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.
