III期外科手术试验中伦理要求的报告
Reporting of ethical requirements in phase III surgical trials.
作者信息
Bridoux Valérie, Schwarz Lilian, Moutel Grégoire, Michot Francis, Herve Christian, Tuech Jean-Jacques
机构信息
Department of Digestive Surgery, Rouen University Hospital, Rouen, Cedex, France Laboratoire d'Ethique Médicale, et de Médecine Légale et Réseau de Recherche en Ethique INSERM, Paris, France.
Department of Digestive Surgery, Rouen University Hospital, Rouen, Cedex, France.
出版信息
J Med Ethics. 2014 Oct;40(10):687-90. doi: 10.1136/medethics-2012-101070. Epub 2013 Aug 19.
BACKGROUND
Disclosure of obtaining informed consent from patients (ICP) and research ethics committee (REC) approval in published reports is sometimes omitted. To date, no disclosure data are available on surgical research.
OBJECTIVE
Our aim was to assess whether REC approval and ICP were documented in surgical trials.
STUDY DESIGN
Overall, 657 randomised trials, published between 2005 and 2010 in 10 international journals, were included. We collected the report rate of REC approval and ICP and contacted the corresponding author when ethical information was lacking.
RESULTS
Among the 657 randomised controlled trials (RCT), 576 (87.7%) stated that an REC had approved the research, and 606 (92.2%) stated that ICP had been requested. Furthermore, 28 RCTs (4.3%) reported neither REC nor ICP.
CONCLUSIONS
The phase III randomised surgical trials that were analysed were shown to have respected fundamental ethical principles in approximately 90% of the cases examines.
背景
在已发表的报告中，有时会遗漏关于获得患者知情同意（ICP）以及研究伦理委员会（REC）批准的披露信息。迄今为止，尚无关于外科研究的披露数据。
目的
我们的目的是评估外科试验中是否记录了REC批准和ICP。
研究设计
总共纳入了2005年至2010年间在10种国际期刊上发表的657项随机试验。我们收集了REC批准和ICP的报告率，并在缺乏伦理信息时联系了通讯作者。
结果
在657项随机对照试验（RCT）中，576项（87.7%）表明REC已批准该研究，606项（92.2%）表明已征求了ICP。此外，28项RCT（4.3%）既未报告REC也未报告ICP。
结论
在大约90%的被审查案例中，所分析的III期随机外科试验显示尊重了基本的伦理原则。
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