Readability of Informed-Consent Forms
- 29 May 2003
- journal article
- letter
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 348 (22) , 2262-2263
- https://doi.org/10.1056/nejmc030704
Abstract
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 any changes were to be made . . . justification would be required with a copy of the specific law or regulation that supports the change. All information would then be submitted to the [sponsor's] legal department for review.” We are concerned that this trend will interfere with the ability of IRBs to ensure that information is provided at an appropriate level of comprehension.Keywords
This publication has 4 references indexed in Scilit:
- Readability Standards for Informed-Consent Forms as Compared with Actual ReadabilityNew England Journal of Medicine, 2003
- Beware the Jabberwock and other perils of readability formulaeTransfusion, 1993
- Making Legal Language Understandable: A Psycholinguistic Study of Jury InstructionsColumbia Law Review, 1979
- Ease of Comprehension of Standard and Readable Automobile Insurance Policies as a Function of Reading AbilityJournal of Reading Behavior, 1977