The interdisciplinary research network aims at analyzing the normative implications of systems medicine with regard to three key aspects. Core of the project are questions concerning possible new responsibilities of physicians and researchers. Regarding diagnosis and therapy, researchers become more important for analysis and interpretation of patient data. This raises questions about their responsibilities for patients and attending physicians. Furthermore, since approaches in systems medicine deal with huge amounts of patient-related data, questions about the value as well as need for protecting the patients’ privacy arise. The third key aspect deals with the consequences of systems medicine for the patients’ relatives with regard to the handling of genetic information. The project consists of a socio-empirical, an ethical and a legal subproject and works in close collaboration with a local, natural scientific panel of experts from genomic research and clinical practice.
DASYMED: Big Data in Systems Medicine
Scientific Coordinator: Dr. phil. Christoph Schickhardt
Subprojects 1 and 2: Normative and Social Issues for Physicians, Patients and Society
University of Heidelberg
Medical Faculty and Heidelberg University Hospital
National Center for Tumor Diseases
Head: Prof. Dr. med. Dr. phil. Eva Winkler
Phone: +49 6221 56-36049
Funds: 635.969 EUR
Term: 01.08.2014 - 31.07.2017
The subprojects are located at the interface between genomic research and clinical practice as implemented through the collaboration of several central institutions of the Heidelberg University Hospital (e.g. the interdisciplinary tumor board “The individual patient”). Their first task is the empirical description of the current systems medicine practice in Heidelberg as well as the normatively relevant developments in systems medicine and the definition of key terms. This will be the basis for an analysis of normative implications of systems medicine as well as the development of possible solutions. The third task is to transfer the theoretical results into practice.
Subproject 3: Legal Analysis of the Impacts of Systems Medicine
University of Mannheim
Institute for German, European and International Medical Law, Public Health Law and Bioethics (IMGB)
Head: Prof. Dr. Jochen Taupitz
Phone: +49 621 1811328
Term: 01.08.2014 - 31.07.2017
The legal subproject consists of two parts, namely “Big Data and Privacy” and “Translational Responsibility”. With regard to “Big Data and Privacy”, a key task of the legal entities is to specify the scope of application of the regulations that apply to research as well as clinical practice, especially concerning genetic data. On the one hand, the potential of systems medicine must be acknowledged in an appropriate manner. On the other hand, the undermining of fundamental rights of the person – which is conceivable in the context of the collection of large amounts of data – must be avoided. This, in turn, will be the basis for “Translational Responsibility”, which analyses legal aspects concerning responsibilities and liability in systems medicine. This is necessary because as a result of huge databases in systems medicine, many non-medical persons are involved and computer programs are of major importance.
- Researchers’ Duty to Share Pre-publication Data: From the Prima Facie Duty to Practice
Christoph Schickhardt, Nelson Hosley, Eva C. Winkler
In: Mittelstadt, Brent D./Floridi, Luciano (Hrsg.): The Ethics of Biomedical Big Data. Springer, 309-337
- Henrike Fleischer*, Christoph Schickhardt*, Jochen Taupitz, Eva C. Winkler
Das Recht von Patienten und Probanden auf Herausgabe ihrer genetischen Rohdaten. Eine rechtliche und ethische Analyse samt einer Empfehlung für die Praxis.
Medizinrecht (MedR) 2016: 34, 481-491. DOI: 10.1007/s00350-016-4319-9
Siehe zum Thema der Herausgabe genetischer Rohdaten auch unsere ausführliche Handlungsempfehlung.
- So rare we need to hunt for them: reframing the ethical debate on incidental findings
Sebastian Schuol*, Christoph Schickhardt*, Stefan Wiemann, Claus R. Bartram, Klaus Tanner, Roland Eils, Benjamin Meder, Daniela Richter, Hanno Glimm, Christof von Kalle and Eva C. Winkler
Genome Medicine 2015 7(1):83.
- Ausführliche Darstellung einer Empfehlung für ein mehrstufiges Verfahren zum Umgang mit Anfragen von Patienten und Probanden bezüglich einer Herausgabe ihrer genetischen Rohdaten: Download als PDF-Datei (202 KB)»
- DASYMED-Workshop „Verantwortung und Privatsphäre in der Systemmedizin“ am NCT Heidelberg, 22./23.4.2016.