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Schizophrenia Bulletin Advance Access published online on October 19, 2005
Schizophrenia Bulletin, doi:10.1093/schbul/sbj012
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© The Author 2005. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org.

Article

Emerging Empirical Evidence on the Ethics of Schizophrenia Research

Laura B. Dunn 1*, Philip J. Candilis 2, and Laura Weiss Roberts 3
1 Department of Psychiatry, University of California, San Diego
2 Department of Psychiatry, University of Massachusetts Medical School
3 Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin

* To whom correspondence should be addressed.
Laura B. Dunn, E-mail: Ldunn{at}ucsd.edu


  Abstract

Many challenging ethical questions come with the scientific efforts to understand the nature and treatment of schizophrenia. The empirical study of ethical aspects of schizophrenia research has sought to clarify and resolve many of these questions. In this article we provide an overview of the existing data-based literature on schizophrenia research ethics and outline directions for future inquiry. We examine 5 broad categories of inquiry into the ethics of schizophrenia research: (1) Scientific designs (eg, placebo-controlled studies and medication-free intervals, prodromal and high-risk research, and genetics research); (2) informed consent and decision-making capacity, including assessment of decisional abilities, as well as intervention studies; (3) understanding and perceptions of risk and benefit (including the therapeutic misconception); (4) influences on research participation (including voluntarism, altruism, and other motivations); and (5) key participant safeguards, such as protocol review and participant advocates. We discuss how empirical work in each of these areas answers certain questions and raises new ones. Finally, we highlight important gaps in our understanding of ethically relevant aspects of schizophrenia research and offer a specific research agenda for empirical ethics.

Keywords: schizophrenia; bioethics; clinical trials; decision-making capacity; informed consent; empirical studies.
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