Eliciting Truly Informed Consent

在NIH人类受试者研究增强计划的支持下，威斯康星医学院开发了15个基于网络的教育模块，以指导研究人员和研究协调员为人类研究参与者制作知情同意文件。精心准备的文件是寻求真正知情同意的必要条件；然而，这些文件还不够。还需要建立一种可交流的 与潜在的研究参与者进行清晰、完整和有效的过程。这一过程包括：(A)确保个人有能力做出明智的决定；(B)披露参与研究的风险和好处，包括对参与者健康状况的潜在影响；(C)核实参与者理解信息并能够就参与做出明智的决定。这个应用程序建议开发基于Web的 教育模块和视频演示，展示有效和无效的方式，以争取不同种族和年龄的潜在研究参与者群体的知情同意，这些潜在研究参与者在不同的健康素养水平上发挥作用。拟议的项目有5个目标：(1)确定知情同意的障碍；(2)开发基于网络的文本材料和视频模型，展示克服这些障碍的方法；(3)测试和评估 (4)部署威斯康星州人类研究保护网络，以传播和应用材料和模型；(5)持续评估和改进材料和模型。对该项目的监督将由知情同意过程中的国家公认专家组成的指导委员会进行。信息开发和交付的方法将遵循以下原则 调整FDA的质量体系法规(QSR)流程，以确保用户需求评估、产品设计和开发以及验证和确认流程产生满足最终用户需求和预期用途的教育产品。威斯康星州人类研究保护网络包括目前存在的三个嵌入式信息交换网络：威斯康星州IRB协调员网络、中西部伦理 委员会网络，以及威斯康星州患者安全研究所的成员机构。评估方法可以包括用户焦点小组、调查、在学习材料中完成特定内容的测验以及其他机制。这个项目的总体目标，与之前资助的基于网络的计划相结合，以指导 编写知情同意文件，是为了改进获得知情同意的过程，这是涉及人类参与者的研究的一项基本伦理原则。

With support from the NIH Human Subjects Research Enhancement Program, the Medical College of Wisconsin has developed 15 web-based educational modules to guide investigators and research coordinators in the production of informed consent documents for human research participants. Well-prepared documents are a necessary condition to seeking truly-informed consent; however, they are not sufficient. Also required is establishment of a communicative process with potential research participants that is clear, complete and effective. This process includes: (a) ensuring that individuals are competent to make informed decisions; (b) disclosing the risks and benefits of study participation, including potential effects on the health status of participants; and (c) verifying that the participants have comprehended the information and can make intelligent decisions about participation. This application proposes to develop web-based educational modules and video presentations that demonstrate effective and ineffective ways of eliciting informed consent from ethnically- and age-diverse populations of potential research participants who function at various levels of health literacy. The proposed project has 5 aims: (1) Identification of barriers to informed consent; (2) Development of web-based text materials and video models demonstrating ways to overcome these barriers; (3) Testing and evaluation of the materials and models; (4) Deployment of the Wisconsin Network for Human Research Protection for dissemination and application of the materials and models; and (5) Ongoing evaluation and improvement of the materials and models. Oversight of the project will be exercised by a steering committee of nationally-recognized experts in the informed consent process. The approach to information development and delivery will follow an adaptation of the FDA's Quality Systems Regulations (QSR) process to ensure that user need assessment, product design and development, and verification and validation processes yield an educational product that satisfies end-user needs and intended uses. The Wisconsin Network for Human Research Protection includes three embedded information-exchange networks currently in existence: the Wisconsin IRB coordinators network, the Midwest Ethics Committee Network, and the member institutions of the Wisconsin Patient Safety Institute. Evaluation methodologies may include user focus groups, surveys, completion of content-specific quizzes within learning materials, and other mechanisms. The overall goal of this project, when combined with the previously funded web-based program to guide preparation of informed consent documents, is to improve the process of eliciting knowledgeable informed consent, a fundamental ethical principle of research involving human participants.