Informed consent: Reality or illusion?

Examination of consent forms being used by major hospitals in Pittsburgh suggested that there was considerable room for improvement. Thus, the major goal of this study was to produce a better consent form. Our revision focused on three major areas of concern: (1) meeting the needs of the people who use consent forms; (2) deciding how explicit to make the information in the form; and (3) designing the form so that it will be used correctly. We then evaluated our revision using a number of techniques, including readability scores, tests of comprehension, and interviews. Our study suggests a number of points relevant to designing consent forms, as well as to document design in general.