Readability of Informed-Consent Forms

To the Editor: Paasche-Orlow and colleagues report on the readability of informed-consent forms (Feb. 20 issue). 1 An important and interesting problem that we are now encountering is that sponsoring companies approach informed-consent documents as legal tools. Thus, when our institutional review board (IRB) has made recommendations for simplifying or clarifying language, the board has been told by sponsors that this cannot be done. For example, we recently received a letter fro m a company stating, “The language revised per the IRB concerning Privacy and Confidentiality is protected template language and may not be revised or altered in any way. If . . .