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

Dylan W de Lange; Bertrand Guidet; Finn H Andersen; Antonio Artigas; Guidio Bertolini; Rui Moreno; Steffen Christensen; Maurizio Cecconi; Christina Agvald-Ohman; Primoz Gradisek; Christian Jung; Brian J Marsh; Sandra Oeyen; Bernardo Bollen Pinto; Wojciech Szczeklik; Ximena Watson; Tilemachos Zafeiridis; Hans Flaatten

doi:10.1186/s12910-019-0373-y

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

Dylan W de Lange, Bertrand Guidet, Finn H Andersen, Antonio Artigas, Guidio Bertolini, Rui Moreno, Steffen Christensen, Maurizio Cecconi, Christina Agvald-Ohman, Primoz Gradisek, Christian Jung, Brian J Marsh, Sandra Oeyen, Bernardo Bollen Pinto, Wojciech Szczeklik, Ximena Watson, Tilemachos Zafeiridis, Hans Flaatten

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Abstract

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.

Original language	English
Article number	39
Journal	BMC Medical Ethics [E]
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s12910-019-0373-y
Publication status	Published - 3 Jun 2019

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de Lange, D. W., Guidet, B., Andersen, F. H., Artigas, A., Bertolini, G., Moreno, R., Christensen, S., Cecconi, M., Agvald-Ohman, C., Gradisek, P., Jung, C., Marsh, B. J., Oeyen, S., Bollen Pinto, B., Szczeklik, W., Watson, X., Zafeiridis, T., & Flaatten, H. (2019). Huge variation in obtaining ethical permission for a non-interventional observational study in Europe. BMC Medical Ethics [E], 20(1), Article 39. https://doi.org/10.1186/s12910-019-0373-y

@article{71ae0f57e5104eb48e303cedf429ad10,

title = "Huge variation in obtaining ethical permission for a non-interventional observational study in Europe",

abstract = "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.",

author = "{de Lange}, {Dylan W} and Bertrand Guidet and Andersen, {Finn H} and Antonio Artigas and Guidio Bertolini and Rui Moreno and Steffen Christensen and Maurizio Cecconi and Christina Agvald-Ohman and Primoz Gradisek and Christian Jung and Marsh, {Brian J} and Sandra Oeyen and {Bollen Pinto}, Bernardo and Wojciech Szczeklik and Ximena Watson and Tilemachos Zafeiridis and Hans Flaatten",

note = "Publisher Copyright: {\textcopyright} 2019 The Author(s).",

year = "2019",

month = jun,

day = "3",

doi = "10.1186/s12910-019-0373-y",

language = "English",

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de Lange, DW, Guidet, B, Andersen, FH, Artigas, A, Bertolini, G, Moreno, R, Christensen, S, Cecconi, M, Agvald-Ohman, C, Gradisek, P, Jung, C, Marsh, BJ, Oeyen, S, Bollen Pinto, B, Szczeklik, W, Watson, X, Zafeiridis, T & Flaatten, H 2019, 'Huge variation in obtaining ethical permission for a non-interventional observational study in Europe', BMC Medical Ethics [E], vol. 20, no. 1, 39. https://doi.org/10.1186/s12910-019-0373-y

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 - 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 - 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

SN - 1472-6939

VL - 20

JO - BMC Medical Ethics [E]

JF - BMC Medical Ethics [E]

IS - 1

M1 - 39

ER -

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

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