Evidence-Based Improvement in the Consenting Process

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The goal of this proposed research is to enhance the protection of human subjects through evidence-based improvement of the informed consent process. The research team proposes a three-step model to achieve this goal. First, the research team will design and apply a questionnaire to assess participants' level of knowledge pertinent to clinical research studies. Subjects will be selected from ongoing studies and will be asked to complete a computer-aided questionnaire immediately following the review and signing of their consent form. Second, the information obtained will be presented to the investigators and their staff. It is the specific aim of this project to enhance the clarity of informed consent statements and to improve associated informed consent processes. This will be achieved by showing weaknesses in the standard process and by suggesting potential improvements for an enhanced consent process. Finally, based on the findings of the previous two steps, the research team will develop the content of educational materials for investigators and research staff, as well as patients. Education will include seminars to disseminate and discuss the results of the assessment study, targeted talks for research staff and research administrators, and the development of a patient newsletter and a short research volunteer video. It is anticipated that much of the patient education will include information dissemination on the potential risks and benefits; and patients' rights and responsibilities in clinical studies. This proposed project is build upon the hypothesis that gathering this information and educating research teams will improve the protection and ethical treatment of human subjects. We are committed to continue educational activities beyond the project period of this request for funding.