학술논문
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
Document Type
Academic Journal
Author
Timmers, Marjolein; van Dijck, Jeroen T. J. M.; van Wijk, Roel P. J.; Legrand, Valerie; van Veen, Ernest; Maas, Andrew I. R.; Menon, David K.; Citerio, Giuseppe; Stocchetti, Nino; Kompanje, Erwin J. O.; Ãkerlund, Cecilia; Amrein, Krisztina; Andelic, Nada; Andreassen, Lasse; Anke, Audny; Antoni, Anna; Audibert, Gérard; Azouvi, Philippe; Azzolini, Maria Luisa; Bartels, Ronald; Barzó, Pál; Beauvais, Romuald; Beer, Ronny; Bellander, Bo-Michael; Belli, Antonio; Benali, Habib; Berardino, Maurizio; Beretta, Luigi; Blaabjerg, Morten; Bragge, Peter; Brazinova, Alexandra; Brinck, Vibeke; Brooker, Joanne; Brorsson, Camilla; Buki, Andras; Bullinger, Monika; Cabeleira, Manuel; Caccioppola, Alessio; Calappi, Emiliana; Calvi, Maria Rosa; Cameron, Peter; Lozano, Guillermo Carbayo; Carbonara, Marco; Cavallo, Simona; Chevallard, Giorgio; Chieregato, Arturo; Ceyisakar, Iris; Coburn, Mark; Coles, Jonathan; Cooper, Jamie D.; Correia, Marta; ÄoviÄ, Amra; Curry, Nicola; Czeiter, Endre; Czosnyka, Marek; Dahyot-Fizelier, Claire; Dark, Paul; Dawes, Helen; De Keyser, Véronique; Degos, Vincent; Corte, Francesco Della; den Boogert, Hugo; Depreitere, Bart; Äilvesi, Äula; Dixit, Abhishek; Donoghue, Emma; Dreier, Jens; Dulière, Guy-Loup; Ercole, Ari; Esser, Patrick; Ezer, Erzsébet; Fabricius, Martin; Feigin, Valery L.; Foks, Kelly; Frisvold, Shirin; Furmanov, Alex; Gagliardo, Pablo; Galanaud, Damien; Gantner, Dashiell; Gao, Guoyi; George, Pradeep; Ghuysen, Alexandre; Giga, Lelde; Glocker, Ben; Golubovic, JagoÅ¡; Gomez, Pedro A.; Gratz, Johannes; Gravesteijn, Benjamin; Grossi, Francesca; Gruen, Russell L.; Gupta, Deepak; Haagsma, Juanita A.; Haitsma, Iain; Helbok, Raimund; Helseth, Eirik; Horton, Lindsay; Huijben, Jilske; Hutchinson, Peter J.; Jacobs, Bram; Jankowski, Stefan; Jarrett, Mike; Jiang, Ji-yao; Johnson, Faye; Jones, Kelly; Karan, Mladen; Kolias, Angelos G.; Kompanje, Erwin; Kondziella, Daniel; Koraropoulos, Evgenios; Koskinen, Lars-Owe; Kovács, Noémi; Kowark, Ana; Lagares, Alfonso; Lanyon, Linda; Laureys, Steven; Lecky, Fiona; Ledoux, Didier; Lefering, Rolf; Lejeune, Aurelie; Levi, Leon; Lightfoot, Roger; Lingsma, Hester; Castaéo-León, Ana M.; Maegele, Marc; Majdan, Marek; Manara, Alex; Manley, Geoffrey; Martino, Costanza; Maréchal, Hugues; Mattern, Julia; McMahon, Catherine; Melegh, Béla; Menon, David; Menovsky, Tomas; Misset, Benoit; Mulazzi, Davide; Muraleedharan, Visakh; Murray, Lynnette; Negru, Ancuta; Nelson, David; Newcombe, Virginia; Nieboer, Daan; Nyirádi, József; Olubukola, Otesile; Oresic, Matej; Ortolano, Fabrizio; Palotie, Aarno; Parizel, Paul M.; Payen, Jean-François; Perera, Natascha; Perlbarg, Vincent; Persona, Paolo; Peul, Wilco; Piippo-Karjalainen, Anna; Pirinen, Matti; Ples, Horia; Polinder, Suzanne; Pomposo, Inigo; Posti, Jussi P.; Puybasset, Louis; Radoi, Andreea; Ragauskas, Arminas; Raj, Rahul; Rambadagalla, Malinka; Rhodes, Jonathan; Richardson, Sylvia; Richter, Sophie; Ripatti, Samuli; Rocka, Saulius; Roe, Cecilie; Roise, Olav; Rosand, Jonathan; Rosenfeld, Jeffrey V.; Rosenlund, Christina; Rosenthal, Guy; Rossaint, Rolf; Rossi, Sandra; Rueckert, Daniel; Rusnák, Martin; Sahuquillo, Juan; Sakowitz, Oliver; Sanchez-Porras, Renan; Sandor, Janos; Schäfer, Nadine; Schmidt, Silke; Schoechl, Herbert; Schoonman, Guus; Schou, Rico Frederik; Schwendenwein, Elisabeth; Sewalt, Charlie; Skandsen, Toril; Smielewski, Peter; Sorinola, Abayomi; Stamatakis, Emmanuel; Stanworth, Simon; Stevens, Robert; Stewart, William; Steyerberg, Ewout W.; Sundström, Nina; Synnot, Anneliese; Takala, Riikka; Tamás, Viktória; Tamosuitis, Tomas; Taylor, Mark Steven; Ao, Braden Te; Tenovuo, Olli; Theadom, Alice; Thomas, Matt; Tibboel, Dick; Tolias, Christos; Trapani, Tony; Tudora, Cristina Maria; Vajkoczy, Peter; Vallance, Shirley; Valeinis, Egils; Vámos, Zoltán; Van der Steen, Gregory; van der Naalt, Joukje; van Essen, Thomas A.; Van Hecke, Wim; van Heugten, Caroline; Van Praag, Dominique; Vyvere, Thijs Vande; Vargiolu, Alessia; Vega, Emmanuel; Velt, Kimberley; Verheyden, Jan; Vespa, Paul M.; Vik, Anne; Vilcinis, Rimantas; Volovici, Victor; von Steinbüchel, Nicole; Voormolen, Daphne; Vulekovic, Petar; Wang, Kevin K. W.; Wiegers, Eveline; Williams, Guy; Wilson, Lindsay; Winzeck, Stefan; Wolf, Stefan; Yang, Zhihui; Ylén, Peter; Younsi, Alexander; Zeiler, Frederick A.; Zelinkova, Veronika; Ziverte, Agate; Zoerle, Tommaso
Source
BMC Medical Ethics. May 12, 2020, Vol. 21 Issue 1
Subject
Language
English
ISSN
1472-6939
Abstract
Author(s): Marjolein Timmers[sup.1], Jeroen T. J. M. van Dijck[sup.2], Roel P. J. van Wijk[sup.2], Valerie Legrand[sup.3], Ernest van Veen[sup.1,4], Andrew I. R. Maas[sup.5,6], David K. Menon[sup.7], Giuseppe Citerio[sup.8,9], Nino Stocchetti[sup.10,11], [...]
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. Keywords: Research ethic committees, European Union, Health-care research, CENTER-TBI, Harmonization
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. Keywords: Research ethic committees, European Union, Health-care research, CENTER-TBI, Harmonization