Research Enhancements and Administration Project

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The broad objective of this project is to enhance the protection of human research subjects by maximizing the institutional capacity for the education and training of individuals who are involved in human subject research at the University of Pittsburgh, Magee-Womens Hospital and regional institutions. The specific aims of the project are: 1) to develop a multimedia community outreach and participant education campaign, 2) to develop a model interactive seminar on human research ethics for investigators, coordinators and students, and 3) to establish a clinical research resource center. This collaborative effort involving the University of Pittsburgh and Magee-Womens Hospital builds upon existing human subject protection initiatives at each institution. The project targets members of the local research community including, but not limited to, institutional review board (IRB) members, investigators, administrators, research staff, students and potential research participants. In Specific Aim 1, a multidisciplinary team of expert faculty and staff will develop a multimedia educational campaign targeting local communities and research participants. The material will be designed to provide a basic understanding of the clinical research process, the value of clinical research, and what to expect as a research participant. Emphasis will be given to issues such as risks and benefits, participant rights, confidentiality and informed consent. In Specific Aim 2, a three-session, 6-hour interactive seminar on human research ethics will be developed. The seminar will cover core ethical values and include interactive sessions wherein participants participate in a mock IRB meeting and role play conversations in an informed consent process. In Specific Aim 3, a clinical research resource center will be created under the auspices of the University of Pittsburgh Office of Clinical Research's Education Program. This center will serve as a centralized, coordinated repository of education and training materials related to the conduct of clinical research. Written, audiovisual and computer resources will be housed in this center. Copies of community outreach and participant education material will be available to other institutions on request. The ethics seminar and resource center will be accessible to faculty, staff and students from the University of Pittsburgh and Ma_ee-Womens Hospital, as well as individuals from outside institutions.