By Melinda Young, Author
Readability is a continuing problem with informed consent (IC) for research. It especially is a problem when participants struggle with low health literacy.
The revised Common Rule suggests ways to make the informed consent process simpler and easier to understand. But there are many people who still struggle when reading an IC form written with a first-page summary and with sentences understandable to middle schoolers.
Researchers assessing readability of sample informed consent forms approved by IRBs between 2013 and 2015 found that the mean readability was 10th grade. After a plain-language IC template was developed and used, the readability was seventh grade.1
“Our federally qualified health center has patients with low health literacy — low literacy, period — and limited English proficiency,” says Parinda Khatri, PhD, chief clinical officer at Cherokee Health Systems in Knoxville, TN.
Researchers may design an informed consent form at a fifth-grade reading level, but even that is too high, Khatri says.
“All of our forms are at a fourth-grade reading level,” she says.
Khatri was a co-author of a study of informed consent materials used with people of low or very low health literacy. The study collected data on how IRBs and researchers can refine IC materials to suit a low literacy population. (See story about study in this issue.)
The findings still are being analyzed, but the experience suggested that people preferred video media with real people instead of animation. Researchers also learned which words and phrases were too difficult for the cohort to understand, and their comfort with technology was very limited.2
Research institutions should make an effort to make informed consent understandable to people with low health literacy for the sake of enrolling a more diverse population of participants, Khatri says.
“If we want to have more underrepresented populations involved in biomedical research, we need to tackle this issue,” she says.
For example, some people will not understand that a study is referring to medications when it mentions “drugs,” she says.
Other medical words they might not understand are “biobank” and “electronic health record,” says Vanessa Barone, MPH, research scientist at Sage Bionetworks in Seattle. Barone is the low health literacy study’s primary author.
“Some people will know the words ‘electronic’ and ‘health’ but not ‘electronic health record,’” Barone says.
Low health literacy is not always easy to identify. People are clever at hiding their difficulty understanding or reading an informed consent document.
“Some folks will say, ‘I left my glasses at home,’ or ‘I don’t have my phone with me today.’ This is very common,” says Kathleen Keogh, LMSW, program manager at HRHCare in Peekskill, NY. Keogh also was involved in the low health literacy study.
“You hear these reasons, and you don’t know whether they are unable to read or not able to use the computer, or maybe they did just forget their glasses,” she says. “That was something we noticed time and again.”
Participants with low technology skills might ask for support or simply say, “I don’t like computers or cellphones,” Keogh notes.
For these reasons, investigators should watch for cues that a person is struggling reading or understanding the informed consent form, she says.
There’s a stigma with low literacy, and people use their glasses as an excuse or ask if they can take the form home and bring it back because they don’t want to admit that they are going to have family members read it to them. When researchers hear those words, they might think they are a proxy for low health literacy, Khatri says.
“They might say their head hurts, so can they take it home, and we have learned to say, ‘How about if we read this to you and give you a copy to take home?’” Khatri says. “Often, people will say, ‘Yes, I will do that if you can read it to me.’”
Other clues of low literacy include participants who just scan the document and sign it. Researchers also can give participants a copy to share with family members or friends, she adds.
Improvements to informed consent’s readability can benefit all participants — not just those with literacy issues. One study found that research participants had significantly better understanding of the research when given a simplified informed consent form, compared with those who received a standard form. The study’s findings were true for those with typical health literacy, as well as those with low health literacy.3
Health Literacy and All of Us
The All of Us Research Program is a National Institutes of Health (NIH) initiative that is building a national cohort of 1 million-plus Americans. People are participating through electronic enrollment and informed consent. Its goal is to extend precision medicine to all diseases. (Read more about All of Us at: https://allofus.nih.gov/.)
A recent study about electronic informed consent and readability found that most participants benefited more from e-consent, noting that it was easier to understand and use and more interesting. Some rural participants had accessibility and privacy concerns about e-consent, and some minority participants had computer literacy and trust barriers.4
The All of Us Research Program has to use e-consent because it will enroll its 1 million participants online over a five-year period, Barone says.
What will help is the use of videos and visual aids.
“The videos are a game-changer,” Khatri says. “People watch those videos and then say, ‘Oh, now I get it.’”
For instance, a video will show a research participant’s blood and what happens to the blood at a biobank.
The videos also ensure consistency in the informed consent process.
“You don’t have 1,000 research assistants saying 1,000 different things,” Khatri says. “Instead, there is a media aid to enhance understanding and comprehension of the consent process.”
As soon as a prospective participant provides contact information online to All of Us, a video plays and moves to the next screen of informed consent. Each screen has some text and a video to elaborate on the text, Keogh says.
“It’s a very new program, but from all of our experiences and what we’ve seen so far, I feel confident about the informed consent,” Keogh adds.
“It’s not just one long informed consent form with a lot of different words and scientific jargon; there’s a real effort to help people who learn in multiple ways — text, video, visual aspect, auditory,” she adds. “It’s geared to cater to lots of different audiences.”
1. Hadden KB, Prince LY, Moore TD, et al. Improving readability of informed consents for research at an academic medical institution. J Clin Transl Sci. 2017;1(6):361-365.
2. Barone V, Munoz F, Chinea C, et al. Did I lose you: formative evaluation of the All of Us Research Program’s informed consent materials with people of low and very low health literacy. Poster presented at 2018 Advancing Ethical Research Conference of the Public Responsibility in Medicine & Research (PRIM&R), Nov. 14-17, 2018, in San Diego. Abstract: 16.
3. Kim EJ, Kim SH. Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level. Clin Trials. 2015;12(3):232-236.
4. Simon CM, Schartz HA, Rosenthal GE, et al. Perspectives on electronic informed consent from patients underrepresented in research in the United States: a focus group study. J Empir Res Hum Res Ethics. 2018;13(4):338-348.