Ethical problems in psychiatric research

  • Nathaniel S. Lehrman
  • Vera Hassner Sharav


This article raises questions about the morality and value of experiments conducted mainly on psychiatric patient-subjects whose mental capacity and judgment are often impaired, making them incapable of giving informed consent. Its focus is on experimental studies in which psychotic symptoms in patients with schizophrenia have been knowingly exacerbated by suddenly withdrawing medications that they needed, administering known psychosis-producing substance such as L-dopa and apomorphine, and ignoring the treatment needs of those serving as experimental controls in placebo studies. Concerns are raised about the draft “Statement of Principles for Ethical Conduct” by the American College of Neuropsychopharmacology. Questions are also raised about the adequancy of current safeguards, including federal regulations, peer review, and the trivialization of “informed consent” by institutional review boards that operate under veils of secrecy. Implications for mental health policy are discussed, and suggestions are made for improving safeguards and reducing risks.


Schizophrenia Ethical Problem Mental Health Policy Psychiatric Research Belmont Report 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 1.
    Katz J: “Ethics and clinical research” revisited: A tribute to Henry K. Beecher.Hastings Center Report 1993; 25(5):31–39.Google Scholar
  2. 2.
    Annas GJ, Grodin MA (Eds.):The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1992.Google Scholar
  3. 3.
    Grodin MA: Historical origins of the Nuremberg Code. In: Annas GJ, Grodin MA (Eds.):The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, 1992, pp. 121–144.Google Scholar
  4. 4.
    Caplan AL: Are existing safeguards adequate?Journal of the California Alliance for the Mentally Ill 1994; 5(1):36–38.PubMedGoogle Scholar
  5. 5.
    Annas GJ: Experimentation and research.Journal of the California Alliance for the Mentally Ill 1994; 5(1): 9–11.PubMedGoogle Scholar
  6. 6.
    Annas GJ: The changing landscape of human experimentation: Nuremberg, Helsinki, and beyond.Health Matrix—Journal of Law and Medicine 1992; 2:119–140.Google Scholar
  7. 7.
    Declaration of Helsinki IV, World Medical Association, 18th World Medical Assembly, 1964; amended Hong Kong, September, 1989. Council for International Organizations of Medical Sciences (CIOMS), Geneva, 1993.Google Scholar
  8. 8.
    National Commission for the Protection of Human Subjects of Bimedical and Behavioral Research:Report and Recommendations: Research Involving Those Institutionalized as Mentally Infirm [The Belmont Report]. DHEW Pub. No. (05) 78-0006. Washington, DC: U.S. Department of Health, Education and Welfare, 1979.Google Scholar
  9. 9.
    45 Code of Federal Regulations (CFR) 46, 1985; revised 1991.Google Scholar
  10. 10.
    Agency says UCLA erred in medical experiments.Reuters, March 9, 1994.Google Scholar
  11. 11.
    Hilts PJ: Agency faults a UCLA study for suffering of mental patients.New York Times, March 10, 1994, p. A-1.Google Scholar
  12. 12.
    Garrett L: Closer tabs on human research urged.Newsday, March 11, 1994, p. A-17.Google Scholar
  13. 13.
    When the patient is also an experiment [Editorial].New York Times, March 14, 1994, p. A-16.Google Scholar
  14. 15.
    Horowitz J: For the sake of science.Los Angeles Times Magazine, September 11, 1994, pp. 16ff.Google Scholar
  15. 16.
    Subotnik KL, Neuchterlein KN: Prodromal signs and symptoms in schizophrenia relapse.Journal of Abnormal Psychology 1988; 97(4):405–412.PubMedCrossRefGoogle Scholar
  16. 17.
    Office for Protection from Research Risks, Division of Human Subject Protections:Evaluation of Human Subject Protections in Schizophrenia Research Conducted by the University of California, Los Angeles, Washington, DC: U.S. Department of Health and Human Services, May 11, 1994.Google Scholar
  17. 18.
