The Human Subjects Protection Program at Purdue University has been going through substantial growth and transformation in the past two years. With the overarching goals--of enhancing the protection of human research subjects, strengthening oversight and management of human subjects research, facilitating collaboration and providing for the education and training of stakeholders--substantial effort and resources are needed. This project will """"""""jump start"""""""" our institutional effort and facilitate our collaboration with Indiana University Purdue University at Indianapolis (IUPUI)/Indiana University (IU) with the goal of individually and jointly improving our effectiveness in ensuring the protection of human research subjects. While Purdue is not home to a medical school, we have clinical health-related research occurring in Biomedical Engineering, Foods and Nutrition, Nursing, Pharmacy Practice, Veterinary Medicine, Audiology and other fields. Purdue and IUPUI have a long history of collaboration at an administrative level as evidenced by our ten-year Human Subjects in Research Cooperative Agreement; at a programmatic level with our combined M.D./Ph.D. degree in Medicine and Biomedical Engineering; and, at the level of investigators collaborating to bridge basic research to clinical trials (e.g. Purdue's NIH funded Botanical Center). The proposed project has two specific aims: 1) information technology infrastructure development and implementation of an on-line web-based protocol submission and review software package in a three-way collaboration with IUPUI (lead developer) and the University of Minnesota (UMN) based on a database system already in use at UMN; and, 2) collaboration with IUPUI in the development of educational materials and training for various stakeholders while improving dissemination and access to information about our Human Subjects Protection Program. As designed, this project will stimulate and advance collaboration among IUPUI/IU, Purdue, and UMN This three-way partnership where each party is contributing to the development of a larger product and sharing the results is a more efficient use of time and resources for all.
