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Longitudinal Study of Informed Consent in Innovative Therapy Research: Experience and Provisional Recommendations from a Multicenter Trial of Intracerebral Grafting

Author

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  • Laurent Cleret de Langavant
  • Sophie Sudraud
  • Christophe Verny
  • Pierre Krystkowiak
  • Clémence Simonin
  • Philippe Damier
  • Jean-François Demonet
  • Frédéric Supiot
  • Amandine Rialland
  • David Schmitz
  • Patrick Maison
  • Katia Youssov
  • Anne-Catherine Bachoud-Lévi

Abstract

Background: There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders. Methods: We performed a longitudinal study of the consent of Huntington’s disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington’s Disease (MIG-HD) in France and Belgium. Patients and their proxies completed a consent questionnaire at inclusion, before signing the consent form and after one year of follow-up, before randomization and transplantation. The questionnaire explored understanding of the protocol, satisfaction with the information delivered, reasons for participating in the trial and expectations regarding the transplant. Forty-six Huntington’s disease patients and 27 proxies completed the questionnaire at inclusion, and 27 Huntington’s disease patients and 16 proxies one year later. Results: The comprehension score was high and similar for Huntington’s disease patients and proxies at inclusion (72.6% vs 77.8%; P > 0.1) but only decreased in HD patients after one year. The information satisfaction score was high (73.5% vs 66.5%; P > 0.1) and correlated with understanding in both patients and proxies. The motivation and expectation profiles were similar in patients and proxies and remained unchanged after one year. Conclusions: Cognitively impaired patients with Huntington’s disease were capable of consenting to participation in this trial. This consent procedure has presumably strengthened their understanding and should be proposed before signing the consent form in future gene or cell therapy trials for neurodegenerative disorders. Because of the potential cognitive decline, proxies should be designated as provisional surrogate decision-makers, even in competent patients.

Suggested Citation

  • Laurent Cleret de Langavant & Sophie Sudraud & Christophe Verny & Pierre Krystkowiak & Clémence Simonin & Philippe Damier & Jean-François Demonet & Frédéric Supiot & Amandine Rialland & David Schmitz , 2015. "Longitudinal Study of Informed Consent in Innovative Therapy Research: Experience and Provisional Recommendations from a Multicenter Trial of Intracerebral Grafting," PLOS ONE, Public Library of Science, vol. 10(5), pages 1-11, May.
    • Handle: RePEc:plo:pone00:0128209
    DOI: 10.1371/journal.pone.0128209
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    References listed on IDEAS

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    1. Gail E Henderson & Larry R Churchill & Arlene M Davis & Michele M Easter & Christine Grady & Steven Joffe & Nancy Kass & Nancy M P King & Charles W Lidz & Franklin G Miller & Daniel K Nelson & Jeffrey, 2007. "Clinical Trials and Medical Care: Defining the Therapeutic Misconception," PLOS Medicine, Public Library of Science, vol. 4(11), pages 1-4, November.
    2. Lidz, Charles W. & Appelbaum, Paul S. & Grisso, Thomas & Renaud, Michelle, 2004. "Therapeutic misconception and the appreciation of risks in clinical trials," Social Science & Medicine, Elsevier, vol. 58(9), pages 1689-1697, May.
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