Development Of An Online Approach To Informed Consent

开发在线知情同意方法

• 批准号: 6832498
• 负责人: SUSAN G BRINK
• 金额: $ 46.25万
• 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 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6832498
• 关键词: Internet; clinical research; clinical trials; computer assisted medical decision making; computer assisted patient care; computer program /software; computer system design /evaluation; data management; health education; human subject; informatics; information dissemination; information systems; informed consent; interactive multimedia; online computer; patient oriented research

DESCRIPTION (provided by applicant): In this Phase II SBIR, HealthMark Multimedia proposes to evaluate the use of the prototype multimedia online informed consent process developed in Phase I with a cancer clinical trial and to further refine the processes needed to aid an investigator in using an online consent process to augment face-to-face interactions with patients. HealthMark Multimedia staff will work with the clinical trial staff to identify key educational elements needed in the consent. HealthMark Multimedia will then develop a multimedia online consent for the trial that features education and decision tools in Spanish and English. After the clinical trial has completed enrollment, key informants at the cancer center will be interviewed to discuss organizational and personal barriers to adoption of this type of consent. Concurrently with the evaluation of use of the online consent process, HealthMark Multimedia will develop the back office system for managing the development of the multimedia consent process, including templates for uploading consent information and data collection, options for multimedia and options for communicating with clinical trial staff (e.g., email). The evaluation and key informant interviews will inform the final business processes for development of an online informed consent process for an individual trial.

描述（由申请人提供）：在第二阶段 SBIR 中，HealthMark Multimedia 建议评估第一阶段开发的原型多媒体在线知情同意流程在癌症临床试验中的使用情况，并进一步完善帮助研究者使用所需的流程在线同意流程，以增强与患者的面对面互动。 HealthMark Multimedia 工作人员将与临床试验工作人员合作，确定同意书中所需的关键教育元素。 然后，HealthMark Multimedia 将为该试验开发多媒体在线同意书，其中包含西班牙语和英语的教育和决策工具。临床试验完成招募后，癌症中心的关键知情人将接受采访，讨论采用此类同意书的组织和个人障碍。在评估在线同意流程的使用的同时，HealthMark Multimedia 将开发用于管理多媒体同意流程开发的后台系统，包括用于上传同意信息和数据收集的模板、多媒体选项以及与临床试验沟通的选项工作人员（例如电子邮件）。评估和关键知情人访谈将为制定个别试验的在线知情同意流程的最终业务流程提供信息。