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Informed consent and cluster-randomized trials

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  • Sim, J.
  • Dawson, A.

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.

Suggested Citation

  • Sim, J. & Dawson, A., 2012. "Informed consent and cluster-randomized trials," American Journal of Public Health, American Public Health Association, vol. 102(3), pages 480-485.
    • Handle: RePEc:aph:ajpbhl:10.2105/ajph.2011.300389_5
    DOI: 10.2105/AJPH.2011.300389
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