[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.