Refer to the PRISM Readability Toolkitwhich contains information about the principles of Plain Language, and examples for improving readability.
The IRB has compiled a document entitled Consent Librarywhich includes Plain Language descriptions of procedures and corresponding risk information. The document can be downloaded as an MS Word file. The IRB does not intend that investigators must use the exact wording for most procedures. Both the descriptions of the procedures, and the associated risks, may be modified and adapted to match each study's specific requirements, with a few exceptions which are noted in the document;
Target the reading level as close as possible to Grades 6 - 8;
Have someone without a medical background, who is unfamiliar with the study, review the consent form;
Edit, revise, and edit again - until the document is clear and concise.