Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.
- de Lange DW Department of Intensive Care Medicine, University Medical Center, University Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands. d.w.delange@umcutrecht.nl.
- Guidet B Hôpitaux de Paris, Hôpital Saint-Antoine, Service de Réanimation Médicale, 75012, Paris, France.
- Andersen FH Department of Anesthesia and Intensive Care, Møre and Romsdal Health Trust, Ålesund Hospital, Ålesund, Norway.
- Artigas A Department of Intensive Care Medicine, CIBER Enfermedades Respiratorias, Corporacion Sanitaria Universitaria Parc Tauli, Autonomous University of Barcelona, Sabadell, Spain.
- Bertolini G Laboratory of Clinical Epidemiology, GiViTI Coordinating Center, department of Public Health, IRCCS - "Mario Negri" Institute for Pharmacological Research, Ranica (Bergamo), Italy.
- Moreno R Unidade de Cuidados Intensivos Neurocríticos, Hospital de São José, Centro Hospitalar de Lisboa Central, Lisbon, Portugal.
- Christensen S Department of Anaesthesia and Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.
- Cecconi M Department Anaesthesia and Intensive Care Units, IRCCS Istituto Clinico Humanitas, Humanitas University, Milan, Italy.
- Agvald-Ohman C Department of Anaesthesiology and Intensive Care, Department of Clinical Intervention and Technology, Karolinska University Hospital, Huddinge, Sweden.
- Gradisek P Clinical Department of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.
- Jung C Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Heinrich-Heine-University, Düsseldorf, Germany.
- Marsh BJ Department of Surgery, Mater Misericordiae University Hospital, Dublin, Ireland.
- Oeyen S Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium.
- Bollen Pinto B Division of Anaesthesiology, Department of Anaesthesiology, Clinical Pharmacology and Intensive Care (APSI), Geneva University Hospitals, Geneva, Switzerland.
- Szczeklik W Division of Intensive Care and Perioperative Medicine, 2nd Department of Medicine, Jagiellonian University Medical College, Krakow, Poland.
- Watson X Intensive Care, Kingston Hospital, Kingston, UK.
- Zafeiridis T Intensive Care Unit, General Hospital of Larissa, Larissa, Greece.
- Flaatten H Department of Anaesthesia, Haukeland University Hospital, University of Bergen, Bergen, Norway.
- 2019-06-05
Published in:
- BMC medical ethics. - 2019
Ethical Review
Ethics Committees, Research
Europe
Humans
Informed Consent
Observational Studies as Topic
Surveys and Questionnaires
Time Factors
English
BACKGROUND
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.
METHODS
Sixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA.
RESULTS
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.
DISCUSSION
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.
CONCLUSION
Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries.
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.
METHODS
Sixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA.
RESULTS
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.
DISCUSSION
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.
CONCLUSION
Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12910-019-0373-y
- PMID 31159853
- Persistent URL
- https://sonar.ch/global/documents/130952
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