The thought of a 17,000-word-long consent form causes our eyes to glaze over — that’s more than 30 pages of single-spaced text. But apparently such a thing exists, according to a recent study about consent forms from IDE studies, accepted for publication in the journal Contemporary Clinical Trials and reported on at the Regulatory Affairs Professionals Society web page.
The study, done by staffers at the FDA’s Center for Devices and Radiological Health, examined 399 consent forms from 2015 and 2016. It found the consent forms were written, on average, at a 10th-grade reading level, and ranged from 2 to 37 pages in length.
Click on the link to read the full RAPS article. The article includes a link to the original manuscript. As you read it, please think about your own consent processes, including the forms or other visual or printed materials you use in them. Yes, certain elements must be addressed in the consent process, by regulation and policy. However, you have wide latitude in how to address them. For starters, we have a plain language informed consent template (see the RCR-compliant plain language template here) developed by the UAMS Center for Health Literacy that’s intended to convey written information in understandable terms. Also, the UAMS IRB encourages researchers to think creatively about the entire consent process. Page after page of printed text is only one way of transmitting information, and perhaps not the best way for your study population. Would pictures, tables, brochures work for your target audience? Many years ago, the IRB reviewed a consent form that included a drawing showing where in the body an investigational device would be implanted. The picture helped the study team avoid having to use a whole lot of words to describe device placement. The reviewers loved it. We haven’t seen one like that since, but we’re definitely open to that sort of thing.