    Hawkins-Prince SL: Personal communication, December, 1994.Google Scholar
  18. 19.
    Thompson DI: Memorandum in opposition (on behalf of) Shalmah Lee Prince v. David L. Garver, M.D., et al., U.S. District Court, So. Dist. of Ohio, Western Division, October, 1995.Google Scholar
  19. 20.
    Becker JC: Amother's testimony.Journal of the California alliance for the Mentally Ill 1994; 5(1):17.PubMedGoogle Scholar
  20. 21.
    Davidson M, Keefe RSE, Mohs RC, et al.: L-dopa challenge and relapse in schizophrenia.American Journal of Psychiatry 1987; 144:934–938.PubMedGoogle Scholar
  21. 22.
    Department of Veterans Affairs, Bronx Medical Center: Consent forms for two-part-study: Neuroleptic withdrawal and Sinemet (L-dopa); obtained by author under FOIA [no date].Google Scholar
  22. 23.
    Davidson M: personal communciation, May 16, 1994.Google Scholar
  23. 24.
    Ogloff JRP, Otto RK: Are research participants truly informed? Readability of informed consent forms used in research.Ethics & Behavior 1991; 1(4):239–252.CrossRefGoogle Scholar
  24. 25.
    Dorwart RA, Adler D, Berlant J, et al.: Taking issue: Outcomes assessment and psychiatric services.Hospital and Community Psychiatry 1994; 45(December):1165.PubMedGoogle Scholar
  25. 26.
    White KL:Healing the Schism: Epidemiology, Medicine and the Public's Health. New York: Springer-Verlag, 1991.Google Scholar
  26. 27.
    Pinel P:A Treatise on Insanity, David DD (Trans.). New York: Hafner, 1962.Google Scholar
  27. 28.
    Bockoven JS:Moral Treatment in American Psychiatry, New York: Springer, 1963.Google Scholar
  28. 29.
    Meyer A:Psychobiology: A Study of Man. Springfield, IL: Charles C Thomas, 1957.Google Scholar
  29. 30.
    Baruk H:Patients Are People Like Us: The Experiences of Half a Century in Neuropsychiatry. Finletter E, Ayer J (Trans.). New York: Morrow, 1978.Google Scholar
  30. 31.
    Lehrman NS: Effective psychotherapy in chronic schizophrenia.American Journal of Psychoanalysis 1982; 42: 121–132.PubMedCrossRefGoogle Scholar
  31. 32.
    Lehrman NS: The bureaucratic destruction of patient’s faith in their doctors: Public psychiatry's negative lessons for general medicine.Bulletin of the New York Academy of Medicine 1994; 71:194–217.PubMedGoogle Scholar
  32. 33.
    Rothman KJ, Michels KB: The continuing unethical use of placebo controls.New England Journal of Medicine 1994: 331:394–398.PubMedCrossRefGoogle Scholar
  33. 34.
    Jonas H: Philosophical reflections on experimenting with human subjects. In: Freund PA (Ed.):Experimentation with Human Subjects. New York: Braziler, 1969, pp. 1–31.Google Scholar
  34. 35.
    21 Code of Federal Regulations (CFR) ch. 1 (April 1, 1993 ed.): 314.126 (b) (2) (iv).Google Scholar
  35. 36.
    Beecher HK: Echics and clinical research.New England Journal of Medicine 1966; 274:1353–1360.Google Scholar
  36. 37.
    Destro RA: Law, professionalism, and bad attitude,Journal of the California Alliance for the Mentally Ill 1994;5(1):50–53.PubMedGoogle Scholar
  37. 38.
    Taubes G: Use of placebo controls in clinical trials disputed.Science 1991; 267:25–26.CrossRefGoogle Scholar
  38. 39.
    Katz J: Human experimentation and human rights.Health Law Symposium: St. Louis University Law Journal 1993; 38(1):7–54.Google Scholar
  39. 40.
