Page 158 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 7
To determine significant differences between the time from submission till approval of the research protocol between primary local IRBs and primary central IRBs, we performed a Mann-Whitney U test (continuous). Analyses were performed using R version 3.6.0. Finally, a descriptive analysis of questions, comments and answers from both IRB and researcher during the IRB review procedure was performed to summarize the problems and challenges that researchers encountered in obtaining IRB approval. IRB reactions were categorized and reported by their appearance: (1) Procedure, (2) Blood collection and biomarkers, (3) MRI, (4) Privacy and data security, (5) Other.
RESULTS
A total of 66 neurotrauma centers from 18 countries were included in this analysis. Most centers were located in Western Europe (N=26, 39%) and least in Eastern Europe (N=5, 8%) and the Baltic States (N=5, 8%). Most participating centers were from the UK (N=9), followed by Italy (N=8), The Netherlands and France (N=7) (Table 1). In all countries the local principal investigators were responsible to submit the general CENTER-TBI research protocol for IRB review and IRB approval.
Observational or interventional
The majority of countries (N=14, 78%) considered the study to be observational, while others judged it to be observational with diagnostic interventions (The Netherlands), interventional (France, Hungary) and observational and interventional (Serbia) (Table 1).
Primary central or primary local IRB review
Primary IRB review started directly after protocol submission and was considered ‘central’ when submitted to a central institution or an institution that was part of a national network (N=11, 61%). There were three options: (1) Primary central IRB approval had a national impact and applied to all participating centers within a country, without the need for additional IRB review (N=5; Denmark, Finland, France, Norway, Sweden). (2) Primary central IRB approval only allowed study start in the research centers associated with the approving IRB. Other participating centers in the country required approval after an additional extensive local IRB review. This involved the re-evaluation of the entire protocol and applicable ethics (N=4; Belgium, Germany, Hungary, Italy). (3) Primary central IRB approval only allowed study start in the research centers associated with the approving IRB. Other participating centers
156