Is Informed Consent as Ethical as It Could Be?

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The article New England IRB on Ethical Issues in Recruiting Patients, in the March 3, 2008, issue of eCliniqua served as a reminder to those involved with the execution of clinical trials of the importance of exercising due diligence to ensure that all aspects of clinical trial conduct are ethical.

I would like to bring to the attention of readers of eCliniqua some of my thoughts about making the informed consent process more ethical (see refs. 1, 2, and 3). Many are aware, particularly in Phase III confirmatory proof of efficacy trials, that the determination of sample size carries with it an efficacy imperative. That is, in order to confirm a question regarding efficacy of a compound, it is imperative that the sample size of the trial be large enough to provide a priori a high probability (large power) that the question will be answered.

Sample size determination carries with it an ethical imperative as well. Before I would agree to participate in a clinical trial, I would want to know first: that the trial was needed to answer a medically important question (and what that question was), and second: what the likelihood was -- for the number of planned participants -- that the question would be answered. Including this second issue in the informed consent document in the protocol, would, I believe, make the informed consent process more ethical.