DEVELOPMENT OF AN ONLINE APPROACH TO INFORMED CONSENT

DESCRIPTION (provided by applicant): In this Phase I SBIR, HealthMark Multimedia proposes to investigate the feasibility of using an online multimedia informed consent process for patients entering cancer clinical trials. Phase I will focus on understanding the needs of prospective participants and clinical investigators; developing a content outline for informational components; developing design and technical specifications, a prototype user interface, and navigation for an Internet portal, onlineinformedconsent.com; and performing ongoing usability testing during development. To ensure that the site meets the needs of both patients and clinical investigators, HealthMark will work with a Patient and Provider Advisory Board during the initial conception of the website. A limited-function prototype will be developed as a proof of concept. This prototype will be subjected to usability testing by both potential research subjects and clinical investigators. In Phase II, we will take the specifications and develop a fully operational program with modular elements for developing and administering online informed consent for clinical trials that can be tested by clinical investigators and study subjects.