IRB takes on readability with staff education
Health literacy education, online training part of push to improve informed consent
Improving the readability of informed consent involves more than a one-time education of researchers or IRB staff — it's a process that requires ongoing commitment.
That's the view of Hallie Kassan, MS, CIP, director of the IRB office at the Feinstein Institute for Medical Research in Manhasset, NY. The office has undertaken staff education to help keep them focused on making informed consent more understandable.
"If you educate on something you need to revisit it — not just educate and talk about it and move on, but refresh people's memories and remind them to watch for these things," Kassan says.
Kassan says she was approached by head of the institution's Office of Diversity, Inclusion and Health Literacy, who also serves as an IRB member.
Marilyn Dienstag, RN, BSN, a clinical research analyst with the IRB, says the health literacy officer has focused on making improvements throughout the hospital — using more lay language in signage, for example.
"As a member of the IRB and reviewing consent forms herself, I think she was noticing that, obviously, they're not written at the seventh- or eighth-grade reading level," Dienstag says.
The health literacy officer gave a two-hour presentation for the IRB office on the difficulties of reading consent forms and steps that could be taken to make them more understandable. At the same time, staff members participated in a free online Program for Readability in Science and Medicine (PRISM), an education initiative by the Group Health Research Institute.
Kassan and Dienstag talked about their office's experience at the recent Advancing Ethical Research Conference sponsored by Public Responsibility in Medicine and Research.
Both the health literacy officer and the PRISM program emphasized that readability is not just about using smaller words, shorter sentences and translating medical jargon into lay language, Kassan and Dienstag say.
Other things that writers and reviewers of consent forms should consider include formatting issues such as:
- Type style and size – Text should be printed in a minimum 12-point type, so that the letters are large enough to read. The writer should use a font that includes serifs (small lines that make up the edges of letters such as those at the ends of the legs in the letter "A.") Studies have shown that serif fonts are easier to read than non-serif fonts.
- Justification – While word processing allows text to be printed so that the ends of lines line up neatly down both sides of the page (left and right justification), it's harder for people to read, Kassan says. Text should have a left-side justification, letting lines end naturally on the right side.
- Other issues – Adequate margins on the bottoms and sides of pages, headings and subheadings to break up text and bulleted lists all help lead a reader through the document more easily.
Kassan says she believes her staff weren't as familiar with these formatting issues before the education program. She created a checklist for staff to use as they review documents.
"I don't think anyone in my office was really aware of those types of formatting issues that are easy fixes."
And Kassan says the education program underlined the difference between basic literacy and health literacy.
"People may have college educations, but they have no scientific or medical background and they're not health literate," she says. "It's not just homeless people or uneducated people who are not health literate — it could be anyone."
Her office conducted a survey of consent forms both before and after the education program. Both sets of forms were run through basic readability tests, which found little difference in the in forms' readability.
Kassan and Dienstag say the results were not surprising. To an extent, they believe the forms before the education weren't that bad, and so little improvement was noticeable. Also, Dienstag says the readability test used may not have been the best measure.
But Dienstag herself found the training extremely valuable, and she says she uses it all the time as she reviews consent forms.
"I can tell you quite honestly it's been a great help," she says. "I don't need to look at the checklist anymore — I have it all in my head."
Kassan says the IRB office has put templates on its website, using the proper formatting, so that investigators can create documents that are correctly formatted before they ever reach analysts.
Dienstag notes that in the past, there were no templates, just suggested language, and investigators frequently cut and pasted that language into their documents.
"The new templates greatly improve things," she says.
Kassan says many institutions have health literacy officers who could help an IRB mount this type of project. She also recommended us of the PRISM program, which can be accessed at www.grouphealthresearch.org
Improving the readability of informed consent involves more than a one-time education of researchers or IRB staff it's a process that requires ongoing commitment.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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