Development Of An Online Approach To Informed Consent

描述（由申请人提供）：在此I期SBIR中，HealthMark Multimedia提议调查在进入癌症临床试验的患者中使用在线多媒体知情同意流程的可行性。I期将侧重于了解潜在参与者和临床研究者的需求；为信息组件制定内容大纲；为互联网门户网站onlineinformedconsent.com开发设计和技术规范、原型用户界面和导航；并在开发过程中执行持续的可用性测试。为了确保网站同时满足患者和临床研究者的需求，HealthMark将在网站的初始构想阶段与患者和提供者咨询委员会合作。将开发一个功能有限的原型作为概念验证。该原型将由潜在的研究对象和临床研究者进行可用性测试。在第二阶段，我们将采用规范并开发一个具有模块化元素的完全可操作的程序，用于开发和管理临床试验的在线知情同意，可由临床研究者和研究受试者进行测试。

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.