Am J Psychiatry 160:356-362, February 2003
© 2003 American Psychiatric Association
The Declaration of Helsinki and Clinical Trials: A Focus on Placebo-Controlled Trials in Schizophrenia
William T. Carpenter, Jr., M.D.,
Paul S. Appelbaum, M.D., and
Robert J. Levine, M.D.
OBJECTIVE: The authors’ goal was to consider ethical approaches to placebo-controlled clinical trials in the light of the evolving Declaration of Helsinki, with special attention to applications to research on schizophrenia. METHOD: They review the Helsinki position on placebos, including the 2002 Clarification, exploring the potential negative effects of banning placebos in studies involving conditions for which at least partially effective treatments exist. The Clarification is examined as an approach to this issue that, in contrast to earlier formulations, better acknowledges the complexity of clinical research and the need for protocol-specific determinations. Placebo controls in schizophrenia studies are used to illustrate issues relevant to all clinical research on therapeutic interventions. RESULTS: The Helsinki Clarification provides a basis for operationalizing criteria for review of placebo use in clinical trials. Six criteria are proposed for judging the ethical acceptability of placebo controls, including the likelihood that the intervention being tested will have clinically significant advantages over existing treatments, the presence of compelling reasons for placebo use, subject selection that minimizes the possibility of serious adverse consequences, and a risk-versus-benefit analysis that favors the advantages from placebo use over the risks to subjects. CONCLUSIONS: The Helsinki Clarification constitutes an important advance in international approaches to placebo use, requiring protocol-by-protocol judgments on complex issues of clinical research ethics. When operationalized, it provides review boards with a useful methodology for reaching determinations on the appropriateness of placebo controls in particular studies.
This article has been cited by other articles:
|
|
|
|
 
R. P. McMahon, D. L. Kelly, D. L. Boggs, L. Li, Q. Hu, J. M. Davis, and W. T. Carpenter Jr.
Feasibility of Reducing the Duration of Placebo-Controlled Trials in Schizophrenia Research
Schizophr Bull,
March 1, 2008;
34(2):
292 - 301.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. L. Spath
Continued Controversies: Issues in Mental Health Research and Implications for Nursing
Journal of the American Psychiatric Nurses Association,
September 1, 2007;
13(4):
221 - 229.
[Abstract]
[PDF]
|
|
|
|
|
|
|
J. R. Bola
Psychosocial Acute Treatment in Early-Episode Schizophrenia Disorders
Research on Social Work Practice,
May 1, 2006;
16(3):
263 - 275.
[Abstract]
[PDF]
|
|
|
|
|
|
|
P. S. Appelbaum and L. W. Roberts
Introduction: Report of the APA's Task Force on Research Ethics
Psychiatr Serv,
April 1, 2006;
57(4):
550 - 551.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. R Bola
Medication-Free Research in Early Episode Schizophrenia: Evidence of Long-Term Harm?
Schizophr Bull,
April 1, 2006;
32(2):
288 - 296.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
W. T Carpenter
Editorial: Traditional Ethics and New Sensitivities
Schizophr Bull,
January 1, 2006;
32(1):
1 - 2.
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. A Fischer IV
A Summary of Important Documents in the Field of Research Ethics
Schizophr Bull,
January 1, 2006;
32(1):
69 - 80.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. B Dunn, P. J Candilis, and L. W. Roberts
Emerging Empirical Evidence on the Ethics of Schizophrenia Research
Schizophr Bull,
January 1, 2006;
32(1):
47 - 68.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. T Wilson and B. Stanley
Ethical Concerns in Schizophrenia Research: Looking Back and Moving Forward
Schizophr Bull,
January 1, 2006;
32(1):
30 - 36.
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. B Dunn, B. W Palmer, and M. Keehan
Understanding of Placebo Controls Among Older People With Schizophrenia
Schizophr Bull,
January 1, 2006;
32(1):
137 - 146.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. C. Glass and D. Waring
The Physician/Investigator's Obligation to Patients Participating in Research: The Case of Placebo Controlled Trials
J. Law Med. Ethics,
September 1, 2005;
33(3):
575 - 585.
[PDF]
|
|
|
|
|
|
|
S. W. Woods, R. V. Gueorguieva, C. B. Baker, and R. W. Makuch
Control Group Bias in Randomized Atypical Antipsychotic Medication Trials for Schizophrenia
Arch Gen Psychiatry,
September 1, 2005;
62(9):
961 - 970.
[Abstract]
[Full Text]
[PDF]
|
|
|
Get information about faster international access.
Privacy Policy
Copyright © 2003
American Psychiatric Association.
All rights reserved.
Home
| Search
| Current Issue
| Past Issues
| Subscribe
| All APPI Journals
| Help
| Contact Us
|
