Objectives—To assess the relationship between the approval of trials by a research ethics committee and the fact that informed consent from participants was obtained, with the quality of study design and methods.Design—Systematic review using a standardised checklist.Main measures—Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published (...) by at least one Spanish author during the same period in any other journal were also included.Results—We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groupsConclusion—Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects. (shrink)

Background: The approval of a research ethics committee and obtaining informed consent from patients could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials.Method: Methodological quality and ethical quality were assessed for all randomised controlled trials published in 10 international journals between 1999 and 2001 .Results: The (...) mean Jadad score was 9.86 ± 1.117. The methodological quality was poor in 75 RCTs . The mean Berdeu score was 0.42 ± 0.133. The mean ethical quality score for poor methodological quality RCTs was 0.39 ± 0.133; it was 0.43 ± 0.133 for good methodological quality RCTs . There was improvement in ethical quality according to the year of commencement of the trials . There was no correlation between methodological quality and the number of participating patients , between ethical quality and the number of participating patients , or between ethical quality and methodological quality . ICP and REC approval were not obtained for 21 and 77 trials respectively.Conclusion: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed. (shrink)