[Quality evaluation of informed consent forms: a pilot study]. / La valutazione qualitativa del consenso informato: uno studio pilota.

ABSTRACT

Informed consent forms must be designed to meet specific requirements but evaluating the structure and content requirements of consent forms from a qualitative point of view is not a simple task. An evaluation tool was therefore developed in the context of a pilot study to evaluate the current quality of informed consent forms at both medical and surgical departments of the San Giovanni Battista Hospital in Turin (Italy). A random sample of 288 medical records of patients hospitalized during 2007-2008 was selected. These were evaluated to determine the presence of a properly executed informed consent form or of a justification for its absence. Each consent form was evaluated based on the presence of a list of requirements. Statistical analysis was conducted by first taking into account all departments and then stratifying by medical and surgical departments. The evaluation tool was found to useful in evaluating, in a standardized and repeatable manner, the adequacy and completeness of informed consent forms in different hospital departments.