David Robinson

TRI Study of the Month

*Deanne King, M.D., Ph.D., (left) meets with TRI’s Kennetha Newman, the study’s lead research coordinator.*

UAMS Principal Investigator: Deanne L. King, M.D., Ph.D., assistant professor and director of Clinical Research, College of Medicine Department of Otolaryngology – Head & Neck Surgery

Summary: A phase 3 multi-center trial will evaluate the safety and efficacy of a new drug candidate for Meniere’s disease.

Significance: There are few treatment options available for Meniere’s disease, a common inner ear disease whose symptoms include hearing loss, dizziness/vertigo and tinnitus. The anti-inflammatory drug candidate has shown promise as a treatment in smaller studies.

TRI Services: Medicare coverage analysis, study budget development, regulatory and nurse/clinical coordinator support, administration of Clinical Trial Management System, and post-award financial management.

Sponsor: Sound Pharmaceuticals Inc.

TRI Advances Health Equity with Computer-Guided Study Consent Forms

Members of the Informed Consent Navigator team include (front, l-r) Mathias Brochhausen, Ph.D., Nicki Spencer, M.H.A., Alison Caballero, MPH, CHES, and Jonathan Bona, Ph.D.; (back row) Justin Whorton, Sarah Fountain, MPH, CPH, CHES, Jennifer Gan-Kemp, MBA, CRS, and Aaron Kemp, MBA. Image by Bryan Clifton (Image credit: Bryan Clifton/UAMS)

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.

Interdisciplinary Research
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.”

Ensuring Readability
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.

Next Steps
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.

Read the Latest TRIbune

Antiño Allen, Ph.D., (right) was among five UAMS research leaders who completed mentorship facilitator training at the University of Wisconsin-Madison.

In this month’s issue of The TRIbune, we feature some significant new efforts in mentorship training for researchers. TRI-supported research leaders have received mentorship facilitator training and will be conducting regular, evidence-based mentor training courses for UAMS-affiliated faculty. TRI’s mentorship training efforts reflect a priority of the National Center for Advancing Translational Sciences (NCATS) at the NIH.

The TRI Study of the Month features Jill Mhyre, M.D., professor and chair, College of Medicine Department of Anesthesiology, who is collaborating with Ronda Henry-Tillman, M.D., chief of Breast Surgical Oncology.

Read The TRIbune.

TRI Seeking Pilot Award Applications

TRI is inviting applications for pilot grants to support a range of translational research projects.

Budgets up to $25,000 for a one-year project will be considered.

TRI is accepting applications that will employ novel approaches in or address any of the following focus areas: Health concerns and challenges of rural and underrepresented populations; implementation science to incorporate new research findings into the health care system, including rural practices; biomedical informatics approaches that examine unique state data resources; team science approaches to address health challenges in Arkansas or overcome barriers to translational science; and/or community and/or stakeholder-partnered research.

Full-time UAMS faculty, including at Arkansas Children’s and the Central Arkansas Veterans Healthcare System, are invited to apply.

Letters of Intent are due Thursday, Feb. 9, 2023, by 5 p.m. (CT)
Invited full applications will be due by Monday, April 3, 2023.

Read the Request for Applications.

Questions? Contact Crystal Sparks, csparks@uams.edu.

TRI Seeking Letters of Intent from Prospective KL2 Scholar Award Applicants

The Translational Research Institute (TRI) is pleased to invite Letters of Intent (LOIs) for the 2023 KL2 Mentored Research Career Development Scholar Awards.

The TRI Mentored Research Career Development Scholars Program provides support for early-career UAMS faculty with a professional degree (M.D., Ph.D., Pharm.D., D.N.P., Dr.PH., D.O., etc.) who are committed to an academic career in multidisciplinary clinical or translational research.

Successful applicants will begin the two-year program July 1, 2023. The KL2 program combines an innovative educational program with mentored clinical/translational science research. KL2 Scholars receive:

Salary support/stipend of up to $95,000 (including fringe) per year.

Up to $25,000 of non-salary support per year, which can be used for research, tuition, travel expenses, educational materials and other costs related to the scholar’s research.

The deadline for submitting LOIs is Friday, Jan. 27, 2023, 5 p.m. (CT).

See attached LOI Cover Page.

View the Request for Applications.

The KL2 program is supported by the Clinical and Translational Science Awards (CTSA) Program of the NIH National Center for Advancing Translational Sciences. Contact: Chaz England, CEngland@uams.edu.

SAVE THE DATE: Join Us April 4 for TRI Research Day!

Image art includes the words, Research Day and Translational Research Institute

All are invited to TRI Research Day on Tuesday, April 4, from 10 a.m. to 4 p.m. at Heifer International in Little Rock.

Our keynote speaker is Duane Mitchell, M.D., Ph.D., professor of neurosurgery and director of the University of Florida Clinical Translational Science Institute (CTSI). He is also assistant vice president for Research and associate dean for Clinical and Translational Sciences at the UF College of Medicine.

The event will showcase TRI-supported research with oral presentations from select TRI-supported investigators. A poster session (with prizes!) will include an array of TRI-supported projects across its range of funding and training programs.

