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Table 1 Baseline study information

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

Region
Country
Centers (N)Central or local IRB reviewIRB decision on study type
Baltic States5  
Latvia3LocalaObservational
Lithuania2LocalObservational
Eastern Europe5  
Hungary3CentralInterventional
Romania1LocalObservational
Serbia1LocalObservational and Interventional
Northern Europe9  
Denmark2CentralObservational
Finland2CentralObservational
Norway3CentralObservational
Sweden2CentralObservational
Southern Europe12  
Italy8CentralObservational
Spain4LocalObservational
United Kingdom9  
United Kingdom9CentralbObservational
Western Europe26  
Austria2LocalObservational
Belgium5CentralObservational
France7CentralInterventional
Germany4CentralObservational
Netherlands7CentralObservational with diagnostic interventions
Switzerland1LocalObservational
  1. a Latvia has a local review procedure, but, after approval had been obtained for the first center, other centers did not require additional approval
  2. b In the UK, the research protocol had to be submitted to an external national committee that was not associated to the submitting center. After primary approval by this national committee, all centers (including the submitting center) required additional IRB approval