Effective use of consent forms and interactive questions in the consent process

IRB Ethics and Human Research

Volumn 30, Issue 2, 2008, Pages 8-12

  Palmer, Barton W ^a,b   Cassidy, Erin L ^c   Dunn, Laura B ^d   Spira, Adam P ^d   Sheikh, Javaid I ^e  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c ETR ASSOCIATES   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; HUMAN; INFORMED CONSENT; METHODOLOGY; QUESTIONNAIRE; STANDARD; UNITED STATES;

HUMANS; INFORMED CONSENT; QUESTIONNAIRES; RESEARCH DESIGN; UNITED STATES;

EID: 42549095453     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (31)

1. Department of Health and Human Services. Office for Human Research Protections. Tips on Informed Consent. (March 1993). http://www.hhs.gov/ohrp/ humansubjects/guidance/ictips.htm.
2. Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46;
3. Food and Drug Administration. Protection of Human Subjects. 21 CFR 50.
4. 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;
5. Moser DR. Using a brief intervention to improve decisional capacity in schizophrenia research. Schizophrenia Bulletin 2006;32:116-120;
6. Dunn LB, Jeste DV. Enhancing informed consent for research and treatment. Neuropsychopharmacology 2001;24(6):595-607;
7. 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, forthcoming (electronic preprint available at http://schizophreniabulletin.oxfordjournals.org/ cgi/content/abstract/sbm148v1).
8. See ref. 3, Dunn et al. 2002;
9. Miller R, Willner HS. The two-part consent form: A suggestion for promoting free and informed consent. NEJM 1974;290:964-966;
10. Taub HA, Kline GE, Baker MT. The elderly and informed consent: Effects of vocabulary level and corrected feedback. Experimental Aging Research 1981;7:137-146;
11. Taub HA, Baker MT. A reevaluation of informed consent in the elderly: A method for improving comprehension through direct testing. Clinical Research 1984;32:17-21;
12. Palmer BW, Nayak GV, Dunn LB, et al. Treatment-related decision-making capacity in middle-aged and older patients with psychosis: A preliminary study using the MacCAT-T and HCAT. American Journal of Geriatric Psychiatry 2002;10:207-211;
13. 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;32:98-106;
14. Palmer BW, Dunn LB, Depp C, et al. Decisional capacity to consent to research among patients with bipolar disorder: Comparison with schizophrenia patients and healthy subjects. The Journal of Clinical Psychiatry 2007;68:689-696.
15. 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.
16. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state." A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research 1975;12:189-198.
17. See ref. 2, Department of Health and Human Services, 45 CFR 46.
18. Palmer BW, Dunn LB, Appelbaum PS, et al. Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: Comparison of a three-item questionnaire with a comprehensive standardized capacity instrument. Archives of General Psychiatry 2005;62:726-733;
19. Jeste DV, Palmer BW, Appelbaum PS, et al. A new brief instrument for assessing decisional capacity for clinical research. Archives of General Psychiatry 2007;64:966-974.
20. Appelbaum PS, Roth LH. Competency to consent to research: A psychiatric overview. Archives of General Psychiatry 1982;39:951-958.
21. Dunn LB, Lindamer LA, Palmer BW, et al. Enhancing comprehension of consent for research in older patients with psychosis: A randomized study of a novel consent procedure. American Journal of Psychiatry 2001;158:1911-1913;
22. Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA 2004;292:1593-1601.
23. Black BS, Kass NE, Fogarty LA, et al. Informed consent for dementia research: The study enrollment encounter. IRB: Ethics & Human Research 2007;29:7-14.
24. See ref. 4, Taub et al. 1981;
25. see ref. 8, Palmer et al. 2005;
26. see ref. 8, Jest et al. 2007.
27. See ref. 3, Dunn and Jeste 2001;
28. Eyler LT, Jeste DV. Enhancing the informed consent process: A conceptual overview. Behavioral Science and Law 2006;24:553-568;
29. see ref. 3, Jeste et al. forthcoming.
30. Brown RF, Butow PN, Butt DG, et al. Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials. Social Science & Medicine 2004;58:379-390;
31. Roberts LW Informed consent and the capacity for voluntarism. American Journal of Psychiatry 2002;159:705-712.