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

BMC Med Ethics 2019 06 3;20(1):39. Epub 2019 Jun 3.

Department of Anaesthesia, Haukeland University Hospital, University of Bergen, Bergen, Norway.

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.

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12910-019-0373-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547492PMC
June 2019
2 Reads

Publication Analysis

Top Keywords

informed consent
12
non-interventional observational
12
ethical approval
12
observational studies
12
observational study
8
european countries
8
observational
7
european
6
ncs
5
ethical
5
subject identification
4
identification code
4
irbs time
4
14/16 4/16
4
approval subject
4
ncs separate
4
code list
4
separate approval
4
4/16 ncs
4
de-pseudonymize patients
4

Altmetric Statistics

Similar Publications