Research Information System University of Greifswald

Langanke M*, Erdmann P, Dörr M, Lorbeer R, Weinert J, Liedtke W, Lieb W, Hoffmann W, Assel H

Zentrum für Innere Medizin / Klinik für Innere Medizin B

Institut für Ethik und Geschichte der Medizin

Institut für Community Medicine / Abt. Versorgungsepidemiologie und Community Health

Institut für Community Medicine / Abt. SHIP KEF

Theologische Fakultät / LS für Systematische Theologie

Research activities dealing with economic aspects of Individualized Medicine (IM) are part of many multidisciplinary IM-related projects in Germany. One important example is the Greifswald Approach to Individualized Medicine (GANI_MED). This paper presents basic principles of data protection and research ethics which are indispensable in order to guarantee that IM-related economic research which uses encoded, but reidentifiable data is in accordance with the regulatory framework and well established ethical standards in Germany. With respect to the patient-related economic research activities in GANI_MED the article also provides an example of a complete integration of an economic sub-project into the Informed Consent and Data Management Concept of a complex IM project. Last but not least the article provides initial data on the response of the GANI_MED patients to those modules of the GANI_MED consent form which enable the economic research group to receive patient-related data from health insurance companies and the “Kassenärztliche Vereinigung”. The response pattern confirms the hypothesis that patients who take part in an IM study do not automatically agree with the scientific usage of data dealing with the costs of their treatment.