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

From: 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

CountryCentral or local IRB reviewDuration in days
Centre
123456789
DenmarkCentral (1)114114       
FinlandCentral (1)7575       
FranceCentral (1)98989898989898  
NorwayCentral (1)233233233      
SwedenCentral (1)8383       
BelgiumCentral (2)131138141257M    
GermanyCentral (2)288296312M     
HungaryCentral (2)177200204      
ItalyCentral (2)6570139141155261273288 
NetherlandsCentral (3)274691209223224M  
United KingdomaCentral (3)58616384104157229282535
AustriaLocal52M       
LatviaLocal113MM      
LithuaniaLocal3147       
RomaniaLocal1        
SerbiaLocal1        
SpainLocal69179349M     
SwitzerlandLocal28        
  1. 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
  2. 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
  3. 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
  4. Local review: Obtained primary local IRB approvals only applied to the associated research centers and allowed study start without any additional requirements
  5. M = Missing
  6. 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