Gökbuget Nicola, Naumann Ralph
Universitäres Centrum für Tumorerkrankungen, Medizinische Klinik II, Hämatologie/Onkologie, Klinikum der Goethe-Universität, Frankfurt a.M., Deutschland.
Onkologie. 2013;36 Suppl 2:29-35. doi: 10.1159/000348270.
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.
在临床试验开始前,需要获得负责的机构伦理审查委员会(IRB)的批准。在德国,近50个独立的IRB可能负责多中心研究的不同参与地点。在罕见病试验中,需要多个中心参与。因此,恶性血液病学术多中心试验的申请程序往往是一场官僚主义的噩梦。本文介绍了IRB申请的不同方面以及可能的改进方法。