You are here

Article Text

Article menu
Download PDFPDF
Research ethics
Electronic pages
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.

https://doi.org/10.1136/jme.2007.023473

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    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.

    Other content recommended for you