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An IRB member and human research protection expert learned firsthand how complicated informed consent (IC) forms could be when her granddaughter was seriously ill.
Both of the girl’s parents are professionals, and the mother is a physician. Yet they could not comprehend the consent document during this stressful period, says Elizabeth Senft, MDiv, MLS, research community liaison at Cincinnati Children’s Hospital Medical Center.
"IRBs need to take that into account," Senft says, referring to how difficult it is to read complicated forms when one is under extreme stress.
Senft chaired a task force to improve informed consent (IC) forms and assent forms. The group consisted of IRB staff, faculty, research professionals, and research nurses.
"When we started the whole simplification, we started with the assent forms because this was something we could have across the board," says Mina Busch, MS, CCRP, CIP, ORCRA education consultant at Cincinnati Children’s Hospital Medical Center.
Older children sign the assent forms, which were written with a sixth-grade readability level, Busch notes.
"We allowed for more white space, bigger fonts," she says.
The IRB encourages the use of tables and diagrams to show patients and their parents what will happen next in a study, Busch adds.
The IC template guidance offers an example of a table to demonstrate risks of a procedure or intervention. The example includes rows for common, uncommon, and rare risks and columns for life-threatening, serious but reversible, and mild and reversible risks. Another example shows a table that could be used to explain which activities would occur on each of five visits: informed consent, physical exam, urine sample, blood draw, and EKG. An IC form would simply have a checkmark next to the activity on the visits at which it would take place. (See sample items in the IC template guidance on this page.)
"Having that information in a table is much more easily digested," she says.
One of their goals was to create an IC template that could be read by someone with a sixth-to-eighth-grade reading level and to reduce the size of IC forms, she says.
"We have some consents that are 52 pages, and that’s ridiculous," Senft says. "Our template with all of its guidance is eight pages, and that includes suggestions for wording."
The IC form still contains all necessary information, but it makes good use of appendices and puts information in digestible units, Busch explains.
The consent template is a table with the guidance and directives on the left and the text on the right. It is completed electronically, and it walks users through an IC form’s creation. When researchers use it they can delete the left column.
"It’s actually simpler to use than the old one," Senft says. "While it’s eight pages long, it doesn’t have to be eight pages; it can be shorter, and our goal is to have the informed consent forms shorter."
Busch also has heard positive reports of the new forms.
"When I ask people about the new consent form, they respond very favorably," Busch says. "People understand the new form better; they like it better, and it’s a lot cleaner."
This isn’t always practical because some areas have long standard of care sections included in their IC forms, she notes.
"We’ve been shortening those, too, and we’re trying to get people to separate the research part from the standard of care," Senft says.
The IRB also has been working with sponsors to encourage them to use simpler language in consent documents, she notes.
"Usually, they say No, we can’t take anything out of the form,’ if it’s the investigator who asks," Senft says. "But if the IRB from a nationally-ranked hospital sends the forms back, saying the sponsor’s consent form is too complicated and has too much information, then sponsors are more willing to negotiate."
There are many ways IRBs can change standard IC wording to make it easier to understand, but it requires thinking differently about even the most common of terms, such as the word "risk," Senft says.
"We have found anecdotally that people respond toward risk as if it’s something they take upon themselves," she explains. "Risky behavior is doing drugs or jaywalking or something like that."
Informed consent documents would be able to align research participants’ expectations and understanding of risk more precisely if they did not use the word "risk" and instead explained with this kind of wording: "What are the bad things that could happen to you because you’re on this study?" Senft says.
Developing the IC template was a fairly quick process. The task force began in December 2011 and finished in May 2012. Then it was rolled out in the fall of 2012, Senft notes.
Like all changes, it took a while for stakeholders to accept the new template, but once they began to use it they found it to be easier than their previous template, she adds.
"What I’ve heard from IRB staff is they like it better because it’s easier to use," she says.