Schizophrenia Bulletin Advance Access originally published online on February 8, 2006
Schizophrenia Bulletin 2006 32(2):307-309; doi:10.1093/schbul/sbj049
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© The Author 2006. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org.
Ethics of Medication-Free Research in Schizophrenia
2 Departments of Public Health Sciences and Psychiatric Medicine, Charlottesville, VA
3 Center for Biomedical Ethics, University of Virginia
| The first 10% of the full text of this article appears below. |
Bola's study highlights two important points about the ethics of medication-free research in early episode schizophrenia.1 First, the question of whether "biological toxicity" results from short periods of medication-free research in early episode schizophrenia is an important, though very narrow, question in the debate over ethics of medication-free research in schizophrenia. Second, even on this narrow question, the paucity of good data is striking.
Based on a meta-analysis of 623 participants in 4 randomized controlled trials and 3 quasi-experimental studies otherwise meeting his selection criteria for study inclusion, Bola concludes that "in the absence of substantive evidence of long-term harm from short periods of medication-free research in schizophrenia, a categorical prohibition of medication-free research in early episode schizophrenia on ethical grounds of harm to human subjects should probably be reconsidered." Instead, he suggests applying
| Compelling Scientific Rationale |
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| "No Serious Harm or Significant Discomfort" |
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| Provisions to Minimize Risks of Harm |
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1To whom correspondence should be addressed; Center for Biomedical Ethics, Box 800758, University of Virginia Health System, Charlottesville, VA 22908, phone: 434-243-5804, fax: 434-982-3971, e-mail: dtc6k@virginia.edu.