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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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References

Alzheimer's Association (1997). Ethical issues in dementia research: Position of the Alzheimer's Association. Chicago: Author.Google Scholar
American Geriatrics Society Ethics Committee (1998). Informed consent for research on human subjects with dementia. Journal of the American Geriatrics Society, 46, 1308–1310.CrossRefGoogle Scholar
American Psychiatric Association, Council on Psychiatry and Law (1998). Guidelines for assessing the decision-making capacities of potential research subjects with cognitive impairment. American Journal of Psychiatry, 11, 1649–1650.Google Scholar
Bravo, G., Dubois, M.F., & Pâquet, M. (2003). Advance directives for health care and research: Prevalence and correlates. Alzheimer Disease and Associated Disorders, 17, 215–222.CrossRefGoogle ScholarPubMed
Brodaty, H., Dresser, R., Eisner, M., Erkunjuntti, T., Gauthier, S., Graham, N., Jonker, C., Sachs, G., & Whitehouse, P. (1999). Consensus statement: Alzheimer's disease international and international working group for harmonization of dementia drug guidelines for research involving human subjects with dementia. Alzheimer Disease and Associated Disorders, 13, 71–79.CrossRefGoogle Scholar
Burns, A., Rossor, M., Hecker, J., Gauthier, S., Petit, H., Môller, H.J., Rogers, S.L., Friedhoof, L.T., & the Donepezil Study Group (1999). The effects of donepezil in Alzheimer's disease: Results from a multinational trial. Dementia and Geriatric Cognitive Disorders, 10, 237–244.CrossRefGoogle ScholarPubMed
Canadian Study of Health and Aging Working Group (1994). The Canadian Study of Health and Aging: Study methods and prevalence of dementia. Canadian Medical Association Journal, 150, 899–913.Google Scholar
Clark, D.C. (2001). Variability among institutional review boards and the value of local research context. Critical Care Medicine, 29, 444–445.CrossRefGoogle ScholarPubMed
Council for International Organizations of Medical Sciences (1993). International ethical guidelines for biomedical research involving human subjects. Geneva: Author.Google Scholar
Council of Europe (1997, April) Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine. Convention on human rights and biomedicine. Oviedo.CrossRefGoogle Scholar
Etchells, E., Sharpe, G., Walsh, P., Williams, J.R., & Singer, P.A. (1996). Bioethics for clinicians: 1. Consent. Canadian Medical Association Journal, 155, 177–180.Google ScholarPubMed
Feinberg, L.F., & Whitlatch, C.J. (2001). Are persons with cognitive impairment able to state consistent choices? Gerontologist, 41, 374–382.CrossRefGoogle ScholarPubMed
Feldman, H., Gauthier, S., Hecker, J., Vellas, B., Subbiah, P., Whalen, E., & the Donepezil MSAD Study Investigators Group (2001). A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease. Neurology, 57, 613–620.CrossRefGoogle ScholarPubMed
Feldman, H., Gauthier, S., Hecker, J., Vellas, B., Emir, B., Mastey, V., Subbiah, P., & the Donepezil MSAD Study Investigators Group (2003). Efficacy of donepezil on maintenance of activities of daily living in patients with moderate to severe Alzheimer's disease and the effect on caregiver burden. Journal of the American Geriatrics Society, 51, 737–744.CrossRefGoogle ScholarPubMed
Fisk, J.D., Sadovnick, A.D., Cohen, C.A., Gauthier, S., Dossetor, J., Eberhart, A., & LeDuc, L. (1998). Ethical guidelines of the Alzheimer Society of Canada. Canadian Journal of Neurological Sciences, 25, 242–248.CrossRefGoogle ScholarPubMed
Gauthier, S., Bouchard, R., Lamontagne, A., Bailey, P., Bergman, H., Ratner, J., Tesfaye, Y., Saint-Martin, M., Bacher, Y., & Carrier, L. (1990). Tetrahydroaminoacridinelecithin combination treatment in patients with intermediate-stage Alzheimer's disease. New England Journal of Medicine, 322, 1272–1276.CrossRefGoogle ScholarPubMed
Glass, K.C., & Lemmens, T. (2002). Research involving humans. In Downie, J., Caulfield, T. & Flood, C. (Eds.), Canadian Health Law and Policy (2nd ed., pp. 459–500). Toronto: Butterworths.Google Scholar
Graham, J.E., Rockwood, K., Beattie, B.L., Eastwood, R., Gauthier, S., Tuokko, H., & McDowell, I. (1997). Prevalence and severity of cognitive impairment with and without dementia in an elderly population. Lancet, 349, 1793–1796.CrossRefGoogle Scholar
Health Canada (2002). Canada's Aging Population. Ottawa: Division of Aging and SeniorsGoogle Scholar
Kapp, M.B. (1999). Ethical issues in legal care. In Johnson, T.F. (Ed.), Handbook on ethical issues in aging (pp. 261–270). Westport: Greenwoods.Google Scholar
Kapp, M.B. (2002). Issues in conducting research with and about older persons: Vol. 8. Ethics, law, and aging review. New York: Springer.Google Scholar
