Page 157 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Institutional review board approval of CENTER-TBI protocol
English, Finnish, French, German, Hungarian, Italian, Latvian, Lithuanian, Norwegian, Romanian, Serbian, Spanish, and Swedish) and were partly translated before analysis. The authors contacted the principle investigators to obtain additional information to minimize the amount of unclear or missing data. Identifiable information was deleted to protect the privacy of stakeholders. This resulted in a final set of documents, that was analyzed for this study.
Analyses
We assessed the IRB review procedures by using the final set of documents and aimed
to answer the following research questions in order to evaluate differences in obtaining
IRB approval (1) Was the study considered to be observational or interventional? (2)
Was the research protocol to be submitted to a central IRB or local IRB for primary
IRB review and primary IRB approval? (3) Was additional IRB review required after
primary IRB approval had already been obtained? If yes, to what extent? (4) How many
review rounds were conducted before primary IRB approval was obtained? What were
the reasons? (5) What was the time between protocol submission and obtaining the
required IRB approval to start the study? The use of ‘primary’ in this context should be 7 interpreted as first in an order and ‘additional’ as second in an order, without including
a statement on importance.
To elaborate on the fifth question, we reconstructed six timeframes regarding the primary IRB review procedure: (1) time between protocol submission and primary IRB approval or first IRB reaction, (2) time between first IRB reaction and first reaction of researcher, (3) time between first reaction of researcher and primary IRB approval or second IRB reaction, (4) time between second IRB reaction and second reaction researcher, (5) time between second reaction researcher and primary IRB approval, and (6) total time between protocol submission and primary IRB approval. The existence of these timeframes naturally depended on the actual procedure. Data on any additional IRB review focused only on the duration of this particular review until the required IRB approval was obtained.
In order to assess regional variation, countries were grouped into six regions based on the United Nation geo-scheme: Baltic States (Latvia, and Lithuania), Eastern Europe (Hungary, Romania, and Serbia), Northern Europe (Denmark, Finland, Norway, and Sweden), Southern Europe (Italy, and Spain), the United Kingdom (UK), and Western Europe (Austria, Belgium, France, Germany, the Netherlands, Switzerland). 16 Incomplete data was marked ‘Missing’ (M) and all timeframes were reported in days.
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