Biobanks or biorepositories refer to collections of specimens of human body substances (e.g., tissue, cells, DNA, proteins, blood or other body fluids) that typically are linked or can be linked to data and information about their donors.
Specimens are normally collected for a biobank in the following ways:
An initial statement of informed consent to removal and storage of specimens in the biobank (especially in the cases in points 2 and 3) must be obtained in writing from the donor. A specific research purpose is not defined in the Biobank Graz Informed Consent form ("broad consent") since often a specific question has not been formulated at the time of donation. Before specimen material is released, a positive decision must be made by the Med Uni Graz Ethics Committee.
According to § 2f par. 1 of the Research Organization Act (FOG), scientific institutions may collect, archive and systematically record research material (§ 2b l. 6) for purposes according to Art. 89 par. 1 of the General Data Protection Regulation (DSGVO) and process all data (§ 2b l. 5) that is required to guarantee optimal access to data (§ 2b Z 5) and research material for purposes according to Art. 89 par. 1 DSGVO. § 7 par. 1 of the Austrian Data Protection Act (DSG) refers to the possibility of processing data for scientific research purposes in the public interest and explicitly to data which have already been permissibly elicited during other investigations (Note: e.g., specimens remaining after diagnostic procedures) or also for other purposes (§ 7 par.1 l. 2 DSG) or are pseudonymized personal data for the data processors (or the biobank) and through which the identity of the persons affected cannot be determined by legally permissible means (§ 7 par. 1 l. 3 DSG).
All personal data is processed exclusively in a pseudonymized form using clear identifiers or area-specific personal identifiers (§ 2d par. 2 l. 1 FOG or Art. 4 Nr. 5 DSGVO). Names are either not published or use is made exclusively of anonymized or pseudonymized forms. According to the purposes listed in §§ 2c to 2i of the FOG and the requirements stated in these provisions, it is also permitted to deliver data and research material to scientific institutions (§ 2b l. 12 FOG) or expert evaluators in member states of the European Union.