Keyserlingk, E.W., Glass, K., Kogan, S., & Gauthier, S. (1995). Proposed guidelines for the participation of persons with dementia as research subjects. Perspectives in Biology and Medicine, 38, 319–361.CrossRefGoogle ScholarPubMed
Kim, S., Caine, E., Currier, G., Leibovici, A., & Ryan, J.M. (2001). Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. American Journal of Psychiatry, 158, 712–717.CrossRefGoogle ScholarPubMed
Lazar, N.M., Greiner, G.G., Robertson, G., & Singer, P.A. (1996). Bioethics for clinicians: 5. Substitute decision-making. Canadian Medical Association Journal, 155, 1435–1437.Google ScholarPubMed
Marshall, D.T. (2000). The law of human experimentation. Toronto: Butterworths.Google Scholar
Medical Research Council of Canada (1987). Guidelines for research involving human subjects. Ottawa: Ministry of Supply and Services Canada.Google Scholar
Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, & Social Sciences and Humanities Research Council of Canada (1998) [with 2000, 2002 updates]. Tri-Council policy statement: Ethical conduct for research involving humans. Ottawa: Public Works and Government Services Canada.Google Scholar
Menikoff, J.A., Sachs, G.A., & Siegler, M. (1992). Beyond advance directives: Health care surrogate laws. New England Journal of Medicine, 327, 1165–1169.CrossRefGoogle ScholarPubMed
Miller, T.A., Coleman, C.H., & Cugliari, A.M. (1997). Treatment decisions for patients without surrogates: Rethinking policies for a vulnerable population. Journal of the American Geriatrics Society, 45, 369–374.CrossRefGoogle ScholarPubMed
Mohr, E., Feldman, H., & Gauthier, S. (1995). Canadian guidelines for the development of antidementia therapies: A conceptual summary. Canadian Journal of Neurological Sciences, 22, 62–71.CrossRefGoogle ScholarPubMed
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Washington, DC: US Government Printing Office.Google Scholar
National Council on Ethics in Human Research (1996). Facilitating ethical research: Promoting informed consent. Discussion document. Ottawa.Google Scholar
Oldham, J.M., Haimowitz, S., & Delano, S.J. (1999). Protection of persons with mental disorders from research risk: A response to the report of the National Bioethics Advisory Commission. Archives of General Psychiatry, 56, 688–693.CrossRefGoogle Scholar
Post, S.G., & Whitehouse, P.J. (1998). Emerging antidementia drugs: A preliminary ethical view. Journal of the American Geriatrics Society, 46, 784–787.CrossRefGoogle ScholarPubMed
Rabins, P.V. (1998). Issues raised by research using persons suffering from dementia who have impaired decisional capacity. Journal of Health Care Law & Policy, 1, 22–35.Google ScholarPubMed
Rockwood, K., Beattie, B.L., Eastwood, M.R., Feldman, H., Mohr, E., Pryse-Phillips, W., & Gauthier, S. (1997). A randomized, controlled trial of linopirdine in the treatment of Alzheimer's disease. Canadian Journal of Neurological Sciences, 24, 140–145.CrossRefGoogle ScholarPubMed
Rockwood, K., Macknight, C., Wentzel, C., Black, S., Bouchard, R., Gauthier, S., Feldman, H., Hogan, D., Kertesz, A., & Montgomery, P. for the CIVIC Investigators. (2000). The diagnosis of “mixed” dementia in the consortium for the investigation of vascular impairment of cognition (CIVIC). Annals New York Academy of Sciences, 903, 522–528.CrossRefGoogle Scholar
Sachs, G.A., & Cassel, C.K. (1990). Biomedical research involving older human subjects. Law, Medicine & Health Care, 18, 234–243.CrossRefGoogle ScholarPubMed
Silverman, H., Hull, S.C., & Sugarman, J. (2001). Variability among institutional review boards' decisions within the context of a multicenter trial. Critical Care Medicine, 29, 235–241.CrossRefGoogle ScholarPubMed
U.S. Code of Federal Regulations. Title 45CFR46. Department of Health and Human Services, Washington, DC. Revised June 18, 1991.Google Scholar
Weijer, C. (2000). The ethical analysis of risk. Journal of Law, Medicine and Ethics, 28, 344–361.CrossRefGoogle ScholarPubMed
Wendler, D., Martinez, R., Fairclough, D., Sunderland, T., & Ezekiel, E. (2002). Views of potential subjects toward proposed regulations for clinical research with adults unable to consent. American Journal of Psychiatry, 159, 585–591.CrossRefGoogle ScholarPubMed
Woodward, B. (1999). Challenges to human subject protections in US medical research. Journal of the American Medical Association, 282, 1947–1952.CrossRefGoogle ScholarPubMed
World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Adopted in Helsinki, Finland (June 1964), and amended in Tokyo, Japan (October 1975), Venice, Italy (October 1983), Hong Kong (September 1989), Somerset West, Republic of South Africa (October 1996), and Edinburgh, Scotland (October 2000).Google Scholar