التفاصيل البيبلوغرافية
| العنوان: |
Huge variation in obtaining ethical permission for a non-interventional observational study in Europe |
| المؤلفون: |
de Lange, Dylan W, Guidet, Bertrand, Andersen, Finn H, Artigas, Antonio, Bertolini, Guidio, Moreno, Rui, Christensen, Steffen, Cecconi, Maurizio, Agvald-Ohman, Christina, Gradisek, Primoz, Jung, Christian, Marsh, Brian J, Oeyen, Sandra, Bollen Pinto, Bernardo, Szczeklik, Wojciech, Watson, Ximena, Zafeiridis, Tilemachos, Flaatten, Hans |
| المساهمون: |
NVIC bedrijfsvoering |
| سنة النشر: |
2019 |
| مصطلحات موضوعية: |
Journal Article |
| الوصف: |
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. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
image/pdf |
| اللغة: |
English |
| تدمد: |
1472-6939 |
| Relation: |
https://dspace.library.uu.nl/handle/1874/381613 |
| الاتاحة: |
https://dspace.library.uu.nl/handle/1874/381613 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: |
edsbas.281F6C37 |
| قاعدة البيانات: |
BASE |
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