Abstract
This editorial introduces articles in this Special Issue, which are based on presentations given at the 2017 meeting of the Global Forum of Bioethics in Research meeting. The main themes presented at the meeting were the use of cluster randomized trials, stepped-wedge cluster randomized trials, and controlled human infection models in research conducted in low-resource settings. The editorial sets out which ethical issues may arise in the context of alternative trial designs and describes the articles in this issue that addresses some or more of the ethical issues, such as justification of the research design, risk-benefit evaluations and consent.
Highlights
In health research, the randomized controlled trial (RCT) has traditionally been the gold standard for evaluating the efficacy and safety of new interventions
Cluster randomized trials (CRTs) are essential when the intervention being evaluated is delivered at the cluster level or at the health professional level
Several ethical issues have been highlighted in the literature that merit specific consideration when using these designs, such as delaying the roll-out of an intervention that is believed to be superior to the standard of care in SW-RCTs [3] and the level of acceptable research risks in Controlled human infection model (CHIM) when healthy participants are deliberately exposed to infectious agents [12]
Summary
The randomized controlled trial (RCT) has traditionally been the gold standard for evaluating the efficacy and safety of new interventions. There are methodological reasons for choosing alternative study designs over conventional RCTs. For example, cluster randomized trials (CRTs) are essential when the intervention being evaluated is delivered at the cluster level (such as public health interventions) or at the health professional level (such as knowledge translation or health systems interventions).
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