Enduring and Emerging Challenges of Informed Consent

To the Editor: In her review article, Grady (Feb. 26 issue) 1 emphasizes the gap between theory and practice in obtaining informed consent. However, the extent of this discrepancy currently appears to be more relevant than expected. By 2003, the readability of informed-consent forms that were provided by institutional review boards did not meet standards, according to the Flesch–Kincaid formula. 2 , 3 Thus, using this formula, we analyzed the current templates for informed-consent forms of the United Kingdom National Health Service, as well as those of ethics committees and umbrella organizations in Austria, Germany, and Switzerland. In summary, most informed-consent forms require . . .