When does therapeutic misconception affect surrogates' or subjects' decision making about whether to participate in dementia research?

AMA Journal of Ethics

Volumn 19, Issue 7, 2017, Pages 678-685

  Dunn, Laura B ^a   Palmer, Barton W ^b  

^a STANFORD UNIVERSITY   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; DEMENTIA; HUMAN; MEDICAL RESEARCH; THERAPEUTIC MISCONCEPTION;

BIOMEDICAL RESEARCH; DECISION MAKING; DEMENTIA; HUMANS; THERAPEUTIC MISCONCEPTION;

EID: 85042008732     PISSN: None     EISSN: 23766980     Source Type: Journal    
DOI: 10.1001/journalofethics.2017.19.7.nlit1-1707     Document Type: Article

References (30)

1. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982;5(3-4):321.
2. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep. 1987;17(2):20-24.
3. Appelbaum, Roth, Lidz, Benson, Winslade, 22.
4. Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420-435.
5. Appelbaum PS. Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception. Am J Bioeth. 2002;2(2):23.
6. Appelbaum PS, Lidz CW, Grisso T. Therapeutic misconception in clinical research: frequency and risk factors. IRB. 2004;26(2):1-8.
7. Lidz CW, Appelbaum PS, Grisso T, Renaud M. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med. 2004;58(9):1689-1697.
8. Appelbaum PS, Lidz CW. Twenty-five years of therapeutic misconception. Hastings Cent Rep. 2008;38(2):5-6; author reply 6-7.
9. Henderson GE, Easter MM, Zimmer C, et al. Therapeutic misconception in early phase gene transfer trials. Soc Sci Med. 2006;62(1):239-253.
10. Daugherty CK, Banik DM, Janish L, Ratain MJ. Quantitative analysis of ethical issues in phase I trials: a survey interview of 144 advanced cancer patients. IRB. 2000;22(3):6-14.
11. Henderson GE, Churchill LR, Davis AM, et al. Clinical trials and medical care: defining the therapeutic misconception. PLoS Med. 2007;4(11):1735-1738.
12. Appelbaum PS, Anatchkova M, Albert K, Dunn LB, Lidz CW. Therapeutic misconception in research subjects: development and validation of a measure. Clin Trials. 2012;9(6):748-761.
13. Lidz CW, Albert K, Appelbaum P, Dunn LB, Overton E, Pivovarova E. Why is therapeutic misconception so prevalent? Camb Q Healthc Ethics. 2015;24(2):231.
14. Horng S, Grady C. Misunderstanding in clinical research: distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB. 2003;25(1):11-16.
15. Miller FG, Joffe S. Evaluating the therapeutic misconception. Kennedy Inst Ethics J. 2006;16(4):353-366.
16. Kimmelman J. The therapeutic misconception at 25: treatment, research, and confusion. Hastings Cent Rep. 2007;37(6):36-42.
17. 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(5):712-717.
18. Kim SY, Karlawish JH, Caine ED. Current state of research on decision-making competence of cognitively impaired elderly persons. Am J Geriatr Psychiatry. 2002;10(2):151-165.
19. Palmer BW, Ryan KA, Kim HM, Karlawish JH, Appelbaum PS, Kim SY. Neuropsychological correlates of capacity determinations in Alzheimer disease: implications for assessment. Am J Geriatr Psychiatry. 2013;21(4):373-381.
20. Jefferson AL, Lambe S, Moser DJ, Byerly LK, Ozonoff A, Karlawish JH. Decisional capacity for research participation in individuals with mild cognitive impairment. J Am Geriatr Soc. 2008;56(7):1236-1243.
21. Appelbaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press; 2001.
22. Black BS, Wechsler M, Fogarty L. Decision making for participation in dementia research. Am J Geriatr Psychiatry. 2013;21(4):355-363.
23. Black BS, Rabins PV, Sugarman J, Karlawish JH. Seeking assent and respecting dissent in dementia research. Am J Geriatr Psychiatry. 2010;18(1):77-85.
24. 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.
25. Cooper C, Mukadam N, Katona C, et al. Systematic review of the effectiveness of pharmacologic interventions to improve quality of life and well-being in people with dementia. Am J Geriatr Psychiatry. 2013;21(2):173-183.
26. Dunn LB, Hoop JG, Misra S, Fisher SR, Roberts LW. “A feeling that you're helping”: proxy decision making for Alzheimer's research. Narrat Inq Bioeth. 2011;1(2):107-122.
27. Dunn, Hoop, Misra, Fisher, Roberts, 115.
28. Overton E, Appelbaum PS, Fisher SR, Dohan D, Roberts LW, Dunn LB. Alternative decision-makers' perspectives on assent and dissent for dementia research. Am J Geriatr Psychiatry. 2013;21(4):346-354.
29. Dunn LB, Fisher SR, Hantke M, et al. “Thinking about it for somebody else”: Alzheimer's disease research and proxy decision makers' translation of ethical principles into practice. Am J Geriatr Psychiatry. 2013;21(4):337-345.
30. Federal policy for the protection of human subjects; final rule. Fed Regist. 2017;82(12):7149-7274. To be codified at 6 CFR sec 46; 7 CFR sec 1c; 10 CFR sec 745; 14 CFR sec 1230; 15 CFR sec 27; 20 CFR sec 431; 22 CFR sec 225; 24 CFR sec 60; 29 CFR sec 21; 32 CFR sec 219; 34 CFR sec 97; 38 CFR sec 16; 40 CFR sec 26; 45 CFR sec 46, 690; 49 CFR sec 11. https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf. Accessed May 23, 2017.