If one wants to make something understandable for the largest possible audience, then it might make more sense to offer language that can be absorbed by an 8th grader, instead of an 11th grader, for instance. Institutional review boards, for example, recommend the lower level. However, a recent analysis of informed consent documents from 15 studies finds the forms aim too high.
The researchers used five validated, standardized readability tests to analyze consent forms for the studies, which were taking place at Duke University and the University of California, Los Angeles, according to Anesthesiology News. These included four observational-noninterventional studies, five observational-interventional studies, three evaluation studies and three randomized controlled trials, the paper notes.
The upshot? They were tested for readability, but the average reading level was consistent with the ability of an 11th grader, the paper reports. The observational-noninterventional studies rated highest, at grade 11.7, which is really 12th grade. "RCTs and evaluation studies were written at a mean reading level of grade 10.7," the newspaper writes, adding that "RCT consent forms were more readable, but also included the most sentences and words, as well as the most complex words."
The implications, of course, do not bode well for sponsors and those who carry out clinical trials, since some research subjects may not fully comprehend or appreciate the myriad issues raised by participation. This also speaks to ongoing concerns about clinical trial ethics, specifically the full and proper disclosure of health risks that subjects may encounter.
“Subjects who do not fully understand a consent form may initially consent to participate, but withdraw after realizing they are receiving an intervention or procedure they did not understand or agree with at the outset of the study," primary investigator Madhav Swaminathan, associate professor of anesthesiology and director of perioperative echocardiography in the Division of Cardiothoracic Anesthesiology and Critical Care Medicine at Duke University School of Medicine, tells the paper.
He offered a qualifier, though, by suggesting the 11th grade reading level may be acceptable for research conducted in more educated populations, such as participants living in urban areas with more educational institutions, according to the paper." Of course, there are urban settings where educational levels vary widely, which means that tailoring consent forms to specific regions can be dicey.