The informed consent form navigator: a tool for producing readable and compliant consent documents.

Background/Objective: Informed consent forms (ICFs) and practices vary widely across institutions. This project expands on previous work at the University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy to develop a plain language ICF template. Our interdisciplinary team of researchers, comprised of biomedical informaticists, health literacy experts, and stakeholders in the Institutional Review Board (IRB) process, has developed the ICF Navigator, a novel tool to facilitate the creation of plain language ICFs that comply with all relevant regulatory requirements. Methods: Our team first developed requirements for the ICF Navigator tool. The tool was then implemented by a technical team of informaticists and software developers, in consultation with an informed consent legal expert. We developed and formalized a detailed knowledge map modeling regulatory requirements for ICFs, which drives workflows within the tool. Results: The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator uses those responses to produce a clear and compliant ICF, displaying a real-time preview of the final form as content is added. Versioning and edits can be tracked to facilitate collaborative revisions by the research team and communication with the IRB. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand. Conclusion: The ICF Navigator is an innovative, customizable, open-source software tool that helps researchers produce custom readable and compliant ICFs for research studies involving human subjects.

Readability of Human Subjects Training Materials for Research.

Institutions are required to ensure that persons involved in human subjects research receive appropriate human subjects protections training and education. Several organizations use the Collaborative Institutional Training Initiative (CITI) program to fulfill training requirements. Most researchers find the CITI program too complex for community members who collaborate with researchers. This study aimed to determine the readability of CITI modules most frequently used in community-based participatory research (CBPR). The mean readability level of the CITI modules is 14.8 grade; CBPR readability levels ranged from 11.6 to 12.0 grade (sixth- to eighth-grade reading level is recommended). With a baseline objective measure, modifications can be made to improve the plain language quality and understandability of human subjects training modules for community members.

Improving readability of informed consents for research at an academic medical institution.

INTRODUCTION: The final rule for the protection of human subjects requires that informed consent be "in language understandable to the subject" and mandates that "the informed consent must be organized in such a way that facilitates comprehension." This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention. METHODS: Readability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year. RESULTS: The mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade. CONCLUSIONS: Providing investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.