title: Reporting of ethical requirements in phase III surgical trials.
abstract: 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.
  
  
  METHODS
  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.
authors: 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.
authors: Valérie
authors: V
authors: Bridoux
authors: Department of Digestive Surgery, Rouen University Hospital, Rouen, Cedex, France.
authors: Lilian
authors: L
authors: Schwarz
authors: Laboratoire d'Ethique Médicale, et de Médecine Légale et Réseau de Recherche en Ethique INSERM, Paris, France.
authors: Grégoire
authors: G
authors: Moutel
authors: Department of Digestive Surgery, Rouen University Hospital, Rouen, Cedex, France.
authors: Francis
authors: F
authors: Michot
authors: Laboratoire d'Ethique Médicale, et de Médecine Légale et Réseau de Recherche en Ethique INSERM, Paris, France.
authors: Christian
authors: C
authors: Herve
authors: 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.
authors: Jean-Jacques
authors: JJ
authors: Tuech
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000941:ethics* / Q000592:standards; D030881:Disclosure / Q000941:ethics; D032984:Ethics, Research; D013502:General Surgery; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D010506:Periodicals as Topic; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012107:Research Design / Q000592:standards
keywords: Clinical Ethics; Ethics Committees/Consultation; Research Ethics; Surgery