Ethical considerations for the conduct of antidementia trials in Canada

Canadian Journal of Neurological Sciences

Volumn 34, Issue SUPPL. 1, 2007, Pages

  Fisk, John D ^a,b  

^a DALHOUSIE UNIVERSITY   (Canada)

^b AJ Lane Memorial Building ^*  (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CHOLINESTERASE INHIBITOR; NOOTROPIC AGENT; PLACEBO;

ALZHEIMER DISEASE; CANADA; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; DEMENTIA; ETHICAL DECISION MAKING; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; PATIENT EDUCATION; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; TREATMENT RESPONSE;

EID: 34248593270     PISSN: 03171671     EISSN: None     Source Type: Journal    
DOI: 10.1017/s0317167100005539     Document Type: Conference Paper

References (54)

1. Miller FG, Brody H. What makes placebo-controlled trials unethical? Am J Bioethics. 2002; 2: 3-9.
2. Lemmens T, Miller PB. Avoiding a Jekyll-and-Hyde approach to the ethics of clinical research and practice. Am J Bioethics. 2002; 2: 14-7.
3. World Medical Association, World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects. Adopted 1964, last amended 2002, [cited April 13, 2006]. Available from: http://www.wma.net/e/policy/b3.htm.
4. Council for International Organizations of Medical Sciences. (2002). International Ethical Guidelines for Biomedical Research Involving Human Subjects. [cited April 13, 2006]. Available from: http://www.cioms.ch/ frame_guidelines_nov_2002.htm.
5. Graham C, Holmes C, Lindesay J. Clinical involvement in anti-dementia drug trials - why bother? Int J Geriatric Psychiatry. 1999; 14: 258-60.
6. Lader EW, Cannon CP, Ohman EM, Newby LK, Sulmasy DP, Barst R, et al. The clinician as investigator: participating in clinical trials in the practice setting. Circulation. 2004; 109: 2672-9.
7. 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, [cited April 13, 2006]. Available from: http://www.nihtraining.com/ohsrsite/guidelines/belmont.html.
8. 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. [cited April 13, 2006], Available from: http://conventions.coe.int/Treaty/en/Treaties/ Html/164.htm.
9. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 1998 (with 2000, 2002 updates), [cited April 13, 2006]. Available from: http://pre.ethics.gc.ca/english/policystatement/policystatement.cfm.
10. International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use. (2004). Good Clinical Practice: Consolidated Guidelines E6. [cited April 13, 2006]. Available from: http://www.ich.org/cache/compo/276-254-1.html.
11. Department of Health and Human Services. (2001). Code of Federal Regulations Title 45 Part 46 Regulations for the Protection of Human Subjects, Section 46.102.i, [cited April 13, 2006]. Available from: http://www.hhs.gov/ ohrp/humansubjects/guidance/45cfr46.htm.
12. Steinbrook R. Improving protection for research subjects. N Eng J Med. 2002; 346: 1425-30.
13. Office of Human Subjects Research, Information Sheet 7, National Institutes of Health, [cited April 13, 2006]. Available from: http://ohsr.od.nih.gov/info/sheet3.html.
14. Weijer C. The ethical analysis of risk. J Law Med Ethics 2000; 28: 344-61.
15. High DM, Whitehouse PJ, Post SG, Berg L. Guidelines for addressing ethical and legal issues in Alzheimer disease research: a position paper. Alzheimer Dis Assoc Disord 1994; 8: 66-74.
16. Keyserlingk EW, Glass K, Kogan S, Gauthier S. Proposed guidelines for the participation of persons with dementia as research subjects. Perspect Biol Med 1995; 38: 319-62.
17. Birks J. Cholinesterase inhibitors for Alzheimer's disease. The Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD005593. DOI: 10.1002/14651858.CD005593.
18. Craig D, Birks J. Rivastigmine for vascular cognitive impairment. The Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD004744. DOI: 10.1002/14651858.CD004744.pub2.
19. Malouf R, Birks J. Donepezil for vascular cognitive impairment. The Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD004395. DOI: 10.1002/14651858.CD004395.pub2.
20. Maidment I, Fox C, Boustani M. Cholinesterase inhibitors for Parkinson's disease dementia. The Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD004747. DOI:10.1002/14651858.CD004747.pub2.
21. Wild R, Pettit T, Burns A. Cholinesterase inhibitors for dementia with Lewy bodies. The Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.: CD003672. DOI:10.1002/14651858.CD003672.
22. Birks J, Harvey RJ. Donepezil for dementia due to Alzheimer's disease. The Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD001190. DOI: 10.1002/14651858.CD001190.pub2.
23. Greenberg SM, Bacskai BJ, Hyman BT. Alzheimer disease's double-edged vaccine. Nature Med. 2003; 9: 389-90.
