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 1 Baseline study information

Region Country	Centers (N)	Central or local IRB review	IRB decision on study type
Baltic States	5
Latvia	3	Local^a	Observational
Lithuania	2	Local	Observational
Eastern Europe	5
Hungary	3	Central	Interventional
Romania	1	Local	Observational
Serbia	1	Local	Observational and Interventional
Northern Europe	9
Denmark	2	Central	Observational
Finland	2	Central	Observational
Norway	3	Central	Observational
Sweden	2	Central	Observational
Southern Europe	12
Italy	8	Central	Observational
Spain	4	Local	Observational
United Kingdom	9
United Kingdom	9	Central^b	Observational
Western Europe	26
Austria	2	Local	Observational
Belgium	5	Central	Observational
France	7	Central	Interventional
Germany	4	Central	Observational
Netherlands	7	Central	Observational with diagnostic interventions
Switzerland	1	Local	Observational

^a Latvia has a local review procedure, but, after approval had been obtained for the first center, other centers did not require additional approval
^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

ISSN: 1472-6939