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Assessing Ethics of Trials in Systematic Reviews Downloaded from bmj.com on 4 March 2009 Assessing ethics of trials in systematic reviews Michael A Weingarten, Mical Paul and Leonard Leibovici BMJ 2004;328;1013-1014 doi:10.1136/bmj.328.7446.1013 Updated information and services can be found at: http://bmj.com/cgi/content/full/328/7446/1013 These include: References This article cites 10 articles, 4 of which can be accessed free at: http://bmj.com/cgi/content/full/328/7446/1013#BIBL 1 online articles that cite this article can be accessed at: http://bmj.com/cgi/content/full/328/7446/1013#otherarticles Rapid responses 3 rapid responses have been posted to this article, which you can access for free at: http://bmj.com/cgi/content/full/328/7446/1013#responses You can respond to this article at: http://bmj.com/cgi/eletter-submit/328/7446/1013 Email alerting Receive free email alerts when new articles cite this article - sign up in the service box at the top left of the article Topic collections Articles on similar topics can be found in the following collections Journalology (771 articles) Clinical trials (epidemiology) (3867 articles) Informed consent (638 articles) Research and publication ethics (1429 articles) Legal and forensic medicine (1699 articles) Notes To Request Permissions go to: http://group.bmj.com/group/rights-licensing/permissions To order reprints go to: http://journals.bmj.com/cgi/reprintform To subscribe to BMJ go to: http://resources.bmj.com/bmj/subscribers Downloaded from bmj.com on 4 March 2009 Education and debate Assessing ethics of trials in systematic reviews Michael A Weingarten, Mical Paul, Leonard Leibovici Routine assessment may improve ethical standards and overall quality of trials Our awareness of the requirements for ethical clinical review, but the ethical principles to be applied need to Department of Family Medicine, research has increased over the past century. Research be defined. Among the approaches to research ethics, Tel-Aviv University, ethics committees were set up after the Declaration of we find that proposed by Foster most attractive. She Tel-Aviv, Israel Helsinki to review research proposals. Many journals suggests examining the project from three perspectives: Michael A now require a statement that ethical approval has been goals, duties, and rights.6 We used this model to devise a Weingarten professor obtained before they consider a research report for pub- protocol to help assess the ethical quality of clinical Internal Medicine lication. Nevertheless, many published studies do not trials included in systematic reviews (box). and Infectious come up to standard, or at least do not report that they Should systematic reviews merely delineate the Diseases Unit, do. For example, 30 out of 37 consecutive studies ethical quality or attempt to integrate the observations Beilinson Hospital, Rabin Medical published in five general paediatric journals did not into its conclusions? We believe that reviews should at Centre, Petah Tikva, report whether informed consent was obtained. Twenty least include a report of the ethical assessment and that Israel four of them did not report whether the committee on the implications for further research should address Mical Paul research ethics had approved the study.1 We propose the ethical gaps observed in existing studies. registrar that systematic reviews of experimental clinical research Beilinson Campus, Rabin Medical on humans should also include information on the How would the protocol work in practice? Centre ethical standards of the trials. Leonard Leibovici We applied our protocol to a recently published head of department Why include ethical information? systematic review of trials comparing lactam Correspondence to: monotherapy versus lactam combined with M A Weingarten The main reason for including ethics in the checklist of 9 weingml@ aminoglycoside for febrile neutropenia. The review post.tau.ac.il systematic reviews is to increase awareness in the scien- included 47 studies carried out during 1981-2000 and tific community about the need for high ethical stand- 7807 randomised patients. BMJ 2004;328:1013–4 ards in research on humans. The proposal would also encourage reviewers to identify those occasional stud- Goal related considerations ies that were so unethical that there may be doubts Financial support—Twenty eight trials gave information about the morality of using the results. Although such on financial support: all had received funding from the trials are rare, history has given us too many real company that manufactured the monotherapy anti- examples to allow us to be complacent.23Opinions dif- biotic. Three trials declared research grant support as fer on whether it is justified to disseminate the results well as commercial support. of such studies.4 Either way, a conscious decision Conflicts of interest—None of the studies included a should be made and revealed to readers of the review. statement related to potential conflicts of interest. Issues around ethical quality overlap importantly Justification—Thirty seven studies did not report with the central issues of the validity, reliability, and a sample size calculation. We calculated that an generalisability of research findings. They relate to some of the more subtle potential sources of bias in experimental clinical research. It is thus important to Guide for ethical assessment of trials in systematic reviews include ethical assessment in systematic reviews on prudential grounds as well as on moral grounds. The Goal related considerations • results of ethically sound trials may be more reliable Is there a clear declaration on financial support in all trials? • than those from other trials. In a review of 767 Is there a statement that relates to potential conflicts of interest in all trials? • randomised controlled trials published during 1993-5 Justification—Could the results have been obtained by laboratory or in the New England Journal of Medicine, Lancet, BMJ, and animal experiments? Were any of the trials superfluous? Was the size of the study sufficient to achieve adequate statistical power? JAMA, trials of higher methodological quality were • Publication bias—How many of the identified trials remained more likely to provide information about their ethical unpublished? Is bias detectable by funnel plot analysis? aspects; so it seems that more reliable research is also more sensitive to the ethical requirements of research.5 Duty related considerations • Were the comparators appropriate? If a placebo was used, was it justified? Which issues should we assess? Rights related considerations • Ethical issues at the level of a systematic review are Safety—Was the risk for participants appropriate to the importance of the research?7 Was appropriate follow up care assured? different from those for original research, and it might • Was informed consent obtained? be unfair to examine all trials under the same ethical • When participants had reduced competence, were appropriate measures loupe. Older trials will have been done when ethical taken to protect their best interests?8 standards of research had not been as clearly • Were adequate steps taken to prevent unauthorised access to personal formulated as they are today. Ethical standards depend and clinical data? not only on the time the study was performed but also on place and social mores. Global considerations • Nevertheless, we think that examination of the Was the study approved by a research ethics committee? ethical standards of trials should form part of every BMJ VOLUME 328 24 APRIL 2004 bmj.com 1013 Downloaded from bmj.com on 4 March 2009 Education and debate equivalence trial design with an overall success rate of 60% (as observed in this review), and permitting a 20% Summary points difference between the treatments, would require around 200 assessable patients to ensure an 80% chance Many clinical trials do not report details of of rejecting at = 0.05 the null hypothesis of ethical issues equivalence.10 Thirty eight trials had fewer than 200 patients. This requirement is modest given the broad Including ethical assessment in systematic reviews difference permitted between the treatments. Compila- will encourage researchers to conduct ethical tion of all existing data in this review led us to believe research that further trials comparing lactam monotherapy with a narrower spectrum lactam combined with an Ethical research may provide more reliable results aminoglycoside would be unjustified. However, we could not identify a specific time at which this conclusion Ethics can be assessed systematically by using the should have been reached. suggested protocol Publication bias—Five trials completed before 1990 (943 patients) remained unpublished or were pub- lished only as conference proceedings. The results of straightforward and systematic extraction of data on one study including 460 patients were never formally ethical issues. The details of how to assess several of the 11 published. Although we included these studies in our measures, such as the justification of studies or the review, the funnel plot showed that small studies appropriateness of the comparators, may need further favouring combination therapy might be missing. consideration to allow for uniform evaluation in systematic reviews of different sorts. Duty related considerations We believe that including ethical considerations in Appropriate comparators—We considered antibiotic systematic reviews will increase research workers’ combinations advised by guidelines contemporary to awareness
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