We propose to strengthen and enhance the educational component of our human subjects protection program by l) developing learner-centered training modules on a wide range of topics, at varying levels of depth; 2) integrating these training modules into existing institutional training and education activities; and 3) assessing the effectiveness of the training modules. We have made significant advances in tracking and monitoring protocol activities and adverse events. It is this improvement in our ability to see what is happening that has pointed to a greater need for education. Invariably, the root cause of problems of compliance stem from a lack of understanding or misinformation on the part of those engaged in research activities. The following examples illustrate the variety of learning experiences these modules will present: ? Background reading materials and a directed case study introducing basic human subject protection concepts for inclusion in an introductory research methods course in which medical students will be expected to carry out a research project. ? Video and role-playing activities designed to introduce clinical coordinators to a variety of situations that may be encountered obtaining informed consent. ? An on-line training and list of references for faculty researchers designed to present issues and alternatives form consenting individuals with questionable capacity to consent. These modules will be incorporated into current training programs (existing seminar series, courses, and so on). By offering education that is learner-centered and integrated into a pre-existing training program we will overcome negative perceptions such as, """"""""this doesn't apply to me,"""""""" or, """"""""I don't have enough time,"""""""" which may hinder learning. Trainers currently working in these settings will participate in the development and delivery of the modules. Increased involvement of trainers outside of the IRB administrative office will facilitate the development of an institutional culture of concern and respect for research participants. In order to assess the effectiveness of this approach we will collect information about which modules project personnel have completed and track this information in our compliance-monitoring database. We will then correlate the end result of the monitoring visit with the training undergone by the research staff.
