Consent form creation for multicenter trials can be complex, requiring site-specific injury, consent, and HIPAA language. The key study information in each consent document must be consistent between sites, with only local language differences, to enable the reviewing IRB to review a single consent document for each study.
University of Utah researchers have developed an electronic consent building tool that enables the creation of multiple consent and parental permission and assent documents for a single study. Consent Builder guides research staff through the required consent form sections with instructions and examples. Consent language is collected via online data collection forms through REDCap and then, once study information is collected, research staff can output consent forms by selecting a study and site, and clicking on the “generate forms” button. The tool aggregates the study and consent information in REDCap, and then merges it with a LaTeX template. The LaTeX template organizes and compiles the data and produces a high-quality informed consent document.