Ethical Concerns in Placebo-Controlled Studies: An Analytical Approach
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0092-8615/2002 Copyright D 2002 Drug Information Association Inc.
ETHICAL CONCERNS IN PLACEBOCONTROLLED STUDIES:
AN ANALYTICAL APPROACH* NORACAVAZOS, MD, D. FORSTER, JD, MA,
AND
A. J. BOWEN,MD
Western Institutional Review Board, Olympia, Washington
The fifiy-second revision of the Declaration of Helsinki included a statement that proscribed, on an ethical basis, the use of placebo in clinical research when treatment is available. Scientific methods suggest that this determination could affect the validity of research in conditions that show placebo response. Researchers became concerned about the impact that this could have on the quality of drug development. Although the clarification to the Declaration of Helsinki reversed this position, the situation called for revisions to the ethical implications of the use ofplacebo. Most authors agree that placebo is unacceptable in life-threatening diseases or when there is a risk of irreversible damage, but other instances require evaluation on a case-to-case basis. Institutional review boards (IRBs) have to consider the principles of research ethics when deciding whether to approve or reject placebo-controlled studies. Some algorithms to review placebo-controlled studies on ethical grounds have been published Based on these darts and the ethical and methodological considerations derived from our own IRB experiences, the authors of this paper have designed a checklist to assist IRBs in the evaluation of placebo-controlled studies. The checklist was tested in IRB meetings and modified to better reflect the needs expressed in the discussions, It has been useful in guiding deliberations and obtaining consistency in the evaluation of placebo-controlled studies. Key Words: Placebo; Ethical review; IRB; Declaration of Helsinki
INTRODUCTION THE FIFTY-SECOND revision of the Declaration of Helsinki, issued after the World Medical Association General Assembly held in Edinburgh, Scotland, in October 2000, asserted that ‘The benefits, risks, burdens and effectiveness of a new method should be tested against the best current prophylactic, diagnostic and therapeutic method” (1). Although the World Medical Association recently reconsidered this absolute position (2), the isReprint address: Nora Cavazos, MD, 3535 Seventh Avenue, SW. Olympia, WA 98502. E-mail: ncavazos@ wirb.com. *Funding for this project was provided by Western Institutional Review Board.
sue of placebo-controlled studies was once again brought under scrutiny. Ethical review is intended to ensure that the subjects are not exposed to unnecessary risks when participating in a research study, and the use of placebo is but one element of the riskhenefit assessment. It is understood that the risks of receiving treatment within a research protocol may be higher than the risks of regular treatment, therefore, subjects must: be protected from excessive risks; be informed about the risks, discomforts, and burdens of the study; and freely consent to participate. United States federal regulations regarding clinical investiga
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