Informed Consent and Cluster-Randomized Trials

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Informed Consent and Cluster-Randomized Trials. / Sim, J; Dawson, Angus.

In: American Journal of Public Health, Vol. 102, No. 3, 01.03.2012, p. 480-485.

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@article{00a51aa4669641e1a26d9312df112517,
title = "Informed Consent and Cluster-Randomized Trials",
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. We further argue that it should be the institutional review board's task to evaluate whether 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.",
author = "J Sim and Angus Dawson",
year = "2012",
month = mar,
day = "1",
doi = "10.2105/AJPH.2011.300389",
language = "English",
volume = "102",
pages = "480--485",
journal = "American Journal of Public Health",
issn = "0090-0036",
publisher = "American Public Health Association",
number = "3",

}

RIS

TY - JOUR

T1 - Informed Consent and Cluster-Randomized Trials

AU - Sim, J

AU - Dawson, Angus

PY - 2012/3/1

Y1 - 2012/3/1

N2 - 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. We further argue that it should be the institutional review board's task to evaluate whether 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.

AB - 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. We further argue that it should be the institutional review board's task to evaluate whether 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.

U2 - 10.2105/AJPH.2011.300389

DO - 10.2105/AJPH.2011.300389

M3 - Article

C2 - 22390511

VL - 102

SP - 480

EP - 485

JO - American Journal of Public Health

JF - American Journal of Public Health

SN - 0090-0036

IS - 3

ER -