The ethical basis of psychiatric research: Conceptual issues and empirical findings

Comprehensive Psychiatry

Volumn 39, Issue 3, 1998, Pages 99-110

  Roberts, Laura Weiss ^a,b,c  

^a UNIVERSITY OF NEW MEXICO SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF NEW MEXICO HOSPITAL   (United States)

^c UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; DECISION MAKING; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; MEDICAL RESEARCH; MENTAL DISEASE; MENTAL PATIENT; PRACTICE GUIDELINE; REVIEW;

EID: 0031954496     PISSN: 0010440X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0010-440X(98)90068-2     Document Type: Article

References (86)

1. Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA 1996;276:67-72.
2. Bonnie RJ. Research with cognitively impaired subjects. Arch Gen Psychiatry 1997;54:105-111.
3. Elliott C. Caring about risks: are severely depressed patients competent to consent to research? Arch Gen Psychiatry 1997;54:113-116.
4. Eichelman B, Wikler D, Hartwig A. Ethics and psychiatric research: problems and justification. Am J Psychiatry 1984;141: 400-405.
5. Kantor JE. Ethical issues in psychiatric research and training. In: Annual Review of Psychiatry. Vol 13. Washington, DC: American Psychiatric Press, 1994.
6. Lidz CW, Meisel A, Zerubavel E, Carter M, Sestak RM, Roth LH. Informed Consent: A Study of Decision Making in Psychiatry. New York, NY: Guilford, 1984.
7. Lieberman JA. Ethical dilemmas in clinical research with human subjects: an investigator's perspective. Psychopharmacol Bull 1996;32:19-25.
8. Meisel A, Roth LH. What we do and do not know about informed consent. JAMA 1981;246:2473-2477.
9. Munir K, Earls F. Ethical principles governing research in child and adolescent psychiatry. J Am Acad Child Adolesc Psychiatry 1992;31:408-414.
10. US Congress, Office of Technology Assessment. Mental Disorders and Genetics: Bridging the Gap Between Research and Society. Washington, DC: US Government Printing Office (OTA-BP-H-133), 1994.
11. Appelbaum PS, Roth LH, Lidz CW. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982;5:319-329.
12. Appelbaum PS. Drug-free research in schizophrenia: an overview of the controversy. Inst Rev Board 1996;18:1-5.
13. Appelbaum PS. Rethinking the conduct of psychiatric research. Arch Gen Psychiatry 1997;54:117-120.
14. 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;17:20-24.
15. Spece RG, Shimm DS, Buchanan AE. Conflicts of Interest in Clinical Practice and Research. New York, NY: Oxford University Press, 1996.
16. Brody J, Gluck JP, Aragon F. Participants' understanding of the process of psychological research: informed consent. Ethics Behav. In press.
17. Roberts LW, Solomon Z, Roberts BB, Keith SJ. Ethics of psychiatric research: resources for faculty development and resident education. Acad Psychiatry. In press.
18. Appelbaum PS, Roth LH. Competency to consent to research: a psychiatric overview. Arch Gen Psychiatry 1982;39: 951-958.
19. Curson DA, Hirsch SR, Platt SD, Bamber RW, Barnes TRE. Does short term placebo treatment of chronic schizophrenia produce long term harm? BMJ 1986;293:726-728.
20. Grinfeld MJ. NY court orders halt to research on psychiatric patients. Psychiatr Times 1996;13:1-3.
21. Griffith JF, Davis FD, Johns ME, Blake DA. Integrity in scientific research. In: Kelley WN, Osterweis M, Rubin ER (eds): Emerging Policies for Biomedical Research. Washington, DC: Association of Academic Health Centers, 1993.
22. Viorst J. Listening at the keyhole: the Anne Sexton tapes. J Am Acad Psychoanal 1992;20:655-658.
23. Zaubler TS, Viederman M, Fins JJ. Ethical, legal and psychiatric issues in capacity, competency, and informed consent: an annotated bibliography. Gen Hosp Psychiatry 1996;18: 155-172.
24. Blumenthal D, Meyer GS. The future of the academic medical center under health care reform. N Engl J Med 1993;329:1812-1814.
25. Cadman E. The academic physician-investigator: a crisis not to be ignored. Ann Intern Med 1994;120:401-410.
26. Kessler DA. Drug promotion and scientific exchange. N Engl J Med 1991;325:201-203.
