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When and how should we cluster and cross over: methodological and ethical issues (letter 1)

  • Jessica SpenceEmail author
  • Emilie Belley-Côté
  • Simon Oczkowski
  • Eric Jacobsohn
  • Richard Whitlock
  • P. J. Devereaux
  • Stuart Connolly
Correspondence

To the Editor,

The editorial by Goldstein et al.1 expresses concern regarding the methods and ethics of our Benzodiazepine-Free Cardiac Anesthesia for Reduction in Postoperative Delirium (B-Free) trial, suggesting that waived consent cannot be justified when interventions are administered directly to individuals. In our view, however, international guidelines and current practice support the concept that trials evaluating treatments administered directly to individual patients can fulfill the requirements for a waiver of individual consent, provided that they have minimal risk.

There are many completed and ongoing cluster trials that test policies related to the use of pharmacologic and other interventions where waiver of consent has been accepted. Such trials include: conventional vs incremental antibiotic prophylaxis strategies on the incidence of pacemaker infection;1 saline compared with buffered crystalloid intravenous fluid on the incidence of acute kidney injury;2...

Notes

Financial disclosure and conflicts of interest

None declared.

Editorial responsibility

This submission was handled by Dr. Gregory L. Bryson, Deputy Editor-in-Chief, Canadian Journal of Anesthesia.

References

  1. 1.
    Goldstein CE, Giraudeau B, Weijer C, Taljaard M. When and how should we cluster and cross over: methodological and ethical issues. Can J Anesth 2018; 65: 760-5.CrossRefPubMedGoogle Scholar
  2. 2.
    Canadian Institutes of Health Research; Natural Sciences and Engineering Research Council of Canada; Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans - December 2014. Available from URL: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ (accessed July 2018).
  3. 3.
    U.S. Department of Health and Human Services; Food and Drug Administration. IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects - July 2017 Available from URL: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM566948.pdf (accessed July 2018).
  4. 4.
    Spence J, Belley-Côté E, Devereaux PJ, et al. Benzodiazepine administration during adult cardiac surgery: a survey of current practice among Canadian anesthesiologists working in academic centres. Can J Anesth 2018; 65: 263-71.CrossRefPubMedGoogle Scholar
  5. 5.
    U.S. National Library of Medicine. Benzodiazepine-free Anesthetic for Reduction of Delirium (B-Free). ClinicalTrials.gov identifier: NCT03053869. Registered February 15, 2017. Available from URL: https://ClinicalTrials.gov/ct2/show/NCT03053869 (accessed July 2018)

Copyright information

© Canadian Anesthesiologists' Society 2018

Authors and Affiliations

  1. 1.Departments of Anesthesia, Critical Care and Health Research Methods, Evidence, and Impact, Population Health Research Institute (PHRI)McMaster UniversityHamiltonCanada
  2. 2.Departments of Medicine (Cardiology and Critical Care) and Health Research Methods, Evidence, and Impact, Population Health Research Institute (PHRI)McMaster UniversityHamiltonCanada
  3. 3.Department of Medicine (Critical Care)McMaster UniversityHamiltonCanada
  4. 4.Departments of Anesthesia and Internal MedicineUniversity of ManitobaWinnipegCanada
  5. 5.Departments of Surgery (Cardiac Surgery) and Health Research Methods, Evidence, and Impact, Population Health Research Institute (PHRI)McMaster UniversityHamiltonCanada
  6. 6.Departments of Medicine (Cardiology) and Health Research Methods, Evidence, and Impact, Population Health Research Institute (PHRI)McMaster UniversityHamiltonCanada
  7. 7.Department of Medicine (Cardiology), Population Health Research Institute (PHRI)McMaster UniversityHamiltonCanada

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