KISS rule: Investigators need to keep it simple

October 2009
Clinical Trials Administrator;Oct2009, Vol. 7 Issue 10, p118
This article reports on the failure of researchers to develop an optimal way of giving study participants information they want to hear during the informed consent process, according to David H. Strauss of the New York State Psychiatric Institute. A regulatory-driven list of criteria is included in the informed consent document. He says informed consent documents should address important issues such as alternatives and what it means to be in a study that is placebo-controlled and randomized.


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