Administrative complexities for a European observational study despite directives harmonising requirements

Pharmacoepidemiology and Drug Safety
Sinem Ezgi GülmezNicholas Moore

Abstract

For pharmacoepidemiological studies in Europe, accessing data should require only authorisation by the relevant data protections committees, as expected from the 1995 Data Protection Directive (95/46/EC). Our experience from a multinational observational study across seven European countries shows that this is certainly not the case. The study was a multicentre, multinational, case-population study in European liver transplant centres in seven countries, retrospectively evaluating a 3-year period. Before data collection started, the procedures to obtain the necessary authorisations for the participating countries were defined. In France, a single opinion from a single data protection committee was enough to start the study. In Italy, Portugal, Greece and the UK, there was a national authority, but the hospitals requested the approval by their local committees/bodies irrespective of whether the authorisation of the national committee came after or before that of local ones. In Ireland, only one hospital participated, and the opinion of its ethics committee was sufficient. In the Netherlands, the opinion of the institutional review board of the local coordinating centre was necessary to obtain the opinions from the institutional ...Continue Reading

References

May 7, 2010·BMJ : British Medical Journal·Mats G Hansson
Mar 18, 2011·Journal of Internal Medicine·S N Whitney, C E Schneider
Sep 2, 2011·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Hélène ThéophileBernard Bégaud

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Citations

Jan 18, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Sinem Ezgi GulmezNicholas Moore
Jun 8, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Sinem Ezgi GulmezDominique Larrey
May 25, 2013·Pharmacoepidemiology and Drug Safety·B WettermarkHt Sørensen
May 29, 2015·British Journal of Clinical Pharmacology·Sinem Ezgi GulmezNicholas Moore
Oct 27, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Nicholas MooreSinem Ezgi Gulmez
Feb 13, 2020·Journal of Empirical Research on Human Research Ethics : JERHRE·Vilius Dranseika, Jan Piasecki
Feb 6, 2020·BMC Medical Ethics·Phaik Yeong Cheah, Jan Piasecki

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