Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review Academic Article uri icon


MeSH Major

  • Decision Making
  • Early Detection of Cancer
  • Patient Participation
  • Primary Health Care
  • Prostate-Specific Antigen
  • Prostatic Neoplasms


  • Of all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems.

publication date

  • July 6, 2016



  • Academic Article



  • eng

PubMed Central ID

  • PMC5130947

Digital Object Identifier (DOI)

  • 10.1007/s11606-016-3780-5

PubMed ID

  • 27384536

Additional Document Info