A small study about improving readability of informed consent examines how investigators and IRBs can make research understandable to people with very limited reading skills.
The NIH plans to enroll at least 1 million people in its All of Us research program over the next five years. People will volunteer online and receive electronic informed consent.
The goal of All of Us is to reach Americans from all walks of life, including populations that are underrepresented in most human subjects research. Investigators decided to study whether the project’s electronic informed consent was understandable to people with low and very low health literacy. (The study, titled Did I Lose You, can be found at: http://bit.ly/2LuNIx3.)
Researchers interviewed 18 people — half individually and half in focus groups. They partnered with four federally qualified health centers, says Vanessa Barone, MPH, research scientist at Sage Bionetworks in Seattle and lead author of the study.
“When the All of Us study launched, we knew we’d have to go back and look at informed consent because literacy was an issue,” Barone says.
“One in five people in the United States has below a sixth-grade reading level, and we want to make sure the All of Us research program is enrolling a million people and specifically looking at underrepresented populations,” she explains. “We want to make sure the program can enroll people from diverse backgrounds and who also have lower health literacy.”
This goal of reaching everyone, regardless of their literacy level, is extremely important to the program, she notes.
About 14% of U.S. adults have below basic health literacy. This means they can only read a short set of instructions or identify what they can drink before a medical test. And only 12% of Americans have proficient health literacy, meaning they can use a table and calculate a worker’s share of health insurance costs for a year, according to the U.S. Department of Health & Human Services, Office of Disease Prevention and Health Promotion. (http://bit.ly/2EHtdMZ)
In most clinical trials, there is someone who helps research participants understand the informed consent document and answers any questions they might have. With the electronic informed consent for the All of Us project, participants will be able to go through the e-consent process wherever and whenever they want without a face-to-face informed consent meeting, Barone says.
The smaller study was designed to find out how well people with low literacy and low technology skills understood the e-consent process.
The low literacy focus groups provided very useful information about this population, including these insights, Barone says:
• low literacy participants sometimes struggled to distinguish between research and clinical care;
• they tended to have low technology use;
• some people with low literacy relied heavily on their families and friends to deal with the barriers created by their lack of literacy;
• there were a number of common research terms they did not understand.
Focus groups also asked questions about blood collections, what participation would cost, whether they could see their lab results, and why investigators needed their blood, DNA, and medical records, Barone says.
“They asked, ‘If I participate in this study, who will see my information?’” she adds.
The participants used electronic consent instead of paper consent, and for some people, that was a problem, she notes.
Underrepresented and low health literacy populations often find ways around their barriers to understanding written information, says Kathleen Keogh, LMSW, program manager, HRHCare in Peekskill, NY.
“One thing I’ve seen throughout working with these folks is their resourcefulness,” Keogh says.
“If they’re not learning by reading, they are leveraging social networks, seeking different media, asking questions, and having a really strong foundation of family and friends and other people they can rely on for a lot of the information they need.”
This surprised Keogh, who says she didn’t realize how strongly people would rely on and trust others to get needed information.
The same resourcefulness was true of people with low technology skills.
“Some people said technology was less of an issue because they had the support of their families, and if they didn’t understand something, they could ask their children or someone else about it,” Barone explains.
“For people who were more isolated, it was a much greater barrier for them.”
The goal is to use these insights to improve the All of Us study’s informed consent, she adds.
“The core value of the program is to enroll a diverse population from underrepresented populations,” Barone says.