24. Karlawish JHT, Casarett DJ, James BD. 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. 2002; 50: 2019-24.
25. Petersen RC, Stevens JC, Ganguli M, Tangalos EG, Cummigs JL, DeKosky ST. Practice parameter: Early detection of dementia: mild cognitive impairment (an evidence-based review). Neurology. 2001; 56: 1133-42.
26. Etchells E, Darzins P, Silberfeld, M, Singer PA, McKenny J, Naglie G, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999; 14: 27-34.
27. Karlawish JHT, Casarett DJ, James BD, Xie SX, Kim SYH. The ability of persons with Alzheimer's disease (AD) to make a decision about taking an AD treatment. Neurology. 2005; 64: 1514-9.
28. Kim SYH, Caine ED. Utility and limits of the Mini Mental State Examination in evaluating consent capacity in Alzheimer's disease. Psychiatr Serv. 2002; 53: 1322-4.
29. McQuillan MP, Tariot P. Who can say yes (or no) to a physician - and how does the physician know they can? Neurology. 2005; 64: 1494-5.
30. Marson DC. Loss of competency in Alzheimer's disease: conceptual and psychometric approaches. Int J Law Ethics. 2001; 24: 267-83.
31. Moye J, Karel MJ, Azar AR, Gurrera RJ. Capacity to consent to treatment: Empirical comparison of the instruments in older adults with and without dementia. Gerontologist. 2004; 44: 166-75.
32. Marson DC, McInturff B, Hawkins L, Bartolucci A, Harrell LE. Consistency of physician judgements of capacity to consent in Alzheimer's disease. J Am Geriatr Soc. 1997; 45: 453-7.
33. Kim SY, Caine ED, Currier GW, Leibovici A, Ryan JM. Assessing the competence of persons with Alzheimer's disease in providing informed consent for participation in research. Am J Psychiatry. 2001; 158: 712-7.
34. High DM. Research with Alzheimer's disease subjects: informed consent and proxy decision-making. J Am Geriatr Soc. 1992; 40: 950-7.
35. Fisk JD, Sadovnick AD, Cohen CA, Gauthier S, Dossetor, J. Eberhart A, et al. Ethical guidelines of the Alzheimer Society of Canada. Can J Neurol Sci. 1998; 25: 242-8.
36. Karlawish JHT. Research involving cognitively impaired adults. N Engl J Med. 2003; 348: 1389-92.
37. Wendler D, Prasad K. Core safe guards for clinical research with adults who are unable to consent. Ann Intern Med. 2001; 135: 514-23.
38. Alzheimer Society of Canada. Ethical Guidelines, 2003. [cited April 13, 2006]. Available from: http://www.alzheimer.ca/english/care/ethics-intro.htm.
39. 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. 1998; 50: 592-5.
40. Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res. 1994; 42: 403-12.
41. Candilis PJ, Wesley RW, Wichman A. A survey of researchers using a consent policy for cognitively impaired human research subjects. IRB. 1993: 15: 1-4.
42. Werner P. Correlates of family caregivers knowledge about Alzheimer's disease. Int J Geriatr Psychiatry. 2001; 16: 32-8.
43. Karlawish JH, Casarett D, Klocinski J, Sankar P. How do AD patients and their caregivers decide whether to enroll in a clinical trial? Neurology. 2001; 56: 789-92.
44. 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: 1110-9.
45. Karlawish JH, Klocinski JL. Merz J, Clark CM, Asch DA. Caregivers' preferences for the treatment of patients with Alzheimer's disease. Neurology. 2000; 55: 1008-14.
46. Huston P, Peterson R. Withholding proven treatment in clinical research. N Engl J Med. 2001; 345: 912-4.
47. Freedman B, Glass K, Weijer C. Placebo orthodoxy in clinical research. II: ethical, legal, and regulatory myths. J Law Med Ethics. 1996; 24: 252-9.
48. Shapiro E, Shapiro A. The powerful placebo: from ancient priest to modern physician. Baltimore: The John Hopkins University Press; 1997.
49. Guess HA, Kleinman A, Kusek JW, Engel LW, editors. The science of the placebo. London: BMJ Books; 2002.
50. International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use. (2000) Choice of Control Group and Related Issues in Clinical Trials E10. [cited April 13, 2006]. Available from: http://www.ich.org/cache/compo/276-254-1.html.
51. National Placebo Initiative, Final Report of the National Placebo Working Committee on the Appropriate use of Placebos in Clinical Trials in Canada, July 2004, [cited April 13, 2006]. Available from: http://www.cihr-irsc.gc.ca/e/ 25139.html.
52. Chen DT, Miller FG, Rosenstein DL. Clinical research and the physician-patient relationship. Ann Intern Med. 2003; 138: 669-72.
53. Morin K, Rakatansky H, Riddick FA. Managing conflict of interest in the conduct of clinical trials. JAMA. 2002; 287:78-84.
54. Kim SYH, Millard RW, Nisbet P, Cox C, Caine ED. Potential research participants' views regarding researcher and institutional financial conflicts of interest. J Med Ethics. 2004; 30:73-9.