True simplicity remains elusive for IC forms
Readability improves, length increases
Informed consent documents remain long and complex, despite successful efforts in recent years to improve their readability, an expert reports.
“Our IRB at Johns Hopkins University was often trying to make consent forms shorter and simpler, recognizing that this tends to make it easier for the participants to understand,” says Nancy E. Kass, ScD, deputy director of the Berman Institute of Bioethics and Phoebe R. Berman Professor of Bioethics and Public Health at Johns Hopkins University in Baltimore.
Unfortunately, the IRB ran into roadblocks in the form of multicenter studies where the IC form was drafted centrally and could not be shortened by the IRB, she notes.
“Our IRB was frustrated by this, so I decided to look into it further,” Kass adds.
The IRB worked with a contact at the National Institutes of Allergy & Infectious Diseases (NIAIDs) of the National Institutes of Health (NIH) to review all informed consent forms used in HIV study networks. The consent forms reviewed came from studies that were conducted across the world, she says.
“We asked only for the HIV networks,” Kass says. “We found good news and bad news: The good news is that compared to studies done 10 to 20 years ago, the readability of consent forms as measured by the Flesch-Kincaid readability score was at a 9.2 grade level.”
Studies of IC readability from 10 to 20 years ago found that consent forms were written at graduate school level, so the 9.2 grade level average was an improvement, she adds.
“Also, the choice of words and sentences were simpler than what they were 20 years ago, and that’s the good news,” Kass explains. “There have been a lot of messages to investigators and institutions about making consent forms more readable.”
The bad news was that the forms were getting longer, she says.
“No matter how simple the wording on any particular paragraph, if you have a 22-page consent form, it’s hard to believe the information might sink in with anybody,” Kass says. “If you look at studies just geared to adults, the median length is 27 pages, which is a remarkable length.”
This is one of the challenges IRBs face when trying to improve the informed consent process.
“What’s frustrating with informed consent is that almost everybody recognizes that shorter and simpler are better, but there remain some very strong influences that I personally think have to do with liability,” Kass explains. “This keeps consent forms much longer than anybody who is focused on proper understanding thinks is appropriate.”
Participant understanding is another issue, and it wasn’t addressed in that study.
“We simply looked at length of the consent form,” Kass says.
“In another pilot study, a colleague and I did a follow-up to this,” she says. “We’re starting to look at interventions and doing some work where we give patients who are considering enrollment in a clinical trial a one-page fact sheet.”
The fact sheet is user-friendly and has more readable language. For instance, it might say: “You are being asked to be in a research study. This study is looking at a new treatment for HIV in comparison to an old treatment. If you decide to be in the study you will be in it for a year,” Kass says.
The one-page fact sheet was designed to be used by the research staff during study recruitment. The research nurse would go through the one-page sheet before discussing the entire informed consent document with study subjects.
“The idea was to have research nurses go through the consent discussion with the entire picture of the study before they’re mired in details,” Kass says. “The one-pager highlights any really important risks, but does not list 50-100 risks that might be outlined in the 27-page consent form.”
The one-page form was designed based on the principles of learning with low literacy populations, she notes.
“There’s only so much information people can take in at one time,” Kass says. “It’s not to say that other information is useless, but the best becomes the enemy of the good; people understand less.”
The fact sheet is one intervention being tested. Another intervention involves requiring research nurses or enrollers to ask open-ended questions about the study at the end of the consent process, she adds.
“If the research participant doesn’t say anything correctly, or if it’s incomplete, it’s an opportunity to go back and talk about more areas,” Kass says. “We’ve done these interventions in a pilot study that showed promising results, and now we’re trying to test these in a larger way.”