Ethical considerations for decision making for treatment and research participation

Alzheimer's and Dementia

Volumn 3, Issue 4, 2007, Pages 411-417

  Fisk, John D ^a   Beattie, B Lynn ^b   Donnelly, Martha ^b  

^a QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

Alzheimer's disease; Competency; Decision making; Dementia; Ethics

Indexed keywords

CAREGIVER; CLINICAL RESEARCH; COGNITIVE DEFECT; CUSTODY; DEMENTIA; FAMILY; HUMAN; MEDICAL ETHICS; MENTAL CAPACITY; PATIENT ATTITUDE; PATIENT CARE; PATIENT DECISION MAKING; PATIENT PARTICIPATION; PHYSICIAN ATTITUDE; PRIORITY JOURNAL; REVIEW;

EID: 35048824471     PISSN: 15525260     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jalz.2007.08.001     Document Type: Review

References (43)

1. Patterson C.J.S., Gauthier S., Bergman H., Cohen C.A., Feightner J.W., Feldman H., et al. The recognition, assessment and management of dementing disorders: conclusions from the Canadian Consensus Conference on Dementia. CMAJ 160 Suppl (1999) S1-S15
2. Miller F.G., and Brody H. What makes placebo-controlled trials unethical?. Am J Bioeth 2 (2002) 3-9
3. Lemmens T., and Miller P.B. Avoiding a Jekyll-and-Hyde approach to the ethics of clinical research and practice. Am J Bioeth 2 (2002) 14-17
4. American Medical Association. Code of medical ethics. Available at: www.ama-assn.org/ama/pub/category/8292.html. Accessed: September 6, 2007.
5. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects (2002). http://www.cioms.ch/frame_guidelines_nov_2002.htm Available at: www.cioms.ch/frame_guidelines_nov_2002.htm. Accessed: September 6, 2007.
6. Alzheimer Society of Canada. Ethical guidelines (2003). http://www.alzheimer.ca/english/care/ethics-intro.htm Available at: www.alzheimer.ca/english/care/ethics-intro.htm. Accessed: September 6, 2007.
7. Fisk J.D., Sadovnik A.D., Cohen C.A., Gauthier S., Dossetor J.B., Eberhart A., et al. Ethical guidelines of the Alzheimer Society of Canada. Can J Neurol Sci 25 (1998) 242-248
8. High D.M., Whitehouse P.J., Post S.J., and Berg L. Guidelines for addressing ethical and legal issues in Alzheimer disease research: a position paper. Alzheimer Dis Assoc Disord 8 (1994) 66-74
9. National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, the Belmont Report, ethical principles and guidelines for the protection of human subjects of research (1979). http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. Accessed: September 6, 2007.
10. Tri-Council policy statement: ethical conduct for research involving humans (1998). http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm (with 2000, 2002 updates). Available at: http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm. Accessed: September 6, 2007.
11. World Medical Association Declaration of Helsinki, ethical principles for medical research involving human subjects. Available at: www.wma.net/e/policy/b3.htm. Accessed: September 6, 2007.
12. Council of Europe, 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, 4.IV (1997). http://conventions.coe.int/treaty/en/Treaties/Html/164.htm Available at: http://conventions.coe.int/treaty/en/Treaties/Html/164.htm. Accessed: September 6, 2007.
13. International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Revised ICH Terms of Reference. Available at: http://www.ich.org/cache/compo/276-254-1.html. Accessed: September 6, 2007.
14. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, Studies in Support of Special Populations: Geriatrics E7 (1993). http://www.ich.org/cache/compo/276-254-1.html Available at: http://www.ich.org/cache/compo/276-254-1.html. Accessed: September 6, 2007.
15. Karlawish J.H.T. Research involving cognitively impaired adults. N Engl J Med 348 (2003) 1389-1392
16. Office of Human Subjects Research, information sheet 7, National Institutes of Health. Available at: http://ohsr.od.nih.gov/info/sheet3.html.
17. Weijer C. The ethical analysis of risk. J Law Med Ethics 28 (2000) 344-361
18. Department of Health and Human Services. Code of federal regulations title 45 part 46: regulations for the protection of human subjects, section 46.102.i (2001). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm Available at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed: September 6, 2007.
