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
Creators: name: Timmers, Marjolein
name: Van Dijck, Jeroen T. J. M.
name: Van Wijk, Roel P. J.
name: Legrand, Valerie
name: Van Veen, Ernest
name: Maas, Andrew I. R.
name: Menon, David K.
name: Citerio, Giuseppe
name: Stocchetti, Nino
name: Kompanje, Erwin J. O.
name: Åkerlund, Cecilia
name: Amrein, Krisztina
name: Andelic, Nada
name: Andreassen, Lasse
name: Anke, Audny
name: Antoni, Anna
name: Audibert, Gérard
name: Azouvi, Philippe
name: Azzolini, Maria Luisa
name: Bartels, Ronald
name: Barzó, Pál
name: Beauvais, Romuald
name: Beer, Ronny
name: Bellander, Bo-Michael
name: Belli, Antonio
name: Benali, Habib
name: Berardino, Maurizio
name: Beretta, Luigi
name: Blaabjerg, Morten
name: Bragge, Peter
name: Brazinova, Alexandra
name: Brinck, Vibeke
name: Brooker, Joanne
name: Brorsson, Camilla
name: Buki, Andras
name: Bullinger, Monika
name: Cabeleira, Manuel
name: Caccioppola, Alessio
name: Calappi, Emiliana
name: Calvi, Maria Rosa
name: Cameron, Peter
name: Lozano, Guillermo Carbayo
name: Carbonara, Marco
name: Cavallo, Simona
name: Chevallard, Giorgio
name: Chieregato, Arturo
name: Ceyisakar, Iris
name: Coburn, Mark
name: Coles, Jonathan
name: Cooper, Jamie D.
name: Correia, Marta
name: Čović, Amra
name: Curry, Nicola
name: Czeiter, Endre
name: Czosnyka, Marek
name: Dahyot-Fizelier, Claire
name: Dark, Paul
name: Dawes, Helen
name: De Keyser, Véronique
name: Degos, Vincent
name: Corte, Francesco Della
name: Den Boogert, Hugo
name: Depreitere, Bart
name: Đilvesi, Đula
name: Dixit, Abhishek
name: Donoghue, Emma
name: Dreier, Jens
name: Dulière, Guy-Loup
name: Ercole, Ari
name: Esser, Patrick
name: Ezer, Erzsébet
name: Fabricius, Martin
name: Feigin, Valery L.
name: Foks, Kelly
name: Frisvold, Shirin
name: Furmanov, Alex
name: Gagliardo, Pablo
name: Galanaud, Damien
name: Gantner, Dashiell
name: Gao, Guoyi
name: George, Pradeep
name: Ghuysen, Alexandre
name: Giga, Lelde
name: Glocker, Ben
name: Golubovic, Jagoš
name: Gomez, Pedro A.
name: Gratz, Johannes
name: Gravesteijn, Benjamin
name: Grossi, Francesca
name: Gruen, Russell L.
name: Gupta, Deepak
name: Haagsma, Juanita A.
name: Haitsma, Iain
name: Helbok, Raimund
name: Helseth, Eirik
name: Horton, Lindsay
name: Huijben, Jilske
name: Hutchinson, Peter J.
name: Jacobs, Bram
name: Jankowski, Stefan
name: Jarrett, Mike
name: Jiang, Ji-Yao
name: Johnson, Faye
name: Jones, Kelly
name: Karan, Mladen
name: Kolias, Angelos G.
name: Kompanje, Erwin
name: Kondziella, Daniel
name: Koraropoulos, Evgenios
name: Koskinen, Lars-Owe
name: Kovács, Noémi
name: Kowark, Ana
name: Lagares, Alfonso
name: Lanyon, Linda
name: Laureys, Steven
name: Lecky, Fiona
name: Ledoux, Didier
name: Lefering, Rolf
name: Lejeune, Aurelie
name: Levi, Leon
name: Lightfoot, Roger
name: Lingsma, Hester
name: Castaño-León, Ana M.
