The George Washington University Medical Center (GWUMC) and the Children's National Medical Center (CNMC), which is geographically separate but serves as the Department of Pediatrics of GWUMC will strengthen oversight of human subjects research at both institutions. A full time Research Compliance Educator (RCE) will be employed to coordinate and provide increased training for the investigators, staff and IRB members to ensure greater patient protections, promote patient's rights and understanding of the research they are part of, and train investigative teams in the ethical and scientific aspects of human subjects research. Educational initiatives will include (1) Protection of Human Subjects, (2) Institutional Review Board Policies and Procedures, (3) Use of the new on-line Biomedical Research and Information Network (BRAIN) for creating, routing, reviewing, approving and archiving human subject protocols, and for handling the submission, review and processing of adverse events, renewals, closures and suspensions, (4) Review of the effectiveness of educational programs and the development of new programs. Telecommunication equipment, which is available at GWUMC and CNMC, will be used to provide simultaneous educational programs at both institutions. Both institutions have agreed to continue the program after the completion of the grant award.
