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. (shrink)

Do all clinical research publications show strong application of ethics principles and respect for biomedical law? We examined, for the year 2009, the ethics requirements displayed on the website of 30 leading medical journals with an impact factor (IF) >10, and 30 others with an IF <10. We carried out a short study looking at the relationship between the IF of a journal and the ethics requirements in its instructions to authors. We show that the IF of a biomedical journal (...) bears a direct relationship to its ethics requirements. Such results should improve the ethics requirements of all biomedical journals, especially those with low IF, so that they are internationally standardised to the higher standard required by journals with higher IF. (shrink)