Huge variation in obtaining ethical permission for a non-interventional observational study in Europe
De Lange, Dylan W. (University Utrecht. Department of Intensive Care Medicine, University Medical Center)
Guidet, Bertrand (Institut Pierre Louis d'Epidémiologie et de Santé Publique)
Andersen, Finn H. (Norwegian University of Science and Technology. Department of Circulation and Imaging, Faculty of Medicine, NTNU)
Artigas Raventós, Antoni (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Bertolini, Guido (IRCCS Istituto Giannina Gaslini (Gènova, Itàlia))
Moreno, Rui (Centro Hospitalar de Lisboa Central. Unidade de Cuidados Intensivos Neurocríticos, Hospital de São José)
Christensen, Steffen (Aarhus University Hospital (Aarhus, Dinamarca))
Cecconi, Maurizio (IRCCS Istituto Clinico Humanitas, Humanitas University. Department Anaesthesia and Intensive Care Units)
Agvald-Öhman, Christina (Karolinska University Hospital and Karolinska Institutet (Suècia))
Gradisek, Primoz (University Medical Centre Ljubljana. Clinical Department of Anaesthesiology and Intensive Therapy)
Jung, Christian (University Hospital of Düsseldorf (Alemanya))
Marsh, Brian J. (Mater Misericordiae University Hospital (Dublín, Irlanda))
Oeyen, Sandra (Universitair Ziekenhuis Gent)
Bollen Pinto, Bernardo (Geneva University Hospitals (Ginebra, Suïssa))
Szczeklik, Wojciech (Jagiellonian University Medical College. Division of Intensive Care and Perioperative Medicine, 2nd Department of Medicine)
Watson, Ximena (Kingston Hospital. Intensive Care)
Zafeiridis, Tilemachos (General University Hospital of Larissa (Grècia))
Flaatten, Hans (Haukeland University Hospital (Bergen, Noruega))

Data:	2019
Resum:	Ethical approval (EA) must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. Sixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. N = 8/16 of the NCs could apply at one single national ethical committee (EC), while the others had to apply to various regional ECs and/or individual hospital institutional research boards (IRBs). The time between applying for EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were (very) unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	BMC Medical Ethics, Vol. 20 (june 2019) , ISSN 1472-6939

DOI: 10.1186/s12910-019-0373-y
PMID: 31159853

7 p, 649.4 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d’Investigació i Innovació Parc Taulí (I3PT)
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