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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

30311 - Medical ethics

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2019

Kód důvěrnosti údajů

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

Název periodika

BMC Medical Ethics

ISSN

1472-6939

e-ISSN

—

Svazek periodika

20

Číslo periodika v rámci svazku

May 7

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

13

Strana od-do

30

Kód UT WoS článku

000467419300001

EID výsledku v databázi Scopus

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