19. Keyserlingk E.W., Glass K., Kogan S., and Gauthier S. Proposed guidelines for the participation of persons with dementia as research subjects. Perspect Biol Med 38 (1995) 319-362
20. Alzheimer's Association. Ethical Issues in Dementia Research (with special emphasis on "informed consent"). Available at: http://www.alz.org/national/documents/statements_ethicalissues.pdf. Accessed: September 6, 2007.
21. Wendler D., and Prasad K. Core safe guards for clinical research with adults who are unable to consent. Ann J Intern Med 135 (2001) 514-523
22. Karlawish J.H.T., Casarett D.J., and James B.D. Alzheimer's disease patients' and caregivers' capacity, competency, and reasons to enroll in an early-phase Alzheimer's disease clinical trial. J Am Geriatr Soc 50 (2002) 2019-2024
23. Petersen R.C., Stevens J.C., Ganguli M., Tangalos E.G., Cummings J.L., DeKosky S.T., et al. Practice parameter: early detection of dementia: mild cognitive impairment (an evidence-based review). Neurology 56 (2001) 1133-1142
24. Marson D.C. Loss of competency in Alzheimer's disease: conceptual and psychometric approaches. Int J Law Ethics 24 (2001) 267-283
25. High D.M. Research with Alzheimer's disease subjects: informed consent and proxy decision-making. J Am Geriatr Soc 40 (1992) 950-957
26. Moye J., Karel M., Azar A.R., and Gurrera R.J. Capacity to consent to treatment: empirical comparison of the instruments in older adults with and without dementia. Gerontologist 44 (2004) 166-175
27. Marson D.C., McInturff B., Hawkins L., Bartolucci A., and Harrell L.E. Consistency of physician judgements of capacity to consent in Alzheimer's disease. J Am Geriatr Soc 45 (1997) 453-457
28. Etchells E., Darzins P., Silberferfeld M., Singer P.A., McKenny J., Naglie G., et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med 14 (1999) 27-34
29. Karlawish J.H.T., Casarett D.J., James B.D., Xie S.X., and Kim S.Y.H. The ability of persons with Alzheimer's disease (AD) to make a decision about taking an AD treatment. Neurology 64 (2005) 1514-1519
30. Kim S.Y.H., and Caine E.D. Utility and limits of the Mini Mental State Examination in evaluating consent capacity in Alzheimer's disease. Psychiatric Services 3 (2002) 1322-1324
31. McQuillan M.P., and Tariot P. Who cand say yes (or no) to a physician: and how does the physician know they can?. Neurology 64 (2005) 1494-1495
32. Kim S.Y., Caine E.D., Currier G.W., Leibovici A., and Ryan J.M. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry 158 (2001) 712-717
33. The Ethics and Humanities Subcommittees of the American Academy of Neurology. Ethical issues in clinical research in neurology. advancing knowledge and protecting human research subjects. Neurology 50 (1998) 592-595
34. Alzheimer Society of Canada. Tough issues: ethical guidelines of the Alzheimer Society of Canada (1997), Alzheimer Society of Canada, Toronto
35. Sachs G.A., Stocking C.B., Stern R., et al. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res 42 (1994) 403-412
36. Candilis P.J., Wesley R.W., and Wichman A. A survey of researchers using a consent policy for cognitively impaired human research subjects. IRB 15 (1993) 1-4
37. Werner P. Correlates of family caregivers knowledge about Alzheimer's disease. Int J Geriatr Psychiatry 16 (2001) 32-38
38. Sugarman J., Cain C., Wallace R., and Welsh-Bohmer K.A. How proxies make decisions about research for patients with Alzheimer's disease. J Am Geriatr Soc 49 (2001) 1110-1119
39. Karlawish J.H.T., Klocinski J.L., Merz J., Clark C.M., and Asch D.A. Caregivers' preferences for the treatment of patients with Alzheimer's disease. Neurology 55 (2000) 1008-1014
40. Connell C.M., Shaw B.A., Holmes S.B., and Foster N. Caregiver's attitudes toward their family members' participation in Alzheimer disease research: implications for recruitment and retention. Alzheimer Dis Assoc Disord 15 (2001) 137-145
41. Vist G.E., Hagen K.B., Devereaux P.J., Bryant D., Kristoffersen D.T., and Oxman A.D. Systematic review to determine whether participation in a trial influences outcome. BMJ 330 (2005) 1175-1181
42. Karlawish J.H.T., Casarett D., Klocinski J., and Sankar P. How do AD patients and their caregivers decide whether to enroll in a clinical trial?. Neurology 56 (2001) 789-792
43. Graham C., Holmes C., and Lindesay J. Clinical involvement in anti-dementia drug trials: why bother?. Int J Geriatr Psychiatry 14 (1999) 257-260