Development Of An Online Approach To Informed Consent

开发在线知情同意方法

• 批准号: 6549590
• 负责人: SUSAN G BRINK
• 金额: $ 11.05万
• 依托单位: HEALTHMARK MULTIMEDIA, LLC
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-08-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6549590
• 关键词: Internet; clinical research; computer assisted patient care; computer program /software; computer system design /evaluation; data management; human subject; informatics; information dissemination; information systems; informed consent; interactive multimedia; online computer

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.

描述（由申请人提供）：在第一阶段 SBIR 中，HealthMark Multimedia 提议调查对进入癌症临床试验的患者使用在线多媒体知情同意流程的可行性。第一阶段将重点了解潜在参与者和临床研究人员的需求；制定信息组件的内容大纲；开发设计和技术规范、原型用户界面以及互联网门户网站 onlineinformedconsent.com 的导航；并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 将在网站的最初构想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。该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具有模块化元素的完全可操作的程序，用于开发和管理可供临床研究人员和研究受试者测试的临床试验的在线知情同意书。