Informed consent and cluster-randomized trials

J. Sim and A. Dawson

American Journal of Public Health, 2012, vol. 102, issue 3, 480-485

Abstract: We argue that cluster-randomized trials are an important methodology, essential to the evaluation of many public health interventions. However, in the case of at least some cluster-randomized trials, it is not possible, or is incompatible with the aims of the study, to obtain individual informed consent. This should not necessarily be seen as an impediment to ethical approval, providing that sufficient justification is given for this omission. Wefurtherarguethat itshould be the institutional review board's task to evaluatewhether the protocol is sufficiently justified to proceed without consent and that this is preferable to any reliance on community consent or other means of proxy consent.

Date: 2012
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Persistent link: https://EconPapers.repec.org/RePEc:aph:ajpbhl:10.2105/ajph.2011.300389_5

DOI: 10.2105/AJPH.2011.300389

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