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

Area of Science:

• Biomedical Informatics
• Health Literacy
• Regulatory Compliance

Background:

• Informed consent form (ICF) practices and content vary significantly across research institutions.
• Existing ICFs often lack plain language, hindering participant comprehension.
• The University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy aimed to improve ICF clarity and compliance.

Purpose of the Study:

• To develop a novel, web-based tool, the ICF Navigator, to facilitate the creation of plain language informed consent forms.
• To ensure that the generated ICFs comply with all relevant regulatory requirements.
• To support researchers in producing accessible and legally sound ICFs for human subjects research.

Main Methods:

• Development of user requirements for the ICF Navigator tool.
• Implementation by informaticists and software developers, with legal expert consultation.
• Creation of a knowledge map detailing regulatory requirements to drive tool workflows.

Main Results:

• The ICF Navigator is a web-based application guiding users through ICF creation via interactive questions.
• The tool provides a real-time preview of the ICF as content is generated.
• It supports version tracking, collaborative editing, and communication with Institutional Review Boards (IRBs).

Conclusions:

• The ICF Navigator is an innovative, open-source software solution.
• It enables researchers to generate customized, readable, and compliant ICFs.
• The tool enhances the quality and accessibility of informed consent for research participants.