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The need for additional safeguards in the informed consent process in schizophrenia research
  1. K K Anderson,
  2. S D Mukherjee
  1. Health Research Methodology Programme, Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada
  1. Kelly K Anderson, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Purvis Hall, 1020 Pine Avenue West, Montreal, QC, H3A 1A2 Canada; kelly.anderson{at}


The process of obtaining informed consent to participate in a clinical study presents many challenges for research conducted in a population of patients with schizophrenia. Morally valid, informed consent must include information sharing, decisional capacity, and capacity for voluntarism. This paper examines the unique features of schizophrenia that may threaten each of these elements of informed consent, and it proposes additional safeguards in the process of gaining informed consent from individuals with schizophrenia in order to maximise the decision-making potential of this patient population.

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  • i For more information on informed consent, see Faden RB, Beauchamp TL, King NMP, A history and theory of informed consent, Oxford University Press: New York, 1986.

  • Competing interests: None declared.

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