Page 162 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 7
Table 2. Duration of protocol submission until required IRB approval before study start.
All centers Local review Central review - Central (1)
- Central (2) - Central (3)
Duration (days)*
114 (75-224)
50 (29-102) 138 (91-229)** 98 (94-114) 189 (140-270) 104 (62-224)
Centers (N)
58 10 48 16 17 15
Missing (N)
8 4 4 0 3 1
Legend:
*Duration was reported in median number of days (IQR).
**Group difference between local and central review were significant (P=0.0074, Mann-Whitney U).
Local review: Obtained primary local IRB approvals only applied to the associated research centers and allowed study start without any additional requirements
Central (1): Primary central IRB approval with national impact, applying to all center within a country, without the need for additional local IRB review.
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.
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.
In Norway and Denmark, the majority of time from submission to primary central IRB approval was spent by researchers (67% and 69%, respectively), while in France (95%) and Hungary (71%) most time was consumed by IRBs. Regarding primary local IRB submissions, researchers only accounted for 12% of time in Spain and 21% in Austria (Figure 2).
Additional IRB review rounds after primary central IRB review were required in 55% of countries. An additional marginal (feasibility) review had a median duration of 104 days (IQR: 62-224), whereas an additional extensive IRB review took 189 days (IQR: 140- 270) (Table 3).
Variation between centers within countries was least in Lithuania (31 to 47 days), Germany (288 to 312 days), Belgium (131 to 155 days), and Hungary (177 to 204 days), compared to Spain (69 to 349 days), the Netherlands (27 to 224 days), the UK (58 to 535 days), and Italy (65 to 288 days) (Table 3).
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