TY - JOUR
T1 - 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
AU - Timmers, Marjolein
AU - van Dijck, Jeroen T. J. M.
AU - van Wijk, Roel P. J.
AU - Legrand, Valerie
AU - van Veen, Ernest
AU - Maas, Andrew I. R.
AU - Menon, David K.
AU - Citerio, Giuseppe
AU - Stocchetti, Nino
AU - Kompanje, Erwin J. O.
AU - CENTER-TBI Investigators and Participants
AU - van Heugten, Caroline M.
N1 - Funding Information:
75 Hungarian Brain Research Program - Grant No. KTIA_13_NAP-A-II/8, University of Pécs, Pécs, Hungary. 76 Cyclotron Research Center, University of Liège, Liège, Belgium. 77 Centre for Urgent and Emergency Care Research (CURE), Health Services Research Section, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK. 78 Emergency Department, Salford Royal Hospital, Salford UK. 79 Institute of Research in Operative Medicine (IFOM), Witten/Herdecke University, Cologne, Germany. 80 VP Global Project Management CNS, ICON, Paris, France. 81 Department of Anesthesiology-Intensive Care, Lille University Hospital, Lille, France. 82 Department of Neurosurgery, Rambam Medical Center, Haifa, Israel. 83 Department of Anesthesiology & Intensive Care, University Hospitals Southhampton NHS Trust, Southhampton, UK. 84 Cologne-Merheim Medical Center (CMMC), Department of Traumatology, Orthopedic Surgery and Sportmedicine, Witten/Herdecke University, Cologne, Germany. 85 Intensive Care Unit, Southmead Hospital, Bristol, Bristol, UK. 86 Department of Neurological Surgery, University of California, San Francisco, California, USA. 87 Department of Anesthesia & Intensive Care,M. Bufalini Hospital, Cesena, Italy. 88 Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Germany. 89 Department of Neurosurgery, The Walton centre NHS Foundation Trust, Liverpool, UK. 90 Department of Medical Genetics, University of Pécs, Pécs, Hungary. 91 Department of Neurosurgery, Emergency County Hospital Timisoara, Timisoara, Romania. 92 School of Medical Sciences, Örebro University, Örebro, Sweden. 93 Institute for Molecular Medicine Finland, University of Helsinki, Helsinki, Finland. 94 Analytic and Translational Genetics Unit, Department of Medicine; Psychiatric & Neurodevelopmental Genetics Unit, Department of Psychiatry; Department of Neurology, Massachusetts General Hospital, Boston, MA, USA. 95 Program in Medical and Population Genetics; The Stanley Center for Psychiatric Research, The Broad Institute of MIT and Harvard, Cambridge, MA, USA. 96 Department of Radiology, University of Antwerp, Edegem, Belgium. 97 Department of Anesthesiology & Intensive Care, University Hospital of Grenoble, Grenoble, France. 98 Department of Anesthesia & Intensive Care, Azienda Ospedaliera Università di Padova, Padova, Italy. 99 Dept. of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands and Dept. of Neurosurgery, Medical Center Haaglanden, The Hague, The Netherlands. 100 Department of Neurosurgery, Helsinki University Central Hospital. 101 Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Injury Centre, Turku University Hospital and University of Turku, Turku, Finland. 102 Department of Anesthesiology and Critical Care, Pitié -Salpêtrière Teaching Hospital, Assistance Publique, Hôpitaux de Paris and University Pierre et Marie Curie, Paris, France. 103 Neurotraumatology and Neurosurgery Research Unit (UNINN), Vall d’Hebron Research Institute, Barcelona, Spain. 104 Department of Neurosurgery, Kaunas University of technology and Vilnius University, Vilnius, Lithuania. 105 Department of Neurosurgery, Rezekne Hospital, Latvia. 106 Department of Anaesthesia, Critical Care & Pain Medicine NHS Lothian & University of Edinburg, Edinburgh, UK. 107 Director, MRC Biostatistics Unit, Cambridge Institute of Public Health, Cambridge, UK. 108 Department of Physical Medicine and Rehabilitation, Oslo University Hospital/University of Oslo, Oslo, Norway. 109 Division of Orthopedics, Oslo University Hospital, Oslo, Norway. 110 Institue of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. 111 Broad Institute, Cambridge MA Harvard Medical School, Boston MA, Massachusetts General Hospital, Boston MA, USA.
Publisher Copyright:
© 2020 The Author(s).
PY - 2020/5/12
Y1 - 2020/5/12
N2 - 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.
AB - 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.
KW - Research ethic committees
KW - European Union
KW - Health-care research
KW - CENTER-TBI
KW - Harmonization
KW - HARMONIZATION
KW - MULTICENTER
KW - CARE
U2 - 10.1186/s12910-020-00480-8
DO - 10.1186/s12910-020-00480-8
M3 - (Systematic) Review article
SN - 1472-6939
VL - 21
JO - BMC Medical Ethics
JF - BMC Medical Ethics
IS - 1
M1 - 36
ER -