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.
| Original language | English |
|---|---|
| Article number | 30 |
| Journal | BMC Medical Ethics |
| Volume | 20 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 7 May 2019 |
Bibliographical note
Funding Information:The GenOSept study was supported by the European Union and the 6th Framework Programme (European Commission Reference: LSHM-CT-2005-518226) and the Wellcome Trust Core Award (Grant Number 090532/Z/09/Z). Clinical engagement was gained through the Trials Group of the European Society of Intensive Care Medicine. National coordinators in each country provided their time to support the project. Additional support was obtained from the Wellcome Trust Centre for Human Genetics (Wellcome Trust grant reference 090532/Z/09/Z and MRC Hub grant G0900747 91070). ACG is funded by a National Institute for Health Research Clinician Scientist Fellowship award. German project management was partly funded by the Federal Ministry of Education and Research (0312617) and the Thuringian Ministry of Education (B309–00014). We thank the VASST and PROWESS investigators and Eli Lilly and Company for allowing us to access the genome-wide genotyping data and phenotypic information for patients recruited to these trials. We acknowledge the support of the National Institute for Health Research (NIHR), through the Comprehensive Clinical Research Network for patient recruitment in the UK and A. C. G. as an NIHR Clinician Scientist award holder. The funding bodies did not contribute to the study design, the collection, analysis, and interpretation of data, nor in writing the manuscript.
Publisher Copyright:
© 2019 The Author(s).
