Stanford University seeks to strengthen its oversight of human subjects research and enhance its protection of human research subjects by focusing on infrastructure/technology development, educational initiatives, and process and system integration. Specifically, the Research Compliance Office will: 1) build an electronic protocol submission, review, tracking, and routing system that will enable investigators, IRB members, and research administrators to process protocol applications online; 2) expand the human subjects education program by enhancing the Online Human Subjects Tutorial, integrating the Human Subjects Tutorial Certification Database with the new electronic submittal system, and developing an educational program on Informed Consent, the cumulative effects of which will increase research subjects' knowledge and enhance IRB members', investigators', and study staff's abilities to protect the rights and welfare of human subjects; and 3) use the NCQA accreditation standards and develop assessment tools that will allow an evaluation of Stanford's level and quality of compliance. In order to achieve these goals, the Research Compliance Office will evaluate, adapt, and deploy the software package - Baylor Research and Assurances Information Network (BRAIN) - implemented at Baylor Medical College. A project evaluation team and an advisory team will provide technical guidance and identify opportunities for improvement. 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 this project will be maintained as part of the overall IT structure of the Univesity. 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. New educational modules, to be delivered over a variety of media, will be designed. Matrices to measure the level of compliance with the NCQA standards will be developed. Consultants will be brought in as needed.
