Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.
BMC Med Ethics
; 20(1): 39, 2019 06 03.
Article
em En
| MEDLINE
| ID: mdl-31159853
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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Revisão Ética
/
Estudos Observacionais como Assunto
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article