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Correspondence
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Volume 361:1811-1812 October 29, 2009 Number 18
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Death in a Gene-Therapy Trial

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 by Frank, K. M.
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To the Editor: Frank et al. (July 9 issue)1 do not discuss the issue of therapeutic misconception2 — namely, the belief by a research subject that the investigational agent is actually therapeutic. Admittedly, there was no concrete evidence for this issue here, but on the basis of the nature and timing of events, the issue was relevant and became an important part of the report and recommendations of the Recombinant DNA Advisory Committee of the National Institutes of Health.

Therapeutic misconception for the subject can be addressed during the consenting procedure.3,4 However, therapeutic misconception is also an issue for investigators . . . [Full Text of this Article]




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