Using plain language in informed consent forms means exchanging medical and statistical jargon for words that people with low health literacy and low health numeracy would understand.
It’s not easy, but there are strategies that can help IRBs and investigators improve the readability of their informed consent documents.
The following are suggestions from IRB professionals:
• Develop a plain language template. IRBs can help investigators get a good start on improving readability through the development of a plain language template.
“It’s different from typical templates out there,” says Kristie Hadden, PhD, associate professor in the college of medicine and executive director of the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy in Little Rock.
“We wanted to develop a template that could be used by every investigator at UAMS,” she says. “We used health literacy best practices, plain language best practices, and we made sure it complied with legal requirements and had all of the necessary elements.”
The template also needs to be easy to use and benefit both researchers and research participants, she notes.
UAMS implemented the 10-page template after two years of development. They encourage investigators to use it and give them assistance to adapt their own informed consent information to the template.
“I look at the new submissions that come in, and I steer them to the template, saying, ‘You might want to consider this, at least for future studies,’” says Edith Paal, MSJourn, MPH, IRB program manager at UAMS.
Sometimes, IRB staff will improve a study’s informed consent form. Then they’ll email it to the investigator, asking if the modifications will work, Paal says.
“We find when we do the legwork on these things, they are quite appreciative,” she adds.
The template is available online at: http://bit.ly/2o4hYU9.
The template puts standard informed consent information in as simple of language as it can, including this sampling of sentences:
- “We are asking you to be in a research study.”
- “You do not have to be in the study.”
- “If you say yes, you can quit the study at any time.”
- “Please take as much time as you need to make your choice.”
- “You can still get your medical care from UAMS even if you are not in the study.”
- “This form may have words you don’t understand. Research staff will read it with you, if you like.”
- “The local study team will know your name and have access to your information.”
- “We will do our best to make sure no one outside the study knows you are part of the study.”
- “There are people who make sure the study is run the right way. These people may see information from the study about you. They are (insert study sponsor or funding source; OHRP; UAMS Institutional Review Board, other institutional oversight offices, etc.).”
- “Being in the study may or may not help you, but may help people with (insert condition) in the future.”
- “By signing the document I am saying: I understand that joining this study is voluntary; I agree to be in the study.”
- “I know that I can stop any and all parts of the study at any time and nothing bad will happen to me.”
• Involve IRB staff and research staff in process of improving informed consent. Research and IRB staff can help with developing the simple language template.
“We have an office that does development for some protocols and consent forms, so we were involved with researchers and exchanged several emails back and forth with their staff members,” says Jennifer Holland, JD, IRB director at UAMS IRB.
IRB staff also met with researchers multiple times.
“It was a very long process, and we’ve changed and modified the template a few times,” Holland says.
There were so many template drafts that Paal lost count: “I think there were 3 million drafts before we came up with the final one,” she jokes. “There were lots of stakeholders weighing in.”
Plus, the tweaking is ongoing.
“Every now and then, I’ll notice this one word or sentence that needs tweaking, and we point that out and discuss it, and, if everyone agrees, we change it,” Paal says.
In assessing the readability, IRBs could use Word’s readability tool. It’s not a perfect measure, but it gives a good idea of the document’s reading level, Hadden says. IRB staff also can work with researchers on fixing wording problems they are unable to do on their own.
For example, Paal worked with a principal investigator who was a non-native English speaker.
“He had the consent form based on the template, and we went back and forth on its content,” she says. “Finally, I told him that I have a few language fixes for him, and I’ll fix it and send it back to him. He wrote back, ‘You are reading my mind because I even showed it to my research assistants who are native English speakers, and we couldn’t think of how else to word it.’”
• Remind research team that the template is designed to be modified. “One challenge we’ve faced is that principal investigators are not aware that the template is not set in stone,” Paal says. “They can delete parts that don’t apply to their studies.”
At the beginning of the template’s instructions, it specifically says to delete sections and language that doesn’t apply, Holland says.
“As with any template, people sometimes skip past that, and a lot of times people use templates, but not in the best way for their study,” Holland adds. “So even though we have the language in there, they may not delete anything and tend to skip down to the section they want to use right then.”
Also, the study staff might write the consent form, basing it on the protocol that the investigator wrote. This means they use some of the same complicated language, not paying close attention to the need to communicate clearly and simply, Holland notes.
Then they’ll plug it into the template, leaving the template language when they should have deleted some parts. They overlook things in the informed consent as they rush to complete the document so they can submit the protocol, she adds.
• Tweak wording of regulatory language. “One challenge we faced was that certain regulatory requirements have to be addressed, and the easiest way to address them is to use regulatory language,” Paal says. “We did a lot of work on that aspect of making sure all regulatory requirements were met while using plain language precepts.”
While going through this process of translating the regulatory requirements, Holland kept in mind the acronym SMOG, which stands for “simple measure of gobbledygook.”
“It’s a very fitting acronym for research consents and medical consents,” Holland says.
• Keep in mind that there is no perfect solution. Moving to plain language in informed consent requires compromises.
“In plain language writing, it’s an exercise in compromise all the time,” Hadden says. “You want to keep it as short as possible because people who are struggling with language don’t want a 13-page document.”
But if the form provides additional explanations, then that adds to its word count. The key is to eliminate what is unnecessary.
“There is a lot of unnecessary content in informed consent: A lot of paragraphs were copied and pasted from protocols, and there are methodologies that are not necessary for informed consent,” Hadden says.
It’s important to make the most important changes and to compromise on the ideal when perfection is elusive.
“It’s not always possible to take out all of the complicated words and substitute them,” Hadden says. “So what we do is provide an easy-to-understand explanation for the complicated words, and we use plenty of white space.”
IRBs also could add bullet points instead of sticking to the header-and-paragraph format, Hadden suggests.
The typical informed consent form is too complicated in wording and how it appears. “You can provide a question-and-answer format with lots of white space,” Hadden suggests.
Another strategy is to put the most important information first in the document because there is a fatigue factor when people read the forms.
“People don’t retain things at the end of the form as much as they do in the beginning,” Hadden says. “So make sure important information is first and put explanations where they make sense.”
• Make changes to address low numeracy literacy. Informed consent forms express numerical information in multiple ways, and potential research participants might not understand what these mean. (See story on health numeracy in this issue.)
“If they don’t understand a percentage, then give them a graphic,” Hadden says. “We try to integrate all of these into our template.”
Simplifying how percentages, ratios, and proportions are displayed can improve a study’s enrollment, as well as its informed consent form, she notes.
“If participants don’t understand the study’s risks and benefits, then they’ll be less likely to enroll in the study,” she says. “If the study has complicated numbers, then the sample may be adversely affected.”