title: [Application for academic multicenter studies at German ethical review boards].
abstract: Before the start of a clinical trial, approval by the responsible institutional ethical review board (IRB) is required. In Germany, nearly 50 independent IRBs may be responsible for the different participating sites of a multicenter study. In trials for rare diseases, the participation of many centers is required. Therefore, the application procedure for academic multicenter trials in malignant hematologic diseases is often a bureaucratic nightmare. Different aspects of IRB application and possible approaches for improvement are presented.
authors.affiliation: Universitäres Centrum für Tumorerkrankungen, Medizinische Klinik II, Hämatologie/Onkologie, Klinikum der Goethe-Universität, Frankfurt a.M., Deutschland. goekbuget@em.uni-frankfurt.de
authors.forename: Nicola
authors.initials: N
authors.lastname: Gökbuget
authors.forename: Ralph
authors.initials: R
authors.lastname: Naumann
mesh_terms: D000046:Academic Medical Centers / Q000941:ethics* / Q000458:organization & administration*; D002986:Clinical Trials as Topic / Q000941:ethics*; D028744:Ethics Committees, Research / Q000458:organization & administration*; D005858:Germany; D019337:Hematologic Neoplasms / Q000628:therapy*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000941:ethics*