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Plain language consent form templates

Making informed consent information understandable to participants has long been a challenge, as we at the IRB well know. Reading levels of many consent forms often exceed the recommended no-great-than-8th-grade guideline.

The UAMS Center for Health Literacy has been working on coming up with ways to make working with some IRB staff, TRI, and others on campus, has developed a research informed consent template that applies many simplified language best practices (short sentences, simple language, white space, bulleted lists). The template is available on the TRI and IRB websites. It’s under “New Study Tools” on the IRB’s page (irb.uams.edu).

We encourage IRB members to take a look at the template to get familiar with the content and language level. We expect questions about how the convened IRB might encourage use of the template. The best way would be for you to use it yourself or to encourage people you work with to use it in any investigator-initiated research. While it may be tempting to, while reviewing a full-board study, direct a PI to rewrite the consent form using the plain language template, please keep the following issues in mind:

  • Some of the worst offenders, language-level wise, are industry sponsored studies, where we really can’t recommend complete overhauls of consent language, due to sponsor requirements.
  • By the time a study gets to the convened IRB, it will have gone through several prereviews — by IRB prereview, at a minimum, plus possibly another at TRI. So someone will likely have already encouraged the use of the plain language template, if appropriate.
  • The IRB is supposed to limit its reviews to the criteria for approval. In (very brief) summary, those criteria require informed consent to be obtained, to be documented in accordance with the relevant regs, and to ensure that information given to the subject be “in language understandable to the subject or the subject representative.” So the IRB should review consent forms with these requirements in mind, and request changes only if requirements aren’t met.