Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: The GenOSept experience

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Title: Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: The GenOSept experience
Authors: Tridente, A
Holloway, PAH
Hutton, P
Gordon, AC
Mills, GH
Clarke, GM
Chiche, J-D
Stuber, F
Garrard, C
Hinds, C
Bion, J
Item Type: Journal Article
Abstract: Background During 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. Methods Between 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. Results Eighteen 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. Conclusions The potential benefits of the single application portal offered by the European Clinical Trials Regulation will not be realised without harmonisation of research ethics committee practices as well as national legislation.
Issue Date: 7-May-2019
Date of Acceptance: 22-Apr-2019
ISSN: 1472-6939
Publisher: BioMed Central
Journal / Book Title: BMC Medical Ethics
Volume: 20
Copyright Statement: © 2019 The Author(s). Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Keywords: Decision-making
Genetic epidemiology
Human genetics
Intensive care
Research ethics
GenOSept National Coordinators, European Society of Intensive Care Medicine
Applied Ethics
2201 Applied Ethics
Publication Status: Published
Open Access location:
Article Number: 30
Appears in Collections:Division of Surgery

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