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.

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.

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.