Development Of An Online Approach To Informed Consent

描述(由申请人提供)：在这一阶段的SBIR中，Healthmark多媒体公司建议对进入癌症临床试验的患者使用在线多媒体知情同意程序的可行性进行调查。第一阶段将侧重于了解潜在参与者和临床研究人员的需求；开发信息组件的内容大纲；开发设计和技术规范、原型用户界面和互联网门户网站onlineinformedConsenent.com的导航；以及在开发过程中进行持续的可用性测试。为了确保该网站满足患者和临床研究人员的需求，Healthmark将在网站的初始构思期间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。这一原型将接受潜在研究对象和临床研究人员的可用性测试。在第二阶段，我们将采用规范并开发一个完全可操作的计划，其中包括开发和管理临床试验的在线知情同意的模块化元素，这些临床试验可以由临床研究人员和研究对象进行测试。

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.