Page 156 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE
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Chapter 7
This study aims to improve the efficiency of future research initiatives by quantifying the differences in IRB procedures through analyzing the procedural details, problems and challenges that researchers encountered in obtaining IRB approval for the general research protocol of the CENTER-TBI study.
METHODS
Study setting
The Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI, www.center-tbi.eu) Core study is a prospective observational study on traumatic brain injury (TBI), which was conducted between December 2014 and December 2017 in 63 neurotrauma centers across Europe and Israel. 11-12 The study included patients with TBI of all severities, and aims to improve characterization of TBI, in order to facilitate the development of precision medicine approaches and to identify best practices by using a comparative effectiveness research (CER) approach. 11-14 In the context of the project high-quality Personal Health related Data (PHD) were collected with repositories for neuro-imaging, DNA, and serum biomarkers. Prior to the study start and collection of clinical data, a uniform CENTER-TBI research protocol including all relevant documents was sent to all responsible IRBs to ensure its legal, ethical and statistical soundness and to obtain IRB approval.
A total of 68 centers from 19 countries initially submitted applications for IRB approval. Because this article focuses on IRB approval in Europe, two centers from Israel were excluded from our analysis. The 66 center that participated in this present study are from Austria (N=2), Belgium (N=5), Denmark (N=2), Finland (N=2), France (N=7), Germany (N=4), Hungary (N=3), Italy (N=8), Latvia (N=3), Lithuania (N=2), the Netherlands (N=7), Norway (N=3), Romania (N=1), Serbia (N=1), Spain (N=4), Sweden (N=2), Switzerland (N=1), and the United Kingdom (UK), (N=9). Sixty-one European centers were initiated and actively enrolled patients in the study.
Data collection and administration
All IRB submission documents, communication records and approval documents were collated per center by the Contract Research Organization, ICON plc (ICON), directly after final approval of IRBs. 15 ICON is a global company operating in the healthcare industry that was responsible for the clinical monitoring of CENTER-TBI data. The received IRB documents were obtained in 15 different languages (Danish, Dutch,
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