A new software tool developed at the University of Arkansas for Medical Sciences (UAMS) will help researchers quickly create consent documents in plain language for their prospective study volunteers.
Called the Informed Consent Navigator, the web-based tool breaks new ground with its ability to guide researchers through the creation of plain-language informed consent forms at an eighth-grade reading level or below. The Journal of Clinical and Translational Science published the Translational Research Institute team’s work in December, drawing immediate interest from several research institutions across the United States.
“This is a big win for health equity and a big achievement for UAMS,” said co-author Mathias Brochhausen, Ph.D., a professor in the College of Medicine Department of Biomedical Informatics.
First-author Jonathan Bona, Ph.D., led creation of the computer-guided navigation as part of an interdisciplinary research team that includes biomedical informaticists, software developers, research ethicists, and experts in community engagement, health literacy, health education, plain-language writing, clinical trials and informed consent.
“What has been really novel and beneficial is working with folks from across UAMS to make this the best possible tool for researchers and the community,” said Bona, an assistant professor in the College of Medicine’s Department of Biomedical Informatics.
The team was assembled and supported by UAMS Translational Research Institute Director Laura James, M.D., a co-author.
“This project truly played to UAMS’ strengths and is a testament to multidisciplinary team science and the vital support of the Translational Research Institute,” said Brochhausen. “In addition to the institute’s financial support, Dr. James and her team have been with us in the trenches, attending our meetings and helping connect us to key resources.”
Consent forms are often long, detailed, and introduce new concepts, said co-author Alison Caballero, MPH, CHES, director of the Center for Health Literacy. The forms can be a barrier to conducting research, especially with populations underrepresented in research and with limited health literacy.
“Using language that is readable, understandable and actionable is a challenge, but it is essential for truly informed consents and ensuring the greatest possible diversity in research,” said Caballero, an associate professor.
While other institutions across the U.S. have been working on similar automated consent processes, UAMS appears to be first with its automated plain-language consents.
“We were able to get further than any other group with our tool’s added health equity benefits,” Brochhausen said.
The Informed Consent Navigator builds on years of work by a collaborative team including the UAMS Center for Health Literacy, which created a plain-language consent form template and made it available to all researchers. Plain-language experts at the center created a large bank of text that is approved by the UAMS Institutional Review Board and covers a broad range of research. Now part of the navigator, the text is automatically populated in the informed consent form based on the user’s answers to questions presented by the navigator.
Where researchers must write original text about their specific studies, the navigator provides instructional text, content examples and real-time feedback with readability scores and suggestions to improve readability.
The navigator also uses survey logic that helps tailor what researchers see as they are guided through the process, reducing the difficulty and eliminating errors often made when using print-based templates.
“The goal for this is not just to make it easier for researchers to build forms, but to do so in a way that checks and encourages — and in some cases enforces — that the forms are readable,” Bona said.
The team plans to pilot the Informed Consent Navigator with clinical research studies at UAMS and other institutions. Prior to that, the latest version of the navigator will be presented to a Community Review Board made up of community representatives recruited by the Translational Research Institute’s Community Engagement team.
“Having community reviewers tell us what is clear and what is not clear is very useful,” Bona said, noting that the community board has given its feedback twice before. “We’ve had great communication with the board and their input has already led to improvements in the navigator.”
Longer term, the team will establish an electronic consenting platform (e-consent). It will also work toward artificial intelligence-powered management of consents to expand the navigator’s functionality.
Bona said the team ultimately hopes to see the navigator deployed at research institutions across the U.S. and beyond with the ability to query the network’s data.