27. Moran M. Psychiatrist finds patients' dignitary interests often at odds with 'research-industrial complex.' Psychiatr News 1996;10:17.
28. Pincus HA, Dial TH, Gaviland MG. Research activities of full-time faculty in academic departments of psychiatry. Arch Gen Psychiatry 1993;50:657-664.
29. Health United States and Healthy People 2000 Review, 1992. Bethesda, MD: US Department of Health and Human Services, 1993.
30. The Human Radiation Experiments: Final Report of the President's Advisory Committee. New York, NY: Oxford University Press, 1996.
31. Levine RJ. Ethics and Regulation of Clinical Research. Baltimore, MD: Urban & Schwartzenberg, 1981.
32. Rothman DJ. Ethics and human experimentation. N Engl J Med 1987;317:1195-1199.
33. Schaefer A. The ethics of the randomized clinical trial. N Engl J Med 1982;307:719-725.
34. Beecher HK. Ethics and clinical research. N Engl J Med 1966;274:1354-1361.
35. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: US Government Printing Office, 1979.
36. President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: Protecting Human Subjects. Washington, DC: US Government Printing Office, 1981.
37. Lidz CW, Meisel A, Osterweis M, Holden JL, Marx JH, Munetz MR. Barriers to informed consent. Ann Intern Med 1983;99:539-543.
38. Appelbaum PS, Grisso T. Assessing patients' capacities to consent to treatment. N Engl J Med 1988;319:1635-1638.
39. Gostin L. Informed consent, cultural sensitivity, and respect for persons. JAMA 1996;274:844-845.
40. Lane LW, Cassel CK, Bennett W. Ethical aspects of research involving elderly subjects: are we doing more than we say? J Clin Ethics 1990;1:278-284.
41. Roth LH, Appelbaum PS, Lidz CW, Benson P, Winslade WJ. Informed consent in psychiatric research. Rutgers Law Rev 1987;39:425-441.
42. American Medical Association. Code of Medical Ethics: Current Opinions With Annotations. Ed. 1994. Chicago, IL: American Medical Association, 1994.
43. Winston ME, Winston SE, Appelbaum PS, Rhoden NK. Commentary: can a subject consent to a 'Ulysses contract'? Hastings Cent Rep 1982;12:26-28.
44. Dresser RS. Ulysses and the psychiatrists: a legal and political analysis of the voluntary commitment contract. Harvard Civil Rights Civil Liberties Law Rev 1982;16:777-854.
45. Allen M. The dilemma for women of color in clinical trials. JAMWA 1994;9:105-109.
46. Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-146.
47. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med 1994;331:394-398.
48. Orr RD. Guidelines for the use of placebo controls in clinical trials of psychopharmacologic agents. Psychiatr Serv 1996;47:1262-1264.
49. Edlund MJ, Craig TH, Richardson MA. Informed consent as a form of volunteer bias. Am J Psychiatry 1985;142:624-627.
50. Thomasma DC, McElhinney TK. Ethical concerns about AIDS. Pharos 1990;7-11.
51. Gilligan C. Concepts of self and morality. In: Gilligan C (ed): A different Voice. Cambridge, MA: Harvard University Press, 1982.
52. Roberts LW, McCarty T, Lyketsos C, Hardee JT, Jacobson J, Walker R, et al. What and how psychiatry residents at ten training programs wish to learn about ethics. Acad Psychiatry 1996;20:127-139.
53. Yolles B, Connors JD, Grufferman S. Sounding board: obtaining access to data from government-sponsored medical research. N Engl J Med 1986;315:1669-1672.
54. Kodish E, Stocking C, Ratain MJ, Kohrman A, Siegler M. Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons. J Clin Oncol 1992;10:1810-1816.
55. Gray BH. Human Subjects in Medical Experimentation. New York, NY: Wiley, 1975.
56. Stanley B, Sieber JE, Melton GB. Empirical studies of ethical issues in research. Am Psychol 1987;42:735-741.
57. Stanley B, Stanley M, Guido J, Garvin L. The functional competency of elderly at risk. Gerontologist 1988;28(Suppl):53-58.
58. Stanley B, Stanley M, Lautin A, Kanw J, Schwartz N. Preliminary findings on psychiatric patients as research subjects: a population at risk? Am J Psychiatry 1981;38:669-671.
59. Appelbaum PS, Grisso T. The MacArthur Treatment Competence Study I, II, III. Law Hum Behav 1995;19:105-174.
