Enhancing the informed consent process: A conceptual overview

Behavioral Sciences and the Law

Volumn 24, Issue 4, 2006, Pages 553-568

  Eyler, Lisa T ^a,b,c   Jeste, Dilip V ^b,c  

^a Building 13 ^*  (United States)

^b VA SAN DIEGO HEALTHCARE SYSTEM   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; COMPETENCE; CONFERENCE PAPER; DECISION MAKING; HUMAN; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; MENTAL DISEASE; MENTAL HEALTH; METHODOLOGY; PATIENT PARTICIPATION; PATIENT RIGHT; PSYCHOLOGICAL ASPECT; RISK ASSESSMENT; TECHNIQUE;

BIOETHICS; DECISION MAKING; HUMANS; INFORMED CONSENT; PROXY; UNITED STATES;

EID: 33748314459     PISSN: 07353936     EISSN: 10990798     Source Type: Journal    
DOI: 10.1002/bsl.691     Document Type: Conference Paper

References (44)

1. Appelbaum, P. S., & Grisso, T. (1995). The MacArthur treatment competence study. I. Mental illness and competence to consent to treatment. Law and Human Behavior, 19, 105-126.
2. Appelbaum, P. S., & Grisso, T. (2001). MacCAT-CR: MacArthur Competence Assessment Tool for Clinical Research. Sarasota, FL: Professional Resource Press.
3. Baron, J. (1988). Thinking and deciding (pp. 304-312). New York: Cambridge University Press.
4. Bentley, J. P., & Thacker, P. G. (2004). The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics, 30, 293-298.
5. Berg, J. W. (1996). Constructing competence: Formulating standards of legal competence to make medical decisions. Rutgers Law Review, 48, 345-396.
6. California Health and Safety Code, Section 24178, of the amended January (2003).
7. Carpenter, W. T., Gold, J. M., Lahti, A. C., Queern, C. A., Conley, R. R., Bartko, J. J., Kovnick, J., & Appelbaum, P. S. (2000). Decisional capacity for informed consent in schizophrenia research. Archives of General Psychiatry, 57, 533-538.
8. Code of Virginia, Title 32.1, Section 162.16-162.18 (2005).
9. Dunn, L. B., & Gordon, N. E. (2005). Improving informed consent and enhancing recruitment for research by understanding economic behavior. Journal of the American Medical Association, 293, 609-612.
10. Dunn, L. B., & Jeste, D. V. (2001). Enhancing informed consent for research and treatment. Neuropsychopharmacology, 24, 595-607.
11. Dunn, L. B., Lindamer, L. A., Palmer, B. W., Golshan, S., Schneiderman, L. J., & Jeste, D. V. (2002). Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. American Journal of Geriatric Psychiatry, 10, 142-150.
12. Dunn, L. B., Nowrangi, M. A., Palmer, B. W., Jeste, D. V., & Saks, E. R. (In press). Assessing decisional capacity for clinical research or treatment: A review of instruments. American Journal of Psychiatry.
13. Enzenhofer, M., Bludau, H. B., Komm, N., Wild, B., Mueller, K., Herzog, W., & Hochlehnert, A. (2004). Improvement of the educational process by computer-based visualization of procedures: Randomized controlled trial. Journal of Medical Internet Research, 6, e16.
14. Eyler, L. T., Mirzakhanian, H., & Jeste, D. V. (2005). A preliminary study of interactive questioning methods to assess and improve understanding of informed consent among patients with schizophrenia. Schizophrenia Research, 75, 193-198.
15. Flory, J., & Emanuel, E. (2004). Interventions to improve research participants' understanding in informed consent for research: A systematic review. Journal of the American Medical Association, 292, 1593-1601.
16. Franck, L., & Winter, I. (2004). Research participant information sheets are difficult to read. Bulletin of Medical Ethics, 195, 13-16.
17. Freedman, B. (1981). Competence, marginal and otherwise: Concepts and ethics. International Journal of Law and Psychiatry, 4, 53-72.
18. Gardner, W., Hoge, S. K., Bennett, N., Roth, L. H., Lidz, C. W., Monahan, J., & Mulvey, E. P. (1993). Two scales for measuring patients' perceptions for coercion during mental hospital admission. Behavioral Sciences and the Law, 11, 307-312.
19. Grimes, A. L., McCullough, L. B., Kunik, M. E., Molinari, V., & Workman, R. H. (2000). Informed consent and neuroanatomic correlates of intentionality and voluntariness among psychiatric patients. Psychiatric Services, 51, 1561-1567.
20. Halpern, S. D., Karlawish, J. H., Casarett, D., Berlin, J. A., & Asch, D. A. (2004). Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Archives of Internal Medicine, 164, 801-803.
