Hostname: page-component-76fb5796d-r6qrq Total loading time: 0 Render date: 2024-04-25T07:14:09.568Z Has data issue: false hasContentIssue false
  • English
  • Français

Consent in Alzheimer's Disease Research: Risk/Benefit Factors

Published online by Cambridge University Press:  02 December 2014

B. Lynn Beattie
B. Lynn Beattie*
Affiliation:
The Department of Medicine, Division of Geriatric Medicine, University of British Columbia, Vancouver, BC, Canada
Rights & Permissions [Opens in a new window]

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

In the era of chronic disease, we are challenged to find therapies that provide symptomatic relief and ideally, alter the course of the underlying disease. In Alzheimer's disease (AD), these issues are complicated by the disease itself, which affects the subject's decision-making capacity for participation in the research. According to established ethical guidelines it is clear that individuals with impaired capacity may participate in research and their risk should be no greater than that which the individual would have in day to day activities with anticipation of benefits within that realm. Decision making processes are complex and involve proxies who themselves have biases about their loved one and the potential for participating in the research. Newer disease-modifying approaches such as immunotherapy have potential for affecting the course of the underlying disease but with greater risk of more significant side effects. Ideally the health care of the subjects is not disadvantaged by research participation. At the same time, trials of potentially riskier therapy are relevant in subjects with the disease. Research for subjects with AD must have appropriate safeguards in place to enable effective progress in innovative therapy for a vulnerable, often elderly population. Recommendations are made which could further our capacity to undertake ethical research in the AD population.

Type
Original Articles
Information
Canadian Journal of Neurological Sciences , Volume 34 , Issue S1 , March 2007 , pp. S27 - S31
Copyright
Copyright © The Canadian Journal of Neurological 2007

