Eliciting Truly Informed Consent

在NIH人类受试者研究增强计划的支持下，威斯康星州医学院开发了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书。准备充分的文件是寻求真正知情同意的必要条件;然而，它们还不够。还需要建立一个沟通 与潜在的研究参与者的过程是明确的，完整的和有效的。这一过程包括：（a）确保个人有能力做出知情决定;（B）披露参与研究的风险和益处，包括对参与者健康状况的潜在影响;以及（c）验证参与者已理解信息，并能够就参与做出明智的决定。此应用程序建议开发基于Web的 教育模块和视频演示，展示了从不同种族和年龄的潜在研究参与者中获得知情同意的有效和无效方法，这些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 材料和模型;（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）不断评估和改进材料和模型。项目的监督将由知情同意程序方面的国家公认专家组成的指导委员会进行。信息开发和提供的方法将遵循 对FDA质量体系法规（QSR）过程进行调整，以确保用户需求评估、产品设计和开发以及验证和确认过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， 委员会网络和威斯康星州患者安全研究所的成员机构。评价方法可包括用户焦点小组、调查、完成学习材料中的特定内容测验以及其他机制。这个项目的总体目标，当与以前资助的基于网络的程序相结合，以指导 知情同意文件的编写是为了改进征求知情同意的过程，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.