Abstract
BackgroundInstitutional review boards must guarantee the ethical acceptability of a randomized controlled trial before it is conducted. However, some may regard an unbalanced randomization ratio as reflecting an absence of uncertainty between the groups being compared. The objective was to assess institutional review board members’ perceptions of whether unbalanced randomization in randomized controlled trials is justified and ethically acceptable.MethodsInstitutional review board members worldwide completed a survey involving clinical vignettes modeling situations classically advocated to explain the use of unbalanced randomization. Institutional review board members were asked whether unbalanced randomization was justified and ethically sound. Answers were collected by using visual analog scales. Data were analyzed by principal component analysis, and a hierarchical ascending classification was created. Verbatim answers were assessed by qualitative content analysis.ResultsWe analyzed responses from 148 institutional review board members. Three classes of respondents were identified: class 1 (n = 58; 39.2%), mostly skeptics who disagreed with unbalanced randomization, whatever the justification; class 2 (n = 46; 31.1%), believers who considered that unbalanced randomization was acceptable whatever the justification, except cost; and class 3 (n = 44; 29.7%), circumstantial believers for whom unbalanced randomization may be justified for methodological and safety issues but not cost or ethical issues. When institutional review board members were asked whether unbalanced randomization respected the equipoise principle, the mean quotation was low (4.5 ± 3.3 out of 10), especially for class 1 members.ConclusionsInstitutional review board members perceive unbalanced randomization heterogeneously in terms of its justification and its ethical validity.
Highlights
Institutional review boards must guarantee the ethical acceptability of a randomized controlled trial before it is conducted
The survey asked about member characteristics, including age, gender, professional background, experience in planning and approving an unbalanced Randomized controlled trial (RCT), and whether they would agree to be recruited as a patient in an RCT with unbalanced randomization
One third of respondents (34.9%) had been involved in planning an unbalanced RCT, and 54.4% had been involved in approving the conduct of an unbalanced RCT as an institutional review board (IRB) member
Summary
Institutional review boards must guarantee the ethical acceptability of a randomized controlled trial before it is conducted. The clinical equipoise principle is an ethical prerequisite for conducting a RCT and is defined by the existence of a genuine uncertainty in the expert medical community about which of the tested treatments will be the most beneficial [5]. This ethical principle is usually evoked when considering a specific RCT, it can be evoked at a meta-level, considering a sample of RCTs. Djulbegovic reported that “there is a predictable relationship between the uncertainty, that is, the moral principle, upon which randomized trials are based, and the ultimate outcomes of randomized trials” [6]. That hypothesis leads to an expectation that over time, we “find no significant difference between the proportion of randomized trials that favor new treatments and those that favor established treatments”, which can be considered the respect of clinical equipoise at a meta-level [6]
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