Improving Informed Consent in Clinical Research

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The protection of research subjects is at the core of successful biomedical research, and the informed consent document serves as the foundation upon which this protection rests. Yet there is a lack of acceptable understanding among clinical investigators of the informed consent process. It has been demonstrated that interactive, multi-media CD-based programs can be highly effective tools in clinical research. We will systematically develop and implement a CD-based multi-media Informed Consent program for investigators. The specific aims for the project are: 1. To develop and implement, among a group of clinical research investigators and their institutions, a multi-media program focused on the principles of informed consent. 2. To demonstrate that multi-media informed consent protocols can be effectively administered by the Human Subjects Protection Offices (HSPO) of the participating institutions. The program will be fully automatic, run for approximately 30 minutes and use a split-screen format that we have successfully used for previous clinical education CDs. This allows for video presentation on one side and coverage and reinforcement of the major points via a sequential text development on the other side. A physician host will provide the overview, introduce scenarios of increasing complexity and then provide brief comment / interpretation after each scenario. The four scenarios will be based on clinic settings with a clinical investigator and a potential study subject. The four scenarios will depict important elements related to clinical investigations that are Minimal-Risk, Low-Risk, Moderate-Risk and High Risk. All investigators who submit research protocols to the HSPO of each institution listed below during the implementation period will be required to utilize this educational program. The program will contain embedded questions that the viewer must answer to continue. The viewer's responses will be captured electronically and provide a dataset for analysis of the program. The appropriate multi-disciplinary team has been assembled to undertake this project.