banks
KW - Computer Security
KW - Ethics Committees
KW - Germany
KW - Humans
KW - Informed Consent
KW - National Health Programs
U2 - 10.1007/s00104-013-2607-8
DO - 10.1007/s00104-013-2607-8
M3 - SCORING: Zeitschriftenaufsatz
C2 - 24005718
VL - 84
SP - 892
EP - 901
JO - CHIRURG
JF - CHIRURG
SN - 0009-4722
IS - 10
ER -