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

Abstract

ObjectiveTo describe process innovations related to research informed consent documents, and development and formative evaluation of Consent Builder, a platform for generating consent documents for multicenter studies.Materials and MethodsAnalysis of Institutional Review Board workflows and documents, followed by process redesign, document redesign, and software development. Locally developed software leverages REDCap and LaTeX. A small-scale usability study was conducted.ResultsProcess innovations were combining document types, and conceptualizing 2-part informed consent documents: part 1 standardizing the study description and part 2 with local site verbiage. Consent Builder was implemented in the Trial Innovation Network. User survey scores were acceptable; but areas for improvement were noted. LaTeX coding was the biggest challenge for users.DiscussionThe process changes were generally well accepted. The software implementation uncovered un-accounted for assumptions, and variability in IRB review workflow across centers. Technical modifications may be needed before widespread implementation.ConclusionWe demonstrated proof-of-concept of an approach to generate research consent documents that are consistent across sites in study description, but which allow for customization of local site verbiage. The Consent Builder tool is an example of an operational innovation, helping meet a need that arose in part due to regulations around use of Single IRB for multicenter trials.