Informed consent in GANI_MED—A sectional design for clinical epidemiological studies within individualized medicine

Abstract

Clinical epidemiological research is an important approach within Individualized Medicine. This research allows for the identification of possible biomarkers for specific diseases through the use of data from clinical treatments. From a research ethical point of view it needs to be noted that respective studies are mostly very complex. Therefore a variety of different normative requirements of both ethical and legal natures need to be met. On the one hand those studies aim for the scientific use of clinical records. On the other hand samples of biomaterial are to be collected, stored and analyzed using -omics methods. Sometimes there are also study examinations included in these studies which may produce incidental findings. In this Chapter 10 a possible solution shall be demonstrated which meets the mentioned requirements: the informed consent process of the GANI_MED project. By presenting the consent documents design process and their different sections, it can be shown that a good ethical standard can be assured throughout the entire process while providing data from different sources to clinical epidemiological research. Furthermore the response patterns of the patients participating in the GANI_MED project will be presented. The data demonstrate that a possibility to deselect certain aspects of the study through the sectional consent documents is actually used by the participants. The data also show that the patients of different morbidity cohorts answer in a different way.