In this paper, we respond to Andrew Avins's recent review of methods whose use he advocates in clinical trials, to make them more ethical. He recommends in particular, “unbalanced randomisation”. However, we argue that, before such a recommendation can be made, it is important to establish why unequal randomisation might offer ethical advantages over equal randomisation, other things being equal. It is important to make a pragmatic distinction between trials of treatments that are already routinely available and trials of restricted (...) treatments. We conclude that unequal randomisation could, indeed, be an ethical compromise between protecting the interests of participants and those of society. (shrink)

Psychiatric research is of critical importance in improving the care of persons with mental illness. Yet it may also raise difficult ethical issues. This article explores those issues in the context of a particular kind of research: psychosocial intervention research with control groups. We discuss 4 broad categories of ethical issues: consent, confidentiality, boundary violations, and risk-benefit issues. We believe that, despite the potential difficulties, psychosocial intervention research is vital and can be accomplished in an ethical manner. Further discussion and (...) research into these issues are warranted. (shrink)

The use of placebo controls in surgical research, or ‘sham surgery’ as it sometimes described, raises a number of ethical issues. Despite such issues, sham surgery is presently being employed, albeit very rarely, in surgical research. In this paper, the ethical implications of such control groups are discussed in the context of research into various conditions, including Parkinson's Disease and arthritis. Conflicting ethical considerations include: i) patients' best interests in relation to the harms and risks involved; ii) the need for (...) more rigorous methods in surgical research, and iii) the question of patient autonomy. Contextual features which may influence the ethical acceptability of a specific sham-controlled surgical trial are discussed. (shrink)

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)