Researchers at Nationwide Children’s Hospital (NCH) in Columbus, Ohio, have created an electronic consent tool designed to improve comprehension during the informed consent process. However, the resources needed to update the software have been more extensive than expected, the researchers say.
Grace Wentzel, CCRP, director of Clinical Research Services at The Research Institute at NCH, and her colleague, Paulla Dennis, CCRC, thought about creating an electronic consent about nine years ago while attending a conference. Seven years later a prototype was created, the result of collaboration between the Clinical Research Services department and NCH’s research informatics department. “We thought there has to be a better way to do this where families are more engaged,” says Wentzel. “Since we are in pediatrics, we wanted to make sure the kids are engaged, as well. The goal was to start with the consent and move into the assent platform. But what we found was that it ended up being something we needed a lot of funding or support for in order for our informatics group to keep it up and running. Right now we are only using it for a couple of projects.”
Wentzel spoke about the prototype at The Ohio State University’s Tools of the Trade: Research Participation program on June 25, 2015. “We need innovative solutions to ensure true informed consent is being obtained and methods to maximize our efficiency,” she said. Her presentation, “eConsent for Research Participation Model from NCH,” listed four goals the NCH researchers had for their project:
When completed, NCH had a regulatory compliant, personal health information-secure, multilingual-capable (with additional development), and family-friendly mobile IOS application. The electronic, interactive platform allows for the creation of consent and assent templates as well as videos and games that can be modified for each study, Wentzel says. For example, the program leads the potential participant through with an avatar. He or she can pick how they want the avatar to look, such as male or female. “Our future plan was to have kids pick an animal they’d like to use.” The application can also read to the user, which is employed to complement different learning styles. In addition, families can watch embedded videos of different procedures such as a blood draw or EKG, Wentzel says. “We have created games within it of different procedures as well so they can play with the procedures and have them done to the avatar so that it’s not so scary.”
The pilot project for the electronic consent was initiated in 2015. Wentzel says they now use the platform for a couple of the hospital’s infectious disease programs. “For one study, we recruit on the inpatient floors for a variety of infections. The source documents are loaded onto the iPad. We take the iPad with us to the floor, approach the families for recruitment, and once they agree, we sit down and go through the consent form with them on the iPad,” she explains. “What’s nice about the consent form on the iPad is that it forces them to read every page or at least initial every page. It won’t let you go to the next page without indicating by initialing that page that you have read it. If they were doing that on paper, they could skip initialing that page and you wouldn’t know it unless you double-check every form before they left.”
Comprehension questions also are imbedded within the consent. “It asks questions such as ‘who is the study doctor?’ and ‘what procedures will be done during this study?’ If they answer the questions wrong, [the application] takes them back to that section of the consent form to allow them to read that section over again and then it asks them those questions again,” Wentzel says.
The researchers then finalize the consent form with the families. “The person obtaining consent signs, and [the family] signs and dates as well. When we start to sit down, we get information such as the child’s name and date of birth and type that in at the very beginning. That stays with them throughout the consent process,” Wentzel says. The family also enters an email address. As soon as the iPad hits a wifi spot at the end of the process, a copy of the signed consent is sent to both the family and the study coordinator assigned to that study.
Wentzel says the platform also is used for a multisite infectious disease project. “We are doing it at all of the Children’s Hospitals across Ohio. We are the IRB of record here so we used a Reliant model. We have the consent and all of the source documents that they need loaded onto the iPad.” The iPad was delivered to the sites once their contract and IRB was approved. All but one of the sites in the study are using the iPad as a mechanism to get consent and collect data for the study, she says. “[The remaining site] thought it was longer to use the electronic platform so they use paper.”
The electronic consent platform can take a little longer, but since compliance is embedded with it, Wentzel believes the extra time is worth it. “There is also a section that says ‘my child’s samples can be used for future research’ or the other one says ‘my child’s samples cannot be used.’ They have to pick one of these before they can go forward which allows us to track this electronically.”
Updating the platform, however, has been a challenge. Apple updates its IOS often, but the iPads cannot be updated since the platform works for the previous IOS. “From a resource perspective, to make it really plug and play, you would have to do certain sections – the ones that don’t change between studies – in modules,” she says. Researchers can easily do a paper version of consent on an iPad, but NCH’s platform became more costly with the embedded read-aloud capability, games and videos, along with the resources needed to manage content and make changes to the consent, she says.
Although NCH still uses the platform with face-to-face patient and family contact, Wentzel says adding the plug-and-play modules could add more utility, especially since all of the source documents are loaded onto the iPad. “You could turn it into something where you could be skyping someone and get consent and have the study forms on the same platform where they could be sent to the participant and have the completed consent sent back. You are still following the regulations; you are just doing it in an electronic format.”
Doing this type of thing is the wave of the future, Wentzel says. “Honestly, we all need to be thinking about how do we take the research to the participant? As we get more and more technology-based and more mobile as a population, it’s going to become critical if we want to retain our research subjects and even enroll them in the first place. We have to make it as convenient as possible. We just have to figure out how to do that and still remain compliant with the regulations.”
By Sue Coons, MA
This article was reprinted from Research Practitioner, Volume 18, Number 2, March-April 2017.