http://www.ncbi.nlm.nih.gov/pubmed/23959837

J Med Ethics. 2013 Aug 19. doi: 10.1136/medethics-2012-101070. [Epub ahead of print]

Reporting of ethical requirements in phase III surgical trials.

Bridoux V, Schwarz L, Moutel G, Michot F, Herve C, Tuech JJ.

Source

Department of Digestive Surgery, Rouen University Hospital, , Rouen, Cedex, France.

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.