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Full-Text Articles in Arts and Humanities
Ethical And Policy Issues In Cluster Randomized Trials: Rationale And Design Of A Mixed Methods Research Study, Monica Taljaard, Charles Weijer, Jeremy Grimshaw, Judith Brown, Ariella Binik, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Martin Eccles, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein, Allan Donner
Ethical And Policy Issues In Cluster Randomized Trials: Rationale And Design Of A Mixed Methods Research Study, Monica Taljaard, Charles Weijer, Jeremy Grimshaw, Judith Brown, Ariella Binik, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Martin Eccles, Andrew Mcrae, Raphael Saginur, Merrick Zwarenstein, Allan Donner
Charles Weijer
Background: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities--rather than individual themselves--are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main …