Abstract
Governance, underlying general ICT (Information and Communication Technology) architecture, and workflow of the Central Research Infrastructure for molecular Pathology (CRIP) are discussed as a model enabling biobank networks to form operational “meta biobanks” whilst respecting the donors’ privacy, biobank autonomy and confidentiality, and the researchers’ needs for appropriate biospecimens and information, as well as confidentiality. Tailored to these needs, CRIP efficiently accelerates and facilitates research with human biospecimens and data.
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Notes
For an overview see: http://www.p3gobservatory.org/repository/guidelines.htm. Accessed March 25, 2010.
www.isber.org. Accessed March 25, 2010.
http://www.abrn.net/. Accessed March 25, 2010.
Organization for Economic Co-Operation And Development.
http://biospecimens.cancer.gov. Accessed March 25, 2010.
https://www.ctrnet.ca/. Accessed March 25, 2010.
http://www.dna-network.ac.uk/. Accessed March 25, 2010.
www.crip.fraunhofer.de. Accessed March 25, 2010.
www.bbmri.eu. Accessed March 25, 2010.
The UK DNA banking network, which Yuille et al. (2009) termed a “secondary biobank”, is managing samples and data originated by others (including storage and distribution of aliquots).
German Data Protection Act/Bundesdatenschutzgesetz § 3a.
More technical detailed information on CRIP data formats, database structure and software will be published separately.
Charité Universitätsmedizin Berlin, Klinikum rechts der Isar der TU München and Medizinische Universität Graz, funded by: German Federal Ministry for Education and Research (BMBF), the former German Industrial Association for the Promotion of Human Genome Research (Förderverein Humangenomforschung) and seven pharmaceutical companies (Altana, Bayer, Boehringer Ingelheim, Merck, Sanofi-Aventis, Schering, and Roche).
Charité Universitätsmedizin Berlin, Klinikum rechts der Isar der TU München, Medizinische Universität Graz and Universitätsklinikum Erlangen.
Charité has Institutes of Pathology at Campus Benjamin Franklin and Campus Mitte.
Fraunhofer Institut für Biomedizinische Technik/Institute for Biomedical Engineering, Postdam-Golm, Germany; www.ibmt.fraunhofer.de.
http://www.crip.fraunhofer.de/en/about/advisoryboard Accessed March 29, 2010.
In line with Knoppers and Saginur (2005), the German National Ethics Council (2004), and German legislation (German Data Protection Act/Bundesdatenschutzgesetz § 3 Abs. 6 + 6a), we term data “anonymized”, if the data have been pseudonymized and the user/researcher has no access to the code. Pseudonymized data is “coded” in the nomenclature proposed by Knoppers & Saginur (2005).
A specific case can be backed by one or more samples and types of specimen jointly harvested from an individual patient. A patient (i.e. a donor) can be represented by one or more cases.
For registration procedure see: http://www.crip.fraunhofer.de/htdocs/pdf/Access.pdf.
For details see: http://www.crip.fraunhofer.de/en/ethics_policy/data_protection.
Several concepts of minimizing the risk of donors’ re-identification are currently being discussed and evaluated (e.g. El Emam and Kamal Dakar (2008)). More detailed technical information on the concept implemented with CRIP will be published separately, see 12.
For the Rules’ text see: http://www.crip.fraunhofer.de/htdocs/pdf/Ordnung-1.pdf.
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Acknowledgment
We thank Dr. Peter Hecht for stimulating discussions and critical revision of the manuscript. Work described here was supported by grants 01GR0601 and 01GR0701 of the German Ministry for Education and Research (Bundesministerium für Bildung und Forschung, BMBF).
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Schröder, C., Heidtke, K.R., Zacherl, N. et al. Safeguarding donors’ personal rights and biobank autonomy in biobank networks: the CRIP privacy regime. Cell Tissue Bank 12, 233–240 (2011). https://doi.org/10.1007/s10561-010-9190-8
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DOI: https://doi.org/10.1007/s10561-010-9190-8