Proposed Guidelines for the Participation of Persons with Dementia as Research Subjects

Abstract

Proposed Guidelines for the Participation of Persons with Dementia as Research Subjects Edward W. Keyserlingk, Kathleen Glass, Sandra Kogan, and Serge Gauthier Edward W. Keyserlingk and Kathleen Glass McGill University Centre for Medicine, Ethics and Law, 3690 Peel Street, Montreal, Quebec, Canada H3A IW9 Sandra Kogan and Serge Gauthier McGill University Centre for Studies in Aging, St. Mary's Hospital, 3830 Lacombe, Annex Bldg. Room 1712, Montreal, Quebec, Canada H3T 1M5 References 1. Canadian Study of Health and Aging Working Group. Canadian study of health and aging: Study methods and prevalence of dementia. Can. Med. Assoc. J. 150:899-903, 1994. Google Scholar 2. KOGAN, S.; GLASS, K. C.; KEYSERLINGK, E. W.; and GAUTHIER, S. Protecting research subjects with dementia: How do REBs, community elderly, subjects and their families perceive the issues? (Manuscript in preparation.) 3. MELNICK, V. L.; DUBLER, N.; WEISBARD, A.; et al. Clinical research in senile dementia of the Alzheimer's type: Suggested Guidelines Addressing the Ethical and Legal Issues. In Alzheimer's Dementia, edited by V. L. MELNICK and N. N. DUBLER. New Jersey: Humana Press, 1985. Google Scholar 4. American College of Physicians. Cognitively impaired subjects. Ann. Intern. Med. 111:843-848, 1989. Google Scholar 5. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Regulations for Protection of Human Subjects. 45 CFR Sec. 46. 6. LEVINE, R. J. Ethics and the Regulation of Clinical Research. 2nd ed. Baltimore, Urban and Schwarzenberg, 1986. Google Scholar 7. FREEDMAN, B.; FUKS, A.; and WEIJER, C. In loco parentis: Minimal risk as ethical threshold for research upon children. Hastings Center Report 23:13-19, 1993. Google Scholar 8. Additional DHHS Protections for Children Involved as Subjects of Research. OPPR Reports 45 CFR 46, rev. 1991. 9. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Research Involving Those Institutionalized as Mentally Infirm. DHEW Publication No. (OS) 78-0006. Washington, D.C., 1978. Google Scholar 10. Medical Research Council of Canada. Guidelines on Research Involving Human Subjects. Ottawa: Minister of Supply and Services, 1987. Google Scholar 11. The Civil Code of Quebec, 1991, in force Dec. 1993. 12. The Nuremberg Code. In Informed Consent to Human Experimentation: The Subject's Dilemma, edited by G. J. ANNAS; L. H. GLANZ; and B. F. KATZ. Cambridge: Ballinger, 1977. Google Scholar 13. World Medical Association. Declaration of Helsinki, rev. 1983. In Law, Science and Medicine, edited by J. AREEN; P. A. KING, S. GOLDBERG; and A. M. CAPRON. New York: Foundation Press, 1984. Google Scholar 14. DICKENS, B. Substitute consent to participation of persons with Alzheimer's disease in medical research: Legal issues. In Alzheimer's Disease Research: Ethical and Legal Issues, edited by J. M. BERG; H. KARLINSKY; and F. H. LOWY. Toronto: Carswell, 1991. Google Scholar 15. BANKOWSKI, Z., and LEVINE, R., eds. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Association, 1993. Google Scholar 16. Bill 109, An Act Respecting Consent to Treatment, 1st Session, 35th Leg. Ont. 1991. 17. FLETCHER, J.; DOMMEL, F. W.; and COWELL, D. D. A trial policy for the intramural programs of the national institutes of health: Consent to research with impaired subjects. IRB: A Review of Human Subjects Research 7:1-6, 1985. Google Scholar 18. SZAZ, T. S. The psychiatric will. Am. Psychol. 37:762-775, 1982. Google Scholar 19. MACKLIN, A. Bound to freedom: The Ulysses contract and the psychiatric will. U. of Toronto Fac. L.R. 45:37-68, 1987. Google Scholar 20. National Council on Bioethics in Human Research. Report on Research Involving Children. Ottawa: NCBHR, 1992. Google Scholar Appendix Participants in Consultation Sessions H. Brassard (law, public guardianship) M. Burgess (philosophy, ethics) A. M. Clarfield (geriatric medicine) M. Cole (psychiatry) D. Dastoor (Alzheimer's society) P. Deschamps (law) B. Dickens (law) H. Frank (medicine, research ethics) B. Freedman (philosophy, ethics) S. Gauthier (medicine, geriatrics) K. C. Glass (law, ethics) C. Goresky (medicine...