References

1. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Public Works and Government Services Canada; 2005.Google Scholar
2. Emanuel, EJ, Crouch, RA, Arras, JD, editors. Ethical and regulatory aspects of clinical research: readings and commentary. Baltimore, Maryland, USA. The Johns Hopkins University Press; 2003.Google Scholar
3. Buckles, VD, Powlishta, KK, Palmer, JL, Coats, M, Hosto, T, Buckley, A, et al. Understanding of informed consent by demented individuals. Neurology. 2003; 61(12):1662–6.Google Scholar
4. Hirschman, KB, Xie, SX, Feudtner, C, Karlawish, JH. How does an Alzheimer’s disease patient’s role in medical decision making change over time? J Geriatr Psychiatry Neurol. 2004; 17(2): 55–60.Google Scholar
5. Kim, SY, Appelbaum, PS, Jeste, DV, Olin, JT. Proxy and surrogate consent in geriatric neuropsychiatric research: update and recommendations. Am J Psychiatry. 2004; 161(5):797–806.CrossRefGoogle ScholarPubMed
6. Pucci, E, Belardinelli, N, Borsetti, G, Rodriguez, D, Signorino, M. Information and competency for consent to pharmacologic clinical trials in Alzheimer disease: an empirical analysis in patients and family caregivers. Alzheimer Dis Assoc Disord. 2001; 15(3):146–54.CrossRefGoogle ScholarPubMed
7. Warren, JW, Sobal, J, Tenney, JH, Hoopes, JM, Damron, D, Levenson, S, et al. Informed consent by proxy. An issue in research with elderly patients. N Engl J Med. 1986; 315(18):1124–8.Google Scholar
8. Ouslander, JG, Tymchuk, AJ, Rahbar, B. Health care decisions among elderly long-term care residents and their potential proxies. Arch Intern Med. 1989; 149(6):1367–72.Google Scholar
9. Seckler, AB, Meier, DE, Mulvihill, M, Paris, BE. Substituted judgment: how accurate are proxy predictions? Ann Intern Med. 1991; 115(2):92–8.Google Scholar
10. Sachs, GA. Advance consent for dementia research. Alzheimer Dis Assoc Disord. 1994; 8(Suppl. 4):S19–27.Google Scholar
11. Muncie, HL Jr., Magaziner, J, Hebel, JR, Warren, JW. Proxies’ decisions about clinical research participation for their charges. J Am Geriatr Soc. 1997; 45(8):929–33.Google Scholar
12. Williams, BF, French, JK, White, HD. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study. Lancet. 2003; 361(9361):918–22.Google Scholar
13. Lewis, BS, Yuval, R, Halon, DA, Flugelman, MY. Selection bias introduced by the informed consent process. Lancet. 2003; 361(9373):1990–1.CrossRefGoogle ScholarPubMed
14. Sugarman, J, Cain, C, Wallace, R, Welsh-Bohmer, KA. How proxies make decisions about research for patients with Alzheimer’s disease. J Am Geriatr Soc. 2001; 49(8):1110–9.Google Scholar
15. Karlawish, JH, Casarett, D. Addressing the ethical challenges of clinical trials that involve patients with dementia. J Geriatr Psychiatry Neurol. 2001; 14(4):222–8.Google Scholar
16. Beck, C, Shue, V. Surrogate decision-making and related issues. Alzheimer Dis Assoc Disord. 2003; 17 Suppl 1:S12–16.Google Scholar
17. Guidance notes for new applications for clinical ethical review by the UBC Clinical Research Ethics Board. Appendix 1. 2006. www.ors.ubc.ca/ethics/clinical/CREB_GN/CREB_Guidance_Notes.htmlGoogle Scholar
18. Schenk, D, Barbour, R, Dunn, W, Gordon, G, Grajeda, H, Guido, T, et al. Immunization with amyloid-beta attenuates Alzheimerdisease-like pathology in the PDAPP mouse. Nature. 1999; 400(6740):173–7.CrossRefGoogle ScholarPubMed
19. Schenk, D. Amyloid-beta immunotherapy for Alzheimer’s disease: the end of the beginning. Nat Rev Neurosci. 2002; 3(10):824–8.CrossRefGoogle ScholarPubMed
20. Hock, C, Konietzko, U, Streffer, JR, Tracy, J, Signorell, A, Muller-Tillmanns, B, et al. Antibodies against beta-amyloid slow cognitive decline in Alzheimer’s disease. Neuron. 2003; 38(4):547–54.Google Scholar
21. Orgogozo, JM, Gilman, S, Dartigues, JF, Laurent, B, Puel, M, Kirby, LC, et al. Subacute meningoencephalitis in a subset of patients with AD after Abeta42 immunization. Neurology. 2003; 61(1):46–54.Google Scholar
22. Ferrer, I, Boada, RM, Sanchez Guerra, ML, Rey, MJ, Costa-Jussa, F. Neuropathology and pathogenesis of encephalitis following amyloid-beta immunization in Alzheimer’s disease. Brain Pathol. 2004; 14(1):11–20.CrossRefGoogle ScholarPubMed
23. Nicoll, JA, Wilkinson, D, Holmes, C, Steart, P, Markhan, H, Weller, RO. Neuropathology of human Alzheimer disease after immunization with amyloid-beta peptide: a case report. Nat Med. 2003; 9(4):448–52.Google Scholar
24. White, AR, Hawke, SH. Immunotherapy as a therapeutic treatment for neurodegenerative disorders. J Neurochem. 2003; 87(4): 801–8.Google Scholar
25. Robinson, SR, Bishop, GM, Lee, HG, Munch, G. Lessons from the AN 1792 Alzheimer vaccine: lest we forget. Neurobiol Aging. 2004; 25(5):609–15.Google Scholar
26. McGeer, PL, McGeer, E. Is there a future for vaccination as a treatment for Alzheimer’s disease? Neurobiol Aging. 2003; 24(3):391–5.Google Scholar
27. Heppner, FL, Gandy, S, McLaurin, J. Current concepts and future prospects for Alzheimer disease vaccines. Alzheimer Dis Assoc Disord. 2004; 18(1):38–43.Google Scholar
28. Post, SG. Full-spectrum proxy consent for research participation when persons with Alzheimer disease lose decisional capacities: research ethics and the common good. Alzheimer Dis Assoc Disord. 2003; 17 Suppl 1:S3–11.Google Scholar