name: Maegele, Marc
name: Majdan, Marek
name: Manara, Alex
name: Manley, Geoffrey
name: Martino, Costanza
name: Maréchal, Hugues
name: Mattern, Julia
name: McMahon, Catherine
name: Melegh, Béla
name: Menon, David
name: Menovsky, Tomas
name: Misset, Benoit
name: Mulazzi, Davide
name: Muraleedharan, Visakh
name: Murray, Lynnette
name: Negru, Ancuta
name: Nelson, David
name: Newcombe, Virginia
name: Nieboer, Daan
name: Nyirádi, József
name: Olubukola, Otesile
name: Oresic, Matej
name: Ortolano, Fabrizio
name: Palotie, Aarno
name: Parizel, Paul M.
name: Payen, Jean-François
name: Perera, Natascha
name: Perlbarg, Vincent
name: Persona, Paolo
name: Peul, Wilco
name: Piippo-Karjalainen, Anna
name: Pirinen, Matti
name: Ples, Horia
name: Polinder, Suzanne
name: Pomposo, Inigo
name: Posti, Jussi P.
name: Puybasset, Louis
name: Radoi, Andreea
name: Ragauskas, Arminas
name: Raj, Rahul
name: Rambadagalla, Malinka
name: Rhodes, Jonathan
name: Richardson, Sylvia
name: Richter, Sophie
name: Ripatti, Samuli
name: Rocka, Saulius
name: Roe, Cecilie
name: Roise, Olav
name: Rosand, Jonathan
name: Rosenfeld, Jeffrey V.
name: Rosenlund, Christina
name: Rosenthal, Guy
name: Rossaint, Rolf
name: Rossi, Sandra
name: Rueckert, Daniel
name: Rusnák, Martin
name: Sahuquillo, Juan
name: Sakowitz, Oliver
name: Sanchez-Porras, Renan
name: Sandor, Janos
name: Schäfer, Nadine
name: Schmidt, Silke
name: Schoechl, Herbert
name: Schoonman, Guus
name: Schou, Rico Frederik
name: Schwendenwein, Elisabeth
name: Sewalt, Charlie
name: Skandsen, Toril
name: Smielewski, Peter
name: Sorinola, Abayomi
name: Stamatakis, Emmanuel
name: Stanworth, Simon
name: Stevens, Robert
name: Stewart, William
name: Steyerberg, Ewout W.
name: Sundström, Nina
name: Synnot, Anneliese
name: Takala, Riikka
name: Tamás, Viktória
name: Tamosuitis, Tomas
name: Taylor, Mark Steven
name: Ao, Braden Te
name: Tenovuo, Olli
name: Theadom, Alice
name: Thomas, Matt
name: Tibboel, Dick
name: Tolias, Christos
name: Trapani, Tony
name: Tudora, Cristina Maria
name: Vajkoczy, Peter
name: Vallance, Shirley
name: Valeinis, Egils
name: Vámos, Zoltán
name: Van Der Steen, Gregory
name: Van Der Naalt, Joukje
name: Van Essen, Thomas A.
name: Van Hecke, Wim
name: Van Heugten, Caroline
name: Van Praag, Dominique
name: Vyvere, Thijs Vande
name: Vargiolu, Alessia
name: Vega, Emmanuel
name: Velt, Kimberley
name: Verheyden, Jan
name: Vespa, Paul M.
name: Vik, Anne
name: Vilcinis, Rimantas
name: Volovici, Victor
name: Von Steinbüchel, Nicole
name: Voormolen, Daphne
name: Vulekovic, Petar
name: Wang, Kevin K. W.
name: Wiegers, Eveline
name: Williams, Guy
name: Wilson, Lindsay
name: Winzeck, Stefan
name: Wolf, Stefan
name: Yang, Zhihui
name: Ylén, Peter
name: Younsi, Alexander
name: Zeiler, Frederick A.
name: Zelinkova, Veronika
name: Ziverte, Agate
name: Zoerle, Tommaso
Publisher: name: Apollo - University of Cambridge Repository
Year: 2020
Subjects: Research Article
Ethics in Biomedical Research
Research ethic committees
European Union
Health-care research
CENTER-TBI
Harmonization

description: 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.