Stick to the statistics on risk in informed consent documents

May 2009
Clinical Trials Administrator;May2009, Vol. 7 Issue 5, p58
This article explains that Yen-Hong Kuo, a biostatistician at the Jersey Shore University Medical Center in Neptune, New Jersey, is opposing the claim by Indepent Research Board (IRB) members, investigators and others that potential crinical trial participants will find hard data and numbers confusing when reading these descriptions of risk in informed consent documents. Kuo points out that investigators should put in the informed consent document both the statistics related to possible risks and descriptions or characteristics of that risk.


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