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Comparison of Provincial and Territorial Legislation Governing Substitute Consent for Research

Published online by Cambridge University Press:  31 March 2010

Gina Bravo ,
Michaël Gagnon ,
Sheila Wildeman ,
David T. Marshall ,
Mariane Pâquet  and
Marie-France Dubois
Gina Bravo*
Affiliation:
Department of Community Health Sciences, Faculty of Medicine, University of Sherbrooke Research Centre on Aging, Sherbrooke University Geriatric Institute
Michaël Gagnon
Affiliation:
Research Centre on Aging, Sherbrooke University Geriatric Institute
Sheila Wildeman
Affiliation:
Dalhousie Law School
David T. Marshall
Affiliation:
Clinical Ethics Committee, Ottawa Heart Institute
Mariane Pâquet
Affiliation:
Research Centre on Aging, Sherbrooke University Geriatric Institute
Marie-France Dubois
Affiliation:
Department of Community Health Sciences, Faculty of Medicine, University of Sherbrooke Research Centre on Aging, Sherbrooke University Geriatric Institute
*
Requests for offprints should be sent to: / Les demandes de tirés-à-part doivent être adressées à : Gina Bravo, Ph.D., Research Centre on Aging, Sherbrooke University Geriatric Institute, 1036 Belvedere South, Sherbrooke, QC J1H 4C4. ([email protected])
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Abstract

In Canada, provincial and territorial laws address circumstances in which a substitute decision-maker may be appointed for an adult deemed legally incapable of making decisions in one or more areas of life. We searched for provincial and territorial laws that explicitly address substitute decision-making about research participation, and found significant differences among Canadian jurisdictions. In some provinces and territories there is no direct statutory guidance on the issue. Differences among jurisdictions that address substitute decision-making about research in legislation include whether judicial intervention is required to authorize the substitute decision-maker, whether any advance directive in place must explicitly authorize the decision about research in order for a proxy to consent, and how risk and benefit thresholds beyond which substitute consent to research is prohibited are articulated. It is imperative that government, researchers, and the Canadian public revisit the principles underpinning substitute decision-making about research in light of national and international norms, in order to lend clarity and consistency to this area of law and research practice.

Résumé

Au Canada, les lois provinciales et territoriales indiquent les circonstances dans lesquelles un subrogé peut être nommé pour représenter un adulte jugé légalement incapable de prendre des décisions pour un ou plusieurs aspects de sa vie. Nous avons cherché des lois provinciales et territoriales qui portaient explicitement sur la prise de décisions par le subrogé à l'égard de la participation à des recherches et avons découvert des différences considérables entre les sphères de compétence canadiennes. Dans certaines provinces/certains territoires, il n'existe aucune directive légale directe à ce sujet. Parmi les différences législatives, entre les sphères de compétence, à l'égard de la subrogation en matière de recherches, on compte : la question de savoir si une intervention judiciaire est nécessaire pour autoriser le subrogé, la question de savoir si la décision relative à la recherche doit être explicitement autorisée de façon préalable pour qu'un mandataire puisse donner son consentement, ainsi que la question de savoir comment s'articulent les seuils de risques et d'avantages au-delà desquels le subrogé ne peut émettre de consentement à l'égard de la recherche. Il est impératif que le gouvernement, les chercheurs et le public canadien révisent les principes qui sous-tendent la prise de décision par des subrogés en matière de recherche, à la lumière de normes nationales et internationales, de manière à rendre cet aspect de la loi et les pratiques de recherche plus clairs et plus cohérents.

Keywords

lawconsentresearchhealth caredecisional incapacityagingloiconsentementrecherchesoins de santéincapacité décisionnellevieillissement
Type
Articles
Information
Canadian Journal on Aging / La Revue canadienne du vieillissement , Volume 24 , Issue 3 , Fall/Automne 2005 , pp. 237 - 249
Copyright
Copyright © Canadian Association on Gerontology 2005

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