Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data.

Informed consents are a critical and essential component of the clinical research process. Currently, most consents and research privacy authorizations are being captured on paper. In this paper we describe a novel method of capturing this information electronically. The objective is to allow easier tracking of research participants' intent for current and future research involvement, enhance consent comprehension and facilitate the research workflow. After multidisciplinary analysis in key hospital registration areas and research participant enrollment, an open source software product was designed to capture this data through a user-friendly touch screen interface. The data may then be fed into a clinical data warehouse for use in cohort discovery or consent tracking. Despite ethical, legal and informatics challenges in clinical and research environments, we propose that this technology opens new avenues for significantly enhancing the consent process and positively impacting recruitment.

Managing clinical research permissions electronically: A novel approach to enhancing recruitment and managing consents.

BACKGROUND: One mechanism to increase participation in research is to solicit potential research participants' general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. PURPOSE: The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants' interest in current and future research involvement and to provide a foundation for facilitating the research workflow. METHODS: The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users. RESULTS: An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions. LIMITATIONS: There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials. CONCLUSIONS: We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents.