Consent Forms, Lower Reading Levels, and Using Flesch-Kincaid Readability Software

摘要

For clinical research conducted in the United States, the Office of Human Research Protection (OHRP), Department of Health and Human Services (DHHS), and the Food and Drug Administration (FDA) mandate the use of subject consent forms as described in the Code of Federal Regulations (CFR). These regulations define critical, required consent form elements to ensure subjects are informed of study risks, possible benefits, and proposed research methods. The regulations also require that consent formsdefine a subject's rights as a study participant so that the subject can provide an informed decision whether or not to participate in a research study. As per these regulations, it is the clinical investigators' responsibility to ensure that research volunteers understand the information described in the clinical research consent form. Yet research pertaining to consent form comprehension reveals that individuals participating in clinical studies often do not comprehend information contained in consent forms (1). Although subject consent to a clinical research trial must involve a whole process and not just