Human Subject Protection Program

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Stanford University seeks to strengthen its oversight of human subjects research and enhance its protection of human subjects by making optimum use of information technology tools. Specifically, the Research Compliance Office will: 1) Develop infrastructure/technology for computer tracking of human subjects protocols, secure records retention, and electronic protocol submission; 2) Develop means to coordinate the activities of IRBs that allow for the approval of consent forms used in multiple institutions; and 3) Purchase equipment to facilitate IRB activities, such as teleconferencing and computer support. In order to achieve these goals, the Research Compliance Office will enhance the electronic protocol submission system funded by the first HSREP application, funded in September 2002. As with the previous proposal, the advisory team will also be called upon to test various components of the project before release and determine corresponding training needs. The Research Compliance equipment to be used for these enhancements will be maintained as part of the overall IT structure of the University. Stanford's Helpdesk resources and reporting tools will be available and will ensure that the newly acquired software is integrated into the regular information technology offerings.