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What trial participants need to be told about placebo effects to give informed consent: a survey to establish existing knowledge among patients with back pain.

John HughesMaddy Greville-HarrisCynthia A GrahamGeorge LewithPeter WhiteFelicity L Bishop
Published in: Journal of medical ethics (2017)
The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects.
Keyphrases
  • phase iii
  • clinical trial
  • open label
  • healthcare
  • study protocol
  • phase ii
  • double blind
  • public health
  • randomized controlled trial
  • big data
  • emergency department
  • adverse drug
  • machine learning