As IRBs continue to evaluate informed consent (IC) and youth assent forms according to regulatory guidelines and readability, researchers have come up with a format that engages, informs, and even entertains people being asked to participate in biobanking: comic assent.
The comic strip-style format is particularly appealing in an age when the graphic novel market has resurged in popularity among both children and adults.
“Research has shown that people do not understand informed consent forms, in general, and biobanking is a new type of technology that makes research enrollment more complicated than it was in the past,” says Leah R. Eisenberg, JD, MA, assistant professor in the division of medical humanities at the University of Arkansas for Medical Sciences (UAMS) in Little Rock.
“We’re asking for biological specimens that will be used for undetermined purposes for future, undetermined times,” Eisenberg says.
Eisenberg and a colleague at the Mayo Clinic Center for Innovation in Little Rock had already been working on projects involving informing research participants through illustrated panels when Eisenberg realized that children who were being asked for assent in biobanking were not given the kind of information they needed to decide whether this was something they wanted to do.
“My background is in ethics and law, so I want people to have information on which to make actionable decisions — even if these are not required by the letter of the law,” Eisenberg explains.
“We were going through the letter of the law, not the spirit of the law, when we were asking children for assent,” Eisenberg says. “So I thought it would be a good time to do innovative assent work.”
The popularity of graphic novels suggested that illustrated assent might work well for this purpose, she adds.
“I thought comic assent might work for adolescents and children for biobanking involving mitochondrial disease,” she says. “This would give them a more engaging form.”
For example, one page of the Mayo Clinic comic assent panel, relating to biobanking for mitochondrial diseases, begins with teens sitting at a table discussing their participation in a biobank. One boy says, “Okay, so we’re all participating in this biobank thing, right? Why exactly is it important? What does it mean?” The characters express some embarrassment about not knowing the answer, and one boy says he did some reading and can help out. Other teens say they know a little too, and they begin to talk about it, with one athletic character saying, “Well, I know this particular biobank is run by a group of researchers who are studying mitochondrial diseases. Their research might help them learn more about how medicines work, how our bodies work…”
While the adult comic for informed consent follows the Common Rule requirements for informed consent, including risks and benefits, alternatives, etc., the pediatric assent comic doesn’t contain quite as much information, Eisenberg says.
“Adults need to know possible implications, privacy rights, and things like that,” she explains. “Children need information to assent, but they don’t need all the information the informed consent requires.”
Getting broad consent
Comic assent and IC provides a narrative flow that progresses from someone thinking about participation to talking about what a biobank does and then to what the participant needs to give to the biobank, what the pros and cons are, and how they can withdraw from the study, Eisenberg says.
“It’s true that with biobanking you cannot tell everyone all the ways your information may be used because we just don’t know that,” she says. “Research I’ve done shows that patients generally don’t want to be contacted each time their information is being used in a biobank.”
Plus contacting biobank participants each time a new study wants to use their sample is cumbersome and challenging, she adds.
“So I do believe a broad consent is appropriate,” Eisenberg says. “We need to tell people we’re going to use this information, although we can’t say how, and we may come back to you if we have information that is actionable. Then they can decide.”
The comic assent illustrator made the panels more engaging to teens, using different styles. They purposely chose to have a group of teens talking about participation on their own so it wouldn’t appear that a scientist is feeding kids information, she says.
The comic assent and informed consent panels still are in research prototype use, but Eisenberg says she hopes they’ll be ready to use in studies soon. “It’s definitely my goal,” she says.
“I’d definitely like to send participants a PDF of the comic assent so they can read it by email,” she adds. “It’s my idea to give this to them instead of a text-based consent.”
Each comic assent and informed consent can be made disease-specific, targeting people at their appointments with physicians. Some participants also might be recruited through social media and other marketing efforts or through disease advocacy groups.
“I think this has broad application for biobanking or research,” Eisenberg says. “If we can put together data showing this is helping people to understand better, then I think we would need to use it more broadly.”
Some IRBs might never be comfortable with an IC that is entirely in comic format, so the comic version also could be a supplement to the traditional informed consent, she says.
“Each institution has its own comfort level with using nontraditional consent, but the comic was made to stand alone; it contains all the information the text form contains,” Eisenberg says.