    Annas GJ:Judging medicine. Clifton, NJ: Humana, 1988, p. 331.Google Scholar
  40. 41.
    Herz MI, Hawkins LL, Liberman RP, et al.:Practice Guidelines for Treatment of Patients with Schizophrenia, Work Group on Schizophrenia. Draft 1A. Washington, DC: American Psychiatric Association, June 1994.Google Scholar
  41. 42.
    Hegarty JD, Baldessarini RJ, Tohen M, et al.: One hundred years of schizophrenia: A meta-analysis of the outcome literature.American Journal of Psychiatry 1994; 151:1409–1416.PubMedGoogle Scholar
  42. 43.
    Wyatt RJ: Neuroleptics and the natural course of schizophrenia.Schizophrenia Bulletin 1991; 17(2): 325–351.PubMedGoogle Scholar
  43. 44.
    Van Putten T: Why do schizophrenic patients refuse to take drugs?Archives of General Psychiatry 1974; 32:67–72.Google Scholar
  44. 45.
    Willwerth J: Tinkering with madness.Time, August 30, 1993, pp. 40–41.Google Scholar
  45. 46.
    Schizophrenic’s case spurs review of consent guidelines.Los Angeles Times, July 13, 1994, p. A-5.Google Scholar
  46. 47.
    Lehmann C: Family testimony reveals human dimension of UCLA schizophrenia research controversy.Psychiatric News, March 17, 1995, pp. 13–14.Google Scholar
  47. 48.
    Families tell their side of suicides.Santa Monica Outlook, August 13, 1995.Google Scholar
  48. 49.
    Shamoo AE, Irving DN: Accountability in research using persons with mental illness.Accountability in Research 1993; 3:1–17.PubMedGoogle Scholar
  49. 50.
    Sharav VH, Weisburd DE (Eds): Ethics in neurobiological research with human subjects [Special issue]. {jtJournal of the California Alliance for the Mentally Ill} {dy1994}; {vn5}({sn1}):1–69.Google Scholar
  50. 51.
    Shamoo AE: Our responsibility toward persons with mental illness as human subjects in research.Journal of the California Alliance for the Mentally Ill 1994; 5(1):14–16.PubMedGoogle Scholar
  51. 52.
    Shamoo AE, Keay TJ: Ethical concerns about replase studies.Cambridge Quarterly of Health Care Ethics 1996; 5:373–386.PubMedCrossRefGoogle Scholar
  52. 53.
    Gilbert PL, Harris MJ, McAdams LA, et al.: Neuroleptic withdrawal in schizophrenic patients.Archives of General Psychiatry 1995; 52:173–186.PubMedGoogle Scholar
  53. 54.
    Baldessarini RJ, Viguera AC: Neuroleptic withdrawal in schizophrenic patients.Archives of General Psychiatry 1995; 52:189–191.PubMedGoogle Scholar
  54. 55.
    Ghaemi SN, Hundert EM: The ethics of research in mental illness.Journal of the California Alliance for the Mentally Ill 1994; 5(1):47–49.PubMedGoogle Scholar
  55. 56.
    Denber HCB: Tranquilizers in psychiatry. In: Freedman AM, Kaplan HI, Kaplan HS (eds.):Comprehensive textbook of psychiatry, Baltimore, MD: Williams & Wilkins, 1967, pp. 1251–1262.Google Scholar
  56. 57.
    Baldessarini RJ: Chemotherapy. In: Nicholi AM (Ed.):Harvard Guide to Modern Psychiatry. Cambridge, MA: Harvard University Press, 1978, pp. 387–432.Google Scholar
  57. 58.
    Breggin PR:Toxic Psychiatry: Why Therapy, Empathy, and Love Must Replace the Drugs, Electroshock, and Biochemical Theories of the “New Psychiatry” New York: St. Martin’s, 1991.Google Scholar
  58. 59.
