The Informed Consent Navigator: A CTSA Tool Advancing Equity by Producing Readable and Compliant Consent Documents

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Abstract

Informed consent forms (ICFs) and practices vary widely across CTSA institutions. A recent survey identifies “Collecting and Disseminating Best Practices'' and “Template Broad Consent Documents” as informed consent priorities among CTSAs[1]. We have previously developed a “plain language” informed consent template, which was widely adopted by our CTSA hub and meets recommended reading levels for ICFs [2,3]. Expanding upon this work, we have developed the Informed Consent Navigator, a novel tool that can advance health equity by automating the creation of plain language ICFs.

The navigator is a web-based tool that guides researchers through the creation of an ICF by answering a series of questions about their project. It uses question responses to produce a clear and compliant ICF. Each iteration and all edits can be tracked to facilitate shared editing by the research team and communication with the institutional review board. The navigator helps guide the creation of study specific language, while also ensuring compliance with regulatory requirements, and it ensures that the resulting ICF is easy to understand and read.

Our interdisciplinary team of researchers at the University of Arkansas for Medical Sciences (UAMS) Translational Research Institute (TRI), comprising biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board processes, developed the interactive Informed Consent Navigator.

The Navigator was custom-built using Python and Javascript and backed by the Postgres relational database system. Its initial configuration includes ninety questions with survey logic to dynamically adjust and reduce the number of questions a user must answer based on properties of the research. For example, the section on research involving biospecimens is automatically skipped for a researcher who indicates early in the survey that their study does not involve biospecimens. Elements of the navigator and forms are aligned with terms from the Informed Consent Ontology (ICO) [4] to support future use of generated ICFs to collect, integrate, and query consent data.

Following initial development of the tool, we conducted interface usability testing with a multidisciplinary team at UAMS comprising five test users, each with experience in clinical study management or informed consent procedures. These users re-created a total of seven unique ICFs using the ICF Navigator. Each provided feedback on perceived usability of the interface and suggested improvements. We plan a focus group session with that team on completion of the next prototype to help finalize the user interface. We also plan a second, broader, usability study including investigators from other CTSA Hubs.

Our next step is to test a prototype of the output ICFs with a community audience inclusive of individuals who have failed health literacy screening, to ensure that our final product is optimally readable, understandable, and actionable. Future work will integrate natural language processing and machine learning to provide real-time guidance on readability of entered text, and to allow use of more context-specific language based on the researcher’s answers to questions about their study.In the next phase of this project, we will pilot use of navigator-generated ICFs as part of electronic consenting workflows.
 

References

[1] Chandler R, Brady KT, Jerome RN, Eder M, Rothwell E, Brownley KA, Harris PA. Broad-scale informed consent: A survey of the CTSA landscape. Journal of clinical and translational science. 2019 Oct;3(5):253-60. 

[2] Hadden KB, Prince LY, Moore TD, James LP, Holland JR, Trudeau CR. Improving readability of informed consents for research at an academic medical institution. J Clin Transl Sci. 2017 Dec;1(6):361-365. doi: 10.1017/cts.2017.312. PMID: 29707258; PMCID: PMC5915809.

[3] Caballero, A., Leath, K., Gan, J. Institutional Improvements in Readability of Written Informed Consent Forms Sustained Post-Revised Common Rule. J Clin and Transl Sci. 2021 Sept; Online ahead of print. 

[4] Otte JN, Stansbury C, Vajda J, Manion F, Umberfield E, He Y, Harris M, Obeid J, Brochhausen M, Duncan W, Tao C. Coordinated evolution of Ontologies of Informed Consent. International Conference on Biomedical Ontology 2018 (ICBO-2018), August 7-10, 2018, Corvallis, Oregon, USA. Pages 1-2.
 

Acknowledgement: The project was supported by the Translational Research Institute (grant UL1 TR003107) through the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

 

Authors
Jonathan
Bona
Assistant Professor
Laura
James
Director, Translational Research Institute
Mathias
Brochhausen
Professor