The CRIP Concept and Toolbox: Metabiobanks for Regenerative Medicine?

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1 The CRIP Concept and Toolbox: Metabiobanks for Regenerative Medicine? ESBB Conference, Leipzig, Oktober 22, 2014

2 Biggest Applied Research Organization in Europe 67 institutes (6 active in Life Sciences) > 2 billion annual research budget, 1.6 billion generated through contract research 23,000 staff Potsdam site: Branch Bioanalytics and Bioprocesses (IZI BB) of Fraunhofer IZI Leipzig since July 1st, IZI-BB IZI until : IBMT

3 Humanbiobanken für die Forschung Opinion Human biobanks for research (2010)...development of concepts for networking biobanks and for increasing the efficiency of their use. One example of this kind is being tested and engineered as part of the Central Research Infrastructure for molecular Pathology (CRIP). Using this infrastructure, information on human tissue samples and data which are stored in the affiliated pathology departments in Germany and Austria are made available to enable research projects to be initiated over the internet.

4 Gewebeeinrichtung (Tissue lab / plant) Gewebeeinrichtung Gewebeeinrichtung: Gewebebank, Abteilung eines Krankenhauses oder andere Einrichtung, in der Tätigkeiten im Zusammenhang mit der Verarbeitung, Konservierung, Lagerung oder Verteilung menschlicher Gewebe und Zellen ausgeführt werden. Sie kann auch für die Beschaffung oder Testung der Gewebe und Zellen zuständig sein. Fraunhofer IGB

5 Networking Biobanks: Constraints Biobanks for research / CRIP: Ethical / Informed Consent Legal Technical Biobanks for (regenerative) therapy: Sample quality ICT The My-Syndrome Ethical / Informed Consent Regulatory Drug approval Technical GCP ICT??? The My-Syndrome

6 CRIP Privacy Regime Research Pool 1 FallgPool Fal 2 3 Pool PFallg4pe 4 3) Statistical Groups Metabiobank 2) Anonymize Search Profile Partner 1 IRDB Biobank Partner 2 IRDB 1) Pseudonymize Biobank C. Schröder C, Heidtke KR, Zacherl N, Zatloukal K, Taupitz J: Safeguarding donors' personal rights and biobank autonomy in biobank networks: the CRIP privacy regime. Cell Tissue Bank 12 (2011),

7 CRIP Advisory Board Chairman: Prof. Dr. Jochen Taupitz Universitäten Heidelberg und Mannheim; Direktor d. Instituts für dt., europ. und internat. Med.- und Gesundheitsrecht und Bioethik Deputy Chairman: Prof. Dr. Nikolaus Zacherl IMG Institut für medizinische Genomforschung Planungs GmbH, Wien Prof. Dr. Peter Dabrock Friedrich-Alexander-Universität Erlangen-Nürnberg, FB Theologie; Lehrstuhl für Systemat. Theologie (Ethik) Prof. Dr. Joachim Thiery Universität Leipzig Institut für Labormedizin, Klinische Chemie und Molekulardiagnostik Prof. Dr. Hansjürgen Garstka TU Berlin; bis 2005 Berliner Beauftragter für Datenschutz und Informationsfreiheit Prof. Dr. Christiane Woopen Institut für Geschichte und Ethik der Medizin der Universität zu Köln Prof. Dr. Hans Mathias Kepplinger Universität Mainz; Em. Leiter des Instituts für Publizistik

8 CRIP Toolbox Free text records Import Pseudonymised Data div. Formats Harmonisation Anonymisation Export www: Pools Hospital Biobank Project request

9 Free text records Generic, structured data (ICD, TNM...) Import of Coding Guide (e.g. ICD) no training set and no manual entry of rules required Negations interpreted correctly Quick-and-easy amendment of dictionaries and rules multiple languages under clinical evaluation with Inst. of Pathology, Univ. Bern Hospital Biobank

10 .IDB Free text records Import Pseudonymised Data div. Formats Harmonisation Anonymisation Export Hospital Biobank

11 .IDB Harmonize data Checking of data (text, value, date) Catalog values, calculation of values, regular expressions Pre-processing (prior to data import) Analysis of errors Mapping of parameters Anonymize data No tracing back, no reference list Singular random codes Control data export Review export files; no hidden data transfer Metadata repository Adopt biobank partner s needs without programming efforts Weiler, G., et al. (2014). p-biospre an information and communication technology framework for transnational biomaterical sharing and access. ecancer 2014, 8:401

12 .Anon Configure and document data anonymization De-Identification: Identifiers replaced by anonymized brackets......and / or k-anonymized through Report: Time stamp De-Identifiers: Name(s), status, file K-Anon: Report file Anonymisation Export Hospital Biobank

13 CRIP Search tool Dynamic generation of query interface Corporate design Export www: Pools Hospital Biobank Project request

14 Technologies Server infrastructure: Linux, Apache, PosgreSQL Web Standards (HTML, XML, XSL, CSS, Javascript) Open standards and technologies Programming platform: Perl, Webservices, jquery

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17 Scientific community DPKK Members / biobanks

18 Scientific community Web-based query tool (members only) Webservice API Members only... Anonymised cases / samples Export Project requests Metadata Data Import Biobank operators: Anonymised cases/samples

19 Networking Biobanks: Constraints Ethical Anonymized data only Approved by German data protection authorities Legal Biobank Data Transfer Agreement Contract for research consortia (DPKK) Technical Scalable high-performance database architecture Comprehensive set of modular software tools? Specimen quality? The My-Syndrome

20 Thank you!