Development Of An Online Approach To Informed Consent

描述（由申请人提供）：在本II期SBIR中，HealthMark Multimedia建议评估在I期癌症临床试验中开发的原型多媒体在线知情同意过程的使用，并进一步完善帮助研究者使用在线知情同意过程以增强与患者面对面互动所需的过程。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要素。 HealthMark Multimedia随后将为试验开发多媒体在线同意书，其中包括西班牙语和英语的教育和决策工具。在临床试验完成入组后，癌症中心的主要知情人将接受采访，讨论采用这种同意的组织和个人障碍。在评估在线知情同意过程使用的同时，HealthMark Multimedia将开发后台系统，用于管理多媒体知情同意过程的开发，包括上传知情同意信息和数据收集的模板、多媒体选项以及与临床试验工作人员沟通的选项（例如，电子邮件）。评价和关键知情人访谈将为个体试验在线知情同意程序的开发提供最终业务流程信息。

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.