Title of Presentation
“Harmonized broad consent: a concept facilitating access and cross-border exchange of biosamples & related data”
Date and Place
Born 1963 at Kiel, Germany. From1966-1972 childhood & school enrolment at Madrid, Spain.
Medical studies at the University of Würzburg (1984-1991), thesis 1991 (summa cum laude), licence to practice medicine 1992.
Postdoc (1993-94), CEA-Fellowship at the Laboratoire Jean Maetz, Département de Biologie Cellulaire et Moléculaire, University of Nice/Sophia Antipolis, France;1995 DFG-Fellowship at the Institute of Pharmacology and Toxicology, University of Würzburg.
Cardiology Fellow, Department of Internal Medicine, University of Würzburg (1995-2000); Specialist in Internal Medicine 2000, Specialist in Cardiology and Senior Physician 2002;
2004 Assistant Professor Dpt. of Internal Medicine/Cardiology, University of Würzburg;
2006 GoBio-Award of the Federal Ministry of Education and Research (BMBF); Research group leader at the Rudolf-Virchow-Centre for Experimental Biomedicine (2006-today)
2007 and 2010 Albert-Koelliker Lecturer Award, Faculty of Medicine, University of Würzburg;
2008 Nomination Professor of Internal Medicine, University of Würzburg;
2011 Responsible for the implementation of a faculty-wide centralized biobank at the University and University Hospital Würzburg, biobank-grant of the Federal Ministry of Education and Research (BMBF);
Since 2012 Fellow of the European Society of Cardiology (FESC) and appointed member of the Task-Force of the ESC Working Group on Myocardial and Pericardial Diseases;
2013 Appointment Full Professor for Translational Medicine & Director of the Interdisciplinary Bank of Biomaterials and Data of the Medical Faculty Würzburg.
Since 2006 Member, since 2011Vice Chair of the Ethics Committee at the Medical Faculty of the University of Würzburg and appointed member of the Biobank Task-Force of the Working Party of the German Medical Ethics Committees; since 2013 German Representative in the BBMRI-ERIC Common Service ELSI.
In the last decade biobanks have been recognized as important resources for the progress in biomedical research, particularly for the recent progress in precision medicine. All over the world human biomaterials (e.g., blood and tissues) and related clinical data are currently collected in large biobanks. The samples are long-term stored under strict quality control for current and future (non predictable) research issues that often require cross-border exchange of biosamples and related data. On this background the internationally prevailing informed consents are inadequate, requiring an expanded and at the same time cross-border oriented scope, balancing individual donor-rights and research interests.
The common concept of informed consent to the use of donated biomaterials assumes that the biomaterials are collected and stored for a specific research purpose. Recently, the bio-bank task force of the Working Party of the German Medical Ethics Committees (WP-GMEC) has developed a nation-wide master document for a broad consent approved by all German RECs. The document fulfils the current OECD- and WMA-recommendations for biobanks storing human biosamples for unlimited time and unrestricted biomedical use -including cross-border medical research and, thus, might serve as a basis for a harmonized European-wide consent template. The fact that the use of biomaterials and related data collected under such conditions will not be restricted to certain projects or specific researchers/Nations would largely overcome one major obstacle for cross-border research: only the research project itself but not the many different contributing biobanks would require REC-approval. This would augment the autonomy of individual biobanks willing to participate to trans-border research. On the other hand biobanks are recommended to reciprocate by making processes transparent and intensifying public involvement. Donors must be clearly informed on the unrestricted (including cross-border) use of their donated biomaterials and -in parallel- given the opportunity to question the use of their bio-materials and data to a certain degree. Communicating concepts, objectives, and future benefits of biobanks to the public/citizens is essential for biobanks in order to establish a trustful relationship with current and future donors.
The approved nation-wide applicable patient information and consent document of the WP-GMEC clearly states that biomaterials and data donated for medical research serve to address current and future issues in medical research. It appears well-suited to serve as a model for a harmonized European-wide consent template allowing for biobank-based cross-border research activities that may also extend to hitherto unknown disease entities or genetic disorders.