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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00159816%3A_____%2F19%3A00072710" target="_blank" >RIV/00159816:_____/19:00072710 - isvavai.cz</a>

Result on the web

<a href="https://bmcmedethics.biomedcentral.com/track/pdf/10.1186/s12910-019-0370-1" target="_blank" >https://bmcmedethics.biomedcentral.com/track/pdf/10.1186/s12910-019-0370-1</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1186/s12910-019-0370-1" target="_blank" >10.1186/s12910-019-0370-1</a>

Result language

angličtina

Original language name

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

Original language description

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 6months, and in one 24months; had all countries been able to match the most efficient approvals processes, an additional 74months 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 ethics committee practices as well as national legislation.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30311 - Medical ethics

Project

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2019

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

BMC Medical Ethics

ISSN

1472-6939

e-ISSN

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Volume of the periodical

20

Issue of the periodical within the volume

May 7

Country of publishing house

GB - UNITED KINGDOM

Number of pages

13

Pages from-to

30

UT code for WoS article

000467419300001

EID of the result in the Scopus database

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