Decisional capacity and consent for schizophrenia research

IRB Ethics and Human Research

Volumn 33, Issue 4, 2011, Pages 1-9

  Kaup, Allison R ^a   Dunn, Laura B ^b   Saks, Elyn R ^a   Jeste, Dilip V ^a   Palmer, Barton W ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DECISION MAKING; FEMALE; HUMAN; INFORMED CONSENT; MALE; MENTAL CAPACITY; MIDDLE AGED; PSYCHOLOGIC TEST; PSYCHOLOGICAL ASPECT; PSYCHOLOGY; RESEARCH SUBJECT;

DECISION MAKING; FEMALE; HUMANS; INFORMED CONSENT; INTERVIEW, PSYCHOLOGICAL; MALE; MENTAL COMPETENCY; MIDDLE AGED; RESEARCH SUBJECTS; SCHIZOPHRENIC PSYCHOLOGY;

EID: 80054094334     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (44)

1. National Bioethics Advisory Commission. Research Involving Persons with Mental Disorders That May Affect Decision Making Capacity. Rockville, MD: National Bioethics Advisory Commission, 1998;
2. Carpenter WT, Conley RR. Sense and nonsense: An essay on schizophrenia research ethics. Schizophrenia Research 1999;35:219-225; (Pubitemid 29112973)
3. Anderson KK, Mukherjee SD. The need for additional safeguards in the informed consent process in schizophrenia research. Journal of Medical Ethics 2007;33:647-650.
4. Appelbaum PS. Decisional capacity of patients with schizophrenia to consent to research: Taking stock. Schizophrenia Bulletin 2006;32:22-25; (Pubitemid 43063814)
5. Dunn LB. Capacity to consent to research in schizophrenia: The expanding evidence base. Behavioral Sciences and the Law 2006;24:431-445; (Pubitemid 44328708)
6. Jeste DV, Depp CA, Palmer BW. Magnitude of impairment in decisional capacity in people with schizophrenia compared to normal subjects: An overview. Schizophrenia Bulletin 2006;32:121-128. (Pubitemid 43063826)
7. Wong JG, Clare IHC, Gunn MJ, et al. Capacity to make health care decisions: Its importance in clinical practice. Psychological Medicine 1999;29:437-446. (Pubitemid 29129328)
8. Palmer BW, Savla GN. The association of specific neuropsychological deficits on capacity to consent to research or treatment. Journal of the International Neuropsychological Society 2007;13:1047-1059. (Pubitemid 47617555)
9. Dunn LB, Jeste DV. Problem areas in the understanding of informed consent: Study of middle-aged and older patients with psychotic disorders. Psychopharmacology 2003;171:81-85. (Pubitemid 38134674)
10. Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology 2001;24:595-607; (Pubitemid 32452207)
11. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA 2004;292:1593-1601; (Pubitemid 39314966)
12. Ryan RE, Prictor MJ, McLaughlin KJ, et al. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2008.
13. Marson DC, Annis SM, Mclnturff B, et al. Error behaviors associated with loss of competency in Alzheimer's disease. Neurology 1999;53:1983-1992.
14. Appelbaum PS, Grisso T. MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press, 2001.
15. Palmer BW, Dawes SE, Heaton RK. What do we know about neuropsychological aspects of schizophrenia? Neuropsychology Review 2009;19:365-384.
16. Palmer BW, Jeste DV. Relationship of individual cognitive abilities to specific components of decisional capacity among middle-aged and older patients with schizophrenia. Schizophrenia Bulletin 2006;31:98-106; (Pubitemid 43063823)
17. Palmer BW, Dunn LB, Depp CA, et al. Decisional capacity to consent to research among patients with bipolar disorder: Comparison with schizophrenia patients and healthy subjects. Journal of Clinical Psychiatry 2007;68:689-696. (Pubitemid 46841851)
18. American Psychiatric Association. Diagnostic Criteria from DSM-IV. Washington, DC: American Psychiatric Association, 1994.
19. Kay S, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophrenia Bulletin 1987;13:261-276. (Pubitemid 18039085)
20. Birchwood M, Smith V, Drury V. A self-report insight scale for psychosis: Reliability, validity and sensitivity to change. Acta Psychiatrica Scandinavica 1994;89:62-67. (Pubitemid 24028268)
21. UCSD Human Research Protections Program. UCSD Human Research Protections Program Task Force for Recommending Procedures for Determination of Decisional Capacity in Subjects Participating in Research Protocols. Decision making capacity guidelines, http://irb.ucsd.edu/decisional.shtml;
