TY - JOUR
T1 - Huge variation in obtaining ethical permission for a non-interventional observational study in Europe
AU - De Lange, Dylan W.
AU - Guidet, Bertrand
AU - Andersen, Finn H.
AU - Artigas, Antonio
AU - Bertolini, Guidio
AU - Moreno, Rui
AU - Christensen, Steffen
AU - Cecconi, Maurizio
AU - Agvald-Ohman, Christina
AU - Gradisek, Primoz
AU - Jung, Christian
AU - Marsh, Brian J.
AU - Oeyen, Sandra
AU - Bollen Pinto, Bernardo
AU - Szczeklik, Wojciech
AU - Watson, Ximena
AU - Zafeiridis, Tilemachos
AU - Flaatten, Hans
PY - 2019/6/3
Y1 - 2019/6/3
N2 - © 2019 The Author(s). 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.
AB - © 2019 The Author(s). 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.
U2 - 10.1186/s12910-019-0373-y
DO - 10.1186/s12910-019-0373-y
M3 - Article
C2 - 31159853
VL - 20
JO - BMC Medical Ethics
JF - BMC Medical Ethics
SN - 1472-6939
M1 - 39
ER -