A children’s hospital’s human research protection program has found that obtaining pediatric assent can be as fun for children and teens as a video game. At one research hospital, it is a video game.
“Kids enjoy apps and games and play, and this is one way to incorporate them and help children understand the research process and assent,” says Rebecca Dahl, PhD, CIP, director of the human subjects protection program at Children’s Hospital Los Angeles.
Research involving children and youth requires assent, but research sites can be flexible in how they achieve this.
“Assent is a wonderful tool, and sometimes people go overboard,” Dahl says. “I’m seeing now longer and longer assent forms.”
Assent forms as long as six pages and with language that talks about potential death in a study are pointless, she notes.
“Why would you tell a child there’s potential for death?” Dahl says. “Parents should be aware of [the potential for death] and have information about what will happen to their child and what the risks and benefits are, but is this necessary for assent?”
Instead, IRBs and researchers should keep the language, content, and process simple, she adds.
An assent form should be one page, and if the child’s signature is requested, then that could be an additional quarter page, Dahl suggests.
“We use illustrations with a picture at top, and there could be even more illustrations, so there’s really no need to have a lot of language in it,” she adds.
Fun fonts make the text more interesting to children, and paper assent also should have ample white space so children won’t think it looks like a textbook.
“There are a variety of ways to interact with kids other than saying, ‘Read this,’” Dahl says. “There are lots of things we don’t even think about that could make assent much more child-friendly.”
For example, an IRB could create a board game or an electronic app/video game that educates children about research through play. The idea for the video game assent evolved out of concern about children not understanding what assent is and what their participation meant, Dahl explains.
“In a staff meeting a couple of years ago, we came up with the idea of a board game and had it printed with pieces and cards, just as you might buy it off the shelf,” she says. “But when I approached our tech transfer office, they said, ‘That’s great, but what you really need is an app.’”
So the app was created with a robot head disk, and children play against the computer when they go through the game. There is audio and artistic videos as well, she adds.
“The video game is not cheap to develop,” Dahl notes. “It was a shock to see the cost: $14,000.”
And even that price was a bargain because the hospital already had consultants working on a different app, and the pediatric assent video game was an add-on price, she explains.
“Over the long run it will be cheaper than the board game because we printed the first game for $100,” she adds.
The game includes the following sample items:
- you want to be a scientist when you grow up and figure that being in an experiment would be cool,
- to be in the study means you won’t have as much time to play video games,
- you’ve tried all of the regular treatments and they didn’t work,
- you learn that if you decide to be in the study, you’ll need to keep a diary every day of how you are feeling and when you take your medication,
- you can ask as many questions as you want about the study, and
- being in the study means you’ll have to stay in the hospital for a week and you’ll get to watch all the TV you want.
While the board game prototype was interesting and would have worked, the video game app has a number of advantages over the board game, Dahl says.
For instance, video game apps can be put in electronic systems and easily made available to patients and subjects. They also can be shared hundreds of times at no additional development cost.
“Something electronic can be downloaded to an iPhone,” Dahl adds. “And they can be very innovative and revised quickly.”
The true goal of the video game was to help children better understand whether they wanted to participate in research, Dahl says.
“Kids still get pushed aside sometimes in terms of their needs and their level of understanding of the process, their illness, and care,” Dahl says. “This will make a difference.”