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References

  • 1
    C. Weijer et al., the Ottawa Ethics of Cluster Randomized Trials Consensus Group, and F. Althabe, “The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials,” PLoS Medicine 9, no. 11 (2012) e1001346.
  • 2
    J. Sim and A. Dawson, “Informed Consent and Cluster-Randomized Trials,” American Journal of Public Health 102 (2012): 48085, at 480.
  • 3
    F. G. Miller and E. J. Emanuel, “Quality-Improvement Research and Informed Consent,” New England Journal of Medicine 358 (2008): 76567.
  • 4
    F. G. Miller and E. J. Emanuel, “Quality-Improvement Research and Informed Consent,” New England Journal of Medicine 358 (2008): 767.
  • 5
    G. Ogrinc et al., “An Instrument to Differentiate between Clinical Research and Quality Improvement,” IRB: Ethics & Human Research 35, no. 5 (2013): 18.
  • 6
    F. G. Miller and S. Joffe, “Equipoise and the Dilemma of Randomized Clinical Trials,” New England Journal of Medicine 364 (2011): 47680.
  • 7
    A. Binik et al., “Does Clinical Equipoise Apply to Cluster Randomized Trials in Health Research?,” Trials 12 (2011), doi:10.1186/1745-6215-12-118; A. D. McRae et al., “When Is Informed Consent Required in Cluster Randomized Trials in Health Research?,” Trials 12 (2011), doi:10.1186/1745-6215-12-202; A. D. McRae et al., “Who Is the Research Subject in Cluster Randomized Trials in Health Research?,” Trials 12 (2011), doi:10.1186/1745-6215-12-183; C. Weijer et al., “Ethical Issues Posed by Cluster Randomized Trials in Health Research,” Trials 12 (2011), doi:10.1186/1745-6215-12-100; C. Weijer et al., the Ottawa Ethics of Cluster Randomized Trials Consensus Group, and F. Althabe, “The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials.”
  • 8
    A. Binik et al., “Does Clinical Equipoise Apply to Cluster Randomized Trials in Health Research?”
  • 9
    Descriptive material in italics here and elsewhere is excerpted from ClinicalTrials.gov; see http://clinicaltrials.gov/ct2/show/NCT01008215?term=cluster+randomized+trials&rank=47.
  • 10
    Descriptive material in italics here and elsewhere is excerpted from ClinicalTrials.gov; the source is slightly paraphrased here.
  • 11
    Y.-K. Kim et al., “Effect of a Simple Two-Step Warfarin Dosing Algorithm on Anticoagulant Control as Measured by Time in Therapeutic Range: A Pilot Study,” Journal of Thrombosis and Haemostasis 8 (2009): 101106.
  • 12
    Binik et al., “Does Clinical Equipoise Apply to Cluster Randomized Trials in Health Research?,” 2.
  • 13
    Binik et al., “Does Clinical Equipoise Apply to Cluster Randomized Trials in Health Research?,”, 5.
  • 14
    Binik et al., “Does Clinical Equipoise Apply to Cluster Randomized Trials in Health Research?,”, 9.
  • 15
  • 16
    McRae et al., “Who Is the Research Subject in Cluster Randomized Trials in Health Research?”
  • 17
    McRae et al., “Who Is the Research Subject in Cluster Randomized Trials in Health Research?”, 5.
  • 18
    McRae et al., “Who Is the Research Subject in Cluster Randomized Trials in Health Research?”, 8.
  • 19
    McRae et al., “Who Is the Research Subject in Cluster Randomized Trials in Health Research?”, 9.
  • 20
    McRae et al., “Who Is the Research Subject in Cluster Randomized Trials in Health Research?”, 3.
  • 21
  • 22
    McRae et al., “Who Is the Research Subject in Cluster Randomized Trials in Health Research?”
  • 23
    McRae et al., “Who Is the Research Subject in Cluster Randomized Trials in Health Research?”, 3.
  • 24
    S. H. Chaudhrya et al., “Challenges in the Research Ethics Review of Cluster Randomized Trials: International Survey of Investigators,” Clinical Trials 10, no. 2 (2013): 257-68.