21. Kim, S. Y. H., Appelbaum, P. S., Jeste, D. V., & Olin, J. (2004). Proxy and surrogate consent in geriatric neuropsychiatric research: Update and recommendations. American Journal of Psychiatry, 161, 797-806.
22. Kim, S. Y. H., Caine, E. D., Currier, G. W., Leibovici, A., & Ryan, J. M. (2001). Assessing the competence of persons with Alzheimer's Disease in providing informed consent for participation in research. American Journal of Psychiatry, 158, 712-717.
23. Kovnick, J. A., Appelbaum, P. S., Hoge, S. K., & Leadbetter, R. A. (2003). Competence to consent to research among long-stay inpatients with chronic schizophrenia. Psychiatric Services, 54, 1247-1252.
24. Makdessian, A. S., Ellis, D. A., & Irish, J. C. (2004). Informed consent in facial plastic surgery: Effectiveness of a simple educational intervention. Archives of Facial Plastic Surgery, 6, 26-30.
25. Moser, D. J., Arndt, S., Kanz, J. E., Benjamin, M. L., Bayless, J. D., Reese, R. L., Paulsen, J. S., & Flaum, M. A. (2004). Coercion and informed consent in research involving prisoners. Comprehensive Psychiatry, 45, 1-9.
26. Moser, D. J., Reese, R. L., Schultz, S. K., Benjamin, M. L., Arndt, S., Fleming, F. W., & Andreasen, N. C. (2005). Informed consent in medication-free schizophrenia research. American Journal of Psychiatry, 162, 1209-1211.
27. National Bioethics Advisory Commission (NBAC). (1998). Research Involving Persons with Mental Disorders that May Affect Decision Making Capacity, report and recommendations of the National Bioethics Advisory Commission, Rockville, MD.
28. O'Connor, D., Marshall, S., & Massy-Westropp, N. (2003). Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database of Systematic Reviews, 1, CD003219.
29. Paasche-Orlow, M. K., Taylor, H. A., & Brancati, F. L. (2003). Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine, 348, 721-726.
30. Palmer, B. W., Dunn, L. B., Appelbaum, P. S., & Jeste, D. V. (2004). Correlates of treatment-related decision-making capacity among middle-aged and older patients with schizophrenia. Archives of General Psychiatry, 61, 230-236.
31. Pauker, S. G., & Kassirer, J. P. (1987). Decision analysis. New England Journal of Medicine, 316, 250-258.
32. Poulsen, H. D. (1999). Perceived coercion among committed, detained, and voluntary patients. International Journal of Law and Psychiatry, 22, 167-175.
33. Robinson, A., & Thomson, R. (2001). Variability in patient preferences for participating in medical decision making: Implication for the use of decision support tools. Quality of Health Care, 10, 134-138.
34. Rossi, M. J., Guttmann, D., MacLennan, M. J., & Lubowitz, J. H. (2005). Video informed consent improves knee arthroscopy patient comprehension. Arthroscopy, 21, 739-743.
35. Rossi, M., McClellan, R., Chou, L., & Davis, K. (2004). Informed consent for ankle fracture surgery: Patient comprehension of verbal and videotaped information. Foot and Ankle International, 25, 756 762.
36. Rubak, S., Sandback, A., Lauritzen, T., & Christensen, B. (2005). Motivational interviewing: A systematic review and meta-analysis. British Journal of General Practice, 55, 305-312.
37. Saks, E. R., Dunn, L. B., Marshall, B. J., Nayak, G. V., Golshan, S., & Jeste, D. V. (2002). The California Scale of Appreciation: A new instrument to measure the appreciation component of capacity to consent to research. American Journal of Geriatric Psychiatry, 10, 166-174.
38. Stalmeier, P. F., Roosmalen, M. S., Verhoef, L. C., Hoeskstra-Weebers, J. E., Oosterwijk, J. C., Moog, U., Hoogerbrugge, N., & van Daal, W. A. (2005). The decision evaluation scales. Patient Education and Counseling, 57, 286-293.
39. Tversky, A., & Kahneman, D. (1974). Judgment under uncertainty: Heuristics and biases. Science, 185, 1124-1131.
40. Ubel, P., & Loewenstein, G. (1997). The role of decision analysis in informed consent. Social Science and Medicine, 44, 647-656.
41. Vollmann, J., Bauer, A., Danker-Hopfe, H., & Helmchen, H. (2003). Competence of mentally ill patients: A comparative empirical study. Psychological Medicine, 33, 1463-1471.
42. Wendler, D., & Prasad, K. (2001). Core safeguards for clinical research with adults who are unable to consent. Annals of Internal Medicine, 135, 514-523.
43. Wilkinson, M., & Moore, A. (1997). Inducement in research. Bioethics, 11, 373-389.
44. Wilson, T. D., Lisle, D. J., & Schooler, J. W. (1993). Introspecting about reasons can reduce post-choice satisfaction. Personality and Social Psychology Bulletin, 19, 331-339.