Ever since Mary Politi, PhD, arrived at WashU back in 2009, she has believed the informed consent process for research study participants could be improved.
Many people who think about joining research studies comment on the length and complexity of informed consent documents. They often assume these documents are used for legal purposes rather than to support decisions about study participation. Previously, when meeting with potential study participants, her team presented a separate supplement to the consent documents that was a one-page, bulleted, clear description of the research project to help clarify and engage participants. IRBs would approve these as supplemental flyers or recruitment materials, but could not amend the actual consent document itself.
Then in 2020, during the global COVID pandemic, Politi’s team had to switch to conducting almost all research virtually. When showing people consent documents on a computer screen, it was even clearer that the communication and information being provided to study participants needed a revamp. This propelled Politi to propose this idea of visual key information pages as part of informed consent to the ICTS, where she subsequently received funding in 2023-2025 from the ICTS, in conjunction with the Siteman Cancer Center. Politi says her team did not want to just create something without doing ample research first into what would work best for patients, especially those struggling the most to understand what is being asked of them.
“When information is confusing, people look to a trusted clinician or the coordinator recruiting them, but that doesn’t mean that we shouldn’t try to make sure they really, fully grasp the details of the study we are asking them to participate in,” says Politi. “The Siteman Cancer Center was so supportive in this process, because they focus a lot on patient-centered care experiences, and the ICTS really helped us to consider how these visual consent documents could be successfully used across multiple disciplines.”
Politi’s team started the research into visual informed consent, utilizing four pilot grants and testing out the process in several areas, such as in the Alzheimer’s Disease Research Center and within other behavioral and interventional trials.
What Is Visual Key Information for Informed Consent?
This process brings “key information” to the forefront of the consent process. Key information serves as a plain language summary of the core elements of the entire project, such as the details of the study, the study benefits, the potential risks, the voluntary nature of research, whether the participants will get paid, and who to contact for more information. Politi and team’s visual key information is structured as a one-page document that utilizes a minimal amount of text organized into boxes and icons to summarize and help the participant navigate the information of the study, increasing engagement without being too busy or hard to follow.
“Most people are used to seeing 12 pages of front and back text that is really hard to follow when they sign a consent, so this is just a much nicer and cleaner summary”, says Politi. “We’ve been told by several research participants that, because it is so user-friendly, they actually save this visual key information to refer back to, especially for longitudinal studies that have multiple components where they are coming back to the hospital or site for more surveys, blood draws, or scans.”
Politi also points out that not only is the visual informed consent useful for streamlining information to study participants and increasing engagement and enrollment, but it can also help participants who end up not being interested in the study. It is much easier for them to make an informed decision after they see the key information presented in a way they can easily understand, without having to read through several pages of information first.
Wider Implementation of Visual Consent Process
In addition to the ICTS and Siteman Cancer Center funding, Politi received support from an ICTS Translational Science Supplemental Funding award in 2025 to train investigators and community partners in this process, and also additional supplemental funding from the Agency for Healthcare Research & Quality (AHRQ) to perform interviews with several individuals, such as participants, community members, trial PIs, and research support staff. Politi says her team has tracked about 60 studies within WashU that are using these visual informed consent processes. And through these various funding mechanisms, Politi’s team has been able to develop best practices that could be better implemented in studies across institutions outside of WashU.
“We started this process at WashU, the University of Utah, and the University of North Carolina-Chapel Hill, and it has just continued to expand,” says Politi. “The translational science funds helped us take what we learned from previous research and allowed us to host a training workshop about visual informed consent, which had attendees from other areas as well, like the University of Missouri and the National Cancer Institute (NCI).”
After the workshop, Politi’s team took materials from that and created a website with the template and toolkit for visual informed consent that individuals can access and use at their own institutions. Politi reports the NCI is now using this in their Consent Crafter, which houses a large language model to automate creating visual informed consent documents for its broad collection of studies.
Future Plans
Politi indicates this research has not come without its challenges, as some institutions are hesitant to implement the visual consent documents due to fear of not being granted approval by their IRB. Politi says she hopes to collect additional data to further show the potential impact this process has on enrollment and/or retention of study participants.
“Right now, we have great support at the Siteman Cancer Center, and they currently create these documents for investigators or with the investigators, and my team reviews if they have questions. But it takes time and humans to do that, so it would be great if we could develop a way to automate the process the way they have done this at NCI with a large language model,” says Politi.
Partnering with the ICTS
Politi says working with the ICTS has been instrumental in her success in getting the visual informed consent process up and running. Aside from securing funding for her efforts, Politi praises the other resources that are available within the ICTS.
“I work with a community advisory board through the Center for Collaborative Care Decisions, but I wanted to make sure the feedback we received on our visual consent process was from a broader audience, so I presented to the Community Advisory Board within the Center for Community Health Partnership and Research, which was incredibly helpful to our research,” says Politi. “I would also especially encourage investigators to take advantage of the Mock Study Sections and the Research Forums, which both provide valuable feedback in environments that would be very similar to large panel reviews.”
In addition, Politi praises the abundance of Core services that are available through the Just-In-Time Core Usage Funding Program, and also the facilitation of relationships with investigators outside of WashU that comes from involvement with the ICTS.
“Through working with the ICTS, I was able to get connected with other CTSA programs at the University of Utah and the University of North Carolina-Chapel Hill in order to further the visual consent implementation,” says Politi. “Those CTSAs were able to see what we had success with on our end, and they helped support participant incentives at their sites, as well. I am very grateful for the support of the ICTS in this research and expanding its education and implementation.”