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Chapter 7
Figure 1: Flowchart of IRB review and approval processes in the CENTER-TBI study
Primary IRB review was considered ‘local’ when the protocol was submitted to an independent ‘local’ IRB. Obtained primary local IRB approvals only applied to the associated research centers and allowed study start without any additional requirements (N=7; Austria, Switzerland, Spain, Lithuania, Latvia, Romania, Serbia). Primary local IRB review could be performed simultaneously in each independent IRB (Figure 1).
For every protocol submission, there were two outcome options after IRB review: (1) the required (primary or additional) IRB approval had been obtained and the study could start, or (2) researchers were asked to answer questions or make protocol changes, which was followed by an extra IRB review round. This process varied between IRBs and was repeated until the required IRB approval was eventually obtained. None of the submissions in this study were rejected.
IRB review rounds
Eight countries (44%), including all countries from Eastern Europe and the Baltic State, obtained primary IRB approval in the first round after submission, while six countries (Austria, Belgium, France, Finland, Spain and UK) required one extra review round and four countries (Denmark, Germany, Norway and Sweden) required two extra review rounds (Figure 2). Extra review rounds were found in 73% of centers after primary central IRB submission and in 20% after primary local IRB submission.
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