Simplifying informed consent language
A couple of things happened recently that got us thinking about the IRB approval criterion that requires informed consent information to be provided “in language understandable to the subject.”
First, we prereviewed some industry study consent forms that were between 20 and 40 single-spaced pages, full of big words about serious disease. If I had time to read 40-page consent forms, I’d spend it reading novels instead, frankly, and we’re not sure our subject population is inclined to read complete forms either. Sharon Belvin, who was diagnosed with metastatic melanoma in her early 20s and benefited greatly from an experimental treatment, said of her informed consent experience: “It was pages and pages of this could happen to you and that could happen to you. I didn’t read one page. I just signed at the bottom and said, ‘Give it to me.'” (Quoted in The New Yorker, April 23, 2012.)
Then, we heard back from the people who reviewed our poster abstract about the plain language consent form (we got accepted to do a poster! Yay us!). One of the limitations of the plain language consent project we listed was that it wasn’t really applicable to industry-sponsored studies, as industry sponsors provide their own consent language and aren’t open to negotiating. One of the reviewers punted that right back to us, pointing out that ultimately, “the IRB is tasked with determining the appropriateness of the language.” This reviewer advised us to address how the IRB will plan to work with sponsors to “establish better adoption of the more simplified” consent language.
Well, by the time an industry-sponsored consent form gets to the IRB, it will have been negotiated and reviewed and who-knows-what-elsed by attorneys and doctors and sponsors and the like. So there’s not much we can do about the language in the sponsor-provided consent form itself. However, remember that nothing in the regulations or policies or anyplace else prohibits us from requiring the creation and use of supplementary materials written in actual “language understandable to the subject.”
When was the last time you made a significant decision based on a quick review of a 40-page, single-spaced document? In fact, when was the last time you even read a 40-page document all the way through in a short time and retained most of what you read (not counting reviewing new submissions for the IRB)? Here at the IRB, we know of at least one FDA-regulated study whose PI (it was investigator-initiated) knew that his potential subjects weren’t going to read his full consent form (which he deliberately kept short — only 4 pages), so he created a separate brochure, with lots of white space, bulleted lists, and pictures, that covered the highlights of the study.
Requiring supplementary consent information, whether it be a brochure, or some other format suited to the subject population, is well within the IRB’s purview, in order to meet the criterion that consent information be “in language understandable to the subject.” PIs could be encouraged to, for example, adapt plain-language-consent-template language into a single-page information sheet that covered study highlights. We also note that these dense, multi-page consent forms may not fly solo under the revised Common Rule, slated to be implemented January 2018. The revised rule contains a requirement that consent materials be clearer and more focused, and must facilitate a potential subject’s understanding of why one might want to participate, or not. While guidance about how this requirement is to be met has not yet been released, we should continue thinking of ways to make consent-related information easier to understand.