60. Kleinman I, Schachter D, Jeffries J, Goldhamer P. Effectiveness of two methods for informing schizophrenic patients about neuroleptic medication. Hosp Community Psychiatry 1993;44:1189-1191.
61. Schacter D, Kleinman I, Prendergast P, Remington G, Schertzer S. The effect of psychopathology on the ability of schizophrenic patients to give informed consent. J Nerv Ment Dis 1994;182:360-362.
62. Katz M, Abbey S, Rydall A, Lowy F. Psychiatric consultation for competency to refuse medical treatment. Psychosom Bull 1995;36:33-41.
63. Marson D, Cody HA, Ingram KK, Harrell LE. Neuropsychological predictors of competency in Alzheimer's disease using a rational reasons legal standard. Arch Neurol 1995;52:955-959.
64. Marson D, Ingram KK, Cody HA, Harrell LE. Assessing competency of patients with Alzheimer's disease under different legal standards. Arch Neurol 1995;52:949-954.
65. Grossman L, Summers F. A study of the capacity of schizophrenic patients to give informed consent. Hosp Community Psychiatry 1980;31:205-206.
66. Benson PR, Roth LH, Winslade WJ. Informed consent in psychiatric research: preliminary findings from an ongoing investigation. Soc Sci Med 1985;20:1331-1341.
67. Block SD, Billings JA. Patient requests for euthanasia and assisted suicide in terminal illness: the role of the psychiatrist. Psychosomatics 1995;36:445-457.
68. Brown JH, Henteleff P, Barakat S, Rowe CJ. Is it normal for terminally ill patients to desire death? Am J Psychiatry 1986;143:208-211.
69. Cavanaugh S. Depression in the medically ill: critical issues in diagnostic assessment. Psychosom Bull 1995;36:48-59.
70. Ganzini L, Lee MA, Heintz RT, Bloom JD, Fenn DS. The effect of depression treatment on elderly patients' preferences for life-sustaining medical therapy. Am J Psychiatry 1994;151: 1631-1636.
71. Breitbart W, Rosenfeld BD, Passik SD. Interest in physician-assisted suicide among ambulatory HIV infected patients. Am J Psychiatry 1996;153:238-242.
72. Soskis DA. Schizophrenic and medical inpatients as informed drug consumers. Arch Gen Psychiatry 1978;35:645-647.
73. Sachs GA, Stocking CB, Stern R, Cox DM, Hougham G, Sachs RS. Ethical aspects of dementia research: informed consent and proxy consent. Clin Res 1995;403-412.
74. Warren JW, Sobal J, Tenney JH, Hoopes JM, Damron D, Levenson S, et al. Informed consent by proxy: an issue in research with elderly patients. N Engl J Med 1986;315:1124-1128.
75. High DM. Research with Alzheimer's disease subjects: informed consent and proxy decision making. J Am Geriatr Soc 1992;40:950-957.
76. Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Informed consent: why are its goals imperfectly realized? N Engl J Med 1980;302:896-900.
77. Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol 1994;12:2211-2215.
78. Taub HA, Baker MT, Stuff JF. Informed consent for research: effects of readability, patient age, and education. J Am Geriatr Soc 1986;34:601-606.
79. Tomamichel M, Sessa C, Herzig S, de Jong J, Pagani O, Willems Y, et al. Informed consent for phase I studies: evaluation of quantity and quality of information provided to patients. Ann Oncol 1995;6:363-369.
80. Maslin A. A survey of the opinions on 'informed consent' of women currently involved in clinical trials within a breast unit. Eur J Cancer Care 1994;3:153-162.
81. Philips M, Vazquez AJ. Abnormal findings in 'normal' research volunteers. Control Clin Trials 1987;8:338-342.
82. Logue G, Wear S. A desperate solution: individual autonomy and the double-blind controlled experiment. J Med Philos 1995;20:57-64.
83. Harth SC, Thong YH. Parental perceptions and attitudes about informed consent in clinical research involving children. Soc Sci Med 1995;40:1573-1577.
84. Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 1995;13:1062-1072.
85. Cassileth BR, Lusk EJ, Miller DS, Hurwitz S. Attitudes toward clinical trials among patients and the public. JAMA 1982;248:968-970.
86. Cassileth BR, Lusk EJ, Guerry D, Blake AD, Walsh WP, Kascius L, et al. Survival and quality of life among patients receiving unproven as compared with conventional cancer therapy. N Engl J Med 1991;324:1180-1185.