How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study
Timmers, M.; Van Dijck, J. T. J. M.; Van Wijk, R. P. J.et al.
CENTER-TBI; European Union; Harmonization; Health-care research; Research ethic committees
Abstract :
[en] Background: The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods: We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results: From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion: We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.
Research center :
CENTER-TBI
Disciplines :
Life sciences: Multidisciplinary, general & others
Author, co-author :
Timmers, M.; Department of Intensive Care, Erasmus MC-University Medical Centre Rotterdam, P.O. Box 2040, Rotterdam, 3000 CA, Netherlands
Van Dijck, J. T. J. M.; Department of Neurosurgery, University Neurosurgical Center Holland, LUMC, Hmc and Haga Teaching Hospital, Leiden, The Hague, Netherlands
Van Wijk, R. P. J.; Department of Neurosurgery, University Neurosurgical Center Holland, LUMC, Hmc and Haga Teaching Hospital, Leiden, The Hague, Netherlands
Legrand, Victor ; Université de Liège - ULiège > Département des sciences cliniques > Département des sciences cliniques
Van Veen, E.; Department of Intensive Care, Erasmus MC-University Medical Centre Rotterdam, P.O. Box 2040, Rotterdam, 3000 CA, Netherlands, Department of Public Health, Erasmus MC-University Medical Centre Rotterdam, Rotterdam, Netherlands
Maas, A. I. R.; Department of Neurosurgery, Antwerp University Hospital, Edegem, Belgium, University of Antwerp, Antwerp, Belgium
Menon, D. K.; Department of Anaesthesia, University of Cambridge, Cambridge, United Kingdom
Citerio, G.; School of Medicine and Surgery, University of Milan-Bicocca, Milan, Italy, San Gerardo Hospital, ASST-Monza, Monza, Italy
Stocchetti, N.; Department of Physiopathology and Transplantation, Milan University, Milan, Italy, Neuro Icu Fondazione Irccs Cà Granda Ospedale Maggiore Policlinico Milano, Milan, Italy
Kompanje, E. J. O.; Department of Intensive Care, Erasmus MC-University Medical Centre Rotterdam, P.O. Box 2040, Rotterdam, 3000 CA, Netherlands, Department of Medical Ethics and Philosophy of Medicine, Erasmus MC-University Medical Center Rotterdam, Rotterdam, Netherlands
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Laureys, Steven ; Université de Liège - ULiège > Centre du Cerveau² > Giga Consciousness-Coma Science Group
How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study
Publication date :
2020
Journal title :
BMC Medical Ethics
eISSN :
1472-6939
Publisher :
BioMed Central Ltd.
Volume :
21
Issue :
1
Peer reviewed :
Peer Reviewed verified by ORBi
European Projects :
FP7 - 602150 - CENTER-TBI - Collaborative European NeuroTrauma Effectiveness Research in TBI
Funders :
UE - Union Européenne [BE] ZNS Hannelore Kohl Stiftung [DE] One Mind [US-WA] [US-WA] Integra LifeSciences [US-NJ] [US-NJ] NIHR - National Institute for Health Research [GB] CE - Commission Européenne [BE]
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