© 2002 American Thoracic Society
Where are the institutional review boards?To the Editor:I am really concerned about the flaw in the study design of the Acute Respiratory Distress Syndrome (ARDS) Network study (1) as pointed out by Eichacker and colleagues (2). As mentioned by Eichacker and colleagues, treatment for control patients should reflect routine care, which was not the case in the ARDS Network study (3). This would also raise an issue that the central institutional review board (IRB) and the local IRBs involved in the study failed to detect such a fatal flaw in such an expensive, time consuming study. Not conducting a clinical study in a right way puts patients at unnecessary risks and is simply a waste of time and money. We have to make every effort to avoid the tragedy that recently happened at Johns Hopkins (4), and a government study should not be an exception. A standard for minimizing risks in research involving sick people should be as high as in research involving healthy people. Finally, I would like to thank Eichacker and colleagues for their formal analysis on the clinical studies to support my comments in the New England Journal of Medicine (3). I wish that treatment for the control groups in the ongoing ARDS Network trials would reflect routine care.
University of Missouri, Kansas City Kansas City, Missouri REFERENCES
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