This application is in response to NIH's invitation to apply for one-time funds for the improvement of the processes that insure the protection of human subjects in research. The responsibility for this compliance function resides in the Office of the Vice President for Research. The management of internal IRB functions has depended on a substantial level of administrative computerization for over 15 years, The objective of this project is to extend the computerization to the investigator community to enhance the review process of projects involving human subjects. While the administrative data system maintains project attributes, the current review of human subjects project applications is completely paper-based. Paper proposals and supporting documents are provided to the Compliance office which then duplicates the information to IRB members by paper. The data system stores and maintains records of summary actions and dates, but the supporting documents themselves, including amendments and adverse event reports are filed in paper format. In recognition of the fact that virtually all of the paper received by the Compliance Office has been in a computer compatible format during the preparation stages, we seek to eliminate the need for reduction of the materials to paper for both the review process itself and archiving. We have investigated and evaluated several alternatives that enable such elimination and propose to implement a system which will in a short time remove entirely the paper basis of the review of projects involving human subjects. We believe that such an initiative will improve both the efficiency and depth of the review and monitoring of projects involving human subjects.
