When a children’s hospital needed to approach research informed consent and pediatric assent with more creativity and flair, the research office asked children for input.
“We have a research program here, and one of our goals is to increase awareness of our research program amongst the rest of the hospital and our patients,” says Jessica Macha, CIP, associate director of the office of research integrity and compliance at the Stanley Manne Children’s Research Institute, Ann & Robert H. Lurie Children’s Hospital of Chicago.
“We found there is a need to get the right kind of information out to our families and to raise awareness of their ability to take part in research,” she says.
Engaging potential research participants in a process to improve informed consent is a very positive trend, says Ryan Spellecy, PhD, professor of bioethics at the Medical College of Wisconsin in Milwaukee.
“If we engage potential research participants [and] stakeholders from the get-go and beyond the old model of ‘Let’s develop it and test it in this population,’ that can make for a better process,” Spellecy says.
At Lurie Children’s Hospital, the available tools and resources were adult-focused. The video was developed as a tool that could help educate the children and their families.
Families helped develop the video. “We designed the video with focus groups and our stakeholders as part of the process,” Macha says. “Our group is a mix of people who came together around this idea of wanting to create more educational tools for researchers to use and for our patients to help them understand research.”
The hospital has a board of pediatric patients that provides input as needed.
“Our institution has a children’s advisory board of volunteer kids who are patients in the hospital, and they give advice on designing rooms, decorations, and more,” she says.
A research integrity group created a whiteboard animation video called “What Is Research?” The three-minute video shows hand-drawn pictures illustrating a narration about what taking part in a research study is like. It was designed to be used for both guardian consent and children’s assent.
“We targeted the video to children and their families,” Macha says. “We expect it to be used as an adjunct in the consent process.”
The video focuses on these main areas:
• research is voluntary and a person can choose to be in it;
• researchers keep the person’s participation and information private;
• a study is reviewed by an IRB to make certain it is safe and that participants’ rights and welfare are protected;
• a person can volunteer to participate in the study but also can leave at any time, and pulling out of the study would not impact the patient’s medical care.
Involving potential participants in developing the video is similar to other ways researchers engage stakeholders.
“This is patient-centered outcomes research initiative [PCORI] style,” Macha says. “PCORI is an initiative the National Institutes of Health started to make research more tailored to people who would be in the research.”
Potential participants are brought in to help with design and research questions, in all stages of research development. “It’s a good model to bring in people who will take part in the study, your target audience, and bring them in to be more engaged in the process,” Macha says.
The group showed the children’s advisory board the video and obtained feedback on character development, how to focus the story, and what kinds of words and language to use in the video.
“We also brought in a family advisory board, so we had feedback from patients and their parents,” she adds. “They helped us with feedback on images and timing.”
After developing the video script, with the children’s help, they partnered with a professional media company to create the animation.
Children offered helpful suggestions. For example, the story was organized around the idea of a very important participant, or VIP. To illustrate these child VIPs, the original storyboard showed them wearing sunglasses, as celebrities might wear in public.
“They were wearing what we adults thought would be cool,” Macha says. “Every kid asked, ‘Why are they all blind?’” The sunglasses were scrapped.
The children also helped ensure the video’s words were appropriate and that the message was clear.
“As part of the team, we also had health literacy experts and an ethics committee review the script and storyboard,” she says.
“We went back to the kids and the other advisor groups after it was done, and they all really liked the video and thought it was great,” Macha says. “We showed it to the leadership at the hospital, and the overall perception was good.”
Once the finalized video was approved, the research committee was surveyed for additional feedback.
“We did a pre- and post-survey to assess participants’ comprehension of principles and ideas in the video,” Macha says. “In our convenience sample, we asked people in our cafeteria and in other public spaces whether they would take a short survey before and after watching the video.”
Then they were asked questions to assess comprehension. “A statistical analysis found that the majority of people — both children and adults — showed an improvement in comprehension,” she adds.
“The goal of the video was to improve understanding and decision-making and not to say ‘yes’ to participating in research,” she notes. “There seemed to be more interest in learning what research was after viewing it.”
Once rolled out, the goal is to make the video available on the hospital’s internal circuit television and to upload on iPads for study coordinators to use in clinical research, Macha says.
The video’s broad information about research makes it useful for any clinical trial consent and participation.
“Study coordinators seemed interested in the video and thought it might help with study recruitment,” she says. “It’s short enough they could use it to answer questions.”
The next step would be a video library to explain other research topics, such as randomization and biobanking, Macha notes.
“Videos could be available during the study or consent process, and we’ve had groups reach out to us within the institution about creating clinical videos as well,” she adds.