Elsevier

Schizophrenia Research

Volume 35, Issue 3, 15 February 1999, Pages 219-225
Schizophrenia Research

Sense and nonsense:: an essay on schizophrenia research ethics

https://doi.org/10.1016/S0920-9964(98)00128-5Get rights and content

Abstract

In this essay, the authors select topics from the current debate on the ethics of schizophrenia research. Accepting competent and voluntary informed consent as essential for most projects, the authors discuss the relation of diagnosis to deisional capacity, the respective roles of psychosis and cognitive impairments in decsional capacity, and whether impairments in capacity can be remediated. The roles of investigator, external agent, patient subject, and family or suroogate in the informed consent process are reviewed. A lack of understanding of the treatment of persons with schizophrenia has distorted and inflamed public dicussion of issues such as `withholding treatment'. A standard, based in common sense, is proposed: for viweing protocols; for allowing autonomy and altruism despite diagnostic class; and, for a meaningful discussion of what is meant by and what should be done about `risk without direct benefit' protocols.

Introduction

The Toronto Conference on Research Ethics provides an excellent opportunity to consider certain issues in ethics as applied to research with severely mentally ill persons. It is important that views from many vantages be considered in the discussion of these issues. The content of this essay will be focused on issues in schizophrenia research. This is an area of much heat and misunderstanding in the public discussion. The discussion of a few selected issues is offered in the hope that it will increase rational consideration of optimal research procedures and diminish the influence of recommendations based on a misunderstanding of the actual circumstances of clinical investigation. The discussion will be divided into sections on informed consent, on the idea of withdrawing medication, and on the several perspectives in which research protocols are judged.

Section snippets

Informed consent

The conduct of clinical investigation is a noble enterprise and a foundation of scientific medicine. Much human suffering and enhancement of quality of human life emanate directly from clinical investigations. The clinician investigator has many responsibilities, but foremost among them is the protection of the safety, welfare, and dignity rights of persons who participate as subjects in investigations. Informed consent is at the heart of the processes that protect the autonomy, dignity, and

Perspectives on research ethics

There are several vantages from which the ethics of particular protocols can be addressed. In each of these it is important that considerations meet a commonsense standard. Instances to consider include:

References (13)

  • P.S Appelbaum et al.

    Clinical issues in the assessment of competency

    Am. J. Psychiatry

    (1981)
  • Appelbaum, P.S., Grisso, T., 1996. MacArthur Competence Assessment Tool—Clinical Research Version. University of...
  • W.T Carpenter et al.

    Early intervention, time-limited targeted pharmacotherapy in schizophrenia

    Schizophr. Bull.

    (1983)
  • W.T Carpenter et al.

    The rationale and ethics of medication-free research in schizophrenia

    Arch. Gen. Psychiatry

    (1997)
  • P.L Gilbert et al.

    Neuroleptic withdrawal in schizophrenic patients: a review of the literature

    Arch. Gen. Psychiatry

    (1995)
  • Hilts, P.J., 1994a. Agency faults a UCLA study for suffering of mental patients. New York Times, 10...
There are more references available in the full text version of this article.

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