Mark Hochhauser, Ph.D., Readability Consultant/IRB Member, Golden Valley, MN
Abstract: As the science and regulatory requirements behind clinical trials have evolved over the past few decades, consent forms have become very long. This article compares the word count of some oncology consent forms with other documents, and shows that those consent forms are longer than ethical guidelines and federal regulatory documents. Because too many consent comprehension tests and health literacy measures are not psychometrically sound (and of limited value), efforts to improve comprehension and health literacy continue to be serious problems now and in the future.
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