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Huge variation in obtaining ethical permission for a non-interventional observational study in Europe

Authors
  • de Lange, Dylan W.1
  • Guidet, Bertrand2, 3, 4
  • Andersen, Finn H.5, 6
  • Artigas, Antonio7
  • Bertolini, Guidio8
  • Moreno, Rui9
  • Christensen, Steffen10
  • Cecconi, Maurizio11
  • Agvald-Ohman, Christina12
  • Gradisek, Primoz13
  • Jung, Christian14
  • Marsh, Brian J.15
  • Oeyen, Sandra16
  • Bollen Pinto, Bernardo17
  • Szczeklik, Wojciech18
  • Watson, Ximena19
  • Zafeiridis, Tilemachos20
  • Flaatten, Hans21, 22
  • 1 University Utrecht, Department of Intensive Care Medicine, University Medical Center, Heidelberglaan 100, Utrecht, CX, 3584, The Netherlands , Utrecht (Netherlands)
  • 2 Service de Réanimation Médicale, Hôpitaux de Paris, Hôpital Saint-Antoine, Paris, 75012, France , Paris (France)
  • 3 Institut Pierre Louis d’Epidémiologie et de Santé Publique, Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Paris, 75013, France , Paris (France)
  • 4 INSERM, UMR_S 1136, Institut Pierre Louis d’Epidémiologie et de Santé Publique, Paris, France , Paris (France)
  • 5 Ålesund Hospital, Department of Anesthesia and Intensive Care, Møre and Romsdal Health Trust, Ålesund, Norway , Ålesund (Norway)
  • 6 Norwegian University of Science and Technology, Department of Circulation and Imaging, Faculty of Medicine, NTNU, Trondheim, Norway , Trondheim (Norway)
  • 7 Autonomous University of Barcelona, Department of Intensive Care Medicine, CIBER Enfermedades Respiratorias, Corporacion Sanitaria Universitaria Parc Tauli, Sabadell, Spain , Sabadell (Spain)
  • 8 IRCCS – “Mario Negri” Institute for Pharmacological Research, Laboratory of Clinical Epidemiology, GiViTI Coordinating Center, department of Public Health, Ranica (Bergamo), Italy , Ranica (Bergamo) (Italy)
  • 9 Centro Hospitalar de Lisboa Central, Unidade de Cuidados Intensivos Neurocríticos, Hospital de São José, Lisbon, Portugal , Lisbon (Portugal)
  • 10 Aarhus University Hospital, Department of Anaesthesia and Intensive Care Medicine, Aarhus, Denmark , Aarhus (Denmark)
  • 11 IRCCS Istituto Clinico Humanitas, Humanitas University, Department Anaesthesia and Intensive Care Units, Milan, Italy , Milan (Italy)
  • 12 Karolinska University Hospital, Department of Anaesthesiology and Intensive Care, Department of Clinical Intervention and Technology, Huddinge, Sweden , Huddinge (Sweden)
  • 13 University Medical Centre Ljubljana, Clinical Department of Anaesthesiology and Intensive Therapy, Ljubljana, Slovenia , Ljubljana (Slovenia)
  • 14 Heinrich-Heine-University, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Düsseldorf, Germany , Düsseldorf (Germany)
  • 15 Mater Misericordiae University Hospital, Department of Surgery, Dublin, Ireland , Dublin (Ireland)
  • 16 Ghent University Hospital, Department of Intensive Care Medicine, Ghent, Belgium , Ghent (Belgium)
  • 17 Geneva University Hospitals, Division of Anaesthesiology, Department of Anaesthesiology, Clinical Pharmacology and Intensive Care (APSI), Geneva, Switzerland , Geneva (Switzerland)
  • 18 Jagiellonian University Medical College, Division of Intensive Care and Perioperative Medicine, 2nd Department of Medicine, Krakow, Poland , Krakow (Poland)
  • 19 Kingston Hospital, Intensive Care, Kingston, UK , Kingston (United Kingdom)
  • 20 General Hospital of Larissa, Intensive Care Unit, Larissa, Greece , Larissa (Greece)
  • 21 University of Bergen, Department of Anaesthesia, Haukeland University Hospital, Bergen, Norway , Bergen (Norway)
  • 22 University of Bergen, Intensive Care and Department of Clinical Medicine, Haukeland University Hospital, Bergen, Norway , Bergen (Norway)
Type
Published Article
Journal
BMC Medical Ethics
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Jun 03, 2019
Volume
20
Issue
1
Identifiers
DOI: 10.1186/s12910-019-0373-y
Source
Springer Nature
License
Green

Abstract

BackgroundEthical approval (EA) must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study.MethodsSixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA.ResultsN = 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.DiscussionVariations 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.ConclusionGetting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries.

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