Page 159 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Table 1: Baseline study information
Institutional review board approval of CENTER-TBI protocol
required additional approval after marginal local IRB review, mainly assessing local feasibility (N=2; UK, The Netherlands) (Figure 1).
Region
Country
Baltic States Latvia
Lithuania Eastern Europe
Hungary Romania Serbia
Northern Europe Denmark
Finland Norway Sweden
Southern Europe Italy
Spain United Kingdom
United Kingdom Western Europe
Austria Belgium France Germany Netherlands
Centers (N)
5
3 2 5 3 1 1 9 2 2 3 2 12 8 4 9 9 26 2 5 7 4 7
Central or local IRB review
IRB decision on study type
Observational Observational
Interventional
Observational Observational and Interventional
Observational Observational Observational Observational
Observational 7 Observational
Observational
Observational Observational Interventional Observational Observational with diagnostic
interventions Observational
Switzerland 1
Locala Local
Central Local Local
Central Central Central Central
Central Local
Centralb
Local Central Central Central Central
Local
Table 1 legend:
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 IntheUK,theresearchprotocolhadtobesubmittedtoanexternalnationalcommitteethatwasnotassociated to the submitting center. After primary approval by this national committee, all centers (including the submitting center) required additional IRB approval.
157