title: [Data transparency - an ethical imperative? Approaching the issues].
abstract: Several studies show that the findings of clinical trials are often not published in full, resulting in a biased presentation of results (publication bias). First, this paper discusses the ethical arguments in favour of complete transparency of biomedical research data. There are relevant deontological (like obligations towards study participants and research sponsors) and consequentialist (harm for patients and misallocation of scarce resources) ethical reasons for the full publication of all trial results, which cannot be overridden by counter arguments like freedom of research, data protection or the individual interests of researchers and manufacturers. The article therefore discusses (1) which strategies are appropriate to guarantee data transparency and (2) who bears responsibility for the implementation of these strategies. Finally, open questions and the need for further action will be discussed.
authors.affiliation: Institut für Ethik, Geschichte und Theorie der Medizin, Ludwig-Maximilians-Universität München. marckmann@lmu.de
authors.forename: Georg
authors.initials: G
authors.lastname: Marckmann
authors.forename: Daniel
authors.initials: D
authors.lastname: Strech
mesh_terms: D022126:Access to Information / Q000941:ethics*; D002986:Clinical Trials as Topic / Q000941:ethics*; D016494:Computer Security / Q000941:ethics; D032984:Ethics, Research; D005858:Germany; D006801:Humans; D007221:Industry / Q000941:ethics; D011643:Publishing / Q000941:ethics*