Elsevier

Biological Psychiatry

Volume 46, Issue 8, 15 October 1999, Pages 1025-1038
Biological Psychiatry

Reviews
Psychiatric research ethics: an overview of evolving guidelines and current ethical dilemmas in the study of mental illness

https://doi.org/10.1016/S0006-3223(99)00205-XGet rights and content

Abstract

The field of psychiatry has an opportunity to construct a more refined, perhaps more enduring understanding of the ethical basis of mental illness research. The aim of this paper is to help advance this understanding by 1) tracing the evolution of the emerging ethic for biomedical experimentation, including recent recommendations of the President’s National Bioethics Advisory Commission, and 2) reviewing data and concepts related to compelling ethical questions now faced in the study of mental disorders. Empirical findings on informed consent, the ethical safeguards of institutional review and surrogate decision making, and the relationship between scientific and ethical imperatives are outlined. Psychiatric researchers will increasingly be called upon to justify their scientific approaches and to seek ways of safeguarding the well-being of people with mental illness who participate in experiments. Most importantly, psychiatric investigators will need to demonstrate their appreciation and respect for ethical dimensions of investigation with special populations. Further empirical study and greater sophistication with respect to the distinct ethical issues in psychiatric research are needed. Although such measures present many challenges, they should not interfere with progress in neuropsychiatric science so long as researchers in our field seek to guide the process of reflection and implementation.

Introduction

The ethical foundation of psychiatric research has been seriously challenged as our country has focused its attention on the evolving standards of ethical conduct in human investigation Appelbaum 1997, Dresser 1996, National Bioethics Advisory Commission 1998, December, Shamoo 1997. This focus is evidenced by the extensive inquiry (1994–1995) into the Human Radiation Experiments in which thousands of individuals were exposed to experimental hazards without their awareness or consent (The President’s Advisory Committee 1996). It is also reflected in President Clinton’s formal apology in 1997 to survivors of the Tuskegee Study in which 200 black men diagnosed with syphilis were intentionally led to believe that they were receiving treatment but were not (Kampmeier 1974). These experiments serve as just two of many important examples of disquieting research practices from throughout biomedical science in recent decades Beecher 1966, Katz 1972, Rothman 1987. They also illustrate how there has been a substantive change in what is understood by our society to be ethically acceptable for the sake of advancing science.

Seeking to clarify this basic moral and societal question has been a key aim of the President’s National Bioethics Advisory Commission, the National Institutes of Health, and research ethicists nationally over the past few years Bell et al 1998, Brody 1998, Hoagwood et al 1996, National Bioethics Advisory Commission 1998, December, Roberts 1997, December. During this time, psychiatric research has become a topic of immense controversy despite the fact that the most disturbing human studies of the past century have not been performed by psychiatrists, although some certainly have involved people with mental illness Beecher 1966, Katz 1972, Roberts 1998. Ironically, this also occurs at a point in history when neuropsychiatric investigation holds great promise for improving our knowledge of mental illness and its treatment Hyman 1999, Lieberman 1996, Pincus et al 1998, Roberts 1997, December. Therefore, with this controversy comes an invitation to construct a more refined and perhaps more enduring understanding of the ethical basis of psychiatric research. The aim of this paper is to help advance this understanding in two ways: 1) by tracing the evolution of the emerging ethic for biomedical experimentation, including a discussion of the recent recommendations of the National Bioethics Advisory Commission; and 2) by reviewing data and concepts related to compelling ethical questions now faced in the study of mental disorders.

Section snippets

Evolving ethics guidelines for biomedical experimentation

Naiveté regarding the ethics of human experimentation was lost with recognition of the cruel and widespread misuse of human beings in the guise of biomedical science during World War II Angell 1990, Brody 1998, Katz 1972, Menkin 1968, Pincus et al 1998. As part of the judgement against 23 Nazi physicians and officials who conducted “studies” of prisoners (including Jews, Czechs, Poles, twins, homosexuals, individuals with mental illness, individuals with mental retardation, and others) in

The national bioethics advisory commission report

The NBAC issued its revised, extensive draft report on “Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity” in November 1998 after roughly one year of review (National Bioethics Advisory Commission 1998). The Commission found no evidence of widespread exploitative research conduct involving people with mental illness; rather, the Commission stated, it was the perception of a “gap” in the regulations related to research with a vulnerable group that was