    Jeste DV, Gilbert PL, McAdams LA, et al.: Considering neuroleptic maintenance and taper on a continuum.Archives of General Psychiatry 1995; 52:209–212.PubMedGoogle Scholar
  59. 60.
    Wolkin A, Angrist B, Wolf A, et al.: Effects of amphetamines on local cerebral metabolism in normal and schizophrenic subjects as determined by positive emission tomography,Psychopharmacology 1987; 92(2):241–246.PubMedCrossRefGoogle Scholar
  60. 61.
    Daniel DG, Weinberger DG, Jones DW, et al.: The effect of amphetamine on regional cerebral blood flow during cognitive activation in schizophrenia.Journal of Neuroscience 1991; 11:1907–1917.PubMedGoogle Scholar
  61. 62.
    Szymanski S, Lieberman J, Pollack S, et al.: Clozapine effects on neuroendocrine responses to apomorphine challenge in chronic schizophrenia.Biological Psychiatry 1995; 37(1):52–55.PubMedCrossRefGoogle Scholar
  62. 63.
    Wyatt RJ: Risks of withdrawing antipsychotic medications.Archives of General Psychiatry 1995; 52:205–208.PubMedGoogle Scholar
  63. 64.
    Greden JF, Tendon R: Long term treatment for lifetime disorders?Archives of General Psychiatry 1995; 52:197–200.PubMedGoogle Scholar
  64. 65.
    Opler LA: Conducting clinical psychiatric research in “non-research” settings.Journal of California Alliance for the Mentally Ill 1994; 5(1):30–31.Google Scholar
  65. 66.
    Irving DN: Psychiatric research: Reality check.Journal of the California Alliance for the Mentally Ill 1994 5 (1):42–44.PubMedGoogle Scholar
  66. 67.
    Katz J: Final reflections. In: Shamoo A (Ed.).Ethics in Neurobiological Research with Human Subjects, Buffalo, NY: Gordon Breach Science, 1996, pp. 331–337.Google Scholar
  67. 68.
    Klein DF, Schooler N: A statement of principles of ethical conduct for neuropsychopharmacologic research in human subjects. Draft revision, November 1995, American College of Neuropsychopharmacology.Google Scholar
  68. 69.
    Caplan A (eEd.):When Medicine Went Mad. totoa, NJ: Humana, 1992.Google Scholar
  69. 70.
    Wertham F:A Sign for Cain. London: Robert Hale, 1966.Google Scholar
  70. 71.
    Mitscherlich F, Mielke F:The Death Doctors, London: Elek, 1962.Google Scholar
  71. 72.
    Muller-Hill B:Murderous Science. Oxford, UK: Oxford University Press, 1988.Google Scholar
  72. 73.
    Proctor RN:Racial Hygiene: Medicine under the Nazis Cambridge, MA: Harvard University Press, 1988.Google Scholar
  73. 74.
    Hilts PJ: Consensus on ethics in research is elusive.New York Times, January 15, 1995, p. 24.Google Scholar
  74. 75.
    Burd, S: Researchers, advocates for mental patients clash over U.S. rules.Chronicle of Higher Education, January 20, 1995, p. A29.Google Scholar
  75. 76.
    Horvitz LA: Ethics study focuses on mentally ill.Insight, March 27, 1995, pp. 14–17.Google Scholar
  76. 76.
    Lieberman JA: The moral imperatives of medical research in human subjects.Journal of the California Alliance for the Mentally Ill 1994; 5(1):40–41.PubMedGoogle Scholar
  77. 78.
    Goodwin FK: Questions and answers.Journal of the California Alliance for the Mentally Ill 1994; 5(1): 45–47.PubMedGoogle Scholar
  78. 79.
    Van Kammen DP, Kelley ME, Gurklis JA, et al.: Behavioral vs. biochemical prediction of clinical stability following haloperidol withdrawal in schizophrenia.Archives of General Psychiatry 1995; 52:673–678.PubMedGoogle Scholar
  79. 80.
    This month in AGP.Archives of General Psychiatry 1995; 52:619.Google Scholar
  80. 81.
    Lehrman NS: Astate hospital population five years after admission: A yardstick for evaluative comparison of follow-up studies.Psychiatric Quarterly 1960; 34:658–681.PubMedCrossRefGoogle Scholar
  81. 82.
    Rachlin HL, Goldman GS, Gurvitz M, et al.: Follow-up study of 317 patients discharged from Hillside Hospital in 1950.Journal of the Hillside Hospital 1956; 5:17–25.Google Scholar
  82. 83.
    Lehrman NS: Follow-up of brief and prolonged psychiatric hospitalization.Comprehensive Psychiatry 1961; 2: 227–240.PubMedCrossRefGoogle Scholar
  83. 84.
    Angrist B: Ethical issues regarding prospective studies of amphetamine psychosis.Journal of the California Alliance for the Mentally Ill 1994; 5(1):32–33.PubMedGoogle Scholar
  84. 85.
    T.D. vNYS OMH, 626 N.Y.S. 2d 1015 (Sup. Ct. NYCnty 1995); Court order: Docket Order 5136/91 (Sup. Ct. NY Cnty) 3/20/95.Google Scholar
  85. 86.
    Hilts PJ: Judge tells health department to stop experiments on patients.New York Times, March 26, 1995, p. A-13.Google Scholar
  86. 87.
    Two courts put limits on research involving the mentally ill.Chronicle of Higher Education, March 31, 1995, p. A-27.Google Scholar
  87. 88.
    T.D. v. NYS OMH: Appellate Div. Order: Docket No. M-3213, 8/3/95; Appellate Div. [no docket no.] order denying motion to vacate, 1/29/96.Google Scholar
  88. 89.
    Lowenkron R, Zucker C: Court orders state to cease dangerous experiments on psychiatric patients. Press release, January 22, 1996, New York Lawyers for the Public Interest.Google Scholar
  89. 90.
    Mooney M: Halts drug testing on mental patients.Daily News, January 24, 1996, p. 12.Google Scholar
  90. 92.
    Thomasma, DC: Obtaining consent for research in the neurobiologically impaired.Journal of the California Alliance for the Mentally Ill 1994; 5(1):54–55.PubMedGoogle Scholar
  91. 93.
    Willwerth J: Madness in fine print.Time, November 7, 1994, p. 63.Google Scholar
  92. 94.
    Weinstein, HM:Psychiatry and the CIA: Victims of mind control. Washington, DC: APA, 1990.Google Scholar
  93. 95.
    Rubenstein LS: Psychiatric experimentation: The lessons of history,Journal of the California Alliance for the Mentally Ill 1994; 5(1):22–24.PubMedGoogle Scholar
  94. 96.
    Hilchey T: Dr. James Watts, 90, pioneer in use of frontal lobotomy [Obituary].New York Times, November 11, 1994, p. B-7.Google Scholar
  95. 97.
    Wong D: Neuropsychiatric hospital on probation.Daily Bruin, April 18, 1995, p. 1.Google Scholar
  96. 98.
    Shuit DP: Three top officials will leave UCLA clinic.Los Angeles Times, April 19, 1995, pp. B-1, B-4.Google Scholar
  97. 99.
    Hilts PJ: House panel told of more tests done without consent.New York Times, May 24, 1994, p. A-13.Google Scholar
  98. 100.
    President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research:Summing up. Washington DC: Government Printing Office, 1983.Google Scholar
  99. 101.
    Appelbaum P, Lidz C, Meisel A:Informed consent—legal theory and clinical practice, Oxford, UK: Oxford University Press, 1987.Google Scholar

Copyright information

©  0111 0141 V 2 1997

Authors and Affiliations

  • Nathaniel S. Lehrman
    • 2
  • Vera Hassner Sharav
    • 1
  1. 1.Citizens for Responsible Care in Psychiatry and ResearchNew York
  2. 2.Kingsboro Psychiatric CenterBrooklyn

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