ContextIn many cases, informed consent of participants is considered a prerequisite even for exclusively data-based medical research. In this context, a model of broad consent is being discussed. In Germany, the Medizininformatik-Initiative (Medical Informatics Initiative) has developed a proposal for broad consent for German hospitals which suggests a validity period of 30 years.Definition of the problemAgainst this background, the article discusses how the claim of consent beinginformedhas to be regarded in a temporal perspective. The practice of consent is here understood (...) to be oriented towards the realization of well-being, personal sovereignty, and trust. In the context of medical research, an asymmetry of access to information between research participants, researchers, and data-storing institutions has to be assumed.Argument and conclusionThe article argues that in order to appropriately address this information asymmetry, a continuous dissemination of comprehensibly prepared information to research participants is necessary to enable personal sovereignty. (shrink)

Menschen mit Migrationshintergrund kommen im Zuge des demografischen Wandels zunehmend in ein Alter, in dem die Wahrscheinlichkeit, pflegebedürftig zu werden, steigt. Insbesondere Demenzerkrankungen in vorangeschrittenen Stadien führen zu hochgradiger Pflegebedürftigkeit, die eine ausschließlich häusliche Pflege durch Angehörige erschwert. Aktuellen Untersuchungen zufolge werden Pflegebedürftige mit Migrationshintergrund jedoch zumeist zu Hause ausschließlich durch Familienangehörige gepflegt und es werden nahezu keine ambulanten Hilfen in Anspruch genommen. Die geringe Inanspruchnahme von ambulanten und stationären Angeboten ist zurückzuführen auf unzureichende Information und die vom Pflegesystem unzureichende (...) Berücksichtigung der Pflegesituation und -bedürfnisse dieser heterogenen Bevölkerungsgruppe. Auch das Verständnis der Demenzerkrankung ist in unterschiedlichen Kulturen heterogen. So wird die Krankheit häufig nicht als solche akzeptiert, sondern die Symptome als „gewöhnliche“ Alterserscheinungen interpretiert, wodurch die Inanspruchnahme ärztlicher Versorgung erst spät erfolgt. Diese Faktoren führen im medizinischen und pflegerischen Alltag häufig zu ethischen Konflikten zwischen pflegenden Angehörigen und Professionellen, aber auch innerhalb des familiären Kontextes. Der Artikel stellt, ausgehend von zentralen Ergebnissen einer empirischen Studie, ethische Konflikte bei der Versorgung demenzerkrankter türkeistämmiger Menschen in Deutschland anhand von zwei Fallbeschreibungen dar. Die ethischen Herausforderungen an das ärztliche und pflegerische Handeln im stationären und häuslichen Setting bei demenzerkrankten Menschen mit Migrationshintergrund werden erörtert. Es wird der Frage nachgegangen, inwieweit diese Konflikte auf unterschiedlichen Ebenen „kulturalisiert“ werden und welche Implikationen sich für die Medizin- und Pflegeethik ergeben. (shrink)

Deep brain stimulation as investigational intervention for symptomatic relief from Alzheimer disease has generated big expectations. Our aim is to discuss the ethical justification of this research agenda by examining the underlying research rationale as well as potential methodological pitfalls. The shortcomings we address are of high ethical importance because only scientifically valid research has the potential to be ethical. We performed a systematic search on MEDLINE and EMBASE. We included 166 publications about DBS for AD into the analysis of (...) research rationale, risks and ethical aspects. Fifty-eight patients were reported in peer-reviewed journals with very mixed results. A grey literature search revealed hints for 75 yet to be published, potentially enrolled patients. The results of our systematic review indicate methodological shortcomings in the literature that are both scientific and ethical in nature. According to our analysis, research with human subjects was performed before decisive preclinical research was published examining the specific research question at stake. We also raise the concern that conclusions on the potential safety and efficacy have been reported in the literature that seem premature given the design of the feasibility studies from which they were drawn. In addition, some publications report that DBS for AD was performed without written informed consent from some patients, but from surrogates only. Furthermore, registered ongoing trials plan to enroll severely demented patients. We provide reasons that this would violate Art. 28 of the Declaration of Helsinki, because DBS for AD involves more than minimal risks and burdens, and because its efficacy and safety are not yet empirically established to be likely. Based on our empirical analysis, we argue that clinical research on interventions of risk class III should not be exploratory but grounded on sound, preclinically tested, and disease-specific a posteriori hypotheses. This also applies to DBS for dementia as long as therapeutic benefits are uncertain, and especially when research subjects with cognitive deficits are involved, who may foreseeably progress to full incapacity to provide informed consent during the required follow-up period. (shrink)