Der Umgang mit individuellen Befunden bei der Biobank-Forschung

Abstract

During the last decades biomedical science has developed more rapidly than ever. Especially biogenetical and information technologies have contributed to new dimensions in research that were inconceivable in the past. Data about individual genetical patterns, clinical results, individual lifestyle and life circumstances have become the basic raw materials for a new concept of individualized medicine including disease prevention and health promotion. So-called „biobanks“ have been established to foster this new kind of research by collecting bio-materials for genetical investigations and data processing. Due to the core methodology, which is dedicated to finding correlations between the different data (and types of data), huge numbers of clients are needed. And due to the conceptional paradigm, (supposed) healthy people are more interesting than sick patients. So it becomes clear that this new type of research and research organisation is not identical to traditional clinical medical research. The question arises, whether traditional legal and ethical regulations and guidelines are still adequate to deal with new ethical challenges. The key question in this dissertation is whether there is a moral obligation on biobanks and their research personnel to inform clients in the case of life-relevant individual findings (or ‚incidental findings’). Is there an obligation to give feedback to the person? If yes, who has to give it? What qualifications are needed and which criteria for the quality of these findings have to be applied? A second group of questions aims to determine whether existing ethical and legal regulations in selected European countries already give sufficient answers to these challenges. Results: Based on studies of the literature and some expert interviews in different countries, it has become evident that the term „biobank“ stands for a broad range of different phenomena. To avoid misunderstanding the terms „biobanking“ or „biobank-research“ should be preferred to be in the center of bioethical discussion. Instead of „incidental findings“ it would be more precise to talk about „results of individual relevance“. Regarding the WMA Declaration of Helsinki there is a recognised need to find specific solutions for the biobank-experience. Within Europe there is no common understanding of what „biobank“ means nor how to deal with results of individual relevance. Furthermore the discourse inside the bioethics-community about „biobanks“ seems to neglect the economic context. A significant proportion of this kind of research is very closely linked to commercialism and the health industry. More attention should be brought to the fact that the biotech-industry in particular is an important promoter of biobanking. Results of medical examinations should be communicated with the client if they are valid and relevant to his or her health. This is the duty of any physician. „Biobanks“ should be bound to informed-consent principles even if there are no physicians involved. A client’s right of non-information should be respected if explicitly requested.