Please mark your calendars and stay tuned for registration and other details.

Contact: Robin Liston, rliston@uams.edu.

Researchers, Community Organizations Invited to Apply for CBPR Scholars Program

Image of text at top of information flyer stating: New Free Partnered Research Training PRogram with Pilot Funding Opportunities; Community-Based Participatory Research (CBPR) Scholars Program Begins March 2023; TRI is looking for researchers and community organizations interested in partnering, training and working on a research project.

TRI’s Community Engagement Program is seeking researchers and community organizations interested in partnering, training and working on a funded research project.

The Community-Based Participatory Research (CBPR) Scholars Program will provide successful applicants up to $25,000 or up to $50,000 in pilot funding. Applications are due Feb. 1, 2023, and the program begins in March 2023.

If interested, please email the TRI Community Engagement team at triceteam@uams.edu, or call/text 501-291-7301.

More information is available here.

View the flyer.

TRI-Supported Researchers Co-Author JCTS Paper on Virtual Diversity Curriculum

TRI-supported researchers Mathias Brochhausen, Ph.D., and Tremaine Williams, Ed.D., joined Ph.D. student Cilia Zayas (first author) as co-authors on the JCTS paper.

Two UAMS Translational Research Institute (TRI) researchers are co-authors on work published in the Journal of Clinical and Translational Science about developing and testing a diversity, equity and inclusion curriculum for use in higher education.

The research team co-authors from the College of Medicine Department of Biomedical Informatics (DBMI) includes Tremaine B. Williams, Ed.D., assistant professor, and Mathias Brochhausen, Ph.D., professor and vice chair for Academic Programs and Faculty Development. They joined DBMI Ph.D. student Cilia Zayas, first author, on the paper, “Experiences with Developing and Implementing a Courageous Conversations Pilot Classroom through Synchronous Meetings via Zoom.”

Brochhausen is TRI’s director of Pilot Translational and Clinical Studies Program. Williams became a TRI KL2 Mentored Research Career Development Program scholar in 2021.

The paper details the development of the pilot course curriculum in the wake of the murder of George Floyd in summer 2020. The course was implemented as a pilot program at the University of Florida, where Zayas and Brochhausen were employed at the time. The model curriculum takes a collaborative approach and can be used with students, staff and faculty.

Zayas and Brochhausen met with participants at the end of the semester to gain feedback about their experience and found that many reported valuing listening to others talk about their own personal lived experiences.

“We all benefit from learning from each other, but often those conversations are difficult to have. Facilitators encouraged the participants to stay engaged, expect to feel discomfort, speak their truth, and accept non-closure,” said Zayas, who chairs DBMI’s Diversity, Equity and Inclusion Committee. “These ground rules enabled the groups to have real discussions about diversity, equity and inclusion by establishing a safe framework in which to share and explore – even under stressful circumstances. Participants found these discussions valuable, and many reported they would either re-take the course or recommend it to a colleague.”

To learn more about diversity, equity and inclusion research and efforts at DBMI, visit its Diversity, Equity & Inclusion Committee website.

TRI, 5 Rural CTSAs Seek Multi-institutional Pilot Applications for Translational Science Projects

Image of logos of Consortium of Rural States (CORES) institutions with deadlines for submissions, which are repeated in the story.

The Consortium of Rural States (CORES) Multi-institutional Pilot Program will fund translational science projects aiming to identify and overcome barriers to the performance of translational research.

Awards of up to $25,000 per institution will go to the collaborators for projects involving two or more of the six CORES institutions.

View a recording of the CORES Information Session.

The CORES pilot opportunity includes four emphasis areas:

Climate Change and Environmental Health
Health Equity for Underrepresented Populations
Rural Health
Maternal Health

All UAMS-affiliated faculty are invited to apply.

Letters of Intent are due Jan. 18, 2023.

Invited full applications are due March 8, 2023.

In addition to UAMS, the collaborative includes the University of New Mexico Health Sciences Center, University of Kansas Medical Center, University of Kentucky, University of Iowa and University of Utah Health.

If you have questions about this pilot project award, please contact TRI’s Crystal Sparks, csparks@uams.edu.

Read the Request for Applications.

TRI Study of the Month

*Kyle Kalkwarf, M.D., is assisted on the trial by TRI’s Shellah Rogers, B.S.N., RN, CMSRN, the study’s lead clinical research coordinator.*

UAMS Principal Investigator: Kyle Kalkwarf, M.D., assistant professor, College of Medicine Department of Surgery, Division of Trauma and Acute Care Surgery

Summary: This multi-site clinical trial involving hospitalized traumatic brain injury patients will test the effectiveness of a non-invasive device (Infrascanner) for detecting the growth of intracranial hematomas.

Significance: The study of this FDA-approved device, which uses near-infrared light to detect bleeding, may lead to earlier diagnosis and improved treatments for traumatic brain injury patients, especially in areas with limited resources, such as rural America or on military deployments

Sponsor: University of Alabama at Birmingham

Funding: U.S. Department of Defense