22. U.S. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46, http://www.hhs.gov/ohrp/hu-mansubjects/guidance/45cfr46. html.
23. For a detailed discussion of the issue of decisional capacity for research on informed consent, see Saks ER, Dunn LB, Palmer BW. Meta-consent in research on decisional capacity: A "Catch-22"? Schizophrenia Bulletin 2006;32:42-46. (Pubitemid 43063818)
24. Dolder CR, Jeste DV. Incidence of tardive dyskinesia with typical versus atypical antipsychotics in very high risk patients. Biological Psychiatry 2003;53:1142-1145. (Pubitemid 36695090)
25. Eyler LT, Olsen RK, Nayak GV, et al. Brain response correlates of decisional capacity in schizophrenia: A preliminary FMRI study. Journal of Neuropsychiatry and Clinical Neurosciences 2007;19:137-144. (Pubitemid 46649636)
26. See ref. 10, Palmer and Jeste 2006; Stroup S, Appelbaum P, Swartz M, et al. Decision-making capacity for research participation among individuals in the CATIE schizophrenia trial. Schizophrenia Research 2005;80:1-8; (Pubitemid 41587458)
27. Moser D, Schultz S, Arndt S, et al. Capacity to provide informed consent for participation in schizophrenia and HIV research. American Journal of Psychiatry 2002;159:1201-1207. (Pubitemid 34743262)
28. Kovnick JA, Appelbaum PS, Hoge SK, et al. Competence to consent to research among long-stay inpatients with chronic schizophrenia. Psychiatric Services 2003;54:1247-1252. (Pubitemid 37055986)
29. Wong JGWS, Cheung EPT, Chen EYH. Decision-making capacity of inpatients with schizophrenia in Hong Kong. Journal of Nervous and Mental Disease 2005;193:316-322. (Pubitemid 40695732)
30. Moser DJ, Arndt S, Kanz JE, et al. Coercion and informed consent in research involving prisoners. Comprehensive Psychiatry 2004;45:1-9. (Pubitemid 38029968)
31. Appelbaum PS, Roth LH, Lidz CW, et al. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 1987;17:20-25.
32. Dunn LB, Palmer BW, Karlawish JHT. Frontal dysfunction and capacity to consent to treatment or research: Conceptual considerations and empirical evidence. In: Miller BL, Cummings JL. Human Frontal Lobes: Functions and Disorders. New York: Guilford Press, 2005, p. 335-344.
33. Langdon R, Coltheart M, Ward PB, et al. Disturbed communication in schizophrenia: The role of poor pragmatics and poor mind-reading. Psychological Medicine 2002;32:1273-1284; (Pubitemid 35243984)
34. Martin I, McDonald S. Weak coherence, no theory of mind, or executive dysfunction? Solving the puzzle of pragmatic language disorders. Brain and Language 2003;85:451-466. (Pubitemid 36555500)
35. Armstrong GD. The intraclass correlation as a measure of interrater reliability of subjective judgments. Nursing Research 1981;30:314-315.
36. Anastasi A, Urbina S. Psychological Testing. 7th ed. Upper Saddle River, NJ: Prentice Hall, 1997.
37. Van Der Vleuten CPM, Norman GR, De Graaff E. Pitfalls in the pursuit of objectivity: Issues of reliability. Medical Education 1991;25:110-118.
38. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry 1982;5:319-329;
39. Henderson GE, Churchill LR, Davis AM, et al. Clinical trials and medical care: Defining the therapeutic misconception. PLoS Medicine 2007;4:1735-1738. (Pubitemid 350220527)
40. Dunn LB, Lindamer LA, Palmer BW, et al. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. American Journal of Geriatric Psychiatry 2002;10:142-150; (Pubitemid 34685626)
41. Eyler LT, Mirzakhanian H, Jeste DV. A preliminary study of interactive questioning methods to assess and improve understanding of informed consent among patients with schizophrenia. Schizophrenia Research 2005;75:193-198; (Pubitemid 40693053)
42. Moser DR. Using a brief intervention to improve decisional capacity in schizophrenia research. Schizophrenia Bulletin 2006;32:116-120;
43. Palmer BW, Cassidy EL, Dunn LB, et al. Effective use of consent forms and interactive questions in the consent process. IRB: Ethics & Human Research 2008;30:8-12;
44. Jeste DV, Palmer BW, Golshan S, et al. Multimedia consent for research in people with schizophrenia and normal subjects: A randomized controlled trial. Schizophrenia Bulletin 2009;35:719-729.