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Ethical Considerations for the Conduct of Antidementia Trials in Canada

Published online by Cambridge University Press:  02 December 2014

John D. Fisk
John D. Fisk*
Affiliation:
The Departments of Psychiatry, Medicine and Psychology, Dalhousie University, Halifax, Nova Scotia, Canada
*
A.J. Lane Memorial Building, 5909 Veteran's Memorial Lane, Halifax, Nova Scotia, B3H 2E2, Canada.
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Abstract

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Clinical trials in persons with dementia bring into focus the ethical dilemmas frequently confronting the clinician-scientist. Despite the existence of various ethical guidelines, most with common underlying principles, few are specific to dementia. A particular difficulty is finding a balance between respect for the autonomy of the individual and the protection of vulnerable persons, while at the same time defining an acceptable risk/benefit ratio for the study. The availability of symptomatic treatments for Alzheimer's disease also now make it difficult to argue that withholding treatment from those in the placebo arm of a clinical trial fulfills one's duty to provide best care. Those conducting clinical trials must be knowledgeable about existing legislation and ethical guidelines in order to justify to themselves and others, the design of clinical trials and their risks. They must be prepared to educate patients and family members about dementia and research, determine each potential subject's competence to consent, and ensure that decisions about participation are in accordance with the best interests of the subject. Ethical conduct of clinical trials of new antidementia therapies will require that everyone involved understands the values and beliefs that guide their decision-making and the potentially conflicting roles facing the clinician-scientist.

Résumé:

RÉSUMÉ:

Les essais cliniques chez les sujets déments illustrent les dilemmes éthiques auxquels le clinicien-chercheur est fréquemment confronté. Malgré l'existence de différentes lignes directrices en éthique, la plupart ayant des principes sous-jacents communs, peu sont spécifiques de la démence. Il est particulièrement difficile d'établir un équilibre entre le respect de l'autonomie de l'individu et la protection des personnes vulnérables tout en définissant un taux de risques/bénéfices acceptable pour l'étude. Il est devenu difficile de soutenir que le fait de ne pas traiter les sujets du groupe placebo est compatible avec le devoir de leur procurer les meilleurs soins possibles vu la disponibilité de traitements symptomatiques pour la maladie d'Alzheimer. Ceux qui effectuent des essais cliniques doivent connaître la législation et les lignes directrices éthiques afin de se justifier et de justifier vis-à-vis des autres le plan des essais cliniques et les risques qui y sont associés. Ils doivent être prêts à informer les patients et les membres de leur famille sur la démence et la recherche, à déterminer la compétence de chaque sujet potentiel à donner son consentement et à assurer que les décisions au sujet de la participation sont dans le meilleur intérêt du sujet. Il faudra que toutes les personnes impliquées comprennent les valeurs et les croyances qui guident la prise de décision et les rôles conflictuels potentiels auxquels fait face le clinicien-chercheur pour un déroulement éthique des essais cliniques sur les nouveaux médicaments antidémence.

Type
Original Articles
Information
Canadian Journal of Neurological Sciences , Volume 34 , Issue S1 , March 2007 , pp. S32 - S36
Copyright
Copyright © The Canadian Journal of Neurological 2007

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