How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

Table 3 Duration from submission to required IRB approval before study start per country and study center

Central (1): Primary central IRB approval with national impact, applying to all center within a country, without the need for additional local IRB review to start study
Central (2): Primary central IRB approval only allowed study start in the research centers associated with the approving IRB. Other participating centers required approval after additional extensive local IRB review to start study
Central (3): Primary central IRB approval only allowed study start in the research centers associated with the approving IRB. Other participating centers required approval after additional marginal local IRB review to start study
Local review: Obtained primary local IRB approvals only applied to the associated research centers and allowed study start without any additional requirements
M = Missing
^aIn the UK, the research protocol had to be submitted to an external national committee not associated to the submitting center. After primary approval by this national committee, all centers required additional IRB approval

ISSN: 1472-6939