Improving Informed Consent in Clinical Research

改善临床研究的知情同意

• 批准号: 6777988
• 负责人: Jay Moskowitz
• 金额: $ 15万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2006-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6777988
• 关键词: DVD /CD ROM; computer assisted instruction; computer system design /evaluation; educational resource design /development; health science research support; informed consent; interactive multimedia

The protection of research subjects is at the core of successful biomedical research, and the informed consent document serves as the foundation upon which this protection rests. Yet there is a lack of acceptable understanding among clinical investigators of the informed consent process. It has been demonstrated that interactive, multi-media CD-based programs can be highly effective tools in clinical research. We will systematically develop and implement a CD-based multi-media Informed Consent program for investigators. The specific aims for the project are: 1. To develop and implement, among a group of clinical research investigators and their institutions, a multi-media program focused on the principles of informed consent. 2. To demonstrate that multi-media informed consent protocols can be effectively administered by the Human Subjects Protection Offices (HSPO) of the participating institutions. The program will be fully automatic, run for approximately 30 minutes and use a split-screen format that we have successfully used for previous clinical education CDs. This allows for video presentation on one side and coverage and reinforcement of the major points via a sequential text development on the other side. A physician host will provide the overview, introduce scenarios of increasing complexity and then provide brief comment / interpretation after each scenario. The four scenarios will be based on clinic settings with a clinical investigator and a potential study subject. The four scenarios will depict important elements related to clinical investigations that are Minimal-Risk, Low-Risk, Moderate-Risk and High Risk. All investigators who submit research protocols to the HSPO of each institution listed below during the implementation period will be required to utilize this educational program. The program will contain embedded questions that the viewer must answer to continue. The viewer's responses will be captured electronically and provide a dataset for analysis of the program. The appropriate multi-disciplinary team has been assembled to undertake this project.

对研究对象的保护是生物医学研究成功的核心，知情同意书是这种保护的基础。然而，临床研究者对知情同意过程缺乏可接受的理解。它已被证明，互动，多媒体光盘为基础的程序可以在临床研究中非常有效的工具。我们将为研究者系统地开发和实施基于CD的多媒体知情同意程序。该项目的具体目标是：1。在一组临床研究者及其机构中制定和实施一个以知情同意原则为重点的多媒体计划。2.证明参与机构的人类受试者保护办公室（HSPO）可以有效管理多媒体知情同意协议。 该程序将是全自动的，运行约30分钟，并使用分屏格式，我们已经成功地用于以前的临床教育光盘。这使得一方面可以进行视频演示，另一方面可以通过连续的文本开发来覆盖和加强要点。医生主持人将提供概述，介绍日益复杂的场景，然后在每个场景后提供简短的评论/解释。这四种情况将基于临床研究者和潜在研究受试者的临床环境。这四种情况将描述与临床研究相关的重要因素，即最低风险、低风险、中等风险和高风险。在研究期间向下列各机构的HSPO提交研究方案的所有研究者 需要一个实施期来利用这一教育方案。 该程序将包含嵌入式问题，观众必须回答才能继续。观众的反应将被电子捕获，并提供一个数据集，用于分析该计划。已经组建了适当的多学科小组来开展这一项目。