HIPAA and informed consent forms get the comic book treatment
New trend: graphic medical story design
In their search for ways to improve informed consent, IRBs and the research community have used illustrations, different sizes and styles of fonts, simple language, videos, interactive displays, and other innovative methods. Now comic strips can be added to that list. The Mayo Clinic Center for Innovation in Rochester, MN, has designed a consent form with comics.
"Leah Eisenberg and I coordinated on how we might use comics to improve informed consent, and we decided to start with the HIPAA Notice of Privacy Practices because it's more broadly applicable and it's required of every health care institution," says Rose Anderson, service designer for the Mayo Clinic.
"My background is in law and medical ethics, and one of my interests is in helping people understand the law and what their rights are," says Leah R. Eisenberg, JD, MA, who previously worked for the Mayo Clinic Mitochondrial Disease Biobank and now is an instructor in the division of medical humanities at the University of Arkansas for Medical Sciences in Little Rock. Both Eisenberg and Anderson featured a poster on their HIPAA comic form at the 2013 Advancing Ethical Research Conference, held by Public Responsibility in Medicine and Research (PRIM&R), Nov. 7-9, 2013, in Boston.
"Because of my background in law, I disagree when people say legal documents like HIPAA forms have to be complicated because it's the law," Eisenberg adds. "I believe you can satisfy the law while making things clear and understandable."
The comic consent project was Eisenberg's brainchild. She saw an email with comics at a Graphic Medicine medical conference, and it looked so clear and engaging that she felt certain it would work for HIPAA and informed consent for research, as well.
Eisenberg met with Anderson, and the pair decided to create consent forms that use the comic — also called graphic novel — format. They worked with an illustrator who was able to translate their ideas into a comic format.
"There has been an increase in the graphic novel world around medical narratives," Anderson says. "There is an emerging genre of medical narratives in graphic novel format; so why not take these text-heavy medical forms and make them more engaging?"
Anderson was interested in the challenge. She wanted to see how an illustrated storyline or narrative might engage participants and compel them to read further while digesting chunks of information.
The main character is a woman with glasses who is pondering whether to bother reading the HIPAA Notice of Privacy Practices. In the first three panels she decides to read the entire form and learns that her private medical information can be shared. In the next few panels she learns about the specific ways the information could be shared. The panels illustrate the information's use for treatment, payment, quality of care, research, to contact the patient, for public health benefit, for worker's compensation, and, when the patient wishes, to inform the patient's family. Less common ways the information might be shared are also mentioned below the panels.1,2
Using the HIPAA comics, they conducted a small-scale qualitative investigation to understand this format as a proof of concept, Anderson says.
"We wanted to know if it was possible to translate all of this text into images and to try to understand how people might engage with the information," she explains. "So we had people review the comic version and the regular version of the HIPAA form and then give us feedback about what they thought of each."
Getting patient input
They recruited people from the patient cafeteria and showed them the forms. Among the feedback they received, people said that the regular HIPAA form was fairly dense and intimidating and they might just throw it away, Anderson recalls.
By contrast, the same people found the comic version to be engaging and fun, she adds.
"It drew them in, and they found the information relevant; people said they were more likely to read it," she says.
There was one problem, however. The same people who admitted they did not care for the standard HIPAA form also said that the comic version did not meet their expectation of a medical form.
"They said the comic seemed too simplistic and not sophisticated enough for a hospital like the Mayo Clinic," Anderson says. "There was a contrast between what people expected and what they found useful; some people said they thought the traditional form was best, but they wouldn't read it because they trusted the Mayo Clinic."
This reaction to the comic version seeming too simplistic was repeated when Eisenberg had a comic assent created to use with youths ages 12 to 17 enrolling in research, Eisenberg says.
"We gave the kids surveys and talked with them in focus groups with their peers, and they would say about the comics: 'That's not what you show to adults, and we're smart enough to look at what you show adults,'" Eisenberg recalls.
The adults surveyed about the comic HIPAA forms said they were concerned some information was left out of the comic version, but their concerns were unfounded, she says.
"I was careful that the comic version followed all HIPAA rules," Eisenberg says. "We left out excess legalese, but it had all of the necessary information and was vetted by several people."
The next step will be to conduct a quantifiable study, she notes.
"We need some data about the efficacy of a comic HIPAA versus a text HIPAA, and we've also been working on comic consent and assent for biobanking," Eisenberg says. "Informed consent for biobanking is new, and we can't tell people in it what kind of study we're doing or how long it will last because we don't have that information."
Since biobanking informed consent is new, it seems like a good time to employ a new IC format, she adds.
Another possible use of a comic consent form is to supplement the traditional form, Eisenberg says.
"That way, the people who feel like the text document has more information are not missing anything," she says. "My only concern is that it adds a lot of length and paperwork and might turn people off."
Whether IRBs begin to approve comic/graphic novel versions of informed consent documents or some other alternative format, the point is to improve research participants' understanding of consent, Anderson notes.
"Overall in health care we're going to see an increase in the need to engage with and collaborate with patients," Anderson says. "We're going to learn a lot about how patients want to engage, and this will inform how we communicate with people."
- Eisenberg LR, Pringnitz J, Hasadsri L, et al. Drawing Patients in with HIPAA in Comic Form. Poster presented at the 2013 Advancing Ethical Research Conference, held by the Public Responsibility in Medicine and Research (PRIM&R), Nov. 7-9, 2013, in Boston, MA.
- Eisenberg L, Anderson R. Picture this: illustrating the future of HIPAA documents. Atrium. Spring 2012:10-12. Available at http://bioethics.northwestern.edu/docs/atrium/atrium-issue10.pdf