INTERACTIVE INFORMED CONSENT IN CLINICAL RESEARCH: DEVELOPING A MULTIMEDIA EDUCATIONAL TOOL
Abstract:
Background: Improving the informed consent process in clinical research is an ongoing
concern of the regulatory authorities as well as a challenge for both the investigators and the patients
involved. The latest innovations in information technology and Internet provide the opportunity to
develop new methods for getting the informed consent using an online multimedia-training platform in
the context of a computerized medical system. Methods: The platform development took into
consideration the principle of universal accessibility for persons who have limited knowledge using a
web system interface. It has been adapted to run efficiently on a tablet, taking advantage of the mobile
technology. The application is structured as a list of e-learning modules and it will track in real time the
progress recorded by each participant in the training process. Results: Multimedia Interactive Consent
Operating System is an interactive online platform designed to inform and educate the patients about the
clinical trials. It uses multimedia content, displays activity reports and integrates questionnaires for
understanding assessment of the presented information, and for satisfaction assessment that will get the
feedback on the presented training session. Conclusion: Using this online method, the patients have an
interactive tool to get informed, the content being customized to each research protocol, giving
corrective feedback on each concept, information or procedure that has been misunderstood by the
patient.
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