Improving Informed Consent in Clinical Research

对研究对象的保护是成功生物医学研究的核心，而知情同意文件是这种保护的基础。然而，临床研究人员对知情同意过程缺乏可接受的理解。已经证明，交互式的、基于CD的多媒体程序可以成为临床研究中的高效工具。我们将系统地开发和实施以CD为基础的调查人员多媒体知情同意计划。该项目的具体目标是：1.在一群临床研究人员和他们的机构中开发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)可以有效地管理多媒体知情同意协议。 该程序将是全自动的，运行大约30分钟，并使用我们在以前的临床教育CD中成功使用的分屏格式。这允许在一边进行视频演示，并在另一边通过顺序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，然后在每个场景之后提供简短的评论/解释。这四种情况将基于临床环境，有一名临床调查员和一名潜在的研究对象。这四个场景将描述与临床调查相关的重要元素，即最低风险、低风险、中等风险和高风险。在调查期间向下列各机构的HSPO提交研究方案的所有调查人员 使用这一教育计划需要实施期。 该节目将包含观众必须回答才能继续的嵌入问题。观众的反应将以电子方式捕获，并为节目分析提供数据集。已经组建了适当的多学科小组来开展这一项目。

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.