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Informed consent in clinical research in France: assessment and factors associated with therapeutic misconception
  1. I S Durand-Zaleski1,
  2. C Alberti2,
  3. P Durieux3,
  4. X Duval4,
  5. S Gottot5,
  6. Ph Ravaud4,6,
  7. S Gainotti1,7,
  8. C Vincent-Genod1,
  9. D Moreau1,
  10. P Amiel8
  1. 1
    AP-HP, Henri Mondor hospital, Public Health, Faculte de Medecine, Créteil, France
  2. 2
    AP-HP, Robert Debré hospital, Clinical Epidemiology; Inserm, CIE 5, Paris, France
  3. 3
    AP-HP, Hôpital Européen Georges Pompidou, Department of Medical Informatics, Paris; Descartes University, INSERM UMRS, France
  4. 4
    AP-HP, Hôpital Bichat-Claude Bernard, Département d’Epidémiologie, Biostatistique et Recherche Clinique, Paris, France
  5. 5
    AP-HP, Robert Debré Hospital, Paris; Université Paris, Paris, France
  6. 6
    INSERM, U738, Paris; Université Paris, UFR de Médecine, Paris, France
  7. 7
    Istituto Superiore di Sanità, Rome, Italy
  8. 8
    Institut de Cancérologie Gustave-Roussy, Social and Human Sciences Research Unit, Villejuif, France
  1. Professor I Durand-Zaleski, AP-HP, Henri Mondor hospital, Public Health, 51 Avenue du Maréchal de Lattre de Tassigny, 94010 Créteil, France; isabelle.durand-zaleski{at}hmn.aphp.fr

Abstract

Background: Informed consent in clinical research is mandated throughout the world. Both patient subjects and investigators are required to understand and accept the distinction between research and treatment.

Aim: To document the extent and to identify factors associated with therapeutic misconception in a population of patient subjects or parent proxies recruited from a variety of multicentre trials (parent studies).

Patients and methods: The study comprised two phases: the development of a questionnaire to assess the quality of informed consent and a survey of patient subjects based on this questionnaire.

Results: A total of 303 patient subjects or parent proxies were contacted and 279 questionnaires were analysed. The median age was 49.5 years, sex ratio was 1 and 61% of respondents were professionally active. Overall memorisation of the oral or written communication of informed consent was good (69–97%), and satisfaction with the process was around 70%. Therapeutic misconception was present in 70% of respondents, who expected to receive better care and ignored the consequence of randomisation and treatment comparisons. This was positively associated with the acuteness and severity of the disease.

Conclusion: The authors suggest that the risk of therapeutic misconception be specifically addressed in consent forms as an educational tool for both patients and investigators.

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Footnotes

  • Competing interests: None declared.

  • Funding: This project was financed in part by a grant from the French Ministry of Health PHRC AOM98123.

  • Ethics approval: The study was approved by the ethics committee of Henri Mondor hospital, Créteil, France.

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