The Problem of Readability of Informed Consent Documents for Clinical Trials of Investigational Drugs and Devices: United States Considerations

摘要

Informed consent is a fundamental element in the conduct of ethical clinical trials. An important part of the totality of the consent process is the consent document. This document provides the information upon which patients can base their decision regarding participation in the trial. Written informed consent is a requirement in all but rare cases and the content of the consent document is the subject of regulation. Many studies have shown that consent documents are often written at a level that makes them virtually unreadable by many patients. While a number of approaches to improving readability have been tried, only a few have been shown to have a positive effect. This paper examines the nature of the problem, reviews approaches to the improvement of readability, and offers suggestions for achieving such improvement.