Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: the GenOSept experience.
Decision-making
GenOSept
Genetic epidemiology
Human genetics
Intensive care
Research ethics
Journal
BMC medical ethics
ISSN: 1472-6939
Titre abrégé: BMC Med Ethics
Pays: England
ID NLM: 101088680
Informations de publication
Date de publication:
07 05 2019
07 05 2019
Historique:
received:
10
09
2018
accepted:
22
04
2019
entrez:
9
5
2019
pubmed:
9
5
2019
medline:
6
2
2020
Statut:
epublish
Résumé
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. 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 31064358
doi: 10.1186/s12910-019-0370-1
pii: 10.1186/s12910-019-0370-1
pmc: PMC6503539
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
30Subventions
Organisme : Medical Research Council
ID : G0900747 91070
Pays : United Kingdom
Organisme : Department of Health
ID : RP-2015-06-018
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 090532/Z/09/Z
Pays : United Kingdom
Investigateurs
Jordi Rello
(J)
Gonzalo Sirgo
(G)
Paolo Cotogni
(P)
Apostolos Armaganidis
(A)
Thomas Ryan
(T)
Frank Bloos
(F)
Ivan Novak
(I)
Vladimir Gasparovic
(V)
Ilona Bobek
(I)
Adam Mikstacki
(A)
Jan Hazelzet
(J)
Yoram Weiss
(Y)
Antonio Carneiro
(A)
Silver Sarapuu
(S)
Pierre Damas
(P)
Maja Surbatovic
(M)
Vladimir Sramek
(V)
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