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Reporting of ethical requirements in phase III surgical trials
  1. Valérie Bridoux1,2,
  2. Lilian Schwarz1,
  3. Grégoire Moutel2,
  4. Francis Michot1,
  5. Christian Herve2,
  6. Jean-Jacques Tuech1,2
  1. 1Department of Digestive Surgery, Rouen University Hospital, Rouen, Cedex, France
  2. 2Laboratoire d'Ethique Médicale, et de Médecine Légale et Réseau de Recherche en Ethique INSERM, Paris, France
  1. Correspondence to Professor Jean-Jacques Tuech, Department of Digestive Surgery, Rouen University Hospital, 1 rue Germont, Rouen, Cedex 76031, France; Jean-jacques.tuech{at}chu-rouen.fr

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.

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.

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