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

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

SUBMITTER: Tridente A 

PROVIDER: S-EPMC6503539 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature