作者
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
发表日期
2019/12
期刊
BMC medical ethics
卷号
20
页码范围
1-7
出版商
BioMed Central
简介
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 …
学术搜索中的文章
DW De Lange, B Guidet, FH Andersen, A Artigas… - BMC medical ethics, 2019