SCCISARS 2: An e-Solution to Protect Human Subjects

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Specific Aims: The University of Southern California (USC) and Childrens Hospital Los Angeles (CHLA) are collaborating on electronic software to enhance the systems for the protection of human research subjects, the University of Southern California and Childrens Hospital Los Angeles IRB Submission and Review System, (SCCISARS). Webridge Compliance Extranet was selected to provide the electronic automation of the processes of protocol preparation, IRB submissionand review, continuing review, and archival. This customized Phase I version acquired with the funding from OD-02-003 provides no direct educational support. The aims of this proposal are to: (1) Substantially enhance SCCISARS to educate investigators, research staff, IRB members and IRB staff using real-time guidance about federal, State and institutional requirements for conducting research with human subjects. This will include substantial educational components directly associated with the application submission and review process. (2) Provide resources for training and implementation of SCCISARS. (3) Provide resources for electronic review of projects at IRB Meetings. (4) Develop a module to assist investigators with writing informed consent documents. (5) Collaborate with two additional institutions sharing the IRB submission and review system with the County of Los Angeles Department of Health Services Office of Public Health and AIDS Project Los Angeles. Research Design and Methods: SCCISARS is a WEB-based application where investigators and staff prepare research proposals, attach necessary documents, and submit for review. Projects are provided to IRB staff, reviewers and IRB members using the WEB-based interface. Reviewers and committee findings; correspondence to and from the investigator; continuing review activities; and adverse event reporting occuring within the same WEB-based interface. To educate investigators, staff, and IRB members context-sensitive materials will be built directly into SCCISARS application and review forms. These components will provide direct informative guidance as well as contextual links to relevant sections of the HHS and FDA Regulations; ethical guidance documents including the Belmont Report, Nuremberg Code and Declaration of Helsinki; OHRP and FDA guidance documents; selected references and reprints; and to internal policies and procedures. The implementation strategy for the introduction of and user training on a newly developed computerized system offers web-based training, quick-glance guidesheets, and identification and training of "Super Users" who would be available as resources to their home departments and work groups. Equipment including laptop computers and networking will be acquired for each IRB to permit online review of projects. In collaboration with Webridge, an informed consent writing module will be developed.