Page 163 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Central or local IRB review
Central (1) Central (1) Central (1) Central (1) Central (1) Central (2) Central (2) Central (2) Central (2) Central (3) Central (3) Local Local Local Local Local
Local
Duration in days
Centre
123456789
Institutional review board approval of CENTER-TBI protocol
Table 3. Duration from submission to required IRB approval before study start per country and study center.
Country
Denmark Finland France Norway Sweden Belgium Germany Hungary Italy Netherlands United Kingdom* Austria Latvia Lithuania Romania Serbia
Switzerland
Table 3.
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.
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. 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.
*In 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. Local review: Obtained primary local IRB approvals only applied to the associated research centers and allowed study start without any additional requirements
M = Missing
DISCUSSION
This study shows variation in IRB procedures between and within European countries, indicating a lack of uniform legislation and regulation, or inconsistencies in how such legislation or regulation were implemented. In some countries, a primary central IRB approval was sufficient for study initiation, while others required an additional IRB review at the participating site. Also, the number of review rounds, duration until IRB approval, and the nature of questions and comments from the IRBs varied. Not all IRBs considered the study to be observational, demonstrating a different way of
114 75 98 233 83 131 288 177 65 27 58 52 113 31 1
114
75
98 98 98 98 98 98
233 233 83
138
296
200 204
70
46
61
M
M M 47
261 273 288
224 M
157 229 282 535
141 257 M 312 M
139 141 155 91 209 223 63 84 104
1
Spain Local 69 179 349 M 7
28
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