Despite years of guidelines urging simpler and easier-to-understand informed-consent documents, the forms given to clinical trial participants remain too long and use language that is too complex.
A review of 124 informed-consent documents used in 21 HIV clinical trials sponsored by the National Institutes of Health’s Division of AIDS found that the forms were typically written above the ninth-grade level and ran longer than 22 pages. The findings were published online July 6 in the Journal of General Internal Medicine.
“Very few people are going to sit down and read a document that’s that long, and the goal is to have people understand,” said Nancy Kass, ScD, lead author of the study. “The whole reason for putting [informed consent] in writing is with the belief that someone will read it. The longer it is, the less likely people are to read it all the way through, and then you have defeated your own purpose.”
My latest. Read the whole shebang.