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

Abstract

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.

Metadata

Item Type:	Article
Authors/Creators:	Timmers, M Van Dijck, JTJM Van Wijk, RPJ Legrand, V Van Veen, E Maas, AIR Menon, DK Citerio, G Stocchetti, N Kompanje, EJO Åkerlund, C Amrein, K Andelic, N Andreassen, L Anke, A Antoni, A Audibert, G Azouvi, P Azzolini, ML Bartels, R Barzó, P Beauvais, R Beer, R Bellander, BM Belli, A Benali, H Berardino, M Beretta, L Blaabjerg, M Bragge, P Brazinova, A Brinck, V Brooker, J Brorsson, C Buki, A Bullinger, M Cabeleira, M Caccioppola, A Calappi, E Calvi, MR Cameron, P Lozano, GC Carbonara, M Cavallo, S Chevallard, G Chieregato, A Ceyisakar, I Coburn, M Coles, J Cooper, JD Correia, M Čović, A Curry, N Czeiter, E Czosnyka, M Dahyot-Fizelier, C Dark, P Dawes, H De Keyser, V Degos, V Corte, FD Den Boogert, H Depreitere, B Crossed Signilvesi, S Dixit, A Donoghue, E Dreier, J Dulière, GL Ercole, A Esser, P Ezer, E Fabricius, M Feigin, VL Foks, K Frisvold, S Furmanov, A Gagliardo, P Galanaud, D Gantner, D Gao, G George, P Ghuysen, A Giga, L Glocker, B Golubovic, J Gomez, PA Gratz, J Gravesteijn, B Grossi, F Gruen, RL Gupta, D Haagsma, JA Haitsma, I Helbok, R Helseth, E Horton, L Huijben, J Hutchinson, PJ Jacobs, B Jankowski, S
Copyright, Publisher and Additional Information:	© 2020 The Authors. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Keywords:	Research ethic committees; European Union; Health-care research; CENTER-TBI; Harmonization
Dates:	Accepted: 1 May 2020 Published: 12 May 2020
Institution:	The University of Sheffield
Academic Units:	The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research
Funding Information:	Funder Grant number EUROPEAN COMMISSION - FP6/FP7 HEALTH-F2-2013-602150
Depositing User:	Symplectic Sheffield
Date Deposited:	15 Jun 2020 19:18
Last Modified:	15 Jun 2020 19:18
Status:	Published
Refereed:	Yes
Identification Number:	10.1186/s12910-020-00480-8
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:161809

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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

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