Contrary to the stated purpose of helping patients make educated decisions concerning research participation, informed consent forms contain provisions that actually hinder clinical trial enrollment, according to findings published online January 12, 2010, ahead of print in Circulation: Cardiovascular Quality and Outcomes.

Researchers led by Kevin P. Weinfurt, PhD, of the Duke Clinical Research Institute (Durham, NC), surveyed 470 CAD patients to elicit their reactions to an informed consent document for a hypothetical cardiovascular medication trial, which was adapted from a previously approved trial at Duke University Medical Center. Interviewers reviewed the consent forms with study participants, all of whom were ....

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