Consent Builder: an innovative tool for creating research informed consent documents

Area of Science:

• Clinical Research Operations
• Health Informatics
• Regulatory Science

Background:

• Multicenter studies require consistent yet adaptable informed consent documents.
• Existing processes for generating consent forms can be inefficient and prone to variation.
• Regulatory changes, such as the use of Single Institutional Review Board (sIRB), increase the need for standardized documentation.

Purpose of the Study:

• To describe process innovations for research informed consent documents.
• To detail the development and formative evaluation of Consent Builder, a platform for generating consent documents for multicenter studies.

Main Methods:

• Analysis of Institutional Review Board (IRB) workflows and documents.
• Process and document redesign, followed by software development leveraging REDCap and LaTeX.
• Conducting a small-scale usability study of the Consent Builder platform.

Main Results:

• Developed a 2-part informed consent document structure: standardized study description and local site verbiage.
• Implemented Consent Builder in the Trial Innovation Network, receiving acceptable user survey scores with noted areas for improvement.
• Identified LaTeX coding as a significant challenge for users.

Conclusions:

• Demonstrated a proof-of-concept for generating consistent, customizable research consent documents across study sites.
• Consent Builder represents an operational innovation addressing needs arising from sIRB regulations for multicenter trials.
• Process changes were generally accepted, but technical modifications are recommended for widespread implementation due to observed variability in IRB workflows.