The Essential Guide to N-of-1 Trials in Health

pp 125-133

Research Ethics and N-of-1 Trials

  • Andrew CrowdenAffiliated withSchool of Medicine, The University of Queensland Email author 
  • , Gordon GuyattAffiliated withMcMaster University
  • , Nikola StepanovAffiliated withSchool of Medicine, The University of Queensland
  • , Sunita VohraAffiliated withDepartment of Pediatrics, University of Alberta

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Some N-of-1 trials are conducted as part of clinical care, others are developed as research. For those that are research, unless they are deemed exempt from formal review, a relevant Human Research Ethics Committee or Institutional Review Board should review specific projects before they are approved. N-of-1 trials should also be authorized by institutions before commencing. The level of risk to the patient/participant should guide and determine whether a particular project is exempt from review, subject to a low/negligible risk review, or should be reviewed by a full committee. Research ethics reviewers must develop a heightened ethical sensitivity toward ensuring that a misguided approach to N-of-1 review does not occur. Clinical researchers, institutions and research review committees, should recognize the continuum of clinical care and clinical research, in order to set and act from explicit standards which are consistent with the clinical practice – clinical research continuum.


Research ethics N-of-1 trials Clinical research continuum Bias Respect Merit Integrity Justice Beneficence Informed consent Risk assessment Intent Institutional Review Boards Human Research Ethics Committees