Current ethical questions in psychiatric research: empirical review

Three ethical questions are especially prominent within the field of psychiatric research at this time: 1) Are individuals with mental illness able to give informed consent? 2) How well do ethical safeguards work in protecting human participants of research? and 3) What do we understand about the competing scientific and ethical imperatives in current experimental practices? As discussed in this section, insights into these questions may be garnered through review of some of the valuable

Conclusion

Psychiatric researchers increasingly will be called upon to justify their scientific approaches and to enhance the ethics safeguards employed in their experiments with potentially vulnerable human participants. Greater sophistication is needed with respect to the distinct ethical issues in psychiatric research to develop approaches that foster fruitful investigation while adequately protecting human participants, not only in theory, but in practice. Advanced empirical work is necessary so that

References (78)

  • T.S. Zaubler et al.

    Ethical, legal and psychiatric issues in capacity, competency, and informed consentAn annotated bibliography

    Gen Hosp Psychiatry

    (1996)
  • M. Angell

    The Nazi hypothermia experiments and unethical research today

    N Engl J Med

    (1990)
  • P.S. Appelbaum

    Drug-free research in schizophreniaAn overview of the controversy

    IRB

    (1996)
  • P.S. Appelbaum

    Rethinking the conduct of psychiatric research

    Arch Gen Psychiatry

    (1997)
  • P.S. Appelbaum et al.

    The MacArthur treatment competence study I, II, III

    Law Hum Behav

    (1995)
  • P.S. Appelbaum et al.

    Competency to consent to researchA psychiatric overview

    Arch Gen Psychiatry

    (1982)
  • S. Barlas

    Commission makes recommendations for treatment of research subjects with mental illness

    Psychiatr Times

    (1999)
  • H.K. Beecher

    Ethics and clinical research

    N Engl J Med

    (1966)
  • Bell J, Whiton J, Connelly S (1998): Final Report—Evaluation of NIH Implementation of Section 491 of the Public Health...
  • W. Breitbart et al.

    Interest in physician-assisted suicide among ambulatory HIV infected patients

    Am J Psychiatry

    (1996)
  • B.A. Brody

    The Ethics of Biomedical ResearchAn International Perspective

    (1998)
  • J.H. Brown et al.

    Is it normal for terminally ill patients to desire death?

    Am J Psychiatry

    (1986)
  • W.T. Carpenter et al.

    The rationale and ethics of medication-free research in schizophrenia

    Arch Gen Psychiatry

    (1997)
  • B.R. Cassileth et al.

    Survival and quality of life among patients receiving unproven as compared with conventional cancer therapy

    N Engl J Med

    (1991)
  • B.R. Cassileth et al.

    Informed consentWhy are its goals imperfectly realized

    N Engl J Med

    (1980)
  • D.A. Curson et al.

    Does short term placebo treatment of chronic schizophrenia produce long term harm?

    Brit Med J

    (1986)
  • C. Daugherty et al.

    Perceptions of cancer patients and their physicians involved in phase I trials

    J Clin Oncol

    (1995)
  • H. Dermatis et al.

    Psychological distress in parents consenting to child’s bone marrow transplantation

    Bone Marrow Transplant

    (1990)
  • R. Dresser

    Mentally disabled research subjectsThe enduring policy issues

    JAMA

    (1996)
  • R. Dukoff et al.

    Durable power of attorney and informed consent with Alzheimer’s disease patientsA clinical study

    Am J Psychiatry

    (1997)
  • L. Ganzini et al.

    The effect of depression treatment on elderly patients’ preferences for life-sustaining medical therapy

    Am J Psychiatry

    (1994)
  • J.M. Gibson

    Values History Focuses on Life and Death Decisions

    Med Ethics Physician

    (1990)
  • P.L. Gilbert et al.

    Neuroleptic withdrawal in schizophrenic patients

    Arch Gen Psychiatry

    (1995)
  • B.H. Gray

    Human Subjects in Medical Experimentation

    (1975)
  • M.J. Grinfeld

    NY court orders halt to research on psychiatric patients

    Psychiatr Times

    (1996)
  • L. Grossman et al.

    A study of the capacity of schizophrenic patients to give informed consent

    Hosp Comm Psychiatry

    (1980)
  • S.A. Grossman et al.

    Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?

    J Clin Onc

    (1994)
  • D.M. High

    Research with Alzheimer’s disease subjectsInformed consent and proxy decision making

    J Am Geriatr Soc

    (1992)
  • K. Hoagwood et al.

    Ethical issues in mental health research with children and adolescents

    (1996)
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