IRB tackles readability of informed consent forms
Use plain language as a start
IRBs continue to see informed consent (IC) forms that require high school or college reading skills when nearly half of Americans can read no higher than a 5th grade level, an IRB chair says.
"After visiting a PRIM&R conference two years ago, I became interested in readability and wanted to know what is the readability level, the understanding level of patients and potential participants in research," says Thomas "TK" Koesterer, PhD, ATC, associate professor at Humboldt State University in Arcata, CA. Koesterer is the chair of the university's IRB.
Koesterer used the Flesch-Kincaid Readability Statistics function of Microsoft Word to assess 61 informed consent documents reviewed by the IRB.
"Our reading level was 12th grade, when 7th grade was the average we're shooting for," he says. "There is nothing in the federal regulations that says what the readability level should be, but the regulations say the forms should be understandable by subjects."
The IRB's data on IC readability led to an initiative to improve the overall readability of informed consent forms submitted for review. The IRB encourages researchers to check their Flesch-Kincaid scores and shoot for improved readability through the use of simpler language, shorter sentences, fewer clauses, and short words. (See plain language tips, below.)
Federal government offers these plain language tips Checklist can work for IC The U.S. government provides information and strategies for improving readability of documents at the plainlanguage.gov website. These same tips can help IRBs improve informed consent forms. Here is the plain language checklist:
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"When researchers check their Flesch-Kincaid levels they can see right away that their form is written at 15th grade level, and we can help them use simpler words with less syllables to improve it," Koesterer says.
As a follow-up to Koesterer's assessment of IC readability at the university, he would like to check readability again in a year to see if investigators have made improvements.
"Once we have that initial data, we can give it a year and assess again to see how we're doing," he says.
Also, it would be helpful to assess how well participants understand the IC forms, comparing comprehension of the revised forms with their comprehension of forms that are written without particular attention paid to lowering their Flesch-Kincaid reading levels, he adds.
"The next stage would be to provide investigators with a template for writing consent forms, using federal plain language guidelines," Koesterer says.
For example, one tip is to use sentences that speak directly to participants, rather than to use language written in the third person, he says.
"You say, 'You will do this' or 'You will be asked to do this,'" he explains.
Here are some other guidelines for improving IC readability:
• When listing items, use bullet points. "If you use bullets and a number list, it implies an order to what is going on, and it's easier for people to look at," Koesterer says. "It's better to use bullet lists than writing the points in one long paragraph."
There is one important detail to note about using bullet points, he adds.
"If you don't put periods at the end of the bullet lines, then Flesch-Kincaid will skip over that whole section, and you won't know what the true reading level is," Koesterer says.
• Make headings simple and interesting. Informed consent forms need a generous number of headings to break up the copy and make it easier to follow and more readable, he says.
Readers often find headings with questions simpler to understand, Koesterer says.
"Write headings, such as 'What will you be expected to do?' or 'What are the benefits to you?'" he explains.
• Provide writing template. Templates can help investigators with writing informed consent documents by giving them examples of plain language to use.
"A template is a living document that keeps evolving to help with understanding," Koesterer says. "Researchers say, 'Just tell me the language to use that fulfills the federal regulations and that the subject will understand."
While there is no magical formula, IC templates can be helpful.
• Rewrite legalese. Research institutions often have attorneys who want specific phrases and wording placed in informed consent forms, Koesterer notes.
Unfortunately, the language they use often is complex and includes words that make the intent difficult to follow. For instance, legal phrases often include the word "shall," which is no longer commonly used in the English language, he adds.
"'Should' is past tense of 'shall,' but now people use the word 'should' to mean it's an option," Koesterer says. "I prefer to use the words 'must' and 'required.'"
This is why some simple word exchanges can improve reader comprehension.
"You can be technically correct, but people may not understand," Koesterer says.
IRBs can take this legalese and change it to simpler sentences and words. For example, rather than spend a paragraph outlining a subject's right to withdraw from a trial, the IC form can say, "You can stop whenever you want. You will not lose any benefits," Koesterer says.
IRBs continue to see informed consent (IC) forms that require high school or college reading skills when nearly half of Americans can read no higher than a 5th grade level, an IRB chair says.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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