Imperial College London

Professor Anthony Gordon

Faculty of MedicineDepartment of Surgery & Cancer

Chair in Anaesthesia and Critical Care







ICUQueen Elizabeth the Queen Mother Wing (QEQM)St Mary's Campus






BibTex format

author = {Tridente, A and Holloway, PAH and Hutton, P and Gordon, AC and Mills, GH and Clarke, GM and Chiche, J-D and Stuber, F and Garrard, C and Hinds, C and Bion, J},
doi = {10.1186/s12910-019-0370-1},
journal = {BMC Medical Ethics},
title = {Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: The GenOSept experience},
url = {},
volume = {20},
year = {2019}

RIS format (EndNote, RefMan)

AB - BackgroundDuring the set-up phase of an international study of genetic influences on outcomes from sepsis, we aimed to characterise potential differences in ethics approval processes and outcomes in participating European countries.MethodsBetween 2005 and 2007 of the FP6-funded international Genetics Of Sepsis and Septic Shock (GenOSept) project, we asked national coordinators to complete a structured survey of research ethic committee (REC) approval structures and processes in their countries, and linked these data to outcomes. Survey findings were reconfirmed or modified in 2017.ResultsEighteen countries participated in the study, recruiting 2257 patients from 160 ICUs. National practices differed widely in terms of composition of RECs, procedures and duration of the ethics approval process. Eight (44.4%) countries used a single centralised process for approval, seven (38.9%) required approval by an ethics committee in each participating hospital, and three (16.7%) required both. Outcomes of the application process differed widely between countries because of differences in national legislation, and differed within countries because of interpretation of the ethics of conducting research in patients lacking capacity. The RECs in four countries had no lay representation. The median time from submission to final decision was 1.5 (interquartile range 1–7) months; in nine (50%) approval was received within 1 month; six took over 6 months, and in one 24 months; had all countries been able to match the most efficient approvals processes, an additional 74 months of country or institution-level recruitment would have been available. In three countries, rejection of the application by some local RECs resulted in loss of centres; and one country rejected the application outright.ConclusionsThe potential benefits of the single application portal offered by the European Clinical Trials Regulation will not be realised without harmonisation of research
AU - Tridente,A
AU - Holloway,PAH
AU - Hutton,P
AU - Gordon,AC
AU - Mills,GH
AU - Clarke,GM
AU - Chiche,J-D
AU - Stuber,F
AU - Garrard,C
AU - Hinds,C
AU - Bion,J
DO - 10.1186/s12910-019-0370-1
PY - 2019///
SN - 1472-6939
TI - Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: The GenOSept experience
T2 - BMC Medical Ethics
UR -
UR -
VL - 20
ER -