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Thinking clearly about the FIRST trial: addressing ethical challenges in cluster randomised trials of policy interventions involving health providers
  1. Austin R Horn1,
  2. Charles Weijer1,2,
  3. Spencer Phillips Hey1,3,4,
  4. Jamie Brehaut5,6,
  5. Dean A Fergusson5,6,7,
  6. Cory E Goldstein1,
  7. Jeremy Grimshaw5,6,8,
  8. Monica Taljaard5,6
  1. 1Rotman Institute of Philosophy, Western University, London, Ontario, Canada
  2. 2Departments of Philosophy, Medicine, Epidemiology and Biostatistics, Western University, London, Ontario, Canada
  3. 3Harvard Center for Bioethics, Harvard University, Boston, Massachusetts, USA
  4. 4Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts, USA
  5. 5Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  6. 6School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada
  7. 7Departments of Medicine and Surgery, University of Ottawa, Ottawa, Ontario, Canada
  8. 8Department of Medicine, Center for Practice-Changing Research, University of Ottawa, Ottawa, Ontario, Canada
  1. Correspondence to Mr Austin R Horn, Rotman Institute of Philosophy, Western University, London, ON N6A 3K7, Canada; ahorn5{at}uwo.ca

Abstract

The ethics of the Flexibility In duty hour Requirements for Surgical Trainees (FIRST) trial have been vehemently debated. Views on the ethics of the FIRST trial range from it being completely unethical to wholly unproblematic. The FIRST trial illustrates the complex ethical challenges posed by cluster randomised trials (CRTs) of policy interventions involving healthcare professionals. In what follows, we have three objectives. First, we critically review the FIRST trial controversy, finding that commentators have failed to sufficiently identify and address many of the relevant ethical issues. The 2012 Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides researchers and research ethics committees with specific guidance for the ethical design and conduct of CRTs. Second, we aim to demonstrate how the Ottawa Statement provides much-needed clarity to the ethical issues in the FIRST trial, including: research participant identification; consent requirements; gatekeeper roles; benefit-harm analysis and identification of vulnerable participants. We nonetheless also find that the FIRST trial raises ethical issues not adequately addressed by the Ottawa Statement. Hence, third and finally, we raise important questions requiring further ethical analysis and guidance, including: Does clinical equipoise apply to policy interventions with little or no evidence-base? Do healthcare providers have an obligation to participate in research? Does the power-differential in certain healthcare settings render healthcare providers vulnerable to duress and coercion to participant in research? If so, what safeguards might be implemented to protect providers, while allowing important research to proceed?

  • research ethics
  • clinical trials
  • ethics
  • health personnel
  • policy guidelines/inst. review boards/review cttes.

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Footnotes

  • Contributors ARH was responsible for the writing, research, design, analysis and revisions of the many drafts of this article and therefore accepts responsibility as the guarantor for the work. CW contributed to the planning and design of the article, important intellectual content and substantive written edits and oral feedback on drafts. The remaining coauthors made significant contributions to the analysis and intellectual content of the article through both written and oral comments on the numerous drafts. All authors approved the final draft of the article and thus accept responsibility for the accuracy and integrity of the work.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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