This proposal describes a plan to develop, evaluate, distribute and maintain a web-based, interactive, IRB protocol application development and submission software program. The immediate outcome is an electronically guided program to assist the principal investigator in developing and submitting a complete research protocol. The proposed software will guide the investigator through the protocol development process with programming that incorporates ethical principles/practices, regulatory reference, guidance and institutional standards. It is expected that the resulting human subjects protocol will adequately describe methodology and procedures that reflect an ethically considerate and sound research design conducive to substantive review by the IRB. Receiving current information during the protocol development process will assist the investigator in developing an awareness of how ethical principles relate to his/her specific research. Administratively, the automated system will eventually replace the present system, which combines both electronic and manual procedures. Although the current manual system is functional, significant clerical and administrative time is dedicated to procedures that could be automated and result in improved accuracy and efficiency of the IRB review process. Time saved through automated administrative functions will be redirected to enhance programs intended to promote protection of research subjects (e.g., education/training, proactive site visits, etc.) By automating the protocol development and submission process, all stakeholders (e.g., research participants, investigators, IRB, and the institution) will ultimately benefit from the increased quality, performance and efficiency of SDSU's human subject's program. The proposed software will incorporate an existing IRB database and access data used to verify compliance with human subjects education requirements. Specific fields within the database will be accessible to other academic and administrative units that require verification of human subjects approval. Once developed and tested, the electronic program will be disseminated to the other 22 California State University campuses and made available to institutions nationally